Can you expand more on what "advisory rather than mandatory" would look like? Companies would be allowed to seek an FDA seal of approval, but wouldn't have to?
Basically, yes. Obviously I have not given it much thought, so I can’t fill it in. But that is my go-to attitude for reform, don’t make people who are happy already into unwilling experimental subjects, just let the willing subjects give it a try.
I haven't put too much thought into it either, but the view I have seen most often is not 'abolish the FDA'. Rather, it is to make it opt-out. Which I think is DavesNotHere's idea as well.
Require a big red sticker that says 'NOT FDA APPROVED' on any drug choosing to opt out of FDA guidelines. Companies are still liable for torts, as always. One way to discharge your duty is to demonstrate that your drug was FDA-approved. But even currently, that is not sufficient, though it is necessary. Under this proposal, it would be neither necessary nor sufficient.
In the immediate aftermath, things don't look too different. However, an entrepreneur realizes that there is a an opportunity to be had-- start a company that gives a 'gold-seal' of approval that, like the FDA, offers a presumptive case against negligence. Essentially, have a competing FDA.
There is the issue of judgment proof start-ups looking to cut corners, but mandating liability insurance would solve this. The insurance company, not wanting to be on the hook for millions of dollars in damages, would require the company to follow certain regulations. But only insofar as the regulation is efficient. As an aside, this is a libertarian response to most of these kinds of regulations (echoed by Dave)-- if it really is efficient, just mandate insurance, and the insurance company will require the regulations.
There is more to be said, obviously. But I think this kind of proposal makes a lot more sense than the 'abolish the FDA' proposal, for many of the reasons you discussed. Functionally, it is pretty much just a dressed-up version of your legalize synthetics as supplements line of thinking.
Right. Also, something that would make it harder to find insurance companies willing to take on potential liabilities. Of course, Feral might counter with 'what if the insurance company hides their assets and goes bankrupt'. Now, my understanding is that there is federal/state regulation to prevent that sort of thing, but since we are making the libertarian case that would seem like a cop out answer.
A better reply might be that if people are worried about such an issue, then it would be in the interest of an entrepreneurial company (perhaps the same as the FDA competitor, perhaps different) to offer a second seal of approval; namely, that the company has adequate insurance with a company that can pay its debts.
So, one seal vouches for the quality of the product. Another vouches that the company has insurance willing to cover its ass. If consumers value the assurance that a company who will bear the cost of liabilities (the insurance agency) has agreed to indemnify the company, they will opt for that product. Others may take the risk, and opt for the 'insurance-free' bargain.
The likely counterargument is that consumers do not have enough knowledge and sophistication to meaningfully understand the distinction between a drug that carries a seal of insurance and one that doesn't. But you can carry on arguing forever here (eg. grocery stores/pharmacies might, and might not want to sell risky drugs to consumers.. etc.).
Again, not an expert in this-- just my initial thoughts. Happy for better replies/counters.
that's something I don't get about law because if I buy chemical X and it poisons me, why is that the seller's problem? Or if you want to have a default deal that's fine, but why should I not be allowed to buy X with the only promise given that it is X.
If I understand your comment correctly-- you are asking why the presumption shouldn't be 'buyer beware'. I think the reply is that given that currently, most consumers operate on the assumption that a drug is FDA-approved, it would be negligent (perhaps fraudulent) for a company to sell a drug, without explicitly noting that they are not in FDA compliance.
If what you are asking is why it is the seller's problem that they sold something that poisoned you (and not your own problem)-- the answer to that encompasses tort law. There are separate justifications for why we have tort law, that libertarians may or may not agree with-- but that would be a longer explanation that I feel unqualified to offer.
So from what I've seen, the whole problem with this line of thinking is enshittification.
Companies have repeatedly shown that they are willing to build up a good reputation in phase 1, and then take a treacherous turn in phase 2 to cash in that reputation for money at the expense of the customers that got used to trusting them.
UL and UL certification are the exact model I think of w/r/t changing the FDA.
I'll expand down below, but the ideal would be to allow the FDA to carry out its mandate -- generally checking that most things US citizens might *ingest* aren't useless, tainted, or wildly dangerous -- without having de facto total control over the drug industry and huge amounts of government healthcare spending.
(Government healthcare spending being actually ALL healthcare spending, at this point, another thing that Must Change)
How much does it cost to comply with UL certification? What percentage of devices submitted for certification end up being denied?
One of the problems with FDA drug trials is that (apparently) they end up costing in the hundreds of millions of dollars to run, with many of them not successful.
I suspect that UL certification tends to be less of a crap shoot.
This is because we understand electrical engineering far more deeply and reliably than we do pharmacology. It's not a feature of UL vs FDA, it's a feature of their respective domains. When a drug fails its FDA drug trial, it's usually because it's useless.
Speaking honestly, we could probably keep the majority of the apparatus that confirms that some food or drug won't actively kill people. In the pharma world, that's the goal of Phase 0/1 clinical trials, which are notably inexpensive relative to phase 2 (roughly speaking: prove it could work) and phase 3 (prove it works a lot). The result would be a market for drugs that won't hurt you, might not do anything at all for your joint pain, but it only costs you $7 to find out.
Since I've got fatal cancer, I'm particularly interested in that area, and a lot of the emails and comments I've seen have two major complaint components: 1. the FDA is too slow and 2. the FDA is too random. The slowness part entails submitting study plans or data, which the FDA takes months and months to process even though statistical analyses can be done almost immediately via Excel or SciPy or R or whatever.
The randomness part is the failure for the FDA to set and keep to clear guidelines about what constitutes a reasonable trial, what success looks like, and what failure looks like. This raises the cost of compliance and, again, can waste months or years of time. Even in a low-interest-rate environment, that's terrible. In a high-interest-rate one, it's even worse. Meanwhile, people die for lack of treatments.
We saw both pathologies at work during the pandemic.
If a federal drug regulator acts too fast, some people may be hurt or die from bad treatments. But if one acts too slow, some people may be hurt or die from lack of good treatments. There's a scale between them, and right now the FDA is way too far towards the second, and it needs to move towards the first. Governments and government agencies, though, very rarely give up power once they acquire it.
Imagine trying to run a business, but first you have to run a gauntlet of opaque government agencies that take months to years to reply to submissions. That situation would kill many startups and businesses. I realize I'm describing San Francisco, but most startups are Delaware C Corps, which avoids many of SF's pathologies in ways retail can't. In most of the U.S., it only takes ~4.2 days to start a business: https://tradingeconomics.com/united-states/time-required-to-start-a-business-days-wb-data.html.
In thinking about this more, I think one problem is that the FDA does so many different things that are somewhat related but not really the same—like regulating ADHD meds versus oncology treatments—that it's hard to fully accept "FDA good" or "FDA bad." It's too different. Maybe breaking the agency into smaller pieces would make sense.
Most likely, breaking the agency into several pieces results in a world where you need to get the approval of several different agencies to do anything, rather than just one.
I think as a general rule, a major government reform I would like would be to restructure so that you never need permission from more than one body to do something (granted, this is hard to implement)
Yeah, probably. It would seem to make sense to break off, say, the part responsible for "visit the plants and make sure they're not putting melamine in the baby formula" and let them just do that kind of job.
But then you'd probably end up with a whole new agency, with accompanying bureaucracy, for "Going Round To Chemical and Pharma Plants To Make Sure They're Not Putting Shit In Stuff", plus an agency turf war over does this include food production plants or not under their aegis, or shove off new agency this is our bailiwick and always has been?
Yes, rather like Homeland Security. You had a security problem, people fought over whos fault it was, the result was adding another bureaucracy on top of all the existing ones.
I don't think there is one simple answer, or any answer that will satisfy everybody.
Look at the Covid vaccines: opinions went from "skip all the red tape paperwork, this is a crisis and we need them now with minimal approval roadblocks in the way!" and then afterwards "these vaccines are killing healthy young adults, why were they rushed out, where were the approval roadblocks?"
A lot of the problem is reacting to crises. Food and Drug acts were passed in many countries because manufacturers were putting any old shit into products and poisoning the public. As "this drug caused A, B, or C serious side effects" cases came along, and went to court, so the red tape and regulation got cranked up every time.
Now there is (and I think we should err on the side of caution) the cautious approach about "let's dot every i and cross every t" before approving new drugs. But that holds up promising new treatments. But how can you tell "promising in the early stages but useless when given as a medication" from "promising in the early stages, effective when given as a medication" without large scale testing? And that means delays.
I don't know. There probably is a lot of room for improvement, but what part can you safely prune away and what part is going to be load-bearing?
That may be, but we really did see a divergence (i.e. I saw it between members of my family) over the vaccines between person A saying "the FDA is killing people with red tape, how could they possibly be taking so long to approve these vaccines" and person B saying "this is the fastest FDA vaccine approval ever? In an environment where the person A mindset is publicly pressuring them to approve it even faster? No WAY they're not cutting corners; we can't know if these are safe"
Which is to say there are always tradeoffs and the FDA legitimately could have reduced vaccine hesitancy by taking longer to approve the shots
> FDA legitimately could have reduced vaccine hesitancy by taking longer to approve the shots
I don't think that would have helped. Most of the public didn't have the faintest idea how long it takes to produce a new vaccine -- whether it's 6 weeks, 6 months, or 6 years --, and what the different methods of producing one are. The problem was that the media kept yapping about how fast it had been produced, and the novelty of the method -- well, they had to write something to capture eyeballs, and of course for some people it was *good* news that some wonderfully smart people had used this novel method and produced an effective vaccine so fast. But that info was seized on by people who were already angry and mistrustful because of how covid had been handled so far, accurately perceiving that the government was herding us rather than informing us of the best direction to wallk in. And then of course social media amplified the fear, anger and mistrust.
I've asked a few people about what they thought about this. I think many people were nervous about the vaccines because of how quickly they'd been produced - and arrived at this idea independently of press coverage, and would probably have found it eerie if nobody acknowledged that they were brought to market much more quickly than a lot of other vaccines. My sense is that this is because most people don't realize how straightforward vaccines are (the body does the heavy lifting, really, all you need to do is present an antigen) and so they assume it must be a long and complex process fraught with difficulty (perhaps exacerbated by how much people worship the pioneers of immunization like Pasteur and whoever and act like they're geniuses of unimaginable and superhuman magnitude).
People don't realize that one-in-ten-thousand safety risks don't really happen with vaccines (not to mention the obvious safety risks of not getting a covid shot, which many people don't really think about, because of some sort of cognitive bias I don't really understand), regardless of how quickly they're brought to market, but I think, in the absence of any information either way, people would assume that one-in-ten-thousand safety risks are actually a common pitfall, just because of how difficult I think people assume vaccine development is. (Yes, I know about vaccine-mediated enhancement, but that doesn't really have any bearing on this because it was conclusively rules out by clinical trials.)
(Another reason people might assume it's fraught is that development of small-molecule pharmaceuticals is definitely very fraught, and I think a lot of people don't understand the huge difference between vaccines and small-molecule drugs.)
>many people were nervous about the vaccines because of how quickly they'd been produced - and arrived at this idea independently of press coverage, and would probably have found it eerie if nobody acknowledged that they were brought to market much more quickly than a lot of other vaccines.
But it's not as though new vaccines are brought to market often, right?, which would give people a sense of what typical pace for developing them is. I think the only vaccine development process most people are aware of is the flu vaccine, which is different every year. Actually, of course, pharmaceutical companies don't build a whole new flu vax in a whole new way every year -- they just tweak the formula. But how much of the public knows that?
And in any case: People you know are saying they would have been worried without the media's yammering about the novel technique and rapid development of the covid vax? How can they know that? It was utterly impossible not to be exposed to a shit-ton of info, speculation and opinion about mRNA vaxes and the speed of development, unless one was a hermit. How can any of us know how we would have felt about various developments in the covid saga if we had had no input from the news media and the goddam social media?
The answer, of course, is "most vaccines take years to approve because raising money for the trials takes ages; the trials themselves are pretty quick. This is what it looks like when we don't dawdle."
But if you don't trust it when it's first approved, you can wait half a year more until millions of less skeptical people have got it (perhaps until it has full, not emergency, approval), and there is much more data than there would be from half a year more of clinical trials. I don't have high confidence that this actually convinced many people, but I also don't think a slower but still fast by ordinary standards approval would have convinced many people.
But of course by the time half a year had passed Twitter and no doubt other sites were full of stories about people developing grotesque symptoms and severe illnesses and flat-out dropping dead right after receiving the vax. I was on medical Twitter all through covid, following epidemiologists, immunologists, researchers, etc. and saw literally hundreds of these stories in comments made in response to posts about research by smart, honest professionals who were working their asses off to understand covid better. Over time the tone of stories changed from alarmed to snarky: "Sure, asshole researcher, promote the vax. We've figured out what's really going on."
Sure, but if you wait half a year longer to approve it, those scaremongering stories would have still appeared by the time half the population has got it. Except perhaps if they manufacture enough doses for everyone before approving it, and then they gave out the shots very quickly, before anyone has a chance to put out those stories. And doing that would give up a genuine safety benefit of having data from millions of people by the time less vulnerable people who benefited less from the vaccine got it, and it would generate another form of skepticism in the form of "why do they insist we take it immediately?".
And then there is that the benefit of less vaccine skepticism would have been far outweighed by the harm of later access for less skeptical people. And that the former benefit would have primarily accrued to people making poor decisions, while the latter harm would have accrued to people making good decisions.
There's no rigorous psychological evidence that reduces vaccine hesitancy, and instead when the FDA engaged in amateur psych to pause the J&J they INCREASED hesitancy.
Different people have different levels of risk tolerance and even different understandings of what risk looks like. While I think some of the anti-vax opinions related to COVID were outright mistakes rather than just value disagreements, I think a good solution would include a system that allows people to take on risk if they do so with informed consent. The devil is in the details. But in theory there's room enough in this world for the ravers and the anti-drug folk and everything in between.
More narrowly: If a drug is approved in another OECD country it should be available with warnings and outside of a standard of care in the US. If people want to pay for it, they should be able to purchase it. Or someone should make an argument that the approval process for that country is significantly worse than the one for the US.
In the current system, the FDA micromanages product testing conducted by other entities - usually the manufacturer. If the manufacturer doesn't comply with extremely detailed testing parameters that are only conveyed in secret closed-door meetings then there are delays and people are forbidden to choose potentially life-saving medicines. There's no independent peer review mechanism for the question of whether the FDA's demands are reasonable - and that's important because, from my perspective, the FDA appears to frequently be falling into the type of dangerous sit-tight-and-assess behavior parodied in Don't Look Up.
It might help to drill down on a specific example. Based on published data, I would bet that a Covid vaccine called SKYCovione could offer me broader, more durable protection than first-generation Covid vaccines. Here's more detail:
SKYCovione was approved in South Korea a year and a half ago, but FDA continues to judge the overseas data as inadequate to support approval. I can read the overseas data for myself and I think the FDA is wrong - to the point that I've literally considered flying to South Korea as a refugee vaccine tourist. FDA vaccine committees seem to me to be trapped in a bureaucratic cover-your-ass funhouse on this question. The myopia could realistically have something to do with the fact that vaccine manufacturers are paying their salaries:
And the decision-making process could be distorted by the fact that manufacturers are allowed to offer FDA employees top 0.1% salaries on the other side of the revolving door:
The fundamental problem is that there are no checks and balances in the current system - FDA veto authority is inscrutable, unaccountable, and unbreachable.
In a separate comment I sandbox the idea that creation of competitive independent testing agencies could, in the longer run, make it possible to abolish the FDA. Independent testing works fine for dangerous products like cars - so why not for medicine? Figuring out how best to organize independent testing infrastructure is an interesting debate. What I don't understand is why any American on either side of the aisle would think that having a government agency with unchecked veto authority is a great idea. It's obviously an abomination. We should abolish the FDA's unchecked veto authority as soon as possible.
Your piece points out a number of reasons why the libertarian approach seems unworkable, and notes that if there is a way to make it work, it hasn't been discovered yet. I read that as your not supporting abolition until the solution is discovered, which is the kind of position that (if stated explicitly) tends to get a lot of rude responses.
I'm not unsympathetic to libertarian policy options but LRGs are definitely a common type of RG, though maybe not on your substack since the things you write wouldn't normally wind them up.
Not a direct response, but do you associate "RG" with "low-information high-temperature responder"? I'm not sure this is actually true (and kinda dislike the stereotype, mostly because I find it easier to respond to things than proactively write them).
There's definitely a thing where if you look at a random insightful post most replies will be low-quality, but that's just because most content is low-quality and it being in response to an insightful post doesn't counteract that much. I don't think replies are inherently lower-quality in general though (though there is a good argument that it's harder to filter them for insightful ones).
This is me. My ratio of replies to posts is definitely greater than 10. I strive to reply in a manner that is interesting or useful so do find the pejorative use of RG a little unfortunate. Part of it is status I guess and part of it is simply that a lot of replies are genuinely low to no value. Maybe we need a new term for us RGs to aspire to: the high value reply guy (HVRG). Hehe.
I think you seem to be failing to grasp that Scott does not want you to cavalierly dismiss people on the other side of the argument as “reply guys,” which is rather anti-intellectual and unnecessarily inflammatory.
I hope I wasn't being cavalier. But Scott's argument felt like something that a sensible progressive could have written in peak 2020: "Here are a few issues we need to resolve before we move forward on abolishing the police", followed by a laundry list of reasons the whole approach is misconceived.
In other words, it seemed like a reasonable argument that was carefully phrased to reach people whose views on a given issue aren't entirely reasonable, without triggering a dismissive "reply guy" reaction from them.
There's a need for that style of argument. If I'd been assigned to write a piece on this topic it would have been much shorter than Scott's and the tone would have been "what a dumb idea", which wouldn't have been helpful in changing anyone's minds. Scott is more libertarian than I am and that (plus his medical degree) gives him credibility in explaining to FDA abolitionists that this is, in fact, not a well-thought-out proposal.
I thought he managed that in a very tactful way and by pointing out that this seemed to be what he was trying to do, it may have looked as if I was trying to spoil his rhetorical strategy. But I hadn't meant to imply that people with ill-considered opinions are stupid, only that it helps to address them with respect.
I think rip-off-the-bandaid solutions will produce chaos, which the well-off and well-educated will be able to navigate with decent success. Everyone else will suffer greatly.
FWIW, I don't think anyone would be able to navigate that successfully...or at least not safely. Scot points out a number of things that would need to be addressed. If they weren't...I doubt that even caffeine tablets would be safe. And he left out a bunch of things that currently really need more effective regulation. (Meat packing plants are currently a lot better than they once were, but they're hardly very sanitary.) The problem is, with the current setup, being sanitary, safe, etc. isn't sufficient. You also need inspection seal which can be both expensive, and require a bunch of stuff that's irrelevant for what you're doing.
I don't see any good solution, only modest improvements. And a lot of the improvements are disallowed by bureaucratic regulations which either don't reasonably apply (in some situations), or were always for the purpose of empire building. But there's no clear way to disentangle the necessary from the extraneous.
Well, the FDA isn't the only drug-regulating agency on the planet. In principle, educated people could just choose to rely on e.g. European regulators for judgments of safety and efficacy, and Canadian and Mexican authorities for quality/contamination control.
(This is more-or-less what a lot of smaller countries do as a matter of policy.)
It's still a really terrible idea, but it's not necessarily catastrophic for *everyone.*
Would be nice to have some high quality, RCTs looking at the aggregate effects of healthcare utilisation accross various margins, expensive but could potentially save a lot of resources. Also would be nice if politically more emphasis was on the more robust correlates of health such as diet, exercise, pollution, stress etc.
Most abolish the FDA types are proposing a grand remaking of the relationship between government and citizens. Courts, insurance, medical licensing and welfare would all be changed so much it doesn’t make sense to speculate on the effects of FDA disbandment on present institutions.
This is very similar to what I’ve been told about abolishing police or prisons: we’re talking about totally transforming society so there’s no point trying to figure out how it would work.
I really don't understand who finds this argument pursuasive - surely the bigger the change, the more important it is to think it through first!
I don't think "don't worry, this change will be radical so don't worry about the details of it" is pursuasive in any practical context - If I was on a plane to New York and the pilot told me our flight was being redirected to Boston, I might have a few questions but I'm sure it would work out in the end, but if I was told our flight was being redirected to Havanna I would have a lot more questions about the practical implications of our change of course.
Yes, I agree, and it also seems like an acknowledgment by the speaker that they are not talking about changes they ever expect to happen. It’s Land of Cockaigne stuff.
This way of thinking comes from Hegelians, who are the cause of all America's present political woes. Hegel argued that there is a World Spirit guiding humanity on a path towards ultimate perfection. At each step on this path, the World Spirit chooses one nation to move humanity forward to the next level. If you are one of the Chosen People, all you must do is destroy your current society, and the World Spirit will see to it that the next, more-perfect iteration of human society springs up from the ashes.
This is stupid, and few if any people believe it consciously. Yet it is/was obviously assumed by Marxists, the early modern artists, the leftists of the 1960s, and many leftists today. I think most leftists today would justify this by saying that humanity is naturally kind and cooperative, and any instances of suffering are necessarily caused by evil people who have gotten into power. Destroy the system, and "the people" will be in power, and everyone knows the people are good.
You could also attribute this to Rousseau, who taught that the natural state of humanity is idyllic, and civilization is corrupting. It ultimately traces back to Plato, who taught that the world began with the perfect Forms, and that over time, things can only degrade, as copies of copies of copies, unless they are destroyed and remade in the image of the original Form by a philosopher who has insight into the Forms.
The first step toward wisdom in this matter was by Adam Smith in 1776, the first person AFAIK who realized that the question that needed an answer is not why some people are poor and miserable, but why some people are not.
I don't think that's true. Many people who want to abolish the FDA may also want to abolish other government agencies, but their support for abolishing the FDA is in no way contingent on other reforms. I think Scott is overselling necessary changes. You could easily abolish the FDA and everything would continue exactly as before except insurers would have to find a new basis for what new treatments to cover (and doctors for what new treatments to prescribe). Anyway many proposals are for FDA approval to be optional or to revert to safety review only (not effectiveness).
One, libertarians are just as much a monolithic creed as are Substackers, YouTubers or TikTokkers. Two, agreed that the FDA is one of the wonders of the modern world, barely a whisker below the NHS. They admitted once that they'd made a mistake but turns out they were wrong.
Fine-tuning a steampunk balloon wouldn't have got it to the moon. But Americans love one-hundred thousand page legislative documents. They provide work not only for the drafters but for millions of bureaucrats, and cavernous warehouses for pork. Yes I am aware of Chesterton's Fence. Ask why the fence is there before you tear it down. Finland for example probably has a platoon of one or possibly two thousand accomplishing the same as or better than the armies of the FDA. Elon Musk has built a fine if fugly truck by throwing away everything that doesn't absolutely essentially have to be there. It outperforms Porsches and Lamborghinis.
Elon built a truck that people who drive trucks are unlikely to buy, because it misses the point of a truck. It's not easy to repair or modify, it is likely to struggle in rural areas, it has no way to fit plows, dump bodies or PTO driven accessories. Etc etc.
The NHS saved my partner's life, so I have a somewhat rosier view of it (and indeed object to it being not only compared to the FDA, but compared *unfavourably*).
I mean, probably any first-world healthcare system would have been able to do the same (though some would have tried to stick us with an enormous bill for several days of inpatient care). But the NHS was the one that actually did it.
FWIW, and as someone who is not a health professional, I think the FDA is marvelous. It's got a number of places where it needs to be improved, but it's an organization managed by teams of humans, and it's still trying to do it's job more than increase its power. And the job that it's trying to do is an extremely important one.
I don't think legal fentanyl has been that much of a problem. Matt Yglesias has a point that the scientific discovery of fentanyl wreaked disaster once drug-dealers realized they could make their products more potent by cutting it with cheap fentanyl, but that's a different topic.
The trailer emphasizes money. They were able to get a lot of money because insurance companies were paying for this treatment. If this were out of pocket, there would be no movie. The Purdue problem was that the standard (which was probably not explicit and certainly wasn't created just by the FDA) was that oxycodone was bad and anything new was good. This sounds like the same problem, but it was after Purdue! Was this about bribing FDA and DEA?
Surprised you haven't mentioned a common proposal: autoapprove anything the European Medicines Agency approves. This could replace, or be added to, current FDA approval processes. We can keep the FDA around for enforcement (e.g. factory inspections), or create a new body that only does this.
This would have instantly solved the great formula shortage of 2022. But I did get a bit of a high from smuggling in a dozen boxes of Canadian formula in the trunk without the CBP noticing.
(Fun fact: the "Canadian" formula was actually made in the USA. Apparently bilingual labels aren't FDA-approved.)
This would also have avoided the absolute scandal of millions of doses of AstraZeneca Covid vaccine sitting in warehouses for months while the FDA insisted on duplicating the trials that had already been done, but this time in America.
FDA ended up never approving AstraZeneca, right? I think they did end up shipping those doses to other countries that approved them, but it seems like such a shame that it was never approved here (and that Novavax approval was held up so long that most people never even heard it was approved).
Looks like the FDA approved it for travel purposes only: https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations#Oxford%E2%80%93AstraZeneca I'm glad to hear that those doses did eventually get used (and even more pleased to see that AZ is the most widely-administered vaccine worldwide: not surprising, since it used well-established tech and was designed to be manufactured cheaply and at enormous scale). But it's still infuriating that those doses weren't released earlier when they could have done much more good.
The AZ vaccine was not well-established tech. The only prior approved vector vaccine was an ebola vaccine with emergency approval in 2015 and full in 2019. The total number of vector vaccines administered before the AZ trial was probably 1/10 as many as in the trial.
Everyone agrees that vector vaccines are (for now) easier than nanolipids, but they aren't that easy. While Russia and China were able to make their own, they weren't able to produce enough to matter. So India, which produced most of the doses, probably really needed the help of AZ.
The small mystery is why the West didn't just print protein vaccines. A rogue German distributed 20k doses, so it probably would have been even easier. The answer about the West is probably corruption. The big mystery is why China and Russia didn't use 20th century technology, but went back to 19th century vaccines.
> The only prior approved vector vaccine was an ebola vaccine with emergency approval in 2015 and full in 2019.
Huh, OK. Wikipedia gives examples going back to 1972: I guess none of those were approved for use in humans?
> The small mystery is why the West didn't just print protein vaccines.
Looking at https://en.wikipedia.org/wiki/COVID-19_vaccine#List_of_authorized_vaccines, the first "subunit" vaccine to be approved (that's the same thing, right?) was China's Zifivax, in March 2021. I remember there being several protein subunit vaccines under development in 2020, so I guess either they didn't pan out or took longer to get to market for some reason?
> The answer about the West is probably corruption.
Could you expand on this?
> The big mystery is why China and Russia didn't use 20th century technology, but went back to 19th century vaccines.
I see both Chinese and Russian subunit vaccines on the list, but all debuting after their respective inactivated-virus vaccines.
I'm anti-world government because I don't want a single authority being able to restrict everyone's freedom. The FDA shouldn't exist, so multiplying the number of agencies sufficient to approve gets us closer to that ideal.
It's not one worldwide government. It's just saying that if the German government (or a small group of other trusted countries) approves a drug, American doctors should be allowed to prescribe it.
This isn't politically viable. If it happened, no clinical research would ever be done in the USA, which is probably hundreds of billions of dollars a year. Any industry that large will fight back politically, and they'll fight back hard.
I was not the one who made the claim that the just because an industry heavily relies on the presence of a regulatory infrastructure this necessarily implies the entire industry is "nothing more" than a rent-seeking apparatus.
I merely pointed out that there would be significant unintended consequences of attempting to shift approval reliance from US regulatory authorities onto OUS authorities - one of which being the alignment of lots of interest groups in keeping clinical research in the USA. As someone who works in clinical research (and had an FDA interaction this week, actually) I agree that the current system needs a LOT of work, but I've also seen a lot of what the rest of the world has to offer, and I agree with Scott's assessment that an attempt to cut out the FDA cold-turkey would be a disastrophe.
It’s rarely correct to say that *anything* is *only* something. Plenty of what the FDA does is good and proper. Most of it could probably be done better. Much of it could probably be done privately.
But yes, crony capitalism and regulatory capture is certainly a huge part of the current situation, and it would be foolish to assert otherwise.
ISTM that we were moving in that direction before Thalidomide happened. I think a lot of pharma companies would get behind a treaty for the EU and the US to "conditionally approve" any drug approved by the other. (Conditionally would mean it would be a lot easier to revoke approval if any problems surfaced...but until they did it could be treated as if approved.)
In the US, we have something called "breakthrough" designation, where the FDA will allow conditional approval for drugs based on surrogate endpoints (like improved lab values), while we wait for results of endpoints we really care about (like improved overall survival). Interestingly, the FDA has never rescinded approval for a drug that got conditional approval but failed to meet the later efficacy threshold. Indeed, some drug companies have failed to complete the follow-up studies and the FDA hasn't punished them by pulling the drugs until the studies are done. I imagine something similar would happen under any other conditional approval scheme.
"But if it worked somewhere else, won't it work in the US, too?" Probably? Vinay Prasad has done some great work on this. He talks about how many drug companies will do studies outside the US so they can shop around for comparator treatment regimens that have long since been abandoned in the US. It's easier to show your drug is better than the state of the art from 20 years ago, but not so much the state of the art today. Drug companies do a lot to game the system, so I would expect them to find new ways to game the system if we change it. Perhaps get the EU to conditionally approve anything approved in Australia. Then go from Australia to India, to Azerbaijan, etc.
I was intentional in my country selections (with the exception of the last one). The EU is the logical next market after the US for focusing clinical research, given market share. (China is probably larger, but ability to pay isn't as large. Japan is important, but EU is the focus after US for clinical development in the industry.)
Meanwhile, countries like Australia are trying to incentivize companies opening up clinical research in their country by offering some very steep discounts for doing studies there.
Then you have India, which had some pretty major scandals around 2015-2016 involving made-up/fraudulent data. Since then, Indian regulatory authorities have made major changes to increase confidence in Indian clinical research. Everyone wants a piece of this industry, given how much money is involved. The probability of a bad actor arising in a race to the bottom is not negligible. If US regulators stop caring where studies are done, a race to the bottom is inevitable.
> The probability of a bad actor arising in a race to the bottom is not negligible. If US regulators stop caring where studies are done, a race to the bottom is inevitable.
I've actually been making the same point a lot in these comments, against people who think the FDA should auto-approve drugs already approved by some other regulatory agency (either EMA, or any of the G7 nations' agencies seem to be popular choices). My objection is to the auto- part, for exactly the reasons you say, but surely there's room for compromise here - are European drug trials really sketchier than American ones? If anything I'd have thought the opposite. I'm thinking some kind of reciprocal fast-track approval process, subject to the agencies demonstrating comparable standards to each other and the receiving agency checking over the trial results.
I think there's absolutely a case for the G7 regulatory agencies to all fast-track approvals of drugs for which one of the others has already done the hard work.
Seems like there could be a hybrid between this and "EXPERIMENTAL" drugs, namely that you would be allowed to sell experimental drugs with a label that says which other countries they're approved in. Not sure if that would help at all with getting insurance to cover them, though.
This *sort of* exists already. Regulatory bodies in a few different high intensity health economies put their heads together and developed 'Project Orbis' (which isn't an acronym, just a really cool name I think). The details are a bit complicated, but the idea is that a regulatory submission made through Project Orbis will satisfy every regulator in the scheme at once, so any regulator can pick up the work of reviewing a submission and therefore approval from any country can lead to approval for every country. Naturally there are a few teething issues (the biggest being that only oncology drugs are eligible at the moment), but products are being approved through this process, most famously osimertinib (Tagrisso)
That comment got triple-posted for some reason. AFAICT there isn't any obvious difference in the letter of the law, but the FDA seems more stringent, and is clearly much slower — a big recent case is covid vaccine approvals, for example.
While I do think we need a form of overarching patient protection when it comes to drug development\factory safetey, the FDA has reached well past oversight and moved into actively causing harm by being slow and paternalistic. They likely don’t see it that way, but in their attempts to avoid the doctrine of double effect—in this case being afraid of potentially harming a few people even while most others benefit—they shut or slow down patient access to off-label treatments and compassionate use drugs which they have to green light in addition to the providing pharma company, and delay access of novel therapies to terminal patients.
They’re making an irrelevant distinction between killing and letting people die, all the while filling the invisible graveyard with patients they saved from potentially being harmed by treatment by instead letting them die. (I talk about this at length in an essay I wrote about the insane process of finding a clinical trial, https://open.substack.com/pub/bessstillman/p/please-be-dying-but-not-too-quickly?r=16l8ek&utm_campaign=post&utm_medium=web) I’m specifically thinking of my husband, Jake, who is dying of recurrent metastatic HNSCC and isn’t a Keytruda responder. There’s some exceptionally compelling research about using fecal transplants to transform non responders into Keytruda responders, and small scale studies out of UMPC have demonstrated this effect in melanoma patients, demonstrating improved responses in around 30% of patients. That’s huge. I’m a doc at the hospital where Jake’s getting treatment and brought up the possibility of performing a fecal transplant for him using a PD-1 responder donor and wrote a protocol. His gastroenterologist is on board with the idea. But the FDA cracked down on off-label fecal transplants after 2 deaths (in immunocompromised patients) around 2 years ago. For reference over 10k are performed a year for C. diff. Off-label would be any use that’s not treating C.diff. So we need IRB and FDA approval for this n of 1 study with Jake as the only trial participant. Or, Jake as the only off-label recipient. However you want to spin it. Jake consented to the risks and is fully educated about what the procedure entails. We even have a friend who meets criteria and offered to be a donor (non invasive! simple!). But it’s been 5 months of waiting and there still hasn’t been approval. Luckily Jake got into a different study that’s keeping his tumors stable. But if he hadn’t he would have died from his aggressive cancer, while the FDA protected him from the scant possibility of dying from a procedure that could potentially significantly extend his life. How kind! This is what I mean by overshooting. When I’ve made this argument in other settings, I’ve had examples of catastrophic failures of oversight given as reason why there should be tighter control over everything. Say the word “thalidomide” and it has the same effect on public opinion about relaxing FDA oversight as saying “chernobyl” has on people against nuclear power. They should exist, but they need to loosen their grip there it makes sense.
Some of the insane restrictions seem like theater anyhow. In the clinical trial essay I wrote that:
“Safety” sounds great, but the FDA is providing safetyism. There’s a process by which the FDA can fast-track a drug based on promising early-phase data, allowing the drug to come to market contingent on confirmatory trials. In exchange for accelerated approval, pharmaceutical companies will perform follow-up studies collecting additional data. The drug companies can use the drug, but they don’t always fulfill the obligations to complete additional safety testing. This kind of wild-west “give it a try” approach extended to the drug companies by the FDA isn’t extended in kind to patients who want to try certain off-label uses of established drugs of therapeutic interventions.
This kind of internal inconsistency is frustrating. The FDA is trying to do too much of everything, and instead, ends of doing a lot very poorly. I don't think there's a single solution, but rather, different areas of oversight: drugs, clinical trials, compasisonate use, etc. should all be addressed separately.
Since you've written candidly about all this, I hope you don't mind me asking: have you considered DIY'ing the whole fecal transplant process? It seems like the main issue would just be finding a Keytruda responder in moderately good health who's willing to be a donor? Such a person might be found through Keytruda support groups or other patient support networks. Then they need to get some screening, but I have heard that it can work fairly well to just ask one's doctor, "Hey, I'm planning to be the donor in a fecal transplant, I would like to do that more safely, can I get XYZ tests for that?". And then the actual procedure can be done at home in a few hours with simple equipment.
Seconding this - this is exactly what I'd be doing, and I don't have an MD - it seems somebody with actual medical knowledge and an assurance they're doing it safely would be all over this, especially with loved ones' lives at stake.
Of course, us making this public likely means our good doctor can't respond to us in any way except in the strong negative, out of fear of potential medical license impacts or other liability.
I thought it's still valuable to signal boost for other folk reading here, though - the traditional and established medical channels aren't the only option. Self treatment, going overseas to countries with less-murdery regulatory regimes, going overseas to concierge doctors with broader ideas about what's medically advisable, etc. Especially if important lives are on the line, doing EVERYTHING you can to save your loved one is actually an option you can consider and do.
To follow up on Paul Kreiner’s comments about DIY home FMT: this is explicitly not regulated by the FDA, and it is trivially easy to do. I’ve walked over 1,000 patients through it in the past decade and in my clinical experience the safety and efficacy (at least for refractory C diff infections, inflammatory bowel disease, and irritable bowel syndrome) of DIY home FMT are indistinguishable from the safety and efficacy of FMT in clinical trials. As a side-note, since FDA approved the FMT products Rebyota in Nov ‘22 and Vowst in April ‘23, they *can* be used off label, although they are ridiculously expensive. And they absolutely are not coming from donors who have responded to specific chemotherapies, immune checkpoint inhibitors, etc. There are FMT clinics around the world that I have sent patients to, but so far, none of them are selecting donors with response to cancer drugs. Outside of a prohibitively cumbersome and expensive clinical trial, the only way you can accomplish this is through DIY home FMT. I myself learned almost everything I know about FMT from other doctors who generously gave of their time over the past 15 years, and although a substantial part of my practice is educating patients about FMT during paid visits, I’ve always had a policy of educating other clinicians at no charge, which I would be happy to do for you Dr. Stillman. Feel free to send me a message (mark@IBDspecialty.com) if you’d like to chat.
The doctor presumably knows something about the patient they're prescribing the drug to. The person making and selling the drug does not.
As an example, there was a case in the (UK) media recently about British people being 80 to 120 times as vulnerable to severe negative side effects (agranulocytosis leading to death) from metamizole as Spaniards, and as such expats died or went into comas upon being prescribed a rather popular Spanish painkiller with a low rate of side effects (for Spaniards).
Suppose you're a Spanish drug maker: you do your tests, they're all positive, you start selling the drug -- and then a tourist takes it and dies. Is it fair that you have liability here? Do you need to test on representative population groups all around the world because one of them might have an adverse reaction?
"As an example, there was a case in the (UK) media recently about British people being 80 to 120 times as vulnerable to severe negative side effects (agranulocytosis leading to death) from metamizole as Spaniards"
That's fascinating and astounding, not something I would have expected. What is the genetic difference between the Spanish and the Brits likely to cause this, or is it just that the Brits aren't used to taking it and misdose? I mean, if we're assuming Anglo-Saxon heritage, it should be as bad for the Germans, and yet:
"In Germany, the drug is the most commonly-prescribed painreliever."
Wikipedia is just teasing me more with intriguing questions but no answers:
"Metamizole is banned in several countries, available by prescription in others (sometimes with strong warnings, sometimes without), and available over the counter in yet others. For example, approval was withdrawn in Sweden (1974), the US (1977), and India (2013, ban lifted in 2014).
Although metamizole is banned in the US, it was reported by small surveys that 28% of Hispanics in Miami have possession of it, and 38% of Hispanics in San Diego reported some usage."
What was that study about elderly Hispanic women, again? 😁
Say there's a drill manufacturer that manufactures and sells a drill. They tested the drill in Minnesota, and it seemed safe, but it actually explodes in temperatures over 100 degrees. Then they sell it I Texas, and a contractor installing a bathroom is using the drill and it explodes and a piece of shrapnel flies off and takes off the neighbour's finger who should be liable?
I think it's reasonable to say if you're selling a product you should have a responsibility to check it is safe to use in the conditions you sell it in. And if they say on the box "warning this drug has not been tested in XXX population" then the doctor needs to make a risk benefit calculation and ideally have some mechanism to have the patient waive their right to sue if it goes wrong (which Scott has talked about before).
So, suppose that drill manufacturer expects to sell that drill in Texas, and tests it thoroughly to not explode up to 150 degrees (hotter than any recorded temperature in Texas), sells it in Texas, to a company that installs it in an industrial lathe that runs so hot that it hits 160 degrees and explodes, taking the million-dollar lathe with it. Who should be liable?
It's not practical to always put liability on the manufacturer, since there's no way for the manufacturer to anticipate every use case. It *might* be practical for the manufacturer to test the conditions he believes are *likely*, and it's even in his interest to do that and clearly label that it's guaranteed under those conditions so that more customers will believe the product is reliable enough to buy, and it turns out that's what a lot of product manuals say.
This is harder to do with drugs, since the condition is something like "safe in the people we tested it in" and the doctor is considering that drug for his patient who might have some rare condition that makes that drug worse, and given how complicated human bodies are, this is distressingly common.
Which is why clinical trials are so incredibly expensive.
As I understand it, the standard legal strategy is to sue everyone whom you have a vaguely plausible legal theory for suing and see what sticks. Any lawsuit that doesn't immediately get dismissed by the court gives you a chance to win at trial. Also, trials are slow, expensive, uncertain, and tedious, so defendants are very often willing to settle for at least a token amount even if they have a good chance of willing at trial, so more defendants lets you stack up more small settlements. One more factor that seems plausible but I don't know how much it applies in real life is that with responsibility uncertainly divided between multiple defendants, each defendant might make arguments in pre-trial filings that can strengthen the case against other defendants.
My vision of an FDA-less world is one in which all drug companies immediately give up boring and not-so-profitable drugs that actually cure things, and start working on making hyper-addictive narcotics.
You think fentanyl is bad? Wait 'til you see what it looks like when Pfizer, Merck etc have sunk a trillion dollars worth of the best pharmaceutical research into the world to optimise it for addictiveness at the expense of everything else.
Now it's a simple matter of getting the whole world addicted, and gently jacking up the price until your drug is 90% of the global economy.
As an ex-libertarian who used to roll in such circles, there's a big difference between "end the war in drugs" and "legalize all controlled substances".
Only your proper ancaps and extremists would really hold to the exact line of no restrictions on free trade between consenting adults.
In actual fact the majority of libertarians are some kind of minarchist, (not spelled incorrectly, not monarchist) that is advocated for the minimum possible state. That is, accept immediately and right away the proper place of government as police, military, and court system. And then as far as determining what things are enforceable laws, a _presumption_ away from state action or interference into free trade or association between consenting adults, but not a total unwillingness to do so at all. Basically, the argument is, anything the state does is at the barrel of a gun, so you'd better use it only in extreme circumstances and you'd better be damn sure.
The result in practice is that the majority of libertarians I actually met or heard speak would legalize marijuana, mdma, cocaine, and hallucinogens, but probably not heroin or meth, and wouldn't balk at controlling pharma-optimized-mega-heroin. A lot of libertarians are a short cry away from rugged-individualist-conservatives and would end the war on drugs but not legalize anything except marijuana. That is, leave it illegal and prevent import / export / manufacture / distribution and just not go after users or dealers.
Only a few libertarians really are the recreational mcnukes type.
The libertarian is primarily concerned with the liberty of the individual and their right to choose how to spend their days and what to put in their body.
The more you aggregate and create collectives, the less concerned your archetypical conservative libertarian is with freedom of collective action. That's not to say it's not valued, but other things also are valued. He believes in creating and securing borders (as opposed to the archetypical liberal libertarian) and would not balk at preventing international industry from importing things that were very harmful, like explosives, biological or chemical dangers, or addictive drugs. Similarly, as a cultural and social conservative, while he may be okay with an individuals choice to buy and consume a particular drug, as this concerns his direct right to bodily autonomy, this does not equally extend to a right of a mass manufacturer to produce at industrial scale addictive drugs (where the ancaps and extremists differ, as they do extend such personal freedom to essentially all actions)
A small time "dealer" is not meaningfully a distributor. He's some guy in the middle of the chain, not the manufacturer or the mass-quantity-trafficker. You can leave him alone and just prevent anyone from distributing mass quantities like a food or retail company distributes their goods.
I've never heard of a self-described minarchist who wanted to ban recreational drugs. An anarchist wants to get rid of all government, including the "night watchman state". A minarchist wants that state to only police coercion, not engage in any kind of paternalism.
I don't know what to tell you other than that I met em, at Porcfest and at in the formal party. If they were coming from the more conservative side it was pretty common.
I'm not very well-informed about this, but I see a strong case that the vast majority of the harm caused by opioids is caused by their prohibition, rather than the substance itself. As far as I understand, their side-effects aren't all that bad as long as they are manufactured and dosed correctly. But due to their illegality
- People use black market drugs that may not be reliably dosed, may be contaminated, and lack basic quality control (even what would be incentivized by reputation considerations on a free market).
- People use especially potent opioids that are especially easy to overdoes, because they are easier to smuggle in a small space.
- People inject instead of taking it through other routes because a smaller dose is needed for the same effect, and it's very expensive due to the prohibition. Frequent injections of stuff that may be contaminated have bad side-effects regardless of what is injected.
- Some people share needles, which spreads severe diseases like AIDS and Hepatitis C.
- It strengthens criminal gangs, which then commit violence and other crimes besides selling drugs.
- Users may become destitute and commit crimes to get money to pay for the drugs made expensive by the prohibition.
- Imprisonment of drug users and dealers, besides harming the prisoners directly, probably has harmful knock-on effects even after they are released.
- Some people get addicted to legal prescription opiates, and then when prescription rules are tightened, they turn to the black market and suffer or die from any of the above.
Cutting through all of this by making reliably dosed stuff legal and cheap, with a big fat warning that even one try can get you addicted, seems much preferable to this.
It's famous for going to war to ban opium, but I've no idea how good a reason it had to want to ban it. And that was before the effects of prohibition were seen; alcohol prohibition also looked like a better idea before it was tried.
Seconding this - most of the "deaths of despair" are due to drug prohibition and illegality. The actual drugs cost pennies - if they were legally available at a fair cost+20% or whatever at a known strength and purity, there would essentially be zero overdose deaths, and very little negative physical downsides. With pharmaceutically pure stuff, addicts can live and work and function in society for decades. Just look at William Burroughs or Keith Richards!
And a lot of the deaths are precisely due to strength and purity - the strength varies every time on the street, and with fentanyl a 1mg difference can be the difference between "feel good" and "OD." And contamination is rampant - there are 'zenes that are even cheaper than fentanyl that contaminate most street opiates now. They are cheaper AND more addictive, and they absolutely destroy tolerance in addicted people so they have to do more and more, so it's sort of a double punch in terms of incentives for illegal drug folk to include them. Unfortunately, they are much worse for human biology and orderly function than real opiates too.
And it is exactly a policy of "who cares about drug addicts, they deserve to die" in the USA that leads to these deaths too. It's at epidemic numbers, and lots of the people are people who got addicted to legal pills and then can't get them anymore because doctors are under more scrutiny and negative pressure to not prescribe any actually effective painkillers.
But for every doctor that refuses that script, they're probably killing .1 of a person due to this illegal drug purity / contamination / overdose dynamic. Deny ten scrips and statistically kill somebody! But you know, that's totally in line with Hippocratic Oaths, it would be MUCH worse to prescribe somebody painkillers that work and have very little physical downsides. Really.
> Abolishing the FDA does not one would presume legalize all controlled substances
Who decides what substances are and are not legal in the absence of an FDA?
We could certainly continue to ban already-banned substances, but what about new ones? If Bayer comes along next week with a brand new chemical formulation for a "headache tablet" that's really really good at getting rid of headaches (and also makes you really want to take another one in three hours) then who decides whether or not that's legal to sell, in the absence of an FDA equivalent?
I think you have a misunderstanding of what government agencies do what.
While the FDA is the gatekeeper for food drugs and medical devices for commercialization, it is not the body that decides what is a controlled substance and to what degree.
The CSA (Controlled substances act) empowers the DEA and the Department of Health and Human Services to schedule out drugs, determine their restrictions, and enforce them.
The FDA is intended as a watchdog to prevent patient risk in the course of normal healthcare business, that is, primarily by accident or corporate fraud.
It is not the body intended in any way to police narcotics, recreational drugs, controlled substances etc.
In the absence of an FDA, a company can commercialize a drug in absence of a pre-market approval, but if the department of health and human services or the DEA decides it should be a controlled substance, its a simple matter to schedule and control it.
The same way they and the DHHS do it now - the FDA is not a part of that chain.
The FDA may decide whether a drug is allowed to be sold or not but them saying it can't be sold doesn't make it a controlled substance. Totally different pipelines
Isn't it a DEA matter if I'm producing and selling prescription medicines without a prescription? And doesn't the FDA decide what is a prescription-only medication versus an unregulated one?
If that goes away, the DEA suddenly has a whole lot of new drugs coming onto the market that they need to decide whether or not to declare as controlled substances. If they choose to say "Meh, if it comes from a respectable company it must be fine" then you get the wirehead pharma-world I descried above. On the other hand, if they decide to look carefully at new drugs before deciding whether or not they should be banned then you've probably just reinvented the FDA as the DEA.
"My vision of an FDA-less world is one in which all drug companies immediately give up boring and not-so-profitable drugs that actually cure things, and start working on making hyper-addictive narcotics."
A new lucrative market doesn't make the existing market unprofitable.
I doubt that it's possible to make all that many novel, hyper-enjoyable recreational drugs, let alone ones where an addition can't be satisfied by different, generic alternatives. As far as I understand, if you get addicted to one opioid, another opioid will satisfy the addiction.
Why would people buy the new hyper-addictive drug, instead of the (sometimes less addictive) existing ones?
I expect that if recreational drugs were legalized, without excessive regulatory burden, the market would look more like the market for aspirin: old, cheap drugs with many competing generic manufacturers.
I suspect that FDA could only (and in the -- however distant -- future, will) be abolished in the exact same way in which e.g. the Praetorian Guard or the Gestapo were abolished.
> Right now your doctor doesn’t worry you’ll sue them, because “the medication was FDA-approved” is a strong defense against liability. But if there are thousands of medications out there, from miraculous panaceas to bleach-mixed-with-snake-venom, then it becomes your doctor’s responsibility to decide which are safe-and-effective vs. dangerous-and-useless. And rather than take that responsibility and get sued, your doctor will prefer to play it safe and only use medications that everyone else uses, or that were used before the FDA was abolished. You might even find it’s even harder to get a medication into common use than it was back when the FDA existed!
This is part of a genre of "we can't do without regulation" arguments that doesn't really work. The hidden premise is that the FDA has always existed.
The reason that other defenses to liability are weak is that it's presumed that only the FDA can make reasonable judgments about what medical treatments are appropriate. In the absence of the FDA, that presumption isn't available, and which defenses are strong will change.
It's true that if you abolish anything, or for that matter establish anything, and then attempt to run every other part of the world as if the change you made had never occurred, those parts of the world that depended on the presence of the thing you abolished, or on the absence of the thing you established, won't work. But that is not actually an argument that the systems they implemented will stop functioning, despite what the people making this observation usually claim.
It does not seem like the quality of food and drugs was great prior to the founding of the FDA was very high, that is in fact the reason why it was created:
The quality of food was much higher before the problem period that led to pressure to create the FDA. The low quality was the historically anomalous period.
I think it would be fair to attribute that development of low quality to a disconnect between food manufacturers and food consumers. This made it more difficult for consumers to obtain information about manufacturers, and manufacturers responded, as you note, by becoming untrustworthy in ways that were difficult to assess. (Consumers also responded by shifting their consumption to foods in which defects were very, very easy to assess, such as white bread and large cuts of meat served with very little in the way of flavorings.)
Moving into a much more speculative area, I think it's also fair to observe that the period of low quality essentially coincided with the beginning of the large-scale distribution of food. Systems are more chaotic and display more undesirable behavior when they are new; the problem might have driven itself out of existence given more time. (There is a really interesting piece from Bret Deveraux comparing the social structures of the Mongols with those of the Plains Indians, and noting that in many ways the Mongol structures functioned better. He specifically observes that this is likely due to the Mongol social structure having developed over thousands of years while the Plains Indian lifestyle existed for no more than a few centuries.)
There are several things we might say about this:
1. The same pressure that led to establishing the FDA, if the FDA had instead never happened, would have led to something else. It is not obvious that the FDA is a better solution than the counterfactual one would have been; what we know is that the FDA was a _faster_ solution. (This point is similar to my "speculative" paragraph above.)
2. Between then and now, methods of propagating information at very large scales have come into being, making it much easier for people to obtain good information about manufacturers.
A Chinese formula manufacturer (Sanlu) decided to save costs by cutting the formula with melamine. This killed six babies and hospitalized hundreds. And the result of the state's investigation was that two company executives were executed, one got life in prison, and a handful received shorter prison terms.
By contrast, an American drug manufacturer (Merck) introduced a pain medication that -- as Merck was aware when it introduced the drug -- frequently caused fatal side effects. Vioxx was voluntarily recalled from the market when Merck learned that the FDA had discovered those side effects.
Unz:
> Although the Vioxx scandal certainly did generate several days of newspaper headlines and intermittently returned to the front pages as the resulting lawsuits gradually moved through our judicial system, the coverage still seemed scanty relative to the number of estimated fatalities, which matched America’s total losses in the Vietnam War.
> The circumstances of this case were exceptionally egregious, with many tens of thousands of American deaths due to the sale of a highly lucrative but sometimes fatal drug, whose harmful effects had long been known to its manufacturer. But there is no sign that criminal charges were ever considered.
> A massive class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007, with almost half the money going to the trial lawyers. Merck shareholders also paid large sums to settle various other lawsuits and government penalties and cover the heavy legal costs of fighting all of these cases. But the loss of continuing Vioxx sales represented the greatest financial penalty of all, which provides a disturbing insight into the cost-benefit calculations behind the company’s original cover-up. When the scandal broke, Merck’s stock price collapsed, and there was a widespread belief that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck’s stock price eventually reached new heights in 2008 and today is just 15 percent below where it stood just before the disaster.
> Furthermore, individuals make decisions rather than corporate entities, and none of the individuals behind Merck’s deadly decisions apparently suffered any serious consequences. The year after the scandal unfolded, Merck’s long-time CEO resigned and was replaced by one of his top lieutenants, but he retained the $50 million in financial compensation he had received over the previous five years, compensation greatly boosted by lucrative Vioxx sales. Senior FDA officials apologized for their lack of effective oversight and promised to do better in the future.
We have here a perfect liability shield - the FDA can't be liable for Vioxx because they weren't trying to kill anyone, and Merck can't be liable for Vioxx (in a way that would actually act as a deterrent) because, sure, they were trying to kill people, but they had approval to do that from the FDA!
Which system do you think is likely doing a better job preventing counterfactual decline in manufacturing standards?
Yes, it's large scale commercial and industrialised processes which lead to the worst adulteration scandals (see link below) but even before the "historically anomalous period" food could be contaminated, either through ignorance, the methods used (grinding grain with a quern stone meant grit in the resulting flour) or greed/cheating.
To produce food in the quantities needed for today's population, large scale processes are necessary, and that means the need for oversight. Your mention of "white bread" as one of the foods in which defects were very, very easy to assess is ironic, because adulterating bread - including things to make it whiter - is one of the complaints:
"When basic staples like bread started to be produced cheaply and in large quantities for the new city dwellers, Victorian manufacturers seized on the opportunity to maximise profit by switching ingredients for cheaper substitutes that would add weight and bulk. Bread was adulterated with plaster of Paris, bean flour, chalk or alum. Alum is an aluminium-based compound, today used in detergent, but then it was used to make bread desirably whiter and heavier. Not only did such adulteration lead to problems of malnutrition, but alum produced bowel problems and constipation or chronic diarrhoea, which was often fatal for children."
And of course, where there is large scale industrialisation, there is both the necessity and the temptation to cut costs and sell at lower prices than the competitors:
"More than a decade earlier [in 1855], in his testimony before a Parliamentary committee, the Select Committee to inquire into the Adulteration of Food, Drinks and Drugs, Arthur Hill Hassall pointed out that the practice “prevails in nearly all articles which it is worth while to adulterate, whether it is food, drink or drugs.” and he went on to point out that
The majority of adulterations consist in the addition of substances of greatly inferior nature, for the sake of weight and bulk. Others consist in the addition of various colouring matters, to conceal other adulterations, or to heighten, and, as it is considered, to improve the appearance. Lastly, a few adulterations are for the purpose of imparting smell, pungency, or taste.
Among the items adulterated and the adulterants used were alum, added to flour in the production of white bread; sloe, ash and elder leaves used to adulterate tea; peas and beans in ground coffee; alum to brighten wine; Brazil wood to colour Port; and sawdust and filbert husks to make red wine more astringent. Just how widespread was the adulteration of food and drink? Certainly it varied from area to area, but it is likely that it was as great or greater in London than in any other part of the British Isles. Writing at the very beginning of the Victorian Era, Theodore Sedgwick commented that it was “difficult to mention a single article of food that is not adulterated.” Some items, he noted, could hardly be found in their genuine state. Even medicines were adulterated and the “quantity of medical preparations thus injured is said to exceed belief.”
"In 1820, Frederick Accum published a book, best known by its biblical subtitle ‘Death in the Pot', showing the widespread fraudulent and dangerous adulteration of common foods and drinks bought in London. Despite its brief popularity, there was no effective legislation in Britain until 1875 after more extensive analytical surveys by Hassall and Letheby in 1855 and a parliamentary enquiry had confirmed the frauds and risks to public health. There were similar surveys and legal action against food adulteration in France and Germany towards the end of the 19th century. In the USA, campaigning by Harvey Wiley and others revealed the same risks and frauds and led to the Pure Foods and Drugs Act in 1906 and formation of the FDA. We should have celebrated Accum’s bicentennial in 2020 to recognise his achievement and to remind us of the continuing dangers of food adulteration today."
Case study from Finland today. For context, dog and cat food intended for household pets is minimally regulated. In November, news and social media was filled with reports and videos of pets having deadly paralysis attacks. The cause was quickly pinpointed to a major brand of pet foods, which were recalled, but nobody still knows for sure why and how the dog food was contaminated: the manufacturer (Musti Group) argues that the potatoes they bought from the Netherlands were defectively high in glycoalkaloids (but claims they are not responsible as nobody expects to test dog food ingredient potatoes for that); the Dutch supplier argues the glycoalkaloid content was high but not high enough cause major side-effects.
In this case, some pets died. Yet we are not in the 19th century early industrialization information environment. Turns out, despite the internet, the assessment of quality in dog foods comes down to (a) avoiding food that obviously gives your pet a deadly seizure (b) trusting the brand you've previously bought and hoping they have not changed manufacturing process. Modern information environment makes information about (a) spread a little faster, but it helps only if the harmful effect is obvious and already killed someone else's pet.
If the regulation of human foodstuffs were reduced to similar level as dog foods, it seems likely that we'd have similar cases with bad or adulterated human foodstuffs are noticed only after someone dies after eating a product that turned out to be clearly poisonous ... coincidentally similar to the Chinese melamine adulteration case. If one compares melamine and Merck, Merck was not stupid enough to sell a product that contained large amount of chemical that is known to kill your baby just to make it look like it passed quality control; they sold a painkiller that sort-of did what it promised but also had known prevalent but not ubiquitous harmful effects. The Chinese melamine milk producers had been going unnoticed and unpunished for years as long the producers added amounts of melanin that was still harmful but didn't obviously kill babies. Nobody went prison or was executed for killing babies slowly, their mistake was increasingly adding it so much that many babies started dying immediately, which couldn't go unnoticed.
The part in the Merck case that appears the largest injustice to me has nothing to do with the existence of FDA or its regulatory tasks, but the feature of the US legal system where the executives who make money killing people can often escape unscathed with minor personal consequences by having the corporation to pay large monetary settlements (I don't think such cases are limited to FDA only, American system is famous for out-of-court settlements and plea deals).
> The part in the Merck case that appears the largest injustice to me has nothing to do with the existence of FDA or its regulatory tasks, but the feature of the US legal system where the executives who make money killing people can often escape unscathed with minor personal consequences
I did explicitly make the argument that that feature of the US legal system is due to the existence of the FDA.
> If the regulation of human foodstuffs were reduced to similar level as dog foods, it seems likely that we'd have similar cases with bad or adulterated human foodstuffs are noticed only after someone dies after eating a product that turned out to be clearly poisonous ... coincidentally similar to the Chinese melamine adulteration case.
That is also what we have right now. Do problems occur with the dog food in Finland more often than they do with the human food?
I'm not sure what you're trying to tell me with the example of the dog food. If it had been regulated more heavily, what would have happened differently?
Honestly, I think "Carve up the FDA" is a better plan than "Abolish the FDA". Remove more and more of their control over medicine, starting with the easiest stuff.
Step 1: Remove AI tools and medical devices from their regulation.
The argument here is simple, the FDA is not competent to regulate AI in healthcare. A ton of new "AI" medical devices have been approved, per Wu ~500, and I'd bet that 80% of them are crap because, well, reality. But there's a ton of AI products that are going to hitting hospitals over the next 5-10 years. And the FDA, to the best of my knowledge, has nowhere near the technical capacity to understand these tools or regulate them in a meaningful sense. With all due respect, at worst they're bureaucrats and at best they're pharmacists, neither of which qualifies them to regulate AI or, frankly, even read some simple Python code.
And we had a perfect example of this with the Epic EMR and their Sepsis prediction model v 1.0. It came out, lots of hospitals adopted it, some ran their own numbers to check their effectiveness, found out Epic significantly overstated it's effectiveness, Epic went back and came out with a new version that genuinely seems better, various hospitals are still evaluating it, and at no point was the FDA involved because....why would you? If a new "AI" device drops and it tries to alert a nurse when a patient at home is potentially having heart problems, whether that's effective or not, especially when faced with an exasperated nurse and 20 false alarms, is a decision for the hospital.
So keep the FDA out of field it's, with all due respect, not qualified to regulate.
Second, cut out medical devices in general:
My CPAP probably isn't going to kill me and doesn't need to cost $3k...this is pretty settled technology. And, again, the FDA isn't engineers, it doesn't build stuff, why are they regulating this?
Now I'm more hesitant here, because there have been a number of dangerous medical devices and there's real danger here and legitimate problems. And I pretty clearly want some sort of regulation of pacemakers, for example. But it sure seems like there's a lot of easy money to be saved in removing regulation from...non-surgical medical devices, for example.
Finally, tackle drugs. Which, ick, for reasons laid out above.
But I should stick up "Abolish the FDA" a bit here by suggesting that politics in the US might...not allow us to pursue our policy goals in as sensible and circumspect a manner as we might ideally like. And while it pains me to suggest that our noble civil servants might undermine or ignore any laws or executive orders they personally disagree with, I think any Libertarian president might want to consider simple and easily verifiable plans rather than detailed and surgical ones. In an ideal world you might want to slowly carve away at the authority of the FDA, and you might even find that their performance improves as their mission gets smaller and more coherent, but in our fallen world of...not ideally functioning politics, we may be left with "Abolish the FDA" or "status quo".
The FDA already has in place a classification system for the risk profile of a medical device (class 1 2 or 3 (or "not a medical device))
To be honest cutting out the class 1 devices from their purview entirely would be pretty risk free. - but it nearly works this way already. To commercialize a class1 requires paperwork and a promise that you have a system for hearing about it if people use your device and have complaints. There's no approval process. (requires registry only)
More generally, and this is commonly misunderstood, In the med devices space the FDA are NOT the arbiters of whether a device is safe and effective. They are actually just an organization that sets a standard of due diligence and checks whether you followed it.
(Clarification edit for wording. The FDA is not a panel of technical experts that themselves evaluates the safety and efficacy of a device. They are a panel of regulators that sets standards for what it means to be safe an effective, tell industry to do the work proving it, and check their work)
They are not engineers or even doctors really and they know this - they make no attempt to "understand" the technology such that they could decide whether it's risk benefit profile is acceptable (though contrary to popular belief, risk benefit analysis is baked into the regulation at all levels, it's cost / benefit that isnt)
Rather, the FDA requires you to make a clinical trial, do your own testing, with competent third parties and doctors, and _they_ are the ones who say whether it's safe and effective, and the FDA just needs to be able to trust their credentials. They will look at your study design and data and see if they agree, and ask questions where they don't. In practice this still ends up cumbersome because they can ask about any kind of data and halt you til you get an answer and trials themselves are difficult and time consuming.
But, the one elegance of the system is that it can actually do it's job explicitly without the FDA needing to be subject matter expert or understand the treatment or modality. They just need to understand study design.
It's really great to have a comment from someone with actual experience in the field. For me, one comment like that is worth 10 or 100 from theorizers. Similar kudos to the fecal transplant post above.
Thanks for the response, that was very insightful.
I find myself confused though. So the FDA just...double checks the study, at least for medical devices? Like, all the testing and analysis comes from reputable third parties and the FDA just double checks their credentials?
Is this similar for drugs? Does the FDA do more for drugs, do they have actually specialists or is it also just reputable third parties?
Because two notes:
First, this kinda makes abolition sound...sensible. Like, if all the FDA is doing, fundamentally, is double checking qualified third party experts, it doesn't sound that crazy to just abolish the FDA and hospitals and doctors judge off the third party experts. Not that this sounds faultless but, I mean, as far as I can tell the bond markets are based on independent third party experts like the S&P rating agency. Which is far from ideal but if we abolished the FDA, what's the prevent the expert market from consolidating into a few medical device "rating agencies"?
Second, genuine question, does anybody know who and how the FDA is approving these new medical devices? Because ML prediction algorithms don't...work fantastically with standard studies. I don't want to step too heavily here, I'm not that much of an expert, but I know plenty of ML prediction algorithms have had ugly failure modes because their training data was limited to 2-3 hospitals and so those algorithms don't generalize to the wider population, or more appropriately, other niche populations. Any links would greatly be appreciated.
1. I'm really familiar with medical devices but not at all familiar with drugs and from what I hear that's a different animal altogether. So, can't say anything about how the FDA does drugs.
2. So, you want to commercialize a new medical device? Here's what happens.
A. If your device is simple and non-critical and has a low risk profile, like a laparoscopic grasper or chest retractor or blood pressure cuff, your device is a class 1 device. You will create a "Design History File" which includes the user of the devices needs from the device, the engineering requirements that satisfies those needs, a set of drawings and specifications that fully define a device that meets those needs, and then probably only one kind of testing which you will run yourself, checking that a device made to your drawing meets your specifications, in an objective manner.
Then youll have a way to prove that the manufacturer is building that same device. You do a pre-market registration with the FDA, where you notify them you are selling this and where it's being manufactured, and you're done.
All of this has to be well documented with traceability. If your device has complaints the FDA may look into it.
For class 1 devices a lot of this can be left out and does based on the size of the company but if you do at least the above you're in good shape if the FDA checks and it's usually just good practice engineering anyway.
B. Your device is potentially critical and could be risky, but it's based off something that already exists and so you can make pretty good guesses about it's risk profile. This can include basic implants, monitors, surgical devices, etc. Your device is class 2.
You will be using the "510K" submission pathway, where you demonstrate that your new device is substantially equivalent to a device or combination of devices that already exists.
Your design history file will include all of the same as before, with the addition of the following: documented design reviews at a minimum of 3 defined stages in the product design. Documented "risk evaluation" where you assess what the likely failure modes are, what happens if they occur and how bad it is and develop a semi-quantitative sense of risk level, and then implement risk controls to address each until they are acceptable.
A second kind of testing, where a licensed clinician uses your device in a simulated use environment and agrees that the device made to your drawing meets the needs of the user.
Statistical process qualifications of the manufacturing process by which the manufacturer will make.
A clinical registry, where once you start selling the device you'll be carefully tracking the first physicians who use it and checking their outcomes.
A few other documentation requirements but this comment is already too long.
C. Your device is critical to the patient, risky, and brand new. Your device is class 3 and you will need a pre-market approval, i.e., a clinical trial.
You'll do all the same documentation and testing as in (B), plus a bit more, but the big difference is that you run a clinical trial before you can sell anything.
The results of the clinical trial are outcomes and judgements made by clinicians. Typically you run these with a third party who specializes in doing so.
So the FDA receives your submission and reviews it. The first thing they do is check your argument for classification. If they disagree with the device class your submission is DOA. A lot of new devices get held up here - tiny companies who have sold a class 1 and the FDA scrambles to tell them no that's a class 2 stop, or much more frequently someone trying to say something is class 2 and the FDA is t convinced and says it's class 3.
This is a partially expert opinion call, but they have some fairly objective ways of making it that are honestly pretty decent: devices are the same if they have the same intended use on the same patient population and use broadly the same modality.
Usually the disagreements are when there's different intended uses but sometimes the FDA won't buy that the modality is similar enough.
The FDA then goes through your submission, checks all your documentation and testing and data and the outcomes of the data.
If they're confused or disagree with something, they will ask you for additional information, and possibly data.
If youve answered all their questions to their satisfaction, and in the case of class 3 completed the trial, congratulations you can sell a medical device.
But we're not done yet
In addition, the FDA also audits you on an irregular basis, to check whether you have a defined procedure in place for creating all that documentation and running the testing etc and for capturing that it happened and that it happened the way you said it did. If you fail an audit you may have to make corrections or may have to not sell devices.
They also perform inspections in manufacturing facilities and audit them similarly but with experts on manufacturing facilities. Here they really do have subject matter expertise.
They also are tracking the healthcare space and looking for complaints or devices creating bad outcomes, and require you to do this as well. If the device is not performing, they are the watchdog for when you have to recall your device. (In practice no one let's it get so bad that the FDA has to tell them to recall, they do it themselves first because if mom has to tell you to stop you're in trouble).
3. For the review of special cases, the FDA does keep on staff some genuine technical and medical experts. But for the review of business as usual submissions, they are not involved.
4. The FDA typically leaves the design and performance of a device totally up to the designer, but they do have in place a list of industry standards for basic and very quantifiable things that your device is required to meet (things like biocompatibility of materials, sterile barrier packaging tests, etc)
5. Honestly the main risk o see of dissolving the FDA specifically in regard to medical devices is a lot of companies commercializing devices made to varying engineering standards, that have only been tested internally, manufactured in facilities that are poorly controlled, especially ones that really should have had clinical trials.
There is a lot of pressure for this in the space already. I absolutely do not believe companies would perform this testing if they were not required to.
6. In regard to AI, the big fight that's going on right now is companies trying to make an AI based device and arguing it's a physician _aid_ and not an alarm or diagnostic modality, and therefore class 2, and the FDA saying look we all know damn well they are going to just trust the machine or they wouldn't use it and you wouldn't sell it, it's class 3, and imo both arguments have merit. That pushes the AI algorithms into clinical trial land. And until they can consistently get good outcomes they won't be approved. Tbh the FDA doesn't need to understand AI, if you can demonstrate your device achieved good outcomes with low risk according to the defined statistical practices, they will let you. But nobody wants to run an AI trial.
On the bright side, after a bunch of AI class 3s HAVE been made, someone will be able to claim equivalence and then some of them will start being class 2s.
Finally, admittedly, the FDA can be pretty arbitrary with what they ask for in a submission. We've never been able to predict what things they'd be confused about and ask for more data on ahead of time. And for anything shiny and new (AI) they are much more inclined to ask to show more work and data regarding risks. This can really bog things down and make it take a long time and a lot of money.
Depends on the particular use of AI. But mostly nobody wants to run an AI trial because it's cumbersome and impractical to set up. (Read: expensive and time consuming)
In the case of a hospital alarm system like mentioned before somewhere, to have a proper control and experimental group would probably involve a dozen hospitals and hundreds of patients. Or in the case of using AI to interpret some kind of massive diagnostic data set, the trial required to properly vet that might demand enormous numbers of samples, especially if no one can tell you how the AI works under the hood.
To a first order, whether you have to do a trial for an AI or not is a difference of at least one and probably 2 orders of magnitude in terms of cost to actually release your device.
Where did you get the idea that the FDA isn't the arbiter of whether a device is safe and effective? How, then, did the FDA stop 23andme from helping people interpret their genotype? (Answer: They claimed that a microarray was a medical device, and that it needed to go thru the full approval process.) How has the FDA managed to block the introduction of broad-spectrum genetic pathogen-detection tests for decades? I've spoken to several companies who sell such tests overseas, and all said they will never sell them in the US, because of the FDA.
Hey, the wording was unclear, ive added the following edit to the top level:
(Clarification edit for wording. The FDA is not a panel of technical experts that themselves evaluates the safety and efficacy of a device. They are a panel of regulators that sets standards for what it means to be safe an effective, tell industry to do the work proving it, and check their work)
They dont scientifically evaluated whether a particular device is safe or effective, they are a group that makes sure you proved it before you sell anything. Sorry for the poor choice of the word arbiter (since that word has such strong associations / connotation with gatekeeper)
My question was rhetorical. Your post suggests that the FDA doesn't have the power to keep "medical devices" off the market for stupid reasons, and to apply the term "medical devices" outrageously broadly. Yet they have done so, over and over again.
23andme takes your saliva and runs it on a microarray that detects 640,000 different SNPs (single nucleotide polymorphisms). They used to have software which then checked the disease risks associated with all those SNPs, and provided the user a summary showing which diseases they had an elevated risk for.
The FDA declared that this constituted a medical device, and that 23andme needed to go through the approval process for EVERY ONE OF THOSE 640,000 SNPs. That's 640,000 different approvals.
It was stupid to pretend that the microarray is a dangerous medical device, and it is stupid to demand going thru a regulatory process on literally every nucleotide in the human genome before you can tell a patient anything about it. And this kind of abuse of power is not the exception, but the rule. The business with banning broad-spectrum pathogen tests is far worse, and has probably killed millions of Americans.
I dont think my post suggests that at all, in fact its exactly for the reasons im trying to describe that such a thing as the above can happen - The FDA are not scientists, doctors, or engineers. They are regulators working within a constrained definition of what a medical device is, and if something meets that definition they expect an approval process, and they arent capable of understanding the technology scientifically in order to know when to make an exception or change their protocol.
They are the gatekeeper, but not because they do the math, because they make you do it.
I dont disagree that this results in a lot of stupid things. Im just explaining how it works.
Frankly, such a product really _does_ seem like a medical device, but one that should probably have a single submission altogether. But like I said in my later post, most of the sticking points on a project is the FDA disagreeing with the classification and requiring arbitrary things.
Ah, sorry. I interpreted "the FDA are NOT the arbiters of whether a device is safe and effective" as "the FDA doesn't regulate devices". I didn't interpret your statement within the context of the comment you were responding to, which said the FDA doesn't have the expertise to do so, but instead only in the context of Scott's post.
As a libertarian who wants to abolish the FDA (and every other government agency), my answers to your questions are:
1. Are we also eliminating the concept of prescription medication?
Yes, in the sense that people should be free to put whatever they want into their own bodies. If patients, doctors, pharmacist, pharmaceutical companies, insurance companies, or others find the concept of prescription medication useful, they can recreate it for those who want it while leaving the rest alone.
2. Are we also eliminating factory inspections to make sure drugs aren’t contaminated?
My answer is essentially the same as to the previous question.
Factory inspections are probably useful, and could probably be even more useful if done by people with better incentives than the FDA.
Factories could be inspected and certified by organizations created for that purpose. These could be anything from for-profit companies to non-profit patient organizations.
3. How do we deal with the fact that many doctors are dumb?
Certainly not by replacing them with even dumber bureaucrats. At least the good drug is also available in your scenario. In the equivalent scenario with the FDA, only the bad drug would have been approved.
No system can create the optimal outcome every time. The FDA certainly doesn't. Sometimes doctors make mistakes or act maliciously, but the harm caused by such events is smaller and easier to deal with than when bureaucrats and politicians do the same. When a doctor is malicious or incompetent, the only challenge is finding out and convincing everyone else. That may be a big challenge, but even that's not enough when the FDA is malicious or incompetent because the FDA doesn't need the consent of the people it has the potential to harm.
4. How will the smart doctors get the data they need?
I don't share your confidence in the FDA reliability. The FDA's ability to enforce its decisions creates bad incentives because it means that it doesn't need the trust of patients. I think that also makes the agency easier to manipulate compared to a voluntary organization because there is no counterweight to the individual decision makes' incentives to maintain good a good relationship with the large pharmaceutical companies that they often end up working for once they leave the FDA.
Regarding supplements, I would assume the reason there are not as many studies into their safety is that unsafe supplements are a relatively small problem. How likely are people to die or suffer serious injury after consuming supplements compared to FDA approved drugs? What are the consequences of the average supplement not doing anything compared to the average FDA approval drug not doing anything? I don't know the answer to those questions and I could be wrong, but I suspect they explain the lack of large scale studies.
5. What would insurance cover?
That should be decided by patients, doctors, insurance companies, mutual aid organizations, etc., not by government agencies.
However, if you don't want to reform the healthcare system, I assume there is already a system in place for determining what insurance companies have to cover when it comes to procedures such as surgery, physical therapy, etc. that is outside the FDA's remit. That system could perhaps be extended to cover drugs as well.
While I would abolish the FDA in a heartbeat if I could, making the FDA advisory and voluntary by removing their enforcement powers as DavesNotHere suggests would be an acceptable compromise. Almost all harm caused by the FDA comes from their monopoly and their ability to enforce their decisions by force.
What happens in a situation where a drug has good effects for most people but unexpectedly causes death to a few? While the FDA frustrates a lot of beneficial medical innovation I worry that without it private lawsuits could have an even bigger chilling effect.
That's a good point. Lawsuits could definitely lead to a chilling effect that limit access to drugs even without the FDA if pharmaceutical companies are forced by law to accept liability. That wouldn't be a problem if liability was regulated by contract rather than law.
The amount of liability that it makes sense for a patient to expect and a pharmaceutical company to accept would probably vary wildly depending on the drug and the context in which it's used. A patient probably wouldn't care nearly as much about the chance of getting compensation if something goes wrong if they take the drug in a last-ditch attempt to save their life compared to if they take the drug to treat something less serious or if there are other treatments options.
The amount of liability a pharmaceutical company is willing to accept for a drug when there are multiple competing drugs available can also serve as an indication of how safe the drugs are, as a compliment to independent certifications and studies.
So you'd need to sign a contract with each customer? I... don't actually see major problems with that. Obviously creates a bit of a transaction cost but eh. Prescription meds are already transaction costed out the wazoo.
I kind of expect that pharma companies would just waive all liability as a default though. Even if you're selling basic ultra-safe paracetamol, the cost of one random person dying and their family trying to blame your pill for it could easily be high enough that it's just easier to say "buyer beware".
There should be some default, but it should be alterable in contract.
One possible default is that the manufacturer is only liable for whatever they explicitly state on the box or in the leaflet. Then the "contract" doesn't need signatures, so it has little transaction cost.
If the box only states that it contains 30 pills of 5 mg fluxomoxacil each plus these-and-these excipients, they have fulfilled their duty as long as they actually give you 30 pills of 5 mg fluxomoxacil and excipients, regardless of what effects that has on you. You probably shouldn't take this unless it's recommended by a doctor who knows what fluxomoxacil does.
If they state that here is the list of side-effects and their prevalences, they are liable for any side-effect that's not on the list or more prevalent than that. If they also say that they limit their responsibility to no more than $100,000 per patient, that applies.
If they state that they have done FDA-standard clinical trials (or some FDA-equivalent if the FDA is not preserved even in an advisory role), and here is the list of *known* side-effects and their prevalences, they are responsible for that being true, but not for any unknown rare side-effects.
If there are many scandals of people dying from unsafe drugs, people will pay more for drugs that make stronger promises.
This is definitely what I expected the lib answer to be: liability law makes all the above manageable.
But thats where they lose people, who respond have you actually SEEN liability law? Its insane.
For my part I could believe liability law is the lesser of two evils, but would appreciate more effort showing its not quite as terrible as everyone thinks it is.
Started fine, but I felt Scott had already done other - dare I say: better - suggestions for reform, didn't he? With a four star system of FDA approval, I vaguely remember. Not just: new supplements - experimental - the ol' stuff. On SSC I a quick search only turned up https://slatestarcodex.com/2013/11/26/a-letter-i-will-probably-send-to-the-fda/
which is a fine but different story. Was it on ACX?
That said, the new supplements should make all libertarians happy enough. Though I wonder: Won`t many of the bad outcomes described for an "FDA deleted" still apply?
I agree with you that making the FDA optional (which is sort of what legalizing artificial supplements would do) is a better solution that abolishing it. Selective deregulation is not the same thing as a free market, at all.
I don't think your "abolition would be bad" arguments are quite as strong as they appear, though. I don't think supplements are the only relevant comparison. Their high degree of safety and low price (for the most part) goes a long way to explaining the paucity of evidence. I also think the existence of the FDA drives more dubious claims into the supplement market. Take the personal computer market for example. There is reliable evidence about performance and reliability characteristics which experts (e.g. system integrators) can reliably interpret to recommend things to lay clients, sort of like doctors do for medicines. There's no compelling case for a regulator here. It is not the case that a PC hardware company can make a terrible product and make billions in sales anyway with slick marketing.
I think the ideal starting place for reform is insurance, not drug approvals. Meaningful price signals are necessary for a functioning market.
So instead of infinite paper clips killing us all, we’ll have an AI torture us to death with medication „studies“ GlaDOS-Style, because the best representative study is of course testing everyone on every drug. For science!
I like your two proposed solutions, but I disagree with your assertion that "if you throw the average 2023 American into the jungle, they will die within days." People would certainly be unhappy and uncomfortable, but I think humans are far more resilient than you give them credit for. When push comes to shove and a human's life is on the line, they have a strong tendency to get over themselves and figure things out.
The jungle is harsh, and survival is hard, and your life expectancy is certainly going to go down. But you aren't going to just lay down and fail to find water or stand by while a tiger gnaws on your leg. Take a look at Uruguayan Air Force Flight 571 for an extreme example of how modern humans will "figure it out" when they need to.
I think if we remove this assumption that humans are incapable of "figuring it out" without the state telling them how to live, then the "just delete the FDA and DEA" solution becomes "viable" (for some definition of viable) and at least worth considering IMO. Your alternative solutions may come up superior depending on how you measure success, but I don't think they are automatic wins no matter what metric of success you choose.
"Throw us into the jungle 2024" is not a great election campaign slogan, irrespective of whether the average person would eventually learn to eat a raw jungle mouse!
If the goal is "to get votes" we have strong evidence that "regulate more" is the optimal strategy (because people that advocate for that historically get elected, while people who advocate for any regulatory reduction don't).
If the goal is to have a plan that may plausibly work over the long term, then Scott's suggestions or the "just delete them" fulfill this requirement.
It would be cool if Scott's plans were sufficiently friendly to the average voter to get them to vote in a direction of such things, but I'm quite skeptical on that.
By that metric, I think both of Scott's proposals are out as well. This is a serious problem with current US politics IMO; there is no "political will" to remove/reduce regulations, only to increase them.
So either we are discussing options that could solve the problem, regardless of whether they are something a politician could run their platform on, or we accept that for now there is no viable path to significantly reducing regulations and we discuss how we change that.
I’m ideologically opposed to almost all consumer protections of which the FDA is maybe the best example. So let me tell you about my libertarian fantasyland, in which consumer protections have been eliminated. People prefer safe food, drugs, etc; so let the free market figure out how best to meet their needs. I imagine that a complicated mixture of partial solutions would emerge:
Liability is one important solution. Even without the FDA, you should still get sued if you lie about your drug and it makes people sick. Maybe drug vendors are still required to purchase liability insurance. This should cover a lot of concerns about potential harms, e.g. “Are we also eliminating factory inspections?” Answer: yes, as long as you can afford the insurance!
How do we deal with BadCorp? Maybe I’m naive but I am a lot more optimistic about certification than you seem to be. “NEVER RECOMMEND UNCERTIFIED DRUGS” is exactly the sort of simple norm which I suspect would be very easy to install in the medical establishment. Similarly, I think it would be easy to establish a protocol where certification bodies publish whatever data the smart doctors need in a standardized format.
> you should still get sued if you lie about your drug and it makes people sick.
Correct me if I'm wrong, but your comment seems to be treating "lie" and "makes people sick" as if observers can easily reach consensus on when these occur. If a company promised that e.g. bleach injection was a safe cure for COVID-19, and most bleach-injectors died rapidly, then that would probably work.
The more likely scenario in FDA-free libertarian fantasyland is that no new drug is rapidly fatal as often as bleach injection would be, and thus it becomes hard for observers to reach consensus without... studies.
But what sort of studies?
As Scott wrote,
> The only reason we have big, less-than-completely-manipulated studies is that the FDA demands it, and employs lots of experts to figure out which studies have been manipulated or not.
Why should the judicial system take over the FDA's role in mandating big, less-than-completely-manipulated studies? Why would we trust judges and juries with data analysis more than we trust FDA bureaucrats?
If that's not what you're proposing, then how are the lawsuits resolved? On the basis of small, completely manipulated studies?
For all its faults, one of the benefits of the tort system over a bureaucracy like the FDA is that if nobody with standing objects, then the former does nothing. The FDA will prevent dying patients from using experimental drugs, even though these people would never bother suing the company for selling them experimental drugs.
" Even without the FDA, you should still get sued if you lie about your drug and it makes people sick."
So how libertarian is this fantasy land? As libertarian as Negidius describes above, where you can put whatever you like into your own body, and same with factory inspections? Or some at least requirement that hey, test this first to make sure it isn't likely to kill people?
You could sell a drug in good faith and it turns out that for the 1 in 100,000 people it has very severe side effects. Is that lying? What happens to the people who do get very sick or even die once your drug is being sold to millions, so the 1 in 100,000 figures add up to 'quite a few'?
We've historically had the environment where "sell what you want, take what you want, and buyer beware", and that's how we ended up with the FDA and similar bodies. Maybe we could go back to "let's put substances in beer to make it even more intoxicating*, and if by selling hundreds of millions of pints of it, it turns out to kill quite a few people, okay now we know", but would the public accept the chance that "today it might be *you* who dies from an additive or sloppy manufacturing"?
And if it's "contracts and lawsuits all the way!" then manufacturers are going to stick to making very, very safe and anodyne products, and so not much in the way of innovation in drugs. Yes, you might get a new drug that does in fact treat Alzheimers if you start people on it aged 50 before any symptoms, but maybe it could be useless (but harmless), or maybe it could produce very bad side effects. Then you get sued for breach of contract and go bankrupt and lose everything. Better to stick to making indigestion remedies, those are a sure-fire money spinner what with people putting lead in the bread and chalk in the milk.
"Anamirta cocculus is a Southeast Asian and Indian climbing plant. Its fruit is the source of picrotoxin, a poisonous compound with stimulant properties.
...Although poisonous, hard multum is a preparation made from Cocculus Indicus, etc., once used (by 19th century brewers) to impart a more intoxicating quality ("giddiness") to beer than provided by the alcoholic content alone. Charles Dickens referred to those engaging in such practices as "brewers and beer-sellers of low degree,... who do not understand the wholesome policy of selling wholesome beverage." Although appearing in many homeopathic volumes and at least two brewers' guides, the use of such preparations was outlawed in England, during the mid-19th century, with fines of £500 for sale and £200 for use of the drug."
Government outlawing and fining usage? How unlibertarian of them!
Yeah that's one of my many problems with libertarianism in general: it's entirely reactive. Ultimately the only check on any kind of behaviour is reputation, so if you're a careless or malicious actor without an established reputation, then you can spread careless malice to your heart's content. Sure, millions of people might die eventually, but you'll rack up megabucks (or megagold, I suppose) in the process, so it's still totally worth it.
If that actually becomes a problem, people won't buy from companies without an established reputation (or perhaps a company with liability insurance from an established insurer).
Beer is a serious issue. I grew up believing the "Commandment of Purity", otherwise translated as "Order of Purity" (https://en.wikipedia.org/wiki/Reinheitsgebot) was an old and universal german law. In fact there were many beer regulations and practices in Germany even after it had become something like one state. The history of beer regulations goes to show people have struggled about their choices of poison for many generations. And there have been quite interesting poisons in ancient beers.
I don't know. I'm a metallurgist (sort of) in industry, and considering the insurance, third party verification, etc involved, se still find fake mill certs and weld consumable certs. The industry is known to literally fly our own people to the manufacturing yard to work there full time just to check that they're doing exactly what they're saying they are, for the duration of the project (1 -3 years).
This works for fabrication of large metallic structures because you can catch any issues before you put people on the structure and it collapses. I don't see how you'd reasonably manage this for drugs, which is a continuous manufacturing environment, where you'd have to manufacture millions of tiny things perfectly for decades unto decades, AND THEN also oversee the entire supply chain.
Even with regulations I know a dumpling store that's been fined for health and cleanliness violations like 3 times. I've eaten there and I was fine, but I didn't consent to the 1/500 chance of getting whatever foodborne illness I was risking to eat there. I have absolutely no doubt that restaurants would be regularly serving food dropped on the floor if there wasn't an authority to shut them down. Maybe an independent outlet that audits the kitchens and publicises the findings, including refusal of inspection?
Nothing wrong with a bit of reform on the margin - but I'm left somewhat puzzled, since the usual contexts in which I've heard cries of FDA Delenda Est...wouldn't seem to have been much ameliorated by the given proposals? The baby formula thing, covid tests, ERB tribulations, perennial skirmishes over stuff like insulin and EpiPens, bioethics, and so on. (Plus the governmental medical hydra having too many overlapping heads, not just the FDA but also the CDC, DEA, WHO...) I guess I always took the slogan to be, let's think harder about tradeoffs and what we really want to accomplish, rather than "literally abolish the FDA". But maybe I'm making the same category error as happened with "Defund the Police" and similar...
I don't think you want approval to be automatic, because then you only need to suborn one G7 regulatory agency to effectively suborn them all. But there should absolutely be a fast-track process which usually requires no further clinical trials.
A better approach IMO would be to not automatically approve anything, but not forbid such medicines either.
To the consumer, this would look like "This $Medicine is approved in the EU, but not the other six, so I could get it in the US, but I've heard some sketchy things about EU approval, so I dunno...". Or "$Medicine was approved by three G7 agencies; pretty good chance it's legit". To the FDA, it would look like they no longer can gatekeep medicines, but they do still hold value in that if they're one more agency that approves $Medicine, that many more people will accept $Medicine. To a pharmaco, it looks like the more agencies approve, the better their sales, provided they don't bribe any of those agencies and get caught and cause consumers to balk at an agency approval that subsequently doesn't count.
I take your meaning as that there's enough money there to motivate someone to actually try and bribe all G7 agencies.
I don't think there's *that* much money in getting any one drug approved, but even if there were, there's also money / fame in uncovering that level of bribery, which is why this is offered as a remedy. Try to bribe one G7 agency and you *might* manage not to get caught. Try to run the table and it's too likely that someone will notice.
> I take your meaning as that there's enough money there to motivate someone to actually try and bribe all G7 agencies.
No, or pharma companies would already be doing it. But there might be enough money there to try and bribe *one* G7 agency, in a world where they all auto-approved each others' decisions so you only needed to bribe one. Also, I don't expect anything so crass as outright *bribery*, just extensive lobbying and an understanding that whichever country's agency manages to be the most... *flexible and responsive to the needs of the industry* will reap rewards in the form of increased investment, more competitive drug costs, all that sort of stuff that nation-states care about.
If you're worried about auto-approval, then check my response to E Dincer; you and I are in the same camp. I also agree that influence would more take the form of bribery's little brother.
This specific exchange all started with your last reply to E Dincer. Maybe I misread what you meant. I thought E Dincer was saying it'd be too hard to influence four G7 agencies at once, and you countering that there's enough incentive for someone to try.
Now, it sounds like you're saying there's incentive for one G7 to be more flexible and thus get a lot more investment. In that case, I notice there's a risk. People aren't obsessed with getting any drug at all costs; rather, they want the drug *that will make them healthier*. If one G7 decides to approve nearly everything in exchange for investment, it risks being seen by the public as exactly that. The public will see a drug approved by one G7 as maybe not that great. Many of them will not be convinced, which means that G7's approval will not be worth that much to investors. Knowing this, G7s will be less likely to certify everything unless they are certain it will meet a consumer need.
There is a case that at the moment the balance is sufficiently far in the direction of safetyism from the optimum that "most lenient and corruptible regulator in the G7" is probably still too strict.
Certainly possible, but it's a moving target and there are trillions of dollars at stake. Recall the Pentagon's definition of trust: a trusted component/system/person/organisation is one that can unilaterally break your security.
The FDA like other regulators is the way it is in response to government demands. So the practical solution is lobby representatives, executive branch and public opinion so the balance of incentives is less in favor of "avoid approving anything because it's a scandal if anything mildly bad happens" to "approve things because it's a scandal if medications aren't approved"
Trying to shift the public opinion in that direction is one of the things we do when we assert that in its present form the FDA is so bad that it would be better to abolish it.
Ah, in the same way that we shift public opinion towards creating more competent and higher paid police departments with the slogan, "Defund the Police."
Yes, but (some) people saying "abolish the FDA" think the status quo is actually worse than abolishing the FDA, even if they might agree that an FDA reformed in a particular way would be better than either. I was responding to a comment by Randomstringofcharacters which argued that lobbying to reform the FDA was preferable to abolishing it, not that the status quo was better than abolishing it. If you are arguing that the status quo is better than abolishing it, then that's another discussion.
I do happen to think the status quo is better than abolition. But you seemed to be asserting that “abolish FDA” was going to sway people “in that direction.” My point is that, like “Defund,” you are far more likely to sway most people in the other direction. “Defund” and “Abolish” are both poor slogans as a measured approach fuels less anxiety which fuels much of people’s decision-making.
Primarily, your prior seems to be that the FDA is more or less working (if not necessarily working optimally), wheras the libertarian prior is that is not. There are other comments around here that address that already.
With regards to the liability issue, this is a total red herring. If doctors had concern about liability on perscription, they would form agreements with drug companies that the drug companies would assume liability when the drug was prescribed. If they would refuse, the doctors would refuse to prescripe their drugs. This would have the advantage of drug companies refusing to sell drugs they assumed liability for - a superior situation to now where nobody has liability for bad drugs that are none the less approved.
Some libertarians' view is that the FDA works very well to eliminate unsafe drugs (not always 100% perfectly but that's impossible); the enormous harm they do is in being too strict, not in not being strict enough.
(Actually, even in the current system, nothing prevents a drug manufacturer from accepting more liability than required by law; if unsafe drugs were a major problem even with the FDA existing, people would pay a premium for a drug whose manufacturer accepts more liability than required.)
I don't understand why all the dangers of unregulated drugs that you're worried about don't also apply to unregulated supplements? And why, in spite of those working largely all right, you still think that there's something special about drugs that the FDA solves?
I'm pretty disappointed – not with you but with the post. That's probably because of the shadow cast (in my mind) by the alternate 'full-on Scott Alexander effort post' I know you *could* have written!
Some 'glaring' absences from this post (at least as compared to the post I expected):
1. Prediction markets!
2. David Friedman
3. Robin Hanson
4. Kosher certification agencies
5. The history of the FDA
6. The history of 'food and medicine' *before* the FDA
7. Differences between the FDA and its cousins around the world
One concept that's helpful when 'refactoring' parts of a big/complex/complicated software system is 'backwards compatibility', i.e. preserving the 'public interface' of a part (as much as possible). That's definitely something that would be at the top of my mind were I to be charged with abolishing the FDA.
Responding to some of your points or questions:
> Do you also want all medications to be available without a prescription?
All medications are *already* available without a prescription – we're just 'talking price' as Zvi likes to write.
It's already the case that there are many many ways for people to kill themselves, or die accidentally. A perhaps shocking number of people *currently* die from overdoses of Tylenol (acetaminophen/paracetamol), let alone the consequences of alcohol.
> But if we don’t eliminate prescriptions, how do you protect prescribers from liability?
In the hypothetical world where the FDA *is* abolished, the U.S. Congress would of course pass some sort of (short, readable) bill protecting prescribers as they are now – for drugs already approved by the FDA – and create/fund some new system for new 'drugs'.
> But if there are thousands of medications out there, from miraculous panaceas to bleach-mixed-with-snake-venom, then it becomes your doctor’s responsibility to decide which are safe-and-effective vs. dangerous-and-useless.
I don't think the world as it is now versus one in which the FDA has been abolished is that different. Some people, including doctors – that are not employees or contractors of the FDA – are already deciding these questions, even given the existence of the FDA.
> Are we also eliminating factory inspections to make sure drugs aren’t contaminated?
The 'private FDA alternatives' could do this – or test the drugs afterwards instead. I'm not *definitely* sure that the current inspections 'turn a cost-benefit profit' now.
> How do we deal with the fact that many doctors are dumb?
Presumably, we'd use our abilities/affordances/etc. that we're currently using to deal with the fact that 'the FDA is dumb'.
> How will the smart doctors get the data they need?
It's already *terrible* epistemic practice for pharmaceutical companies to be responsible for studying whether their products are safe and effective. Insurance companies are one good alternative candidate!
What's extra surprising to me is that he writes about an adjacent market - supplements - that has all the basic potential for harm that drugs might, acknowledges that it largely works, but doesn't factor this into the anti-FDA abolition argument a few paragraphs earlier at all
I think his point about supplements – with which I mostly agree – is that there is no useful/practical 'epistemic consensus' regarding supplements, and there is a reasonable worry that 'treating everything like supplements' would be worse, at least along that dimension.
I am – personally – more along the 'think for yourself' end of the 'epistemic status' spectrum. I feel too strongly that doctors and medical researchers just don't grok statistics really at all. I also have had a recent vivid demonstration of the efficacy of concerted 'medical advocacy' – even in an area of medical practice that is, apparently, actually really pretty good nowadays.
The useful consensus is that there are a lot of substances that have the potential to be dangerous, that are marketed for benefits, with largely no regulation, and there are no massive problems of the nature that he's envisaging with drugs
Sure – that's the tradeoff that exists under the current equilibrium, which includes the FDA. I think it effectively relies on the approximate fact that supplements just mostly don't do anything, unlike many many prescription drugs.
I was hoping Scott would write about the _additional_ arguments that, even for drugs that ARE significantly dangerous, evidence from, e.g. people in other countries in the world as it is today, point towards people being MOSTLY responsible still. There are also lots of weaker wonkier arguments about reasonable changes that could be made on the way towards the 'libertarian extreme'.
Supplements just mostly don't do anything is an emergent fact about the kind of supplements that are marketed, not an absolute fact about all the supplements that are possible! There are plenty of risky substances out there that could theoretically be marketed as supplements but aren't, without any thing like the FDA being needed to prevent it.
Regarding elimination of prescriptions - there are certain countries (such as Russia), where most non-narcotic medications (including warfarin, for example) can be purchased without any perscription.
The Russian population does not seem to be bleeding to death in large droves yet.
It does lead to overuse of antibiotics, because a lot of people think you can treat flu with them. Recently, I think, most antibiotics became prescription.
Antibiotics is actually an interesting case that is not mentioned in the article (or most comments). By taking antibiotics when they are not needed, you might not harm yourself (so lawsuits, either against producer or doctor!), but you make everyone's life a bit worse by possibly contributing to rise of resistant bacteria. To me, this is clearly a "tragedy of commons" type scenario, because effects of abuse are removed in time and space, and therefore market cannot respond to them well.
Thank you! I can't believe you're the first person to point out that there are a BUNCH of countries that let any non-fun meds be had over the counter with no prescription. Just off the top of my head and based on my own personal experience, Russia, Philippines, Colombia, Costa Rica, China, and more.
I actually assumed that MOST non-western countries don't require prescriptions based on my experiences.
I can only find a source from 2012 with cursory searching, but going by the countries of the world graphic here, that's largely true:
So if that map is still accurate, indeed MOST countries in the world don't require prescriptions for non-controlled drugs, and they're not all bleeding to death from recreational Warfarin abuse and such - why is it so much to expect that richer, more educated (by % of college degree and HS graduation) Americans can't handle the same degree of freedom that the great majority of the world enjoys?
That map is not about non-controlled drugs in general, but one particular (class of) drugs, contraceptives. That those are available without prescription doesn't mean warfarin is.
Thanks for pointing that out, I hadn't realized and thought it was more general. I'll leave it up without editing so your comment continues to make sense in context.
I just spent another 15min or so trying to find some sort of list or map that's more comprehensive, and it's just a mess of standards and arbitrary dividing lines for prescription / non-prescription, dangerous / non-dangerous / household remedies and more across every country.
Given my own personal experiences, I still think the default in non-western countries is "most non-fun / non-dangerous US prescription meds are over the counter," but I can't find any cite that rigorously supports that, so I'll just have to cite my own anecdata for now.
A suggestion from the land of socialised medicine: split the safety-monitoring agency from the recommendation agency. In the UK these jobs are done by the Medicine and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) respectively. You can tell they were created by doctors, because neither of the abbreviations work. MHRA tests drugs for safety and basic efficacy and operates a side-effect monitoring system for licensed drugs; NICE decides which drugs are cost-effective enough to be available by-right on the NHS and publishes clinical guidelines. Both of these should still be government bodies, because that creates a useful Schelling point. But right now the stakes for the safety half of FDA are very high: they know that if they approve a medicine then everyone and their dog will start prescribing it. A two-step "yes, this is safe", "yes, this is recommended" lowers the stakes considerably, and allows for some time to gather real-world effectiveness data before advancing a drug to "recommended". Basic insurance could cover only drugs recommended by USA!NICE, less-basic insurance could cover all drugs licensed by USA!MHRA, gold-plated insurance could cover only drugs rated as safe, etc.
Also, USA!MHRA should fast-track approval for drugs approved by MHRA, EMA and other peer-nations' regulatory agencies, none of this "very nice, now do the trials again but in America" nonsense (and the other nations should reciprocate). It's a trillion-dollar bill lying on the ground.
Incidentally, it turns out (https://www.nhs.uk/conditions/medicines-information/#how-new-medicines-become-available) it's not illegal to prescribe an unlicensed (not MHRA-approved) drug in the UK! In Soviet Britain, everything that is not forbidden is permitted. I don't know how that works in practice - you might need to pay for the drug privately.
Originally the FDA did just verify that factories weren't contaminating their outputs. But you can't trust a government agency to stick to its original justification.
Rather more Brits and Europeans than Americans :-) Though my information diet does contain a lot of American sources, especially when you restrict to the libertarian-inclined outlets: libertarianism is much more niche over here.
I have thought of a concrete example, though! Remember how there was a delay of several extra weeks before the FDA approved the first Covid vaccine? That didn't happen here because the MHRA did a "rolling review" process, where they started the review as the trials were still going on: https://nibsc.org/about_us/latest_news/c-19_vaccine.aspx That suggests to me that the MHRA has its shit at least somewhat more together than the FDA.
I'm wondering if there's issues like this with other major libertarian policies I like. Would straight up ceqa/NEPA or JA repeal remove any load bearing pieces of policy?
I assume so - all those agencies were established for reasons, and it would IMHO be surprising if they have *no* effect on the thing they were established to combat. Simply abolishing NEPA would probably result in a bunch of environmental damage; simply abolishing the Jones Act would wipe out the existing US shipbuilding industry and put a bunch of American sailors out of work. The benefits may be worth it, but the costs would not be zero.
IIUC NEPA isn't the main barrier to real environmental damage (which is covered by other laws - it's noteworthy that fossil fuel projects are already exempt from it anyway). It's possible that this is a bigger problem than I realize, but if so I'd like to see some stronger more specific example of something that would go wrongs.
Re Jones act, that's the expected effect (which I think is fine in the context of the national economy). The question is whether there's unexpected effects that would be bad.
I don't think the argument about them being established for reasons necessarily holds water - they were established in a very different context (and are specific laws, not major agencies with multiple responsibilities.
Good catch on the agency vs law distinction, thanks.
I think we're mostly arguing about priors here: my prior is "sure, the context may have changed enough such that the law/agency no longer helps with whatever caused it to be established, but you need to do work to show that".
> Re Jones act, that's the expected effect (which I think is fine in the context of the national economy). The question is whether there's unexpected effects that would be bad.
You don't think that ensuring the continued existence of a shipbuilding industry is load-bearing? I'll happily agree that the Jones Act does a very bad job of ensuring the continued existence of a *competitive* shipbuilding industry, which was presumably the original intention. And it's effectively failed at maintaining a Merchant Marine that can be called upon in times of war, because the US Merchant Marine is tiny. But (AIUI) it does succeed at keeping shipyards open for the Navy's use. If you abolished the Jones Act overnight you'd either need to pay even more astronomical costs for warships (since now the US Navy is bearing the entire burden of keeping those shipyards open) or buy warships from elsewhere and suck up the increased scope for supply-chain attacks. I don't know how you could repeal the Jones Act (which I agree would be positive EV) without that problem - perhaps some kind of subsidy for the industry coupled to export discipline?
If shipyards were kept around via the government paying whatever it costs to build warships, and at that point the *marginal* cost of building commercial ships as well is competitive with foreign builders, then they would build commercial ships. If even the marginal cost of building commercial ships is uncompetitive, then it shouldn't be done.
The government *would* have to pay more for warships, but paying for it explicitly like that, via broad-based taxes, would probably cause less deadweight loss than paying for it via the implicit taxes created by the Jones Act.
There's actually an amusing situation where Terraform Industries has an immensely easier time getting solar-powered CCS approved by sort of pretending it's a fossil-fuel plant for regulatory purposes.
I think one outcome of this change would be a big resurgence in brand names in pharma. Without the FDA, consumers would turn to big pharma brands and manufacturers to be drugs that they can trust. So, they might start to ask their doctor “is it made by Pfizer?”
Another thing the FDA regulates is the advertising on drugs. We would start seeing a lot more “generous” ads for all the wrong drugs - but eventually the big brands would own this space
But, that’s only the people that won’t take the first med they see a $1 Facebook ad for that’s targeted on their condition. There’s a solid 10% of people that would be really missing FDA protections. But, those are the same people eating a ton of weird supplements.
Soon - life would stabilize. Just like how there’s no agency running what programs are safe for our computers, people generally would be very cautious and employ blockers/expensive services that would sometimes be counterproductive. But eventually we humans would find a system that just works for 90% off decisions. Probably a regulatory board the big manufacturers sign on to or something in collaboration with each other.
In fact - “big manufacturers create a safety board to regulate each other and scale up all their collective appearance of safety”… might solve most issues and questions?
Two reforms I'd like to see: (1) FDA recognizes other first world country approvals of drugs, and (2) for approval in the U.S., safety is required but not efficacy. Do those two things and maybe I won't want to abolish the FDA anymore.
Wouldn't that lead to big pharma companies jurisdiction shopping for the most lenient regime recognized by the FDA, and then that in turn motivate some jurisdictions to become "drug approval" havens?
Of course if you don't require efficacy jurisdiction shopping is less of a problem, but I find that I do think efficacy is pretty important.
> Wouldn't that lead to big pharma companies jurisdiction shopping for the most lenient regime recognized by the FDA, and then that in turn motivate some jurisdictions to become "drug approval" havens?
Yes. There might also be downsides!
Joking aside, I think the FDA ought to un-recognize any jurisdiction that has a history of shenanigans like this.
Joking aside, what would happen regarding the, possibly thousands, of drugs that were previously recognized on the basis of being approved by the now disavowed jurisdiction? Would they be 'grandfathered' in even though we now know they never went through a rigorous approval process? Would they become unobtainable possibly leaving many patients in the lurch? Would they receive some sort of special status until the studies were redone in a still recognized jurisdiction?
Also wouldn't the FDA be reluctant to un-recognize any jurisdiction whose approval process was the only basis for any substantial number of FDA drug approvals even if the approval process was inadequate, because of the chaos and PR disaster that would cause?
Hmm... I suppose one mitigation might be to simply stipulate that you need at least two trusted countries to approve the drug, rather than just one.
I'm maybe onboard with the second idea. But, practically, every drug manufacturer or marketer will maneuver through this experimental category first for access reasons. They will point to their products' successes as experimental drugs as proof that they're fine, and seek (or possibly require) testimonials from doctors and patients using these drugs as a means to convince more doctors and patients to use their products. It would not take long at all for an experimental drug ghetto to form. Heck, that could be the business strategy of several companies.
If we also manage to get IRBs up to a level of sanity where they don't consider it unethical to study the results of something that's already in widespread practice, that wouldn't be a "ghetto" drugs get trapped in, just an important stage in the development process. People willing to try experimental stuff contribute to datasets on efficacy and subtler or longer-term risks, which then eventually lead to enough formal confidence for full approval or rejection.
"Even those tiny handful of bad outcomes mostly involve a few well-known chemicals like caffeine and other stimulants."
Sorry for my ignorance. Is Scott referring here to consumers OD-ing on caffeine, or is there some well known manufacturer malfeasance that I am unaware of and that escapes my ability to Google?
Not an true overdose, but in the sense that excess consumption triggered something bad that they happened to be susceptible to (probably deadly heart rhythms or heart attack)
“But if you throw patients and doctors - fat and lazy from decades of trusting other people to do their thinking for them - into the unregulated medical jungle, it will take a generation before they’re able to do anything except flail and die.”
Well, I think it will take forever before they do anything besides flail and die. It’s not a matter of being fat and lazy; knowledge about modern complex systems is too massive for anyone to master. Descartes tried to do this in the 17th century—refuse to believe anything that he personally hadn’t derived from first principles—and failed. When a world-historical genius like Descartes couldn’t pull it off in a simpler time, we’ve got no hope. ClinicalTrials.gov says there are close to half a million registered studies this year alone. Patients can’t understand the dosing instructions on a bottle of pills and practicing doctors would have to read [checks notes] a thousand studies a day. This is why we have a division of cognitive labor built on trusting others.
You know what's good at divisions of cognitive labor? Free markets. With the FDA, we're forced to "trust" a bureaucracy imposed on us, with the result being people like Jake Seliger not being able to get the medication that could save their lives.
Not opining on how well a free market would work here, but there is no negative externality here, since people taking the drugs are doing so voluntarily.
Suppose we allow everyone to buy hyperheroin all they like. All the subsequent drug addiction leads to others dying by DUI drivers, costs to the economy, and medical costs borne by taxpayers, plus the human cost to their families. These are negative externalities.
Or suppose we have an outbreak of a very contagious and extremely lethal disease, but we also have a highly effective (but not infallible) vaccine. People can either get the vaccine or not on the open market, but there is no mandate. Without a mandate, many more people who were vaccinated (but it didn't take), or wanted the vaccine but didn't get it yet will die. These are negative externalities.
You're right about vaccines having externalities, but heroin is another story. People on heroin tend to nod off rather than engage in activities while high. DUIs are mostly alcohol, which is legal.
I think the problem there isn't about specific durations, it's the basic assumption of a fixed-term, fixed-price monopoly. Georgist LVT seems potentially applicable - make patents indefinitely renewable, but with a cost set by competitive bidding, so patent trolls can't simply squat in the path of progress and collect rent, they need to be delivering actual value above replacement. That'd still incentivize innovation since the creator presumably has inside info on how well something works which other potential bidders wouldn't.
Better general approach to recouping drug development costs would be something along the lines of posting bounties. "If anyone can provide a treatment meeting such-and-such standards of safety and efficacy, I will buy the first X doses at $Y each." Possibly even with a formally-defined sliding scale of price based on the specific level of performance demonstrated. An escrow agency of some sort could deal with p-hacking shenanigans, and prediction markets or other financial derivatives could cover situations where a particular treatment seems like an obvious winner, but would take an unreasonably long time to technically meet the full criteria, and the researchers need some cash immediately rather than decades down the road.
I'm not for banishing the FDA, but the libertarian idea has some grain of truth at its core (like all of their bad ideas do): Get on the FDA's list of product recalls.
On the one hand, it is good to know something is going on. But once you see the scale, it is clear just how little the FDA is actually doing proactively as opposed to reactively.
The other part of this is the creeping bureaucratic Kafka-esque regulatory creep going on in the US and Europe. Anyone in a remotely consumer consumable industry feels this - the regulations are getting beyond crazy: circular economy packaging documentation. ever more picayune "contaminant" documentation. ever more ridiculous allergy notifications. testing restrictions combined with safety requirements.
It is a wonder that any small companies sell anything at all.
And to be fair, this isn't just the FDA at work. Congress passed a new law requiring new safety overview of cosmetics: MOCRA. The portal is supposed to go online in December - the betting is running heavily that it will not hence the FDA announcing already that it won't enforce for 6 months. But does that mean the ambulance chasers can't sue for 6 months? It does not.The arguments presented above are operational - but the primary reasons to question the FDA are mission oriented.
What exactly is the FDA's mission?
How exactly should the FDA be achieving this mission?
How should the FDA be getting graded in its pursuit of its mission and who would be the oversight authority?
Considering that cosmetics don't actually do anything and it's all a 10000% markup on the cheapest imaginable ingredients, the companies in question could just reduce the ingredient list down to oil and pigment thus avoiding 99% of the regulatory oversight. Had they had the sense to stop including ingredients that they have known full well were cancer causing 10 years ago, then the regulation would likely never been conceived of.
If not, I'd say you have zero basis for commenting on this use case.
Nor is the rest of your comment based on any form of reality.
Are you aware that animal testing is no longer allowed? So how exactly should any products be verified as safe for humans?
Nor does having a "simple" ingredient list, sufficient for "avoiding 99% of the regulatory oversight" - you have no idea what regulatory regimes are these days.
VOCs - i.e. the evaporated ingredients are now controlled.
Labeling on packages to comply with individual national and state regs is a thing, so are language support and adverse effect reporting. The packaging itself is required to undergo all manner of disposal, content, circular economy type reporting.
It is not and never has been primarily about safety.
For example: Japan has a limit of 0.0% formaldehyde in cosmetics. The US doesn't even test to that level. But formaldehyde is literally CH2O - it is a water atom with a carbon atom added on. Or in other words, naturally occurring, meaning "organic" products will often have it in them in a very small amount.
So is formaldehyde safe?
In reverse: natural food colorings are effectively banned in the US in candy. All US foods have to use artificial colorants. Is that safer?
For perspective on the safety/freedom tradeoff question, it's helpful to expand your analysis to areas outside of healthcare. Consider, for example, power tools. You can walk into your local Home Depot, slap some money on the counter, and walk out with a chainsaw or a 24"-diameter concrete cutting saw. No forms to sign, no questions asked, no licenses required. Then you can bring these tools home and get to work.
Depending on what you do, there may be building code or zoning restrictions on modifying your property. But, assuming you have any approvals you need for that, there are essentially zero restrictions on your ability to actually use a wide array of power tools to do it. This area of activity is nearly as unregulated as it was in the 19th century.
Is a large chainsaw more dangerous in the hands of an untrained person than many healthcare products regulated by the FDA and available by prescription only? Yes, definitely. But the healthcare industry is better at using the regulatory system to defend its turf than the logging industry is.
A large chainsaw or concrete cutting saw's dangers are obvious and easily understood. There are well-known safe techniques for using them. The guy that decides to use a chainsaw to cut down a tree isn't going to fell his tree, walk away in one piece...and then five or ten or twenty years later find out that that tree felling he did a decade ago is causing serious lifelong impact. Those things that DO have effects like this have mostly been eliminated due to the industry banning the practice or regulation. Power tools are more intuitive and easily understood than many pharmaceuticals.
I think the dangers of putting random exotic chemicals into your body is pretty obvious and well understood. As is the well-known "ask your doctor or pharmacist..." technique for doing so safely.
However, we have spent a few generations teaching people that if a drug is available OTC, it is known to be so safe that you don't need to bother asking a doctor or pharmacist. In the short term, there would be a lot of problems if we made all the drugs OTC overnight.
Maybe as an interim, anything that doesn't meet approximately today's OTC drug requirements, has to be bought from a pharmacist who will explain the safety implications and any safer alternatives? This could be viewed as an extension of current warning-label requirements, to a case where the "label" would be impractically large and detailed.
Commercial ships are regulated by Underwriter's Certification. It's a market system where insurance agencies specify what regulation the shipyard must adhere to in order for the agency to insure that ship in operation. The shipyard can choose between agencies if it thinks one agency is overregulating. But, it has to choose and adhere to one in order to get insurance. I assume they can sell without insurance if they want to but either they don't or none of their buyers does
Commercial ships are regulated by performance based metrics, guarantees, and critical component inspection - particularly on welding. Navy and nuclear regulation are prescriptive. Rather than inspect dimensions and welding quality in real time, nuclear plants get to have fun things like screws that cost 100x as much as other screws from the same assembly line in order to fund the paperwork for the nuclear screws. I'm less familiar with the FDA but this sounds similar to what I read here
This sounds like it would work well for safety, and that might be enough, while I'm not sure it can work as well for efficacy since whether a crude carrier operates 95% of the year is easily observable compared to drug efficacy. This suggest to me a halfway house regulation starter compromise. The market based system can be used for the 'experimental drug' category and we can see how we like it
Not that I necessarily disagree, but if you're referring to the littoral craft, that program was a notorious disaster. Nuclear powered aircraft carriers might make a better comparison?
Not the littoral craft, the San Antonio is an amphibious transport dock (vessel that launches and retrieves amphibious craft while also being a smallish helicopter carrier).
That being said, a warship and an oil tanker aren't really comparable at all, even when the tanker is bigger physically. Whereas an oil tanker is essentially a floating empty space, the cost of a warship comes from what's inside the hull. For one thing, weapons. The RIM-116 air defense missiles the San Antonio class carries are about a million dollars a piece, and the ships carry two launchers that each hold 21. Even if they carry no reloads (which I doubt), that's half the cost of the VLCC just in missiles.
Then of course you have fire control radars, electronic warfare systems, hangar and helicopter maintenance facilities. Accommodations, food storage, and water generation for about 1,000 people (a cargo vessel generally has a crew of 15-30). A 124 bed hospital with 2 operating rooms. Stealth measures which are classified but presumably expensive. The ability to take extensive battle damage and survive. Not even to mention that a warship is expected to be both faster and more maneuverable than any commercial vessel.
And yes, all of that is certainly subject to the cost disease that impacts all government (and especially military) projects. But an LPD will be a few orders of magnitude more expensive than a VLCC even in an ideal world.
Yes that's on me, I should have said "an order of magnitude". And honestly that's probably not the best way to phrase the difference here to begin with. I'll say "over 10 times the cost".
I'm a big believer in stepwise change, and there's two big strategies that tend to seem appealing: one, making things marginally more like your eventual target, and two, creating alternatives to whatever system you want to do away with so they're already ready to go when you finally remove it.
Your two proposals both do #1. Honestly making the FDA judgment of "this is safe" distinct from "this really works" seems like a great idea. For #2, we have to really beef up the reputations of expert-run NGOs that make recommendations about supplements and/or experimental drugs.
And then, after more steps like that which we haven't yet mapped out, we can eventually actually abolish the FDA without chaos because it will have become a vestigial agency while the functions we needed it for were being performed in parallel in ways that don't suck.
There are a couple more possibilities, my favoured one though the one we do in Prospera that is basically "start from scratch & first-principles" that looks something like:
- Create voluntary FDAs, with a certificatory approach under competitive dynamics
- In practice still follow the same safety standards, innovate conservatively - the much bigger regulatory hurdle is efficacy trials, much less safety; I feel comfortable with efficacy just going out the window and for other market solutions to emerge just like that (e.g. consumer reports)
- There is still medical freedom, if you want to take it - you can take it (in Honduras limited by criminal law, e.g. for psychedelic drugs, but not for most other areas); have strong liabilities in case things like "informed consent" are violated, so providers make extra-extra sure there's informed consent
Within the existing system any reform proposal is a theoretical possibility and tetris-playing exactly like you suggest. If I had to pick two possibilities that are promising it would be:
a) Expand "right to try" laws as much as possible
b) Abolish not to the whole FDA, but start with abolishing efficacy trials
I do think (2) would be a huge improvement. If you really want to get crazy, add a standardized-but-optional data collection method to make the new pathway a way to provide an automatic, IRB-less, Phase 4 trial on efficacy, like a discount for providing feedback.
Could make "collect relevant data from willing patients and make it available to all public-sector researchers" an explicit condition of the safe-but-not-proven-effective status. Ongoing compliance cost would help motivate drug companies to push toward formal efficacy certification sooner rather than later, even though they're already collecting revenue without it, whereas if it's optional they'd avoid or obfuscate in order to deny intel to their competitors. When some random grad student can potentially get a cash-cow drug's license suspended just by complaining that data is being shared in an inconvenient format, hopefully some vast engine of bureaucratic ass-covering will focus its terrible gaze on the task of best-practices UI design, making the scientist's job easier.
What about little things like reciprocal approvals with the EU's EMA, the UK's MHRA, Japan's PMDA or other qualified groups?
I would also like to see a radical reduction in which medicine requires a prescription. I think the experience in moving allergy medications like Allegra, Claritin and Zyrtec to over the counter reduced prices 90% has shown this can be done safely.
In terms of overall coverage of the FDA, having a much more open supplement level, where things are not approved for insurance coverage, but are freely available would be helpful. The FDA's recent moves against nootropics like the racetams are a net negative, and then they are trying to take away anti-aging supplements like NMN just because someone starts a trial for it as a drug.
Essentially, keep the FDA as a body that serves as approval for government insurability processes, but don't let them restrict the sale of chemicals that haven't been able to afford a study. (Although the FDA still should be involved in verifying they contain what is on the label)
The world of supplements seems far from ideal, but...arguably better? You get a lot less certainty in knowledge, but a lot more affordability and convenience. If there are two systems and one costs orders of magnitude less, you can’t just assume the more expensive one is preferable because it delivers higher quality.
Most supplements in the mainstream supplement market aren't particularly new and innovative, though, are they? Old, established generic drugs are cheap too.
One way to ground a discussion of how an alternative regulatory system could work is to look at the existing regulatory systems in the 200 other countries where things function differently.
I haven't *done* that work, but I know India and Mexico have *much* freer drug prescription regimes, and Americans travel to Thailand for procedures that are illegal in the US.
Anyone have more concrete insights in other existing system to learn from?
My brother works in biotech venture capital, often dealing with vaccine development, and he told me there are basically three medical oversight systems that matter: the US, European and Chinese systems. Other countries either accept the results of one of these systems, or have markets too small to matter.
US system has regulatory capture issues where no new regs have passed in a long time due to industry pushback. FDA can no longer govern via new regulations but relies on enforcement actions (warning letters, inspections observations) to address evolving situations.
EU has been the core (European Medicines Agency). EU is universal healthcare. If they approve a drug, they have to pay for it. So they are serious about approvals.
China is becoming a major player recently. Money and lots of potential customers. Now we have three regulatory regimes to appease....
> EU is universal healthcare. If they approve a drug, they have to pay for it.
That's not true. Approval decisions and funding decisions are made separately in the EU, rightly. Approval is mostly made at the EU level, funding decisions are made at the member country level. So there are drugs that are legal to buy but aren't subsidized. (And even when subsidized, what percentage the subsidy is varies widely between countries and drugs.)
As a small step in the right direction, we might allow patients with terminal illnesses to take drugs that have passed phase II trials. I'll just admit that I'm not sure how to handle the larger issues of informed consent, insurer duty to cover treatment, and liability for doctors and pharm companies.
Realistically, this will lead to a lot of desperate patients with slow-motion diseases like cancer paying a lot of money for plausible but unproven treatments. But I think I'm ok with that.
Organizations start out full of competence and energy. Then devolve into bureaucracy and fiefdoms over a few decades. Private companies are no exception, but the old and tired companies get out-competed and replaced by new ones regularly, keeping the herd relatively healthy.
Government agencies don't have many forces working in that direction. NASA had a typical life span. Went to the moon in a decade. A generation later, they could barely keep the deeply flawed space shuttle running. I've talked to a few people who worked with FDA and other TLAs, and their anecdotes confirm my prejudices.
So what if, every few decades, you don't *abolish* the FDA, but replace it with a new one? Give every FDA employee a $1M severance package, and start FDA2 from scratch in another city.
This could even pair well with the approach described in the post.
You could have FDA2: Experimental get started with some energetic, competent leadership. They could instantly recruit the handful of people from FDA1 that are really good and want reform, as well as all the people who would work in FDA1 one in the ideal world but find the culture/rot intolerable.
Then, maybe you start giving FDA2 the right to do full approval, maybe in some easier categories to start. Companies can choose which to pursue. Eventually they can do everything, and FDA1 will reform due to pressure, or (more likely) can be safely closed.
Go to the moon, and then repeat as needed a generation from now.
In concept, I think this is interesting. The problem is standing up an 18,000 person agency. Have you ever started even a 1,000 person organization? 100? It's really, really hard.
Harder or easier than getting ambitious reform through the existing, entrenched 18,000 people?
One of the advantages of the new, focused agency is that you actually *could* start with 100. Yes, building something like that from scratch is still hard. But it does happen!
Assuming you want reform, what's the next best alternative?
Whoops-this content was supposed to go here. Sorry for double-posting.....
vorkosigan1
just now
It depends on your metrics, I think. I think that starting and hyper-rapidly growing a new organization of that scope is likely to fail. If it does succeed, it's more likely to give those reforms, true. But I think success is unlikely.
In my dream world, you provide the existing leaders with better incentives to change. There is already a lot of change going on at FDA, but not on the scale you're talking about.
So I think it's not hard to get FDA to change; I think it's hard to get Congress to change the laws that give FDA its incentives. ANd I think it would be a lot easier to get Congress to pass reform legislation of the kind I'm talking about than "FDA 2".
It's not about being entrenched, it's about incentives. And governing laws. And it's like any other organization-while there are some stick-in-the muds, most of the people at FDA, especially at the higher levels, are highly motivated and value improving health for Americans.
So the first thing I look at is changing incentives for the existing organization.
You need legislation from Congress. Congress says "jump", and FDA will say "how high?"
One more thought on "FDA2"--the way to make that work would be start with with some sub-office of one of the FDA Centers (so like 4 levels down from the FDA Commissioner, but still sizable), and apply FDA2 reforms at that level as a pilot. See what happens, and when you have something that works, expand it.
Oh, and one more thing-it seems like there are really only two areas folks are complaining about-drug (and maybe biologics?) approvals, and ability for people to assume the risk when the alternative is death or disability. Maybe focus the legislative reforms on those two areas, which seems much more doable, than "BRAND NEW FDA" or "NO FDA".
Lastly, I'm not comfortable with assuming that EMA drug approvals are as good as in the US. I vaguely recall seeing some problems with EMA drug approvals....
I have never worked in government, but my experience of coding against Microsoft APIs tells me that the old agencies will never, ever die, and the new agencies will never take the last handful of responsibilities off them, so in practice you'll have to deal with *all* the agencies to get anything done.
Yes for this to work you'd need the will from above to protect FDA2 from FDA1's meddling -- FDA1 will absolutely kill it if they can.
I don't know enough about the politics involved to know how practical this is, but I would be surprised if it's not more practical than "just abolish the FDA and don't replace it" or "actually accomplish meaningful reforms in the existing FDA, without any lever that prevents them waiting you out"
Good point about air cover - AIUI the UK's Government Digital Service (GDS) was very successful in modernising UK government web services in the early days, but then the politicians who supported it moved on and it hasn't been nearly so effective since due to bureaucratic turf wars.
I believe there have been a few cases where a police force has been rebooted successfully: the Republic of Georgia, Northern Ireland, and Camden, NJ. I don't know of any successful hard reboots of other types of government department.
So, if the problem is bureaucracies getting to blotted and self serving (ie, Zvi's Immoral mazes), is there any solution that works from within? Not having to tear the whole thing down. Maybe like monopolies (I'm thinking Ma Bell) can we break it into parts. Have smaller FDA's in the north, south, east and west. And then maybe you get some competition? IDK it seems like a hard problem.
I think the straightforward approach is to take away the FDA's licensing powers and replace it with certification. Insurance companies would be unlikely to pay for drugs that have not been certified as effective, so there would be strong incentive to conduct major phase 3 studies and little change to consumption in practice.
I would definitely let any drug be legally sold anywhere. That said, private pharmacies may still only choose to dispense certain drugs with a prescription, so not everything is likely to be as widely available as alcohol. For the minority of people who want to self-medicate with therapeutics, as long as no one else is forced to pay if it goes wrong, I don't see the problem. People are free to mutilate their bodies or destroy their lives with bad choices.
On liability, I favor laws that create liability multipliers or divisors for failing to or scrupulously complying with industry best standards, respectively. Inspection would be voluntary and opt-in, but any business of size would have a strong legal incentive to get certified as in compliance. This could ultimately replace almost all regulation. No need to punish people for harm they have not actually caused, but if something happens, then negligence would be ruinous. This could work for doctors writing prescriptions as well as companies manufacturing generics. Ultimately, it would be better to see competing private organizations that certify, but government could still play that role.
Never use "complying with industry best standards" as a criterion, because it creates a ratchet. There is an incentive to be at least as good as the industry average, preferably better, and a strong incentive not to ever be worse than the average. That means standards can only ever go up, not down, even when they are well beyond what's worth the cost.
It's interesting that Scott thinks that libertarians always lose, and that apparently this isn't just casual hyperbole but something that until recently was _literally_ true (and now is merely 99.9% true). Off the top of my head:
- The YIMBY movement has been quite successful, and although it doesn't identify in a partisan way, it seems pretty clearly libertarian-aligned.
- There has been some recent bipartisan support for reducing the carceral state, and Trump himself signed a meaningful prison reform bill. Although prison reform may not be the top of the libertarian wishlist, it is definitely an issue that I have heard some libertarians talk about.
- The Niskanen Center is a new-ish think tank that is punching above its weight. Its politics can be a little hard to characterize (in a good way), but to me they basically seem like good government libertarians.
- Matt Yglesias just wrote an interesting piece about bipartisan efforts to decriminalize mobile homes. This issue is more important than it sounds, as it deeply affects housing affordability.
- One could point to the dismantling of Jim Crow as a general victory for freedom. Libertarians (correctly) don't take credit for this or, you know, seem to care about it generally, but the general arc of the last century was toward much greater freedom for really broad swathes of America.
- My impression is that there has also been some bipartisan energy around dismantling rent-seeking occupational licensing regulations, but I'm not really up on the details. This is another issue that some libertarians have talked up a good deal.
This is just off the top of my head, and it would be pretty easy to come up with a much longer list. Perhaps the more interesting question is why libertarians think they always lose. I have a number of theories here, some of them honestly pretty obvious, but if I were to mention them the comments section would probably lose its mind, so I will mostly hold off. The only one I will point out is that the best source of actual libertarian energy in government is probably centrist Democrats, but libertarians for a variety of reasons can't or won't accept that.
This comment could be exhibit one in a list of libertarian pathologies that make libertarians think they always lose. Actually, it could be exhibits two and three as well, as it manages to convey in compressed form a number of terrible ideas about what success in politics means.
Apologies if that reads as snark. I mean it seriously.
It is certainly the case that home schooling is at an all-time high and experiencing a long-term upward trend due in part to legalization and deregulation. This seems straight down the middle for libertarianism. Yet another item for the 0.1% side of the ledger.
It's not clear that self-identified libertarians had anything to do with the legalization of homeschooling. (AFAIK it was 100% from the efforts of religious fanatics, who neither identify as "libertarians", nor support anything else the latter advocate.)
It is my contention that most (but not all) self-identified libertarians have very little to do with meaningful political change, for reasons of self-selection. But libertarian ideas more broadly do have some purchase across the political spectrum. Not a lot of purchase, because libertarianism in general isn't very popular and self-identified libertarians seem mostly allergic to doing the kinds of things that might make it more popular. But definitely some purchase.
Yes, home schooling as a movement originally drew most of its energy from religious people. It has broadened out a bit since then. I was technically a homeschooler during Covid, although we hired a teacher with some other families. And we crammed our kindergartners full of Darwin and Nietzsche.
While parts of Jim Crow were enforced by laws (eliminating which increased freedom), parts of it were enforced by private decisions and contracts, and outlawing that reduced freedom (and did so nationwide, while the previous laws that were struck down only applied in a part of the USA). There wasn't a second when US governments (federal and state governments combined) didn't intervene on the matter in either direction.
I don't think that Scott meant that everything in the US in maximally opposed to liberty, such that some things having been worse the better part of a century ago would be any sort of rebuttal, or that every new law necessarily takes the US further from liberty. In the context of abolishing the FDA, his reference to libertarians never winning seems to be to policies that are *unique* to libertarians, like abolishing the FDA.
1. "FDA" has multiple functions: it deals with food safety (especially for imports), medical devices (hip joint replacements, for example, X ray machines, etc.), pet food and medicine, and tobacco products, beyond just "drugs" which I think includes biologicals, etc.). If you're going to "abolish FDA" (which I do not favor), then you need to think about all those functions.
Great piece. You bring up a lot of good questions.
My own opinion is that the Covid response in particular clearly demonstrated that the FDA is seriously "bent" like many other government agencies. At some point more and more people just throw up their hands in frustration and call for abolishing such an agency rather than continuing to beat their collective heads against the wall trying to reform it.
I am somewhat familiar with the public health system in Taiwan. With the exception of what we call "controlled substances", you can buy most medications without a prescription, including all antibiotics and antivirals. If you go in for a doctor visit and are prescribed a medication, it is provided at nominal cost at the hospital. If you don't have a prescription but want to use it anyway, you can purchase it at a somewhat higher price at any pharmacy. Note here that even when self-purchased, the prices are still vastly lower than here in the US for most meds.
Wasn't there a documentary called "Idiocracy" that described when the Brawndo Company ("it's got electrolytes!") bought the FDA and the FCC and thus was able to sell and print anything it wished?
Electricity is incredibly dangerous (far more dangerous than all but the most dangerous drugs) and yet we all have a zillion electrical devices, made by thousands of nearly unregulated factories all over the world. I suspect if we had a Federal Electricity Administration that got to decide what electrical devices could be sold, first off we’d just be getting home PCs now. But there would also be articles like this asking how we could ever function without such an agency and speculating about the hundreds of thousands of electrocutions we’d have.
The solution is simple – you can sell any chemical for any use to anyone you want, same as for any other product. And as with any other product, the seller is liable for any undisclosed harms. That liability will cause sellers to be clear(ish) about harms, and also to be choosy about what they sell and how they sell it. Some may choose to only sell some drugs to doctors, to offload the liability. Private insurers (like UL) will offer to test drugs and protect doctors or sellers. Some drugs might simply be too dangerous to even sell, or to only sell (with very detailed contracts) to highly trained specialists.
And an agency like the NHTSA could be setup to identify undisclosed problems and go after manufacturers, as we do with autos. But that would be very different from an agency that must sign off on all new products.
Yes, some additional people will abuse painkillers but many who are currently living in pain will get painkillers they need. Yes, some people will overdose, or take meds that are unhelpful. But in exchange, many people currently suffering may find treatment and/or relief from drugs that are blocked by fda approval.
Aren’t there in fact safety regulations for electrical devices? But of course such regulations are a simple matter since electricity’s effects on the body are not complicated. New chemical compounds *can* have quite unpredictable effects on the body, particularly in combination with others: if I buy Drug A from you and Drug B from someone else, and they interact badly, who is liable, you or the other seller, or both?
Medical devices are regulated by the FDA under 21CFR820 and require extensive testing of both drug and mechanical components, very similar to what is required of finished pharmaceuticals.
At least in the US, safety of consumer electrical devices is mostly handled by a private organization, https://en.wikipedia.org/wiki/UL_(safety_organization) , which was originally funded by a consortium of insurance companies that were sick and tired of paying for buildings that burned down because some resident installed a newfangled electrical doohickey.
There's also some statutory regulation, but UL's success in keeping Americans from electrocuting themselves or burning down their homes is frequently cited as one of the strongest existence proofs of "we don't need government regulation to get this right". But, as always, you don't want to extrapolate too much from one data point.
The most obvious answer to "why don't we take supplement certification seriously now?" seems like it's obviously that supplements don't deserve to be taken seriously. If they had a major impact on the body then the FDA would be regulating them, just like what happened with Red Koji.
I think there is one more item that needs to be addressed and I think it is the most important one.
Most drugs have obvious effects on the folks taking them (e.g. fentanyl) and the libertarians are pretty consistent about letting people make their own choices and suffering the consequences. If you make fentanyl not require a prescription then some people will die because they purchased it and they overdose. Their call as long as the fentanyl wasn't labeled as aspirin.
But ... some drugs, specifically drugs that fight bacterial infections (?), can make things worse for everyone if not used judiciously. Over use just creates bacteria that is immune to the drug and then we don't have working drugs for those infections. This is a classic "tragedy of the commons."
Maybe this isn't handled by the FDA today, but any much more laissez-faire approach needs a position on this, even if that position is "we will wind up with drug resistant bacteria and no effective drugs because it is wrong to limit people's choices."
This already happened, and continues to happen, on account of FDA being entirely ok with the practice of feeding antibiotics to livestock by the megatonne.
If the "Federal Death Administration" were abolished, and nothing else changed, predatory tort lawyers will simply fill the power vacuum. A replacement, if you will, of "dragon" with "plague of locusts".
re: "Second, a doctor must prescribe you the medication. “Abolish the FDA” gets rid of the first barrier, but doesn’t specify the status of the second. Do you also want all medications to be available without a prescription?"
There's (maybe?) a partial answer here inasmuch as a) what constitutes a prescription drug can be codified by law either explicitly (X drug requires a prescription) or by defining what fits in the class of "prescription drug" and/or this policy development can be handed off to someone who isn't tied up in also deciding what drugs are effective and b) what requires a prescription is, in practice, generally decided by state Boards of Pharmacy anyways. BoPs typically punt this definitionally backwards though; CA pharmacy law defines "dangerous drug" as "Any drug that bears the legend: 'Caution: federal law prohibits dispensing without prescription,' 'Rx only,' or words of similar import", but I get the sense you could probably appeal to their ego by telling them they get to pick a more specific definition.
Also, where you describe independent accrediting organizations (competing to be) taking the place of the FDA, that's supposed to be what health insurers/PBMs are doing--they're supposed to be deciding what gets covered/how well based on the available evidence, we just already know where that tends to break down.
In Puerto Rico you can already buy any(?) prescription medication over the counter without a prescription, so that probably wouldn't be apocalyptic if you included a carve-out for dangerous or even "dangerous" drugs remaining illegal unless prescribed by a physician.
It is worth noting that millions of people (even if only speaking of USA) already have no serious difficulty at all in regularly obtaining the most dangerous and illicit drugs without any paperwork whatsoever.
"The only problem is that this hasn’t happened with supplements (examine.com, LabDoor, etc, are nowhere close to this level, sorry), even though there are some of the same incentives there today that there would be for medications in a post-FDA world."
Are they the same incentives? I think right now the FDA pushes out what would be good alternatives because it has legal force. Very rarely is anyone going to pay a second, private company after going through the FDA's process, because the FDA is already expensive and cautious, and gets you everything you need (insurance *must* cover it, doctors can prescribe it, etc).
"But if we don’t eliminate prescriptions, how do you protect prescribers from liability?"
The way liability works in the US is an unmitigated disaster. (The way tort works in general is a separate disaster). Reforming it is especially hard because, as Colorodans found out last year (https://kdvr.com/news/local/access-to-14ers-at-risk-after-bill-protecting-landowners-fails/#:~:text=The%202023%20amendment%20to%20CRUS,be%20found%20as%20%E2%80%9Cmalicious.%E2%80%9D), a lot of legislators are lawyers. We probably only have a medical industry at all because of specific carve-outs for things like the FDA approval shield that you mention here. You probably could preserve the carve-out by specifying some comparable liability shield... but how does that work? Saying that specific orgs can "approve" drugs just replicates the FDA's monopoly. Providing for a government bureaucracy that certifies other organizations does the same.
I know that "well just reform the entire legal system alongside getting rid of the FDA" isn't much of an answer, but I do think that we should switch to loser pays and have a reasonable liability system regardless. Ditto for all of the other things you mentioned--we should have legal weed and LSD, we should have a sane health insurance system, etc.
I suppose an intermediate point would be to make FDA approval optional. I expect most doctors and most drugstores would continue to only prescribe/sell approved drugs, but it would allow people with terminal conditions or something particularly resistant to existing drugs to seek out experimental drugs or alternatives that didn't work for most people or that have big risks. We already have clinical trials, and I don't know how liability works in those cases, but presumably it could cover these situations as well.
Part of the libertarian solution to liability is to make all tort liability waivable in contract. The law should set some defaults—I have some ideas what they should be—but whatever they are, it should be possible to override them in a contract in the direction or either less or more liability. A waiver, if made in the right form, should be enforceable, no exceptions. (There can be rules about the form of a waiver, like certain waivers have to be prominent and can't be hidden in the fine print, but there should always be a reliably valid way to waive liability.)
That's true; we should have greater ability to remove liability with explicit agreement. But our current liability law faces serious issues even outside of that: You can trespass on someone's property, get yourself hurt doing something you're not supposed to be doing, and successfully sue them for failing to do more to prevent you from trespassing or for failing to fix a dangerous thing that no one is supposed to go near.
This point isn't so relevant to medicine, since your doctor and pharmacy can always make you sign paperwork before prescribing/selling you medicine. But I'm still not sure if this would work--make the waiver too short and broad, and the courts will say it doesn't cover things; make it too long and detailed, and they'll say it's not reasonable for people to read it. Plus, how many people will be willing to sign their life away every time they need a prescription? Would this substantially impact people's willingness to take important medications? This is where the above point becomes relevant again, because it would be really nice if the standards for being liable in general were somewhat stricter than "did not move heaven and Earth to prevent any negative outcome."
(Except when it comes to driving, for some reason. You can drive like an absolute cretin, break a dozen laws, mow down a child on your way to running a station wagon of nuns off the road, and just go "oops! it was an accident" and suffer minor consequences.)
I definitely agree that there should be saner, stricter (towards the plaintiff), more predictable defaults.
But this: "make the waiver too short and broad, and the courts will say it doesn't cover things; make it too long and detailed, and they'll say it's not reasonable for people to read it" shouldn't fly either. At least one form should be predictably valid.
I don't think this would actually work in practice - for one thing, every EULA and forced clickwrapper will have maximally liability avoidant conditions immediately added.
For another, any business with any history or potential to be tortiously sued will immediately require you to sign maximally liability avoidant participation waivers.
Your employer, as a condition of employment, will force clickwrapper maximal liability avoidance.
Hell, I'd even personally craft a maximally liability avoiding EULA and force anyone who tries to talk or interact with me to click "Agree" before being able to do so, and I'd imagine every single politician or person with assets would do the same.
How does your suggestion not end in a world where everyone is forced to clickwrapper "Agree" for every business transaction or interaction everywhere in a way that maximally absolves the other party of any liability?
In many cases, that would happen—if the default liability that applies isn't also significantly curtailed—, and that's fine. (Btw I think many kinds of liabilities *can* be waived even today, this would just be extending that.)
In cases where the liability is actually important, where there are many well-known scandals of companies hurting their counterparties (like the ones that prompted the creation of the FDA, workers' compensation laws etc. in the first place), people would be willing to pay more, or accept a lower salary, in exchange for the company accepting more liability; it would be a selling point for a company, sort of like extended warranty can be.
For instance, if there are scandals where pharma companies sell ineffective or harmful drugs, people would have no reason to trust that a new, expensive drug is any better than an old, established, cheap generic; if anything, the old drug is safer. So they would buy the old, cheap drugs if they buy any at all. That would be disastrous for pharma companies' profit, and they know it. So they would either proactively make sure no such scandals happen in the first place via some sort of self-regulation, or they would try to regain people's trust by making strong, legally binding promises.
"In many cases, that would happen—if the default liability that applies isn't also significantly curtailed—, and that's fine."
Imagine a Eula clickwrapper, stomping on a face, forever!
I mean props for being internally consistent, but I'd happily become an expat if this happened here, I think that would be a strong net negative and a much worse status quo. And I'm definitely of the opinion that 99% of lawyers and legal cases are entirely useless to net-negative for the average person, so it's not love of litigation or the legal system, or indeed of current liability standards, which I think are ridiculous.
I don't think forced clickwrappers and EULA's should even be legally enforceable today as they stand, just imagine having every possible transaction or person-to-person interaction EULA'd - hell would be upgraded from being other people...at that point, hell would be their EULAs.
But if the inconvenience of signing waivers exceeds the cost of the liability to the two parties summed, then they won't make people sign waivers, because people are willing to pay more for a service if they don't have to sign a waiver. There is no reason to expect the free market wouldn't find the optimal solution here. (Nitpick: EULAs are a kind of license for copyrighted software, what we're talking about are waivers, not EULAs.)
Yeah, I even used "waiver" appropriately in my original post, I was using EULA as a synecdoche of the cluster of things like waivers, forced clickwraps, EULA's, mutual contracts, insurance waivers etc.
I still think we would end in ubiquitously forced EULA / waiver hell if that were passed, due to the hugely assymetrical risk / reward for most companies and people - all it takes is one lawsuit to cost you millions, compared to the not-even-an-inconvenience-to-you of forcing somebody to take 30s to click / sign. But of course in the aggregate, those 30s add up to heinously huge amounts of wasted time, cumulatively many lifetimes worth, for incontrovertibly negative benefit to the people being forced to click / sign.
So the proposal is to waste many cumulative lifetimes, incinerate this huge pile of QALY's, just to feel that we're a solid contractually-savvy country that is smarter than most western countries about liability and litigation? The price isn't worth the reward.
It is not an inviolable law of nature that clickwrap EULAs must be legally binding. If Congress (Parliament, whatever) passes a law saying that people can waive liability to any degree they want, it can just as well say that waiving liability beyond some set standard requires a written contract - or written and notarized. Which would be enough of an inconvenience to drive away more than a few customers, particularly in the age of e-commerce, such that nobody would do it unless they expected to be sued a *lot* if they didn't.
After the apocalypse, as we get used to the burning corpses and the roving gangs of pre-verbal waifs swarming anything that moves, there will be a second great die-off as the billions of us who only survive by taking a cocktail of a few dozen different malady reducers three times a day are rather quickly Darwined into oblivion.
Over a quarter century I’ve plied my trade for Big Pharma (technology auditor) and it is easy to lose track of the fact that medicines are getting developed that do allow people to live fuller and healthier lives. But it is a business and a powerful one with huge (huge!) amounts of capital at its disposal and the ability to push back against the regulators with a fair amount of weight. Money gets what money wants.
A good justification for gatekeepers: antibiotics. Go to a place like Phnom Penh and you'll see locals buy one or two tablets of Cipro from a corner shop thinking it will fix their common cold or sore arm. Over-prescription undermining antibiotic effectiveness is an issue in the U.S., but developing world casual overuse really exacerbates the problem.
The ideal solution is probably some combination of self-regulatory organizations, Consumer Reports-type reviews, and tort reform that protects drug makers and MDs who do their due diligence while exposing those who do not. The real world solution is probably some combination of your arguments re: supplements and experimental drugs plus downgrading lots of medicines to over-the-counter status.
I'd just like to see the FDA reworked into a label enforcing and data gathering institution. Report the patient/user data to the FDA and you get told what sort of labels have to appear on your product. Don't report any data to the FDA and you get some very scary labels. Falsify data and you get to go to prison for the foreseeable future. Drug and food companies have liability for unadvertised product harms (either through neglect or withholding the data).
Ideally, FDA would have open and anonymized medical datasets. As a user/consumer, you get to avoid taxes on medications and foods if you register your national, digital, medical profile with the FDA and buy drugs and food through that profile. Then the FDA and independent researchers could run ML across those datasets to look for correlations and bad interactions between drugs and so forth, which then informs what sorts of labels get applied to products.
Abolish-lite idea 2 (experimental drug category) is the inverse of the reform I want. I would prefer a regime where the FDA regulates for efficacy, and does not regulate safety per se, but rather safety labeling, by which I mean when you buy a drug it would say “taking this drug raises your risk of heart attack by 10%”, and you know that a) it meets the normal FDA threshold of efficacy and b) the FDA thinks the level of risk on the label is truthful. Basically the idea is the FDA makes sure drugs do what they claim to do but is leaving it to patients and doctors to decide what level of risk they are comfortable with for a given treatment.
This idea is mostly motivated by some personal experience - my grandfather had Parkinsons, got on some drug trial, saw a massive improvement in his symptoms, and then was told “sorry, turns out this elevates your risk of heart attack or something by x%, so we have to end the trial.” He wanted to be able to continue using the drug - he felt that the massive improvement in quality of life from the drug was well worth an x% higher chance of heart attack, but some bureaucrat decided that no, he was wrong, he is better off suffering but safe. I have had a burning hatred of the idea the FDA gets to decide what level of risk is ok ever since).
The solution to this has always seemed obvious to me: drugs would be approved for safety, not effectiveness; and any drug with well-understood safety could be sold (if the known safety risks were disclosed on the label).
In this hypothetical universe, the FDA still exists, but only regulates information about safety on drug labels. So, for example, the label for any product containing acetaminophen would be mandated to include that, if you take more than 1000mg in any 6 hour period, or 4000mg in any 24 hour period, then you will have permanent liver damage; that it increases the risk of stomach ulcers; that it increases the risk of hypertension; that it can cause kidney problems; etc. The FDA would still require manufacturers to get their proposed labelling approved before bringing a drug to market.
This is essentially the situation for off-label prescribing: drugs can be used for uses where effectiveness hasn't been shown, but there's still comprehensive information about safety on the label (granting that safety information for one indication could in principle not generalize to another indication). Perhaps off-label marketing would be legalized, or perhaps it would still be illegal to market drugs for unapproved uses, but drugs on the market wouldn't need to be approved for any uses in order to be sold as long as the manufacturer didn't make any particular claims about effectiveness.
It depends on your metrics, I think. I think that starting and hyper-rapidly growing a new organization of that scope is likely to fail. If it does succeed, it's more likely to give those reforms, true. But I think success is unlikely.
In my dream world, you provide the existing leaders with better incentives to change. There is already a lot of change going on at FDA, but not on the scale you're talking about.
So I think it's not hard to get FDA to change; I think it's hard to get Congress to change the laws that give FDA its incentives. ANd I think it would be a lot easier to get Congress to pass reform legislation of the kind I'm talking about than "FDA 2".
It's not about being entrenched, it's about incentives. And governing laws. And it's like any other organization-while there are some stick-in-the muds, most of the people at FDA, especially at the higher levels, are highly motivated and value improving health for Americans.
So the first thing I look at is changing incentives for the existing organization.
There's an old saw "Don't take down a fence until you know why it was put up." In regard to the FDA, the reason it was installed was because businesses had learned how to effectively market completely quack medicines. You can look this up; the modern media documented all of it. A pure libertarian doesn't care, but in practice, once you reach the outer bounds of the effective rationality of the average person, society can (in aggregate) lose a fantastic amount of productivity based on mass poor decisions, and a society that isn't pure libertarian can out-compete one that is.
As I age, I'm less and less interested in libertarian ideas. I still respect and enjoy Heinlein's visions of perfect society, but I fully understand that I would probably die, or at least suffer in such society. I'm too lazy and stupid to be a libertarian. Really, all I want from life is to concentrate on a few things that matter to me, and let the nanny state, or world AI, or whatever take care of the rest, preferably without me needing to pay any attention.
We already live in world where everyone is trying to cheat everyone. I don't feel that relaxing government protections will make it any better, but rather at least more confusing, if not outright worse.
I mean, right now, if I want to check information about a drug, I can go to FDA site and see if it is deemed safe. But if there are multiple voluntary certification agencies? I have to decide which ones I trust. It makes me think of anti-virus software. Even in 90's, I had to run at least two AV programs to check if an executable was safe, because each had its own database. Now? There are dozens of them, so you really can't decide anything without looking at VirusTotal.
For drugs, that means if a company wants its drug to reach the widest possible audience, it must get certification from ALL major agencies. Who will have different processes, different requirements and different outcomes (it's a known problem in software world - sometimes you have to modify your program just to make that one AV shut up, because its heuristics think your little game is a virus). Come to think about it, it would make sense for a certification body to warn consumers about any drug that didn't tried to get its certificate in Big Red Scary Letters on some kind of meta-information site.
Also, what would prevent existence of rubber-stamp certificate mills? Libertarian answer is reputation, but I don't think it works well enough. An enterprising person might set up a network of such companies, to give any drug a feel of substance approved by multiple sources. Even if one of his companies is compromised and sued into oblivion, it doesn't mean the whole network goes down. This probably wouldn't work on a canny consumers who do through research before committing to buying stuff (I would guess some kind of meta-checking site I mentioned above would probably only use results from most trusted sources), but most of us don't do that.
And of course people will self-prescribe anything they see in an ad, without consulting their doctor (this costs money, why would you pay for doctor to say you need exactly the same thing a TV ad said you need?!). This actually already happen with supplements. I don't know the situation in US, but in Russia, supplements already became synonym for snake oil. People, especially old people, spend their last money to buy the latest miracle supplement, and then die of preventable problems, because taking supplements is psychologically easier than going to doctor.
Mostly wishful thinking that the government should have longer-term vision than business. It's mostly an illusion, but a nice one to have. Also, governments are less competent at cheating, so it's easier to see through.
'Mostly wishful thinking that the government should have longer-term vision than business. It's mostly an illusion, but a nice one to have. '
Congratulations on self awareness. It's not a nice illusion though - it's a very dangerous one. I say that as a citizen of a country where the government does far more damage than business, by several orders of magnitude. And, if you look at human history, political power has tended to be a far more pernicious force than business, until it was (relatively) tamed, relatively recently, and in very few places
This suggests there is a market for businesses that will tell you everything is going to be fine, in return for a subscription fee. That fee will likely be even less than the tax you currently pay to the government to tell you the same thing.
I've been Libertarian-adjacent for decades. Have voted for Libertarian candidates, am a past Reason subscriber, etc. "Abolish the FDA" though is always a good reminder that I would not want to live in, and would do whatever it took to avoid raising children in (!), a society run by real-life Libertarians.
The usual American thinking pitfall is refusing to look elsewhere (Scott had a post about it) for alternatives. What kind of FDA-like agencies work elsewhere in the (Western) world, and work better than the FDA?
In my opinion, if people were at risk of dying from drinking a Coca-Cola, the market would react in a matter of hours to minutes, not days. I have a general thought about this problem, which is that we seem to much prefer it if people die for the right official reasons than if they die for 'morally unsanctioned' reasons. People are dying right now because of the FDA/drug laws. That seems to be agreed upon. But if a libertarian says, 'legalize and privatize all drugs and drug safety, and let God sort the rest', the costs of that somehow come off as more heinous, even if the grand utilitarian calculus should ultimately improve. It seems especially heinous, because the costs would cluster among the less-intelligent and agentic. So I can't help but read into this as another question about the goal of equality.
I feel like this whole issue maps onto sending resources to the under-performers in school instead of prioritizing the potential of the gifted. Or moreover, the redistribution of resources generally. Doctors suck. People who rely on them are and will always be behind the curve. That is in my mind the essence of the libertarian position; these institutions don't just fail to work now, they never worked and will never work by their design (being statist/moralistic).
These institutions are designed for the inept, who are now and will always be subject to higher predation anyway. No amount of educational intervention will raise these kids' IQ, and no amount of medical regulation will make people who rely upon the medical system healthier. If ancapistan comes tomorrow, the doc-in-the-box will still exist, and still prescribe largely the same stuff, and they'll still be horrible. But the inept have one thing in their favor, and that's numbers. There are millions, billions of low-agency people, and so their collective intelligence/economies of scale tend to give them at least a stably mediocre product. Yes, that will take some sorting out. But it's not my problem if some people can't handle freedom. Objectively, the costs of ineffective people falling through the cracks is ALWAYS less than the benefits of smart people having more options and using them. That's self-evident, just morally verboten to say.
Maybe I just live in the state with the worst healthcare in the nation, but everyone I know who is healthy, especially those who are aging well, avoid the doctor at all costs. Without exception, they have been better off solving any problem they can outside the state's purview. And if they do go in, it's only to tell the doc exactly what medication they want. "Give me an antibiotic for my strep throat". It's a five-minute visit to a deadweight middleman.
I could tell you a lot of stories, including my own about only being alive because I ignored doctors and followed my own, well-informed senses. But the point is, if you're inclined like I am, you already have a notion of just how much deadweight there is in the system on education, healthcare, hiring, everything because of the dead-end goal of low-IQ-proofing these systems, rebranded as 'safety'. Nothing is safe. You should already be checking all your labels, avoiding baby formula if you can, importing certain ingredients. Meanwhile there's trillions of dollars on the table and futures we can't even imagine.
Just let me buy some coke for my exams, a cocktail of anti-aging drugs on the side, and the 10k Toyota truck. I can handle the freedom, and oh well to those who can't.
> Just let me buy some coke for my exams, a cocktail of anti-aging drugs on the side
This is why the future (to the extent there is a future(tm)) is in... smart people secessionism. Leave the dimwits to the mercy of their bureaucracies, they deserve them.
I am intrigued by your ideas, and wish to subscribe to your newsletter.
But really, how would even a weak version of smart people secessionism actually work? Are you reinventing Prospera and charter cities?
I mean, obviously when we're able to effectively genemod our kids this will happen naturally (a worldwide 20% subpopulation who is literally much healthier, more intelligent, more attractive etc would obviously want to join together in a more exclusive social / legal demesne somehow), but I'm actually pessimistic about genemodding being legal / available anywhere that matters even when the technical capacity is there. I mean, we've been able to substantially genemod human embryos for 7+ years, but you literally can't get it done anywhere.
As I was towards the beginning of this piece, I was on the verge of eye-rolling because I thought that this would just be another take completely ignorant of the alternatives proposed within the libertarian sphere, but then you mentioned a voluntary certifying organization, and from there it just kept on getting better.
Q: "But if we don’t eliminate prescriptions, how do you protect prescribers from liability? Even the best medications sometimes cause catastrophic side effects."
A: I don't know whether we'd have a non-monopolized justice/courts system, but in either scenario I would imagine that legally binding waivers would become commonplace just like what are already presented at hospitals/clinics. It just might shift to having the doctor have you sign it after having discussed the pros and cons of a particular course of treatment and answering any questions that you might have — an informed consent waiver of sorts. Also I highly doubt that prescriptions would be done away with entirely because of their genuine utility to insurers. Rather, non-prescribed medications may just remain prohibitively expensive to those who don't have a prescription.
Q: "And rather than take that responsibility and get sued, your doctor will prefer to play it safe and only use medications that everyone else uses, or that were used before the FDA was abolished. You might even find it’s even harder to get a medication into common use than it was back when the FDA existed!"
A: With waivers, I'm not sure that this would be the case, but it's certainly a feasible behavior for the type of more conformist doctor that we have so many of today. As for common use, my impression is that medications with more side effects will take longer to find sufficient demand while others that are less risky will be more readily tried out by patients with their doctors' monitoring. It might sound bad given how risk-averse the current regulatory regime is, but perhaps a certain amount of the testing would be done by releasing the medication to doctors under agreement that they will order whatever labs/monitoring for patients who decide to try the new medication (and liability waivers for patients of course). Of course there will be some minimal testing beforehand to ensure that certain acute side effects rarely materialize, but beyond that this approach would have the benefit of providing more data for more use cases and also being cheaper since it could actually be sold (albeit at a lower price) during these real-world trials.
Q: "Are we also eliminating factory inspections to make sure drugs aren’t contaminated?"
A: I actually hadn't thought about that. In a regime composed of competing certifying agencies, I would hope that one of the demands upon pharmaceutical producers would be to submit to spontaneous batch testing in order to be bestowed with a seal of approval. If some agencies didn't do that, ones that did could just advertise that they do and tar those that don't for being soft on producers.
Q: "How do we deal with the fact that many doctors are dumb?"
A: This is a tough one that I think most lucid people are coming to grips with ever since COVID, though there were of course those who were ahead of the curve (e.g., AIDS). On the one hand, we hope to build institutions which are trustworthy enough that even the "dumb" doctors will not do too much harm in following guidance they receive from their institutions. However, there is likely a cyclical nature at play, where the reputation of previously reputable institutions shields it from criticism long enough that it can be corrupted or co-opted by special interests. Only when there is a critical mass of individual professionals who sound the alarm will there be either reform or collapse and rebirth/innovation. That said, I would be remiss to not place any blame with the AMA. Not only have they been controlling the number of doctors for the sake of controlling wages, but also they seem to select for and inculcate values of obedience within graduating cohorts of doctors — not to mention their enforcement of conformity by reserving the right to yank medical licenses. Just as this post was about alternatives to the FDA, I think alternatives to the AMA are sorely needed.
Q: "Again, I can imagine mechanisms that could solve a lot of these problems. They’re just the kinds of mechanisms that have never worked in real life. Why aren’t there mechanisms like this for supplements now?"
A: On the one hand, bringing up supplements is an excellent counterargument and serves well as food for thought. On the other, I don't know how old the supplement industry is in its current form, and perhaps as it attracts larger demand there will be sufficient desire for such certifying agencies. Then again, I'm not sure it would be a positive development if the average person moved further towards supplements instead of moving more towards good/healthy eating to get all their dietary needs met. Beauty products are similar in that there's an absolute wealth of options all claiming their own benefits but usually without robust evidence for/against certain effects. This makes me think that it's bound to stay as it is, with marginal improvements because of sites like LabDoor and Examine, simply because they're not as risky and so fundamentally different from pharmaceuticals. I read and shared your fish oil and melatonin posts, so thanks for that; my life is brighter now that I know about the Ambien walrus.
Q: "All of these other things are terrible and should probably be reformed anyway. But you’d have to do it all at the same time, and get it all exactly right."
A: I really don't like sounding like a naive radical, but I think that's what we need to risk. Since all of these systems have developed over time concurrently with state interventions, which inevitably have left us with a whole host of unintended consequences and perverse incentives, it's no surprise that radically rehauling one sector would have significant downstream effects for everything else. My only objection is that we don't need to get it "exactly right" because we don't really know what that even means. Markets and liberty are good means, not necessarily ends, but the results that we get will only sometimes look like what we could have imagined.
As for your suggestions, they're definitely worth trying. As long as we're moving in the direction of liberty — which is to say one where people see voluntary solutions as at least compatible with human nature and flourishing, if not an outright facilitator — then I'll be happy. Also given how fraught any of these issues is, even in the coveted world of ancapistan, I hope people will see that voluntaryism/anarcho-capitalism isn't at all utopian but rather an order permitting maximal association/dissocation, favoring low time preference, and pressuring people to align their actions with their sentiments (putting your money where your mouth is).
> Rather, non-prescribed medications may just remain prohibitively expensive to those who don't have a prescription.
They may not be covered by insurance, but that doesn't necessarily mean prohibitively expensive: many drugs (primarily old ones) are cheap even at the full price.
> Does it include MAOIs, where eating cheese after use makes your blood vessels explode?
One of the two main components in ayahuasca is an MAOI, and people eat cheese after ayahuasca sessions on the regular with nothing bad whatsoever happening, so I suspect this story needs a little qualification.
Correct, but often in low concentrations. I'd like to see reliable statistics on actual incidence of interaction of tyramine from common foods and MAOIs, with a breakdown of which food and which MAOI.
The flailing and dying that occurs during the transition period is a feature, not a bug. It means that our tax dollars will have propped up the individuals that can survive in an environment with regulated drugs but not in an unregulated environment or in the transition period. Afterwards, much less will be spent on healthcare and the survivors would be better adapted to life in modernity.
Also, most of the gains from what we call "healthcare" come from vaccines, germ theory, and antibiotics, plus the diligent work of obstetricians and to a lesser extent, pediatricians. 1950 USA wasn't some kind of hellhole full of children dying left and right to entirely preventable conditions, and life expectancy there was very similar to modern-day Mexico. And far, far higher than any of the great and powerful civilizations that existed before 1900. Yes, even for royalty. Infant and youth mortality used to be incredibly high.
> ...the survivors would be better adapted to life in modernity
This is precisely the doctrine that was pushed (successfully; by US puppets) in 1990s Russia, under the nickname "Shock Therapy". Perhaps it would be only historical fair play for Americans to experience its "joys" first-hand.
> So what does the FDA gain from carving out natural products?
It's worth noting that this is not at all something that the FDA did voluntarily. Quite the contrary, DSHEA was passed in 1994 over strong FDA objection. If it were up to the FDA, there would be no separate category of "supplements." They would all be regulated exactly as are drugs.
At a high level, we can decompose the FDA's function into two components: coordination and application of the precautionary principle. It sounds like Scott fundamental does not object to the coordination component, only to the application of the precautionary principle. So a practical proposal would be one that retains coordination while relaxing the filtering criteria into something weaker than the precautionary principle.
Every day on the internet, I see a reasonable author writing a logical, thorough response attacking a completely bonkers idea that I had literally never heard of before. There was a time when I would have assumed that the otherwise reasonable author was just fighting straw men. But almost every time that I've looked up the bonkers position, I've found that there were, in fact, real people supporting it.
Which brings me to my favorite centrist complaint: "the Republicans and Democrats never agree on anything." It turns out, they agree about tons of stuff! They agree that 99.9% of the madcap stuff flying into the Overton Window like so many sun-blinded birds should get swatted down. That might seem trivial. Yet, as Scott's opener suggests, if we don't swat down the madcap stuff and it makes it in to normal politics, the effects on ordinary people could be awful.
How do you draw the line at what ideas are so stupid as to be not worth considering? I actually disagree pretty strongly that Republican and Democrats agreeing on an issue means that they are correct. Republicans and Democrats agree on quite a few policies that I think are terrible.
Perhaps the clearest example is the Foreign Dredge act of 1906, which forbids any dredging in the US except by boats which are built, flagged and crewed by Americans. This law is pretty blatantly just rent seeking by American dredging companies for the purposes of keeping the price of dredging high. American dredging costs are 10-20 times higher than the Netherlands per unit volume. If the law were to be repealed, the price of dredging would decrease substantially and many more dredging projects would happen that are currently not feasible due to cost.
Just to clarify, I did not say that Republicans and Democrats agreeing on an issue means that they are correct. Republican and Democrat unity keeps out lots of bad ideas, but also keeps out lots of good ideas. It does seem to be most pernicious on issues where a law creates a clear rentseeker class like American dredging companies, and where the people paying off the rentseekers are too diffuse to rally.
So to answer your question, bipartisan unity is just one small sanity-check when assessing whether an idea is stupid. What I usually do is hunt for the part of the proposal where they wave away the downsides rather than address them. As Scott nicely demonstrated, Abolish-The-FDA features a lot of waving-away of problems, some of which are even bigger problems than the problems that the FDA itself is causing.
If you think abolishing certain kinds of regulatory powers (like the FDA) is a completely bonkers idea, I would recommend keeping a more open mind. There are several very good reasons that should make you think why it might not be bonkers, just in this thread.
There are plenty of regulatory powers worth trimming. I get skeptical when entire agencies are being destroyed, because every agency has a chunk of the economy that has arranged its business around that agency continuing to exist. Yes, that is unsavory, but it's the reality we're stuck with. A plan that abolishes an entire agency needs to deal with that reality.
I think the difference is concept vs. execution. Abolish the FDA is a concept that is not necessarily bonkers. If you think of it as a plan, then yes it might be. The plan should have detail and steps, including what and how the ecosystem is going to adjust. But that only comes if as an objective we can find agreement on the nature and level of regulation.
My ideal solution would be to treat medicine like any other consumer good and provide federal support for the development of Consumer Reports-like outfits for medical products. ConsumerLab is an indispensable example of the needed type of testing watchdog on the current supplement market. Federal matching funds could be distributed to competing testing companies based on the number of paid subscribers the company is able to attract. With adequate matching funds, testing companies would have enough resources to independently conduct clinical trials.
The FDA doesn't do product testing. If the current model were applied to, say, refrigerators we'd have a situation where Whirlpool would be required to test the safety and effectiveness of its own refrigerators. Then, if a secretive FDA star chamber decides they're not absolutely convinced by Whirlpool's self-testing data everybody is forbidden to buy the refrigerator. Even if the FDA approves the refrigerator your doctor might still tell you no because she thinks you'll be better off without a refrigerator. I don't think anybody would put up with a refrigerator marketplace that starts with corporate self-dealing and then proceeds through two layers of unchecked veto authority. I'm mystified by the fact that people blithely put up with it for medicines.
Here's a little story to illustrate the problem. I'm a big fan of the FDA-approved Lucira molecular Covid test. In my experience, Lucira is way more sensitive than the rapid antigen tests the government doles out for free. It's important to detect Covid infections early:
There's a new molecular test on the market called Metrix, but the fact that it's FDA approved doesn't really tell me whether the new test is more or less sensitive than the familiar Lucira. I know a ton of people who currently have Covid so we were able to do some DIY community testing. Our casual results suggest Lucira is *much* more sensitive than Metrix. Consumer Reports for medical products would have been an overwhelmingly better approach to this type of problem.
I think it would be best to begin by removing those FDA powers which (A) were never authorized by Congress, but simply claimed by the FDA because no one will stop them, (B) are not critical to protecting people from harm, or (C) hold new drugs up to a standard that nothing else we eat is held up to.
In the 'A' category we have medical tests. About 270,000 Americans die every year of sepsis, and most of these deaths might be prevented by using DNA-based tests which would almost instantly identify every species of pathogen in a sample. I've spoken to several companies who manufacture such tests, and none of them plan to ever sell them in the US, because of the FDA. But these tests are both known to be extremely accurate--far more accurate than the current immunological tests--and are completely harmless. There is no way that putting your blood or tissue on a microarray can hurt you. There is no need for the FDA to be involved. And there is no Congressional mandate, either; the FDA's claim to be allowed to regulate these things is based on very old legislation which speaks of "medical devices", by which they meant things like X-ray machines and pacemakers.
In the 'B' category we have the FDA requirement to prove not just safety, but efficacy. I think we should settle for safety. You might think that a study of safety could just as well prove efficacy, but the problems are that (A) most medical studies are terrible, and (B) a lot of drugs work well for some people but not for others, so when you pick the Z-value you need to pass a t-test at 95% confidence for the entire population, you're screwed.
In the 'C' category we have for instance artificial sweeteners which kill some people, but a whole lot fewer than sugar does. A lot of things we consume regularly--sugar, butter, caffeine, alcohol, Big Macs--are far more-lethal than the FDA would allow. I argue we also here have phentermine, which is very effective at helping people lose fat, and non-addictive (as every study so far has shown, despite what Wikipedia and your doctor will tell you). Current policy is to only allow people phentermine as long as they're obese. As soon as they get down to just plain-old "fat", they're cut off until they get obese again. I don't know if the FDA is responsible for that policy. There's a similar policy governing the use of Ceftriaxone for Lyme disease: as soon as you start to get better, they cut you off, guaranteeing that you're just building up the resistance of your Lyme.
I think I can boil this down to a single sentence:
"The FDA does a bunch of things it would be catastrophic not to have done; replacing it with a functionally near-identical body (possibly with a different institutional character) might conceivably work, but just getting rid of it is a fundamentally unserious suggestion".
And even "replace it with an equivalent body" seems like a pretty terrible idea - you'd lose an awful lot of valuable institutional expertise.
"Keep requiring prescriptions from MDs for everything that might be the least bit dangerous" and "let everyone buy anything they want at the corner store with zero gatekeeping" are not the only options. You could for example make it legal for consenting adults to buy now-prescription-required drugs from a licensed pharmacist, who is required to explain the dangers and/or possible ineffectiveness to them before they buy it, but who cannot actually make a discretionary refusal to sell it. I think I would support having a policy like this for almost everything and reserving MD prescription requirements for things that have serious and unusual externalities, like antibiotics.
"Require a huge study to be completed and painstakingly approved before you can sell it to anyone" and "let anyone sell it with no study at all" is a similarly false dichotomy. You could for example make it legal to start selling after Phase I/II trials, with the proviso that the Phase III trial has to be completed on time and to FDA standards of soundness/non-manipulated-ness in order to keep selling. If the Phase III doesn't meet its endpoints, you can still sell it but with a big red warning label; but if you don't finish the Phase III process in good faith in a timely manner, *then* it's banned outright. This would retain a strong incentive to generate the information the public needs to make good decisions, while avoiding delays for people who want to try the new experimental thing asap.
Why not allow the same substance to be sold both as a supplement and as a drug? Effectively that would mean you can buy any substance without prescription as a supplement, but perhaps doctors would continue to only recommend, and insurance to only cover, approved drugs.
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Re: fish oil and Alzheimer drugs: Aren't these precisely examples that work poorly in the current, non-libertarian American system?
I expect that, on a free market, most people would only have catastrophic health insurance. If people pay for most of their healthcare out of pocket, and their doctor recommends a $300 fish oil capsule, they will ask if there is a cheaper alternative.
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I read drug leaflets, and I don't think they are useless. In Europe they include order of magnitude estimates of the prevalence of side-effects.
Once people get used to Dad^Wthe state no longer watching out for their safety, once there are stories of people dying from taking drugs irresponsibly, they'll read warning labels. It's just that in a non-libertarian society, the government usually steps in faster than people would learn from other people's mistakes. That means somewhat fewer people initially dying from the risk in question, but a lot of harm (in lives, money, convenience and freedom) from excess safetyism.
i know you consider yourself a libertarian, but the first section of this post is as excellent argument for why libertarianism is wrong as i've ever read. going through all the market failures--stemming from asymmetric information, missing markets, limited attention, externalities--that would come roaring out of the "pandora's box" that FDA regulation has them trapped in is a great demonstration of the value of regulation. if the FDA didn't exist, we would have to invent it.
in the second section you suggest the problem is one of path dependence. that in a new equilibria without the FDA, doctors would have to "think for themselves" and critically evaluate the safety of drugs. you seem to suggest that this equilibria is preferable to our current one, but the transition path would be too painful, so we will never cross it. but the "doctors and patients think for themselves" equilibria seems kind of inefficient, right? even if all unthinking doctors get competed out of existence (which seems unlikely--just about all existing markets have both good and bad sellers coexisting in equilibrium), the remaining smart doctors would have to allocate a substantial amount of time and resources to thinking, which all else equal would reduce the number of patients they can treat. reducing the inefficient duplication would require re-inventing the FDA (in part).
'going through all the market failures'. This is not the only relevant thing to think about! Have you gone through all the 'government failures' - and weighed the harms and inefficiencies against those of market failures?
luckily we don’t have to choose between extremes of “no regulation” vs “maximum/current regulation.” scott’s post is convincing to me that non-zero level of regulation is desirable, and a full repeal would be very bad.
That's surprising because as with many other people in the comments thread, it's surprising that Scott's post is convincing even to himself, given that all the points he raises about the 'dangers' of unregulated drugs are very strongly moderated by the example he gives later of the unregulated supplement market
i didn't read the comments, but i personally wouldn't be very confident extrapolating from natural supplements. a salient difference is that they're neither effective nor harmful--for the most part they have no discernible effect. many of the scenarios scott describes (people suing doctors for prescribing something that killed/hurt them) don't really apply in that case.
As I've noted elsewhere, unless your contention is that harmful supplements are physically impossible to create, the fact that they're not harmful is not a given - it's an emergent property of an unregulated market.
we want a system that makes drugs that are effective. harmful is ok as long as when it's consumed in the right quantity and under appropriate circumstances and the benefit outweighs cost. a market for supplements that are ineffective yet harmless is not the gotcha you think it is; the market seemingly has no incentive to develop supplements that are effective. it's good that the drugs that scott describes that make you bleed internally if consumed in the wrong quantity etc exist.
Thank you for reminding me that there is a strain of libertarianism that conceives of freedom solely in terms of government regulation and not the broader set of human institutions that shape or constrain us, and therefore views the abolition of Jim Crow as a net negative for liberty. This would otherwise seem like a bizarre strawman that I hallucinated.
So the idea is that libertarians only win if the win is something that they, and only they, care about? I don't see how that makes any sense, and I think it is a hard proposition to defend. What is special about FDA reform that distinguishes it from occupational licensing reform, housing reform, prison reform, or zoning reform? These aren't things that happened the better part of a century ago. They are happening now.
Also, I fully understand, as I said, that (most not all) libertarians generally don't think or care about things like Jim Crow. But this wasn't just "some things" being worse 70 years ago. It was a major, major upheaval of American society that resulted in major, major advances in liberty.
But sure, if you ignore all the advances in liberty, libertarians always lose, I guess.
As I recall, one of the things the FDA does is define and enforce truth-in-labeling laws. Your product label has to say what's in it, and the label has to be correct. Before the Pure Food & Drug Act of 1906 there were a lot of shams and fraud that outright lied about the contents of the product. So, that's another thing that would have to be addressed by any plan to fully abolish.
The laws against e.g. selling aspirin laced with fentanyl are not the ones anyone, AFAIK, is proposing to abolish. Nor is FDA the only ministry that enforces such laws in the US.
I think a good small-c conservative solution could be to turn back the clock to some tried-and-true solution rather than diving head first into terra incognita.
What about the pre-1962 FDA? The approval process is perfunctory, but disastrously bad drugs were recalled ex-post anyway. And the power to shut down contaminated plants was already there. Basically a very specialized police force rather than a regulatory agency (you can go before 1938 if you want to do away with the approval process anyway, but courts will keep discussing liability of course).
Or, if we insist to abolish the FDA altogether, let be noted that the pre-1906 US was not Galt's Gulch: while the Federal Government did not regulate pharma, the states surely did. Harmful chemicals could be, and were, forced to be sold with a label reading "Poison" or outright banned. This would ameliorate the effects of regulatory capture (it would be discussed democratically rather than among bureaucrats), leave some opening for people who really really want a drug (I trust NH or some other state to scarcely use such powers), while creating some safety for the average patient.
Of course, we are not limited to domestic examples: pretty much any polity in the world regulated pharma one way or another, there must be many example of models more successful than the FDA. The possibilities are nearly endless!
The (US; but this is quite universal) legal system is not (and does not aim to be) logically consistent from a "mathematical" POV. "Justice is incidental to law and order" (J. E. Hoover). See also the famous "What colour are your bits?" essay: https://ansuz.sooke.bc.ca/entry/23
For a concrete example: the poppy plant is legal to grow in your garden in most of USA, while refined and properly dosed opiates are regulated to the point where not all chronic pain sufferers can reliably buy them on the open market.
To take another: the psychedelic DMT is prohibited in USA. Even though it is purportedly found, at all times, in small quantities, in a healthy human brain.
Believers in the logical consistency of law sometimes have interesting misadventures in USA. There exists an entire subculture of "sovereign citizens" -- mentally-touched people who search for what they believe to be logical inconsistencies in the US legal system, and believe that they can make use of them to get out of paying tax, debts, legal judgements, etc. Often, their arguments look superficially correct to the uninitiated. What they don't realize is that "Western democracy" and "rule of law" are simply a fiction used by the powerful to dress up their master-slave relation to the plebes in flowery jargon, strictly to make for cheaper and more effective plebe management. When the "logicians" end up in court, the judges sometimes "let the mask slip" and helpfully remind them of this fact. Such cases very often make for interesting reading.
>What they don't realize is that "Western democracy" and "rule of law" are simply a fiction used by the powerful to dress up their master-slave relation to the plebes in flowery jargon, strictly to make for cheaper and more effective plebe management.
I disagree. Democracy and rule of law are a pseudoformalized agreement. Pseudoformalized in the sense that formal rules are written, and if those rules turn out to have weird edge cases, people go with common sense over the letter of the rules. But none the less, they are rules. And one of their functions is some partial protection against abuse of power. And also some protection against thieves. Which indeed makes people less likely to revolt.
Scott, your questions invite thoughtful contemplation, as do the comments it's received.
It is interesting that underground drug markets like we see within bodybuilding, which exists largely outside the FDA's purview, offers a glimpse into a potential scenario where the FDA is absent.
The underground bodybuilding community operates on a market-driven basis, heavily reliant on reputation. Trust and product efficacy, rather than government regulation, guides consumer choice.
This model isn't flawless, and perhaps those interested in bodybuilding may do a tad more research (though not nearly enough) than an average Joe looking to correct his blood pressure, but it's a representation, albeit an extreme representation of a government-less drug market.
I'm not going to pretend to be naive to the issues such underground markets create, or the damage that has been done as a result of it. But there are lessons learned (in some cases intentionally, by human test subjects trying to inform their peers) from the bodybuilding community which would never get approval in a moral system.
It's a world I both love and hate. I'm glad it exists, to educate others (including medical professionals), but would hate to see such risks adopted by my grandmother.
You can make similar arguments for regulation in any economic sector. For example, suppose software was as heavily regulated as prescription drugs; where any new program would be vetted by an FDA-like agency before its public release. If someone called for deregulation, people would object in a very similar manner: bad actors would publish malware, they'll infect our computers, steal our money, and all kinds of horrors will ensue. They would predict that the entire technological civilization would come crashing down without federal bureaucrats carefully approving each program through rigorous testing.
Since in our world software is deregulated we can understand the folly of this argument. Malware and hacking definitely exist but their negative effects are overwhelmed by the enormous benefits provided by deregulated software. That's why a cost-benefit analysis is necessary concerning any proposal of regulation or deregulation. You don't attempt to do that at all. You list some benefits that FDA provides but you should have also considered the costs that it imposes. FDA's existence can only be justified if the benefits exceed the costs. I don't believe it does; the opportunity costs of delayed or nonexistent drugs vastly outweigh whatever benefits FDA provides.
You also make up imaginary scenarios where BadCorps rule the market absent enlightened bureaucrats. This assumes that every other market participant is a fool. Consumers care about quality too. In a free market, competition will ensure that BadCorps will go out of business. However, there will be tradeoffs between quality and price. IMO that would be an improvement over the status quo.
It's easy to imagine scary scenarios in the absence of regulation. However, such scary scenarios are often less likely than they seem and market competition works to remove them.
Proposals of deregulation are always greeted with predictions of disaster. People predicted disaster when airlines and railroads were deregulated by Carter, or when telecommunications were deregulated by Clinton. The results instead were a wealth of innovation that led to huge efficiency gains and falling prices. I'm sure that deregulating medicine will have the same effect.
The cause of the opioid epidemic was the patent and not the drug that has been around for thousands of years that everyone knew was addictive. So the reason Oxy was pushed by the Pharmaceutical Industrial Complex was because of the huge profits…take away the profits and then the PIC loses interest in pushing the drug.
"“Natural” doesn’t mean “safe” - nature includes venomous snakes, poisonous mushrooms, and produces some of the most dangerous drugs in the world (eg opium, cocaine, digoxin, certain chemotherapy agents)."
I would have to assume that supplement companies are still subject to legal liability, and stand to get sued if they kill or sicken too many people (also, good chance your supplement gets reclassified as a toxin, which might be a challenge for the marketing department).
Would this system continue to work if the FDA were abolished? The prospect of an overloaded court system trying to regulate drug safety gives me pause.
"Natural" does skew towards "has been around long enough for people to understand what it generally does". "Natural" plus "We don't have a gigabuck drug-discovery budget", mostly means stuff that the supplement-peddlers have been cued to look at because some culture's ancient tribal wisdom says its a medicinal herb. And the witch doctors, wise old ladies, etc, were generally smart enough to stop advising their patients to eat the outright poisonous stuff and to advertise the seriously mind-altering stuff as being seriously mind-altering if you're into that sort of thing.
So far, this inherent filtering (plus fear of liability) has worked pretty well to keep the natural-supplement industry reasonably safe, even if it is often nothing more than a safe way to produce expensive urine. If we start allowing synthetic compounds, that might not hold and we'd need to find another path to the same level of safety.
I expect this has already been said to death in the comments, but a practical abolition plan would just make the FDA voluntary, and whoever seeks to have an FDA-approved drug could choose to pursue the exact same process as today.
On day one, no changes due to liability fears. On day 10000 maybe people juts stop paying attention, who knows.
People always complain about comparing an idealized version of the new system to known realistic failures of the old system. But the actually existing system keeps getting worse and people refuse to acknowledge how bad it is. I have about a 10% rate of having my prescriptions refused. We just don't have a system any more.
Is that what they’re teaching in H.S. Chemistry these days? If it’s just one letter away from something familiar, you don’t have to worry about it? So, no need to worry about cyanide (CN) or hydrogen peroxide (H2O2 and at full strength, it will eat your face).
If we had no FDA, wouldn't the covid vaccine have been available 6 months earlier, I have heard, maybe longer. That would have saved a lot of lives, and shortened the lockdown period, maybe kept covid from becoming a pandemic. If that is correct, wouldn't that alone tell us that the FDA had caused more harm than good over the time it existed?
For the experimental drug category, we would possibly have a situation where a medicine would be cheaper as an experimental drug (I assume demand for them at this stage would be lower), but their price increases, possibly by orders of magnitude, at the point where they are FDA approved. This feels like it could lead to all sorts of weird things. A concrete example is the uninsured patient (or a patient in a developing country, where medical insurance could function differently or be non-existent). Here, a drug they had access to suddenly becomes out of reach. This feels like an edge case, but it seems plausible there are other more significant impacts from a drug suddenly shooting up in price, especially in a healthcare system as convoluted as the states'.
Could you force drug companies to fix the price upon FDA approval? Perhaps, but this introduces another layer of regulation. It could be fixed at the final post-FDA price, in which case few patients would be able to benefit from it as it is uninsured. Alternatively, you could fix it at the pre-FDA price, in which case the pharma company could never make the money back from the expensive FDA approval.
I propose one simple reform: “The FDA shall not prevent market access for any claim." This keeps the FDA in it's current form, but removes it's 'monopoly on violence' by taking away it's monopoly power to prevent a drug or device from reaching the market for any reason. This will open the market to other standards like the EU's CE Mark and to new competitive nongovernmental standards. Hospital purchasing departments and Payers will likely still want to see FDA approval for high risk, highly invasive drugs/devices, but may find FDA approval excessive for low risk interventions and look to less burdensome standards for approving those. This one reform will create a competitive landscape for new standards and this will bring more innovation to the marketplace most efficaciously.
Defang the beast and you starve the beast. Time to defang the FDA and make it compete in an open marketplace of standards.
The late, great Steven B Harris proposed simply rolling back the FDA to the powers it had in the early 1960s, before thalidomide. That is, get rid of mandated efficacy studies and keep everything else. Under the old system, the FDA was in charge of ensuring a drug was safe rather than safe *and* effective. Efficacy was a matter for the medical community to decide organically.
When you change the rules, you change the game. It seems that Scott is making a mistake of assuming that when you change the rules, the equilibrium remains the same.
To give an example of this mistake that nobody would make, imagine a city with 2 routes into downtown, with traffic split 50/50 between the routes. One day, the city decides it needs to shut down route A, and leave route B open.
Nobody would assume that the folks who typically take route A would just give up and go home, leading to a 50% reduction in downtown workers that day. Instead, the equilibrium would shift - many of those formerly route A drivers would now take route B (and some would indeed stay home, as the marginal cost of going to work is too high).
Regarding this post - one mistake I see relates to people's habits reading pill bottles. Yes, few people read them today, for two main reasons:
1. Information density - very little of the information is value add; most of it is boiler plate.
2. Incentives - with the FDA, doctors, and pharmacies all warning you of any dangers of your meds, people feel no need to do it for themselves.
When my daughter crosses the street, she looks both ways before crossing. But, when she's with me, she doesn't.
If we were to abolish the FDA and prescription requirements, I can't promise it would be amazing. But at a minimum, I'm pretty sure people would read and understand the nature of the medications they were going to take before taking them.
“What would a practical abolish-the-FDA-lite policy proposal look like?”
The lazy answer is, just leave it as it is, but advisory rather than mandatory. Just let innovations happen on the margin.
Can you expand more on what "advisory rather than mandatory" would look like? Companies would be allowed to seek an FDA seal of approval, but wouldn't have to?
Basically, yes. Obviously I have not given it much thought, so I can’t fill it in. But that is my go-to attitude for reform, don’t make people who are happy already into unwilling experimental subjects, just let the willing subjects give it a try.
I haven't put too much thought into it either, but the view I have seen most often is not 'abolish the FDA'. Rather, it is to make it opt-out. Which I think is DavesNotHere's idea as well.
Require a big red sticker that says 'NOT FDA APPROVED' on any drug choosing to opt out of FDA guidelines. Companies are still liable for torts, as always. One way to discharge your duty is to demonstrate that your drug was FDA-approved. But even currently, that is not sufficient, though it is necessary. Under this proposal, it would be neither necessary nor sufficient.
In the immediate aftermath, things don't look too different. However, an entrepreneur realizes that there is a an opportunity to be had-- start a company that gives a 'gold-seal' of approval that, like the FDA, offers a presumptive case against negligence. Essentially, have a competing FDA.
There is the issue of judgment proof start-ups looking to cut corners, but mandating liability insurance would solve this. The insurance company, not wanting to be on the hook for millions of dollars in damages, would require the company to follow certain regulations. But only insofar as the regulation is efficient. As an aside, this is a libertarian response to most of these kinds of regulations (echoed by Dave)-- if it really is efficient, just mandate insurance, and the insurance company will require the regulations.
There is more to be said, obviously. But I think this kind of proposal makes a lot more sense than the 'abolish the FDA' proposal, for many of the reasons you discussed. Functionally, it is pretty much just a dressed-up version of your legalize synthetics as supplements line of thinking.
So if I make sure all my assets are offshore and held in a jurisdiction that doesn't recognize US court judgments?
That’s the sort of thing that would make your Gold Seal of Approval not carry much weight.
Right. Also, something that would make it harder to find insurance companies willing to take on potential liabilities. Of course, Feral might counter with 'what if the insurance company hides their assets and goes bankrupt'. Now, my understanding is that there is federal/state regulation to prevent that sort of thing, but since we are making the libertarian case that would seem like a cop out answer.
A better reply might be that if people are worried about such an issue, then it would be in the interest of an entrepreneurial company (perhaps the same as the FDA competitor, perhaps different) to offer a second seal of approval; namely, that the company has adequate insurance with a company that can pay its debts.
So, one seal vouches for the quality of the product. Another vouches that the company has insurance willing to cover its ass. If consumers value the assurance that a company who will bear the cost of liabilities (the insurance agency) has agreed to indemnify the company, they will opt for that product. Others may take the risk, and opt for the 'insurance-free' bargain.
The likely counterargument is that consumers do not have enough knowledge and sophistication to meaningfully understand the distinction between a drug that carries a seal of insurance and one that doesn't. But you can carry on arguing forever here (eg. grocery stores/pharmacies might, and might not want to sell risky drugs to consumers.. etc.).
Again, not an expert in this-- just my initial thoughts. Happy for better replies/counters.
So the public are supposed to be lawyers as well as scientific reviewers.
that's something I don't get about law because if I buy chemical X and it poisons me, why is that the seller's problem? Or if you want to have a default deal that's fine, but why should I not be allowed to buy X with the only promise given that it is X.
If I understand your comment correctly-- you are asking why the presumption shouldn't be 'buyer beware'. I think the reply is that given that currently, most consumers operate on the assumption that a drug is FDA-approved, it would be negligent (perhaps fraudulent) for a company to sell a drug, without explicitly noting that they are not in FDA compliance.
If what you are asking is why it is the seller's problem that they sold something that poisoned you (and not your own problem)-- the answer to that encompasses tort law. There are separate justifications for why we have tort law, that libertarians may or may not agree with-- but that would be a longer explanation that I feel unqualified to offer.
So from what I've seen, the whole problem with this line of thinking is enshittification.
Companies have repeatedly shown that they are willing to build up a good reputation in phase 1, and then take a treacherous turn in phase 2 to cash in that reputation for money at the expense of the customers that got used to trusting them.
There are third parties like LabDoor which do this for some supplements. The companies then advertise this in their marketing.
From the post:
> The only problem is that this hasn’t happened with supplements (examine.com, LabDoor, etc, are nowhere close to this level, sorry
so I assume Scott wants something better / something else? Idk.
I've never found an evaluation of how good LabDoor is.
AFAIK this is almost exactly the role Underwriters Laboratories plays in the electronics industry.
UL and UL certification are the exact model I think of w/r/t changing the FDA.
I'll expand down below, but the ideal would be to allow the FDA to carry out its mandate -- generally checking that most things US citizens might *ingest* aren't useless, tainted, or wildly dangerous -- without having de facto total control over the drug industry and huge amounts of government healthcare spending.
(Government healthcare spending being actually ALL healthcare spending, at this point, another thing that Must Change)
How much does it cost to comply with UL certification? What percentage of devices submitted for certification end up being denied?
One of the problems with FDA drug trials is that (apparently) they end up costing in the hundreds of millions of dollars to run, with many of them not successful.
I suspect that UL certification tends to be less of a crap shoot.
This is because we understand electrical engineering far more deeply and reliably than we do pharmacology. It's not a feature of UL vs FDA, it's a feature of their respective domains. When a drug fails its FDA drug trial, it's usually because it's useless.
Which is an argument that taking UL certification as a model for drug licensing is premature. We would need to know a lot more before we can do that.
Speaking honestly, we could probably keep the majority of the apparatus that confirms that some food or drug won't actively kill people. In the pharma world, that's the goal of Phase 0/1 clinical trials, which are notably inexpensive relative to phase 2 (roughly speaking: prove it could work) and phase 3 (prove it works a lot). The result would be a market for drugs that won't hurt you, might not do anything at all for your joint pain, but it only costs you $7 to find out.
I'm an FDA skeptic: https://jakeseliger.com/2023/07/22/i-am-dying-of-squamous-cell-carcinoma-and-the-treatments-that-might-save-me-are-just-out-of-reach/ and there are others: https://marginalrevolution.com/marginalrevolution/2023/12/dont-let-the-fda-regulate-lab-tests.html. But I've never argued for abolishing the FDA, for the reasons you cite. Or, if it were abolished, it'd need to be replaced by *something* to regulate drugs.
Since I've got fatal cancer, I'm particularly interested in that area, and a lot of the emails and comments I've seen have two major complaint components: 1. the FDA is too slow and 2. the FDA is too random. The slowness part entails submitting study plans or data, which the FDA takes months and months to process even though statistical analyses can be done almost immediately via Excel or SciPy or R or whatever.
The randomness part is the failure for the FDA to set and keep to clear guidelines about what constitutes a reasonable trial, what success looks like, and what failure looks like. This raises the cost of compliance and, again, can waste months or years of time. Even in a low-interest-rate environment, that's terrible. In a high-interest-rate one, it's even worse. Meanwhile, people die for lack of treatments.
We saw both pathologies at work during the pandemic.
If a federal drug regulator acts too fast, some people may be hurt or die from bad treatments. But if one acts too slow, some people may be hurt or die from lack of good treatments. There's a scale between them, and right now the FDA is way too far towards the second, and it needs to move towards the first. Governments and government agencies, though, very rarely give up power once they acquire it.
Imagine trying to run a business, but first you have to run a gauntlet of opaque government agencies that take months to years to reply to submissions. That situation would kill many startups and businesses. I realize I'm describing San Francisco, but most startups are Delaware C Corps, which avoids many of SF's pathologies in ways retail can't. In most of the U.S., it only takes ~4.2 days to start a business: https://tradingeconomics.com/united-states/time-required-to-start-a-business-days-wb-data.html.
And then there is the clinical-trial quagmire: https://bessstillman.substack.com/p/please-be-dying-but-not-too-quickly, which has emerged as it has in part from the two FDA pathologies noted above.
So there's a lot that can and should be done better, though a total free-for-all is also undesirable.
In thinking about this more, I think one problem is that the FDA does so many different things that are somewhat related but not really the same—like regulating ADHD meds versus oncology treatments—that it's hard to fully accept "FDA good" or "FDA bad." It's too different. Maybe breaking the agency into smaller pieces would make sense.
Most likely, breaking the agency into several pieces results in a world where you need to get the approval of several different agencies to do anything, rather than just one.
Where does our host come out on this question?
I think as a general rule, a major government reform I would like would be to restructure so that you never need permission from more than one body to do something (granted, this is hard to implement)
Yeah, probably. It would seem to make sense to break off, say, the part responsible for "visit the plants and make sure they're not putting melamine in the baby formula" and let them just do that kind of job.
But then you'd probably end up with a whole new agency, with accompanying bureaucracy, for "Going Round To Chemical and Pharma Plants To Make Sure They're Not Putting Shit In Stuff", plus an agency turf war over does this include food production plants or not under their aegis, or shove off new agency this is our bailiwick and always has been?
Yes, rather like Homeland Security. You had a security problem, people fought over whos fault it was, the result was adding another bureaucracy on top of all the existing ones.
I don't think there is one simple answer, or any answer that will satisfy everybody.
Look at the Covid vaccines: opinions went from "skip all the red tape paperwork, this is a crisis and we need them now with minimal approval roadblocks in the way!" and then afterwards "these vaccines are killing healthy young adults, why were they rushed out, where were the approval roadblocks?"
A lot of the problem is reacting to crises. Food and Drug acts were passed in many countries because manufacturers were putting any old shit into products and poisoning the public. As "this drug caused A, B, or C serious side effects" cases came along, and went to court, so the red tape and regulation got cranked up every time.
Now there is (and I think we should err on the side of caution) the cautious approach about "let's dot every i and cross every t" before approving new drugs. But that holds up promising new treatments. But how can you tell "promising in the early stages but useless when given as a medication" from "promising in the early stages, effective when given as a medication" without large scale testing? And that means delays.
I don't know. There probably is a lot of room for improvement, but what part can you safely prune away and what part is going to be load-bearing?
The "afterwards" set of opinions was exclusively held by idiots who should be ignored.
That may be, but we really did see a divergence (i.e. I saw it between members of my family) over the vaccines between person A saying "the FDA is killing people with red tape, how could they possibly be taking so long to approve these vaccines" and person B saying "this is the fastest FDA vaccine approval ever? In an environment where the person A mindset is publicly pressuring them to approve it even faster? No WAY they're not cutting corners; we can't know if these are safe"
Which is to say there are always tradeoffs and the FDA legitimately could have reduced vaccine hesitancy by taking longer to approve the shots
> FDA legitimately could have reduced vaccine hesitancy by taking longer to approve the shots
I don't think that would have helped. Most of the public didn't have the faintest idea how long it takes to produce a new vaccine -- whether it's 6 weeks, 6 months, or 6 years --, and what the different methods of producing one are. The problem was that the media kept yapping about how fast it had been produced, and the novelty of the method -- well, they had to write something to capture eyeballs, and of course for some people it was *good* news that some wonderfully smart people had used this novel method and produced an effective vaccine so fast. But that info was seized on by people who were already angry and mistrustful because of how covid had been handled so far, accurately perceiving that the government was herding us rather than informing us of the best direction to wallk in. And then of course social media amplified the fear, anger and mistrust.
I've asked a few people about what they thought about this. I think many people were nervous about the vaccines because of how quickly they'd been produced - and arrived at this idea independently of press coverage, and would probably have found it eerie if nobody acknowledged that they were brought to market much more quickly than a lot of other vaccines. My sense is that this is because most people don't realize how straightforward vaccines are (the body does the heavy lifting, really, all you need to do is present an antigen) and so they assume it must be a long and complex process fraught with difficulty (perhaps exacerbated by how much people worship the pioneers of immunization like Pasteur and whoever and act like they're geniuses of unimaginable and superhuman magnitude).
People don't realize that one-in-ten-thousand safety risks don't really happen with vaccines (not to mention the obvious safety risks of not getting a covid shot, which many people don't really think about, because of some sort of cognitive bias I don't really understand), regardless of how quickly they're brought to market, but I think, in the absence of any information either way, people would assume that one-in-ten-thousand safety risks are actually a common pitfall, just because of how difficult I think people assume vaccine development is. (Yes, I know about vaccine-mediated enhancement, but that doesn't really have any bearing on this because it was conclusively rules out by clinical trials.)
(Another reason people might assume it's fraught is that development of small-molecule pharmaceuticals is definitely very fraught, and I think a lot of people don't understand the huge difference between vaccines and small-molecule drugs.)
>many people were nervous about the vaccines because of how quickly they'd been produced - and arrived at this idea independently of press coverage, and would probably have found it eerie if nobody acknowledged that they were brought to market much more quickly than a lot of other vaccines.
But it's not as though new vaccines are brought to market often, right?, which would give people a sense of what typical pace for developing them is. I think the only vaccine development process most people are aware of is the flu vaccine, which is different every year. Actually, of course, pharmaceutical companies don't build a whole new flu vax in a whole new way every year -- they just tweak the formula. But how much of the public knows that?
And in any case: People you know are saying they would have been worried without the media's yammering about the novel technique and rapid development of the covid vax? How can they know that? It was utterly impossible not to be exposed to a shit-ton of info, speculation and opinion about mRNA vaxes and the speed of development, unless one was a hermit. How can any of us know how we would have felt about various developments in the covid saga if we had had no input from the news media and the goddam social media?
The answer, of course, is "most vaccines take years to approve because raising money for the trials takes ages; the trials themselves are pretty quick. This is what it looks like when we don't dawdle."
But if you don't trust it when it's first approved, you can wait half a year more until millions of less skeptical people have got it (perhaps until it has full, not emergency, approval), and there is much more data than there would be from half a year more of clinical trials. I don't have high confidence that this actually convinced many people, but I also don't think a slower but still fast by ordinary standards approval would have convinced many people.
But of course by the time half a year had passed Twitter and no doubt other sites were full of stories about people developing grotesque symptoms and severe illnesses and flat-out dropping dead right after receiving the vax. I was on medical Twitter all through covid, following epidemiologists, immunologists, researchers, etc. and saw literally hundreds of these stories in comments made in response to posts about research by smart, honest professionals who were working their asses off to understand covid better. Over time the tone of stories changed from alarmed to snarky: "Sure, asshole researcher, promote the vax. We've figured out what's really going on."
Sure, but if you wait half a year longer to approve it, those scaremongering stories would have still appeared by the time half the population has got it. Except perhaps if they manufacture enough doses for everyone before approving it, and then they gave out the shots very quickly, before anyone has a chance to put out those stories. And doing that would give up a genuine safety benefit of having data from millions of people by the time less vulnerable people who benefited less from the vaccine got it, and it would generate another form of skepticism in the form of "why do they insist we take it immediately?".
And then there is that the benefit of less vaccine skepticism would have been far outweighed by the harm of later access for less skeptical people. And that the former benefit would have primarily accrued to people making poor decisions, while the latter harm would have accrued to people making good decisions.
There's no rigorous psychological evidence that reduces vaccine hesitancy, and instead when the FDA engaged in amateur psych to pause the J&J they INCREASED hesitancy.
Different people have different levels of risk tolerance and even different understandings of what risk looks like. While I think some of the anti-vax opinions related to COVID were outright mistakes rather than just value disagreements, I think a good solution would include a system that allows people to take on risk if they do so with informed consent. The devil is in the details. But in theory there's room enough in this world for the ravers and the anti-drug folk and everything in between.
More narrowly: If a drug is approved in another OECD country it should be available with warnings and outside of a standard of care in the US. If people want to pay for it, they should be able to purchase it. Or someone should make an argument that the approval process for that country is significantly worse than the one for the US.
In the current system, the FDA micromanages product testing conducted by other entities - usually the manufacturer. If the manufacturer doesn't comply with extremely detailed testing parameters that are only conveyed in secret closed-door meetings then there are delays and people are forbidden to choose potentially life-saving medicines. There's no independent peer review mechanism for the question of whether the FDA's demands are reasonable - and that's important because, from my perspective, the FDA appears to frequently be falling into the type of dangerous sit-tight-and-assess behavior parodied in Don't Look Up.
It might help to drill down on a specific example. Based on published data, I would bet that a Covid vaccine called SKYCovione could offer me broader, more durable protection than first-generation Covid vaccines. Here's more detail:
https://cbuck.substack.com/p/extraordinary-evidence-requires-extraordinary
SKYCovione was approved in South Korea a year and a half ago, but FDA continues to judge the overseas data as inadequate to support approval. I can read the overseas data for myself and I think the FDA is wrong - to the point that I've literally considered flying to South Korea as a refugee vaccine tourist. FDA vaccine committees seem to me to be trapped in a bureaucratic cover-your-ass funhouse on this question. The myopia could realistically have something to do with the fact that vaccine manufacturers are paying their salaries:
https://www.nytimes.com/2022/09/15/health/fda-drug-industry-fees.html
And the decision-making process could be distorted by the fact that manufacturers are allowed to offer FDA employees top 0.1% salaries on the other side of the revolving door:
https://www.hulu.com/series/dopesick-227de06a-d3d4-42e0-9df1-bb5495e1738d
The fundamental problem is that there are no checks and balances in the current system - FDA veto authority is inscrutable, unaccountable, and unbreachable.
In a separate comment I sandbox the idea that creation of competitive independent testing agencies could, in the longer run, make it possible to abolish the FDA. Independent testing works fine for dangerous products like cars - so why not for medicine? Figuring out how best to organize independent testing infrastructure is an interesting debate. What I don't understand is why any American on either side of the aisle would think that having a government agency with unchecked veto authority is a great idea. It's obviously an abomination. We should abolish the FDA's unchecked veto authority as soon as possible.
"… and get it all exactly right." Yeah, that's kinda true, but it's not *tricky* to "reform" them all to the ground (salt to taste).
I think Scott is saying "the FDA needs to be reformed, not abolished" without getting dogpiled by libertarian reply guys
Minor warning for low information, high temperature comment. 25% of a ban.
I'm sorry. It wasn't meant as a criticism at all.
Your piece points out a number of reasons why the libertarian approach seems unworkable, and notes that if there is a way to make it work, it hasn't been discovered yet. I read that as your not supporting abolition until the solution is discovered, which is the kind of position that (if stated explicitly) tends to get a lot of rude responses.
I wasn't saying you were criticizing me, I do think "dogpiled by libertarian reply guys" is an unfair way to put it.
I can see arguments for rip-off-the-bandaid type solutions but that's not my style.
I'm not unsympathetic to libertarian policy options but LRGs are definitely a common type of RG, though maybe not on your substack since the things you write wouldn't normally wind them up.
Not a direct response, but do you associate "RG" with "low-information high-temperature responder"? I'm not sure this is actually true (and kinda dislike the stereotype, mostly because I find it easier to respond to things than proactively write them).
There's definitely a thing where if you look at a random insightful post most replies will be low-quality, but that's just because most content is low-quality and it being in response to an insightful post doesn't counteract that much. I don't think replies are inherently lower-quality in general though (though there is a good argument that it's harder to filter them for insightful ones).
Yeah. Writing a reply doesn't necessarily make you a reply person.
This is me. My ratio of replies to posts is definitely greater than 10. I strive to reply in a manner that is interesting or useful so do find the pejorative use of RG a little unfortunate. Part of it is status I guess and part of it is simply that a lot of replies are genuinely low to no value. Maybe we need a new term for us RGs to aspire to: the high value reply guy (HVRG). Hehe.
I think you seem to be failing to grasp that Scott does not want you to cavalierly dismiss people on the other side of the argument as “reply guys,” which is rather anti-intellectual and unnecessarily inflammatory.
I hope I wasn't being cavalier. But Scott's argument felt like something that a sensible progressive could have written in peak 2020: "Here are a few issues we need to resolve before we move forward on abolishing the police", followed by a laundry list of reasons the whole approach is misconceived.
In other words, it seemed like a reasonable argument that was carefully phrased to reach people whose views on a given issue aren't entirely reasonable, without triggering a dismissive "reply guy" reaction from them.
There's a need for that style of argument. If I'd been assigned to write a piece on this topic it would have been much shorter than Scott's and the tone would have been "what a dumb idea", which wouldn't have been helpful in changing anyone's minds. Scott is more libertarian than I am and that (plus his medical degree) gives him credibility in explaining to FDA abolitionists that this is, in fact, not a well-thought-out proposal.
I thought he managed that in a very tactful way and by pointing out that this seemed to be what he was trying to do, it may have looked as if I was trying to spoil his rhetorical strategy. But I hadn't meant to imply that people with ill-considered opinions are stupid, only that it helps to address them with respect.
I think rip-off-the-bandaid solutions will produce chaos, which the well-off and well-educated will be able to navigate with decent success. Everyone else will suffer greatly.
FWIW, I don't think anyone would be able to navigate that successfully...or at least not safely. Scot points out a number of things that would need to be addressed. If they weren't...I doubt that even caffeine tablets would be safe. And he left out a bunch of things that currently really need more effective regulation. (Meat packing plants are currently a lot better than they once were, but they're hardly very sanitary.) The problem is, with the current setup, being sanitary, safe, etc. isn't sufficient. You also need inspection seal which can be both expensive, and require a bunch of stuff that's irrelevant for what you're doing.
I don't see any good solution, only modest improvements. And a lot of the improvements are disallowed by bureaucratic regulations which either don't reasonably apply (in some situations), or were always for the purpose of empire building. But there's no clear way to disentangle the necessary from the extraneous.
Well, the FDA isn't the only drug-regulating agency on the planet. In principle, educated people could just choose to rely on e.g. European regulators for judgments of safety and efficacy, and Canadian and Mexican authorities for quality/contamination control.
(This is more-or-less what a lot of smaller countries do as a matter of policy.)
It's still a really terrible idea, but it's not necessarily catastrophic for *everyone.*
Would be nice to have some high quality, RCTs looking at the aggregate effects of healthcare utilisation accross various margins, expensive but could potentially save a lot of resources. Also would be nice if politically more emphasis was on the more robust correlates of health such as diet, exercise, pollution, stress etc.
Most abolish the FDA types are proposing a grand remaking of the relationship between government and citizens. Courts, insurance, medical licensing and welfare would all be changed so much it doesn’t make sense to speculate on the effects of FDA disbandment on present institutions.
This is very similar to what I’ve been told about abolishing police or prisons: we’re talking about totally transforming society so there’s no point trying to figure out how it would work.
I really don't understand who finds this argument pursuasive - surely the bigger the change, the more important it is to think it through first!
I don't think "don't worry, this change will be radical so don't worry about the details of it" is pursuasive in any practical context - If I was on a plane to New York and the pilot told me our flight was being redirected to Boston, I might have a few questions but I'm sure it would work out in the end, but if I was told our flight was being redirected to Havanna I would have a lot more questions about the practical implications of our change of course.
Yes, I agree, and it also seems like an acknowledgment by the speaker that they are not talking about changes they ever expect to happen. It’s Land of Cockaigne stuff.
Scott has had some hard words for arguments of this form in the past: https://slatestarcodex.com/2014/09/13/book-review-singer-on-marx/
This way of thinking comes from Hegelians, who are the cause of all America's present political woes. Hegel argued that there is a World Spirit guiding humanity on a path towards ultimate perfection. At each step on this path, the World Spirit chooses one nation to move humanity forward to the next level. If you are one of the Chosen People, all you must do is destroy your current society, and the World Spirit will see to it that the next, more-perfect iteration of human society springs up from the ashes.
This is stupid, and few if any people believe it consciously. Yet it is/was obviously assumed by Marxists, the early modern artists, the leftists of the 1960s, and many leftists today. I think most leftists today would justify this by saying that humanity is naturally kind and cooperative, and any instances of suffering are necessarily caused by evil people who have gotten into power. Destroy the system, and "the people" will be in power, and everyone knows the people are good.
You could also attribute this to Rousseau, who taught that the natural state of humanity is idyllic, and civilization is corrupting. It ultimately traces back to Plato, who taught that the world began with the perfect Forms, and that over time, things can only degrade, as copies of copies of copies, unless they are destroyed and remade in the image of the original Form by a philosopher who has insight into the Forms.
The first step toward wisdom in this matter was by Adam Smith in 1776, the first person AFAIK who realized that the question that needed an answer is not why some people are poor and miserable, but why some people are not.
I don't think that's true. Many people who want to abolish the FDA may also want to abolish other government agencies, but their support for abolishing the FDA is in no way contingent on other reforms. I think Scott is overselling necessary changes. You could easily abolish the FDA and everything would continue exactly as before except insurers would have to find a new basis for what new treatments to cover (and doctors for what new treatments to prescribe). Anyway many proposals are for FDA approval to be optional or to revert to safety review only (not effectiveness).
One, libertarians are just as much a monolithic creed as are Substackers, YouTubers or TikTokkers. Two, agreed that the FDA is one of the wonders of the modern world, barely a whisker below the NHS. They admitted once that they'd made a mistake but turns out they were wrong.
"Agreed"? I think the FDA is terrible, it's just dug itself into the system so deep that it's hard to get rid of it.
Then why are you defending it so hard?
So, what’s your plan?
Fine-tuning a steampunk balloon wouldn't have got it to the moon. But Americans love one-hundred thousand page legislative documents. They provide work not only for the drafters but for millions of bureaucrats, and cavernous warehouses for pork. Yes I am aware of Chesterton's Fence. Ask why the fence is there before you tear it down. Finland for example probably has a platoon of one or possibly two thousand accomplishing the same as or better than the armies of the FDA. Elon Musk has built a fine if fugly truck by throwing away everything that doesn't absolutely essentially have to be there. It outperforms Porsches and Lamborghinis.
What?
What what?
Elon built a truck that people who drive trucks are unlikely to buy, because it misses the point of a truck. It's not easy to repair or modify, it is likely to struggle in rural areas, it has no way to fit plows, dump bodies or PTO driven accessories. Etc etc.
Before you ask why, ask if: https://www.astralcodexten.com/p/adumbrations-of-aducanumab
Scott gives his reasons for the writing the post in the first two paragraphs.
I think Hypatia is saying that both the FDA and NHS are not only terrible, but so terrible that they cause awe and wonder in all who behold them.
Yes, as one would feel viewing a cathedral made entirely of petrified dinosaur shit.
The NHS saved my partner's life, so I have a somewhat rosier view of it (and indeed object to it being not only compared to the FDA, but compared *unfavourably*).
Saved your partner's life contra some world without the NHS?
I mean, probably any first-world healthcare system would have been able to do the same (though some would have tried to stick us with an enormous bill for several days of inpatient care). But the NHS was the one that actually did it.
FWIW, and as someone who is not a health professional, I think the FDA is marvelous. It's got a number of places where it needs to be improved, but it's an organization managed by teams of humans, and it's still trying to do it's job more than increase its power. And the job that it's trying to do is an extremely important one.
As David Friedman said, ""There may be two libertarians somewhere who agree with each other about everything, but I am not one of them."
The current movie "Pain Hustlers" on Netflix with Emily Blunt and Chris Evans as fentanyl lollipop marketers is instructive:
https://www.youtube.com/watch?v=HbPeXsdamT4
I don't think legal fentanyl has been that much of a problem. Matt Yglesias has a point that the scientific discovery of fentanyl wreaked disaster once drug-dealers realized they could make their products more potent by cutting it with cheap fentanyl, but that's a different topic.
What lesson do you draw from it?
The trailer emphasizes money. They were able to get a lot of money because insurance companies were paying for this treatment. If this were out of pocket, there would be no movie. The Purdue problem was that the standard (which was probably not explicit and certainly wasn't created just by the FDA) was that oxycodone was bad and anything new was good. This sounds like the same problem, but it was after Purdue! Was this about bribing FDA and DEA?
Surprised you haven't mentioned a common proposal: autoapprove anything the European Medicines Agency approves. This could replace, or be added to, current FDA approval processes. We can keep the FDA around for enforcement (e.g. factory inspections), or create a new body that only does this.
This would have instantly solved the great formula shortage of 2022. But I did get a bit of a high from smuggling in a dozen boxes of Canadian formula in the trunk without the CBP noticing.
(Fun fact: the "Canadian" formula was actually made in the USA. Apparently bilingual labels aren't FDA-approved.)
This would also have avoided the absolute scandal of millions of doses of AstraZeneca Covid vaccine sitting in warehouses for months while the FDA insisted on duplicating the trials that had already been done, but this time in America.
FDA ended up never approving AstraZeneca, right? I think they did end up shipping those doses to other countries that approved them, but it seems like such a shame that it was never approved here (and that Novavax approval was held up so long that most people never even heard it was approved).
Looks like the FDA approved it for travel purposes only: https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations#Oxford%E2%80%93AstraZeneca I'm glad to hear that those doses did eventually get used (and even more pleased to see that AZ is the most widely-administered vaccine worldwide: not surprising, since it used well-established tech and was designed to be manufactured cheaply and at enormous scale). But it's still infuriating that those doses weren't released earlier when they could have done much more good.
The AZ vaccine was not well-established tech. The only prior approved vector vaccine was an ebola vaccine with emergency approval in 2015 and full in 2019. The total number of vector vaccines administered before the AZ trial was probably 1/10 as many as in the trial.
Everyone agrees that vector vaccines are (for now) easier than nanolipids, but they aren't that easy. While Russia and China were able to make their own, they weren't able to produce enough to matter. So India, which produced most of the doses, probably really needed the help of AZ.
The small mystery is why the West didn't just print protein vaccines. A rogue German distributed 20k doses, so it probably would have been even easier. The answer about the West is probably corruption. The big mystery is why China and Russia didn't use 20th century technology, but went back to 19th century vaccines.
> The only prior approved vector vaccine was an ebola vaccine with emergency approval in 2015 and full in 2019.
Huh, OK. Wikipedia gives examples going back to 1972: I guess none of those were approved for use in humans?
> The small mystery is why the West didn't just print protein vaccines.
Looking at https://en.wikipedia.org/wiki/COVID-19_vaccine#List_of_authorized_vaccines, the first "subunit" vaccine to be approved (that's the same thing, right?) was China's Zifivax, in March 2021. I remember there being several protein subunit vaccines under development in 2020, so I guess either they didn't pan out or took longer to get to market for some reason?
> The answer about the West is probably corruption.
Could you expand on this?
> The big mystery is why China and Russia didn't use 20th century technology, but went back to 19th century vaccines.
I see both Chinese and Russian subunit vaccines on the list, but all debuting after their respective inactivated-virus vaccines.
Ah yes, moving towards one worldwide government. I don't think the anti-FDA folks would support that.
I'm anti-world government because I don't want a single authority being able to restrict everyone's freedom. The FDA shouldn't exist, so multiplying the number of agencies sufficient to approve gets us closer to that ideal.
It's not one worldwide government. It's just saying that if the German government (or a small group of other trusted countries) approves a drug, American doctors should be allowed to prescribe it.
This isn't politically viable. If it happened, no clinical research would ever be done in the USA, which is probably hundreds of billions of dollars a year. Any industry that large will fight back politically, and they'll fight back hard.
So the FDA process is nothing more than crony capitalism, like farm subsidies or public funding for sports stadiums?
I was not the one who made the claim that the just because an industry heavily relies on the presence of a regulatory infrastructure this necessarily implies the entire industry is "nothing more" than a rent-seeking apparatus.
I merely pointed out that there would be significant unintended consequences of attempting to shift approval reliance from US regulatory authorities onto OUS authorities - one of which being the alignment of lots of interest groups in keeping clinical research in the USA. As someone who works in clinical research (and had an FDA interaction this week, actually) I agree that the current system needs a LOT of work, but I've also seen a lot of what the rest of the world has to offer, and I agree with Scott's assessment that an attempt to cut out the FDA cold-turkey would be a disastrophe.
It’s rarely correct to say that *anything* is *only* something. Plenty of what the FDA does is good and proper. Most of it could probably be done better. Much of it could probably be done privately.
But yes, crony capitalism and regulatory capture is certainly a huge part of the current situation, and it would be foolish to assert otherwise.
ISTM that we were moving in that direction before Thalidomide happened. I think a lot of pharma companies would get behind a treaty for the EU and the US to "conditionally approve" any drug approved by the other. (Conditionally would mean it would be a lot easier to revoke approval if any problems surfaced...but until they did it could be treated as if approved.)
In the US, we have something called "breakthrough" designation, where the FDA will allow conditional approval for drugs based on surrogate endpoints (like improved lab values), while we wait for results of endpoints we really care about (like improved overall survival). Interestingly, the FDA has never rescinded approval for a drug that got conditional approval but failed to meet the later efficacy threshold. Indeed, some drug companies have failed to complete the follow-up studies and the FDA hasn't punished them by pulling the drugs until the studies are done. I imagine something similar would happen under any other conditional approval scheme.
"But if it worked somewhere else, won't it work in the US, too?" Probably? Vinay Prasad has done some great work on this. He talks about how many drug companies will do studies outside the US so they can shop around for comparator treatment regimens that have long since been abandoned in the US. It's easier to show your drug is better than the state of the art from 20 years ago, but not so much the state of the art today. Drug companies do a lot to game the system, so I would expect them to find new ways to game the system if we change it. Perhaps get the EU to conditionally approve anything approved in Australia. Then go from Australia to India, to Azerbaijan, etc.
From Omsk, to Tomsk, to Pinsk, to Minsk...?
I was intentional in my country selections (with the exception of the last one). The EU is the logical next market after the US for focusing clinical research, given market share. (China is probably larger, but ability to pay isn't as large. Japan is important, but EU is the focus after US for clinical development in the industry.)
Meanwhile, countries like Australia are trying to incentivize companies opening up clinical research in their country by offering some very steep discounts for doing studies there.
Then you have India, which had some pretty major scandals around 2015-2016 involving made-up/fraudulent data. Since then, Indian regulatory authorities have made major changes to increase confidence in Indian clinical research. Everyone wants a piece of this industry, given how much money is involved. The probability of a bad actor arising in a race to the bottom is not negligible. If US regulators stop caring where studies are done, a race to the bottom is inevitable.
> The probability of a bad actor arising in a race to the bottom is not negligible. If US regulators stop caring where studies are done, a race to the bottom is inevitable.
I've actually been making the same point a lot in these comments, against people who think the FDA should auto-approve drugs already approved by some other regulatory agency (either EMA, or any of the G7 nations' agencies seem to be popular choices). My objection is to the auto- part, for exactly the reasons you say, but surely there's room for compromise here - are European drug trials really sketchier than American ones? If anything I'd have thought the opposite. I'm thinking some kind of reciprocal fast-track approval process, subject to the agencies demonstrating comparable standards to each other and the receiving agency checking over the trial results.
The drug trial industry is big, but so is the pharma industry which has the direct opposite interest (making trials cheaper).
OTOH, maybe we in Europe might just as well save money on abolishing/cutting the EMA and just approving whatever the FDA approves.
I think there's absolutely a case for the G7 regulatory agencies to all fast-track approvals of drugs for which one of the others has already done the hard work.
Seems like there could be a hybrid between this and "EXPERIMENTAL" drugs, namely that you would be allowed to sell experimental drugs with a label that says which other countries they're approved in. Not sure if that would help at all with getting insurance to cover them, though.
Yes, that's a great idea.
This *sort of* exists already. Regulatory bodies in a few different high intensity health economies put their heads together and developed 'Project Orbis' (which isn't an acronym, just a really cool name I think). The details are a bit complicated, but the idea is that a regulatory submission made through Project Orbis will satisfy every regulator in the scheme at once, so any regulator can pick up the work of reviewing a submission and therefore approval from any country can lead to approval for every country. Naturally there are a few teething issues (the biggest being that only oncology drugs are eligible at the moment), but products are being approved through this process, most famously osimertinib (Tagrisso)
Is there much difference between the European and American agencies in what they approve and the requirements?
That comment got triple-posted for some reason. AFAICT there isn't any obvious difference in the letter of the law, but the FDA seems more stringent, and is clearly much slower — a big recent case is covid vaccine approvals, for example.
Is there much difference between the European and American agencies in what they approve and the requirements?
Is there much difference between the European and American agencies in what they approve and the requirements?
While I do think we need a form of overarching patient protection when it comes to drug development\factory safetey, the FDA has reached well past oversight and moved into actively causing harm by being slow and paternalistic. They likely don’t see it that way, but in their attempts to avoid the doctrine of double effect—in this case being afraid of potentially harming a few people even while most others benefit—they shut or slow down patient access to off-label treatments and compassionate use drugs which they have to green light in addition to the providing pharma company, and delay access of novel therapies to terminal patients.
They’re making an irrelevant distinction between killing and letting people die, all the while filling the invisible graveyard with patients they saved from potentially being harmed by treatment by instead letting them die. (I talk about this at length in an essay I wrote about the insane process of finding a clinical trial, https://open.substack.com/pub/bessstillman/p/please-be-dying-but-not-too-quickly?r=16l8ek&utm_campaign=post&utm_medium=web) I’m specifically thinking of my husband, Jake, who is dying of recurrent metastatic HNSCC and isn’t a Keytruda responder. There’s some exceptionally compelling research about using fecal transplants to transform non responders into Keytruda responders, and small scale studies out of UMPC have demonstrated this effect in melanoma patients, demonstrating improved responses in around 30% of patients. That’s huge. I’m a doc at the hospital where Jake’s getting treatment and brought up the possibility of performing a fecal transplant for him using a PD-1 responder donor and wrote a protocol. His gastroenterologist is on board with the idea. But the FDA cracked down on off-label fecal transplants after 2 deaths (in immunocompromised patients) around 2 years ago. For reference over 10k are performed a year for C. diff. Off-label would be any use that’s not treating C.diff. So we need IRB and FDA approval for this n of 1 study with Jake as the only trial participant. Or, Jake as the only off-label recipient. However you want to spin it. Jake consented to the risks and is fully educated about what the procedure entails. We even have a friend who meets criteria and offered to be a donor (non invasive! simple!). But it’s been 5 months of waiting and there still hasn’t been approval. Luckily Jake got into a different study that’s keeping his tumors stable. But if he hadn’t he would have died from his aggressive cancer, while the FDA protected him from the scant possibility of dying from a procedure that could potentially significantly extend his life. How kind! This is what I mean by overshooting. When I’ve made this argument in other settings, I’ve had examples of catastrophic failures of oversight given as reason why there should be tighter control over everything. Say the word “thalidomide” and it has the same effect on public opinion about relaxing FDA oversight as saying “chernobyl” has on people against nuclear power. They should exist, but they need to loosen their grip there it makes sense.
Some of the insane restrictions seem like theater anyhow. In the clinical trial essay I wrote that:
“Safety” sounds great, but the FDA is providing safetyism. There’s a process by which the FDA can fast-track a drug based on promising early-phase data, allowing the drug to come to market contingent on confirmatory trials. In exchange for accelerated approval, pharmaceutical companies will perform follow-up studies collecting additional data. The drug companies can use the drug, but they don’t always fulfill the obligations to complete additional safety testing. This kind of wild-west “give it a try” approach extended to the drug companies by the FDA isn’t extended in kind to patients who want to try certain off-label uses of established drugs of therapeutic interventions.
This kind of internal inconsistency is frustrating. The FDA is trying to do too much of everything, and instead, ends of doing a lot very poorly. I don't think there's a single solution, but rather, different areas of oversight: drugs, clinical trials, compasisonate use, etc. should all be addressed separately.
Substack ate my reference links! Very annoying. Here are some:
Fecal transplants for improved keytruda response (this is SO COOL): https://www.nih.gov/news-events/news-releases/fecal-microbiota-transplants-help-patients-advanced-melanoma-respond-immunotherapy
What is safteyism? https://freddiedeboer.substack.com/p/safetyism-is-the-water-in-which-we
What do you mean the FDA is fast tracking then not following up on further testing? https://www.npr.org/sections/health-shots/2022/07/22/1110830985/drugmakers-are-slow-to-prove-medicines-that-got-a-fast-track-to-market-really-wo
Since you've written candidly about all this, I hope you don't mind me asking: have you considered DIY'ing the whole fecal transplant process? It seems like the main issue would just be finding a Keytruda responder in moderately good health who's willing to be a donor? Such a person might be found through Keytruda support groups or other patient support networks. Then they need to get some screening, but I have heard that it can work fairly well to just ask one's doctor, "Hey, I'm planning to be the donor in a fecal transplant, I would like to do that more safely, can I get XYZ tests for that?". And then the actual procedure can be done at home in a few hours with simple equipment.
Seconding this - this is exactly what I'd be doing, and I don't have an MD - it seems somebody with actual medical knowledge and an assurance they're doing it safely would be all over this, especially with loved ones' lives at stake.
Of course, us making this public likely means our good doctor can't respond to us in any way except in the strong negative, out of fear of potential medical license impacts or other liability.
I thought it's still valuable to signal boost for other folk reading here, though - the traditional and established medical channels aren't the only option. Self treatment, going overseas to countries with less-murdery regulatory regimes, going overseas to concierge doctors with broader ideas about what's medically advisable, etc. Especially if important lives are on the line, doing EVERYTHING you can to save your loved one is actually an option you can consider and do.
To follow up on Paul Kreiner’s comments about DIY home FMT: this is explicitly not regulated by the FDA, and it is trivially easy to do. I’ve walked over 1,000 patients through it in the past decade and in my clinical experience the safety and efficacy (at least for refractory C diff infections, inflammatory bowel disease, and irritable bowel syndrome) of DIY home FMT are indistinguishable from the safety and efficacy of FMT in clinical trials. As a side-note, since FDA approved the FMT products Rebyota in Nov ‘22 and Vowst in April ‘23, they *can* be used off label, although they are ridiculously expensive. And they absolutely are not coming from donors who have responded to specific chemotherapies, immune checkpoint inhibitors, etc. There are FMT clinics around the world that I have sent patients to, but so far, none of them are selecting donors with response to cancer drugs. Outside of a prohibitively cumbersome and expensive clinical trial, the only way you can accomplish this is through DIY home FMT. I myself learned almost everything I know about FMT from other doctors who generously gave of their time over the past 15 years, and although a substantial part of my practice is educating patients about FMT during paid visits, I’ve always had a policy of educating other clinicians at no charge, which I would be happy to do for you Dr. Stillman. Feel free to send me a message (mark@IBDspecialty.com) if you’d like to chat.
Rebyota is wildly expensive! We were quoted 10k for one round. Sending you an email
Why default to liability on the doctor and not the person making and selling the drug?
The doctor has a smaller budget for lawyers, so you're more likely to get a result.
The doctor presumably knows something about the patient they're prescribing the drug to. The person making and selling the drug does not.
As an example, there was a case in the (UK) media recently about British people being 80 to 120 times as vulnerable to severe negative side effects (agranulocytosis leading to death) from metamizole as Spaniards, and as such expats died or went into comas upon being prescribed a rather popular Spanish painkiller with a low rate of side effects (for Spaniards).
Suppose you're a Spanish drug maker: you do your tests, they're all positive, you start selling the drug -- and then a tourist takes it and dies. Is it fair that you have liability here? Do you need to test on representative population groups all around the world because one of them might have an adverse reaction?
"As an example, there was a case in the (UK) media recently about British people being 80 to 120 times as vulnerable to severe negative side effects (agranulocytosis leading to death) from metamizole as Spaniards"
That's fascinating and astounding, not something I would have expected. What is the genetic difference between the Spanish and the Brits likely to cause this, or is it just that the Brits aren't used to taking it and misdose? I mean, if we're assuming Anglo-Saxon heritage, it should be as bad for the Germans, and yet:
"In Germany, the drug is the most commonly-prescribed painreliever."
Wikipedia is just teasing me more with intriguing questions but no answers:
"Metamizole is banned in several countries, available by prescription in others (sometimes with strong warnings, sometimes without), and available over the counter in yet others. For example, approval was withdrawn in Sweden (1974), the US (1977), and India (2013, ban lifted in 2014).
Although metamizole is banned in the US, it was reported by small surveys that 28% of Hispanics in Miami have possession of it, and 38% of Hispanics in San Diego reported some usage."
What was that study about elderly Hispanic women, again? 😁
>Is it fair that you have liability here?
Yes.....
Say there's a drill manufacturer that manufactures and sells a drill. They tested the drill in Minnesota, and it seemed safe, but it actually explodes in temperatures over 100 degrees. Then they sell it I Texas, and a contractor installing a bathroom is using the drill and it explodes and a piece of shrapnel flies off and takes off the neighbour's finger who should be liable?
I think it's reasonable to say if you're selling a product you should have a responsibility to check it is safe to use in the conditions you sell it in. And if they say on the box "warning this drug has not been tested in XXX population" then the doctor needs to make a risk benefit calculation and ideally have some mechanism to have the patient waive their right to sue if it goes wrong (which Scott has talked about before).
So, suppose that drill manufacturer expects to sell that drill in Texas, and tests it thoroughly to not explode up to 150 degrees (hotter than any recorded temperature in Texas), sells it in Texas, to a company that installs it in an industrial lathe that runs so hot that it hits 160 degrees and explodes, taking the million-dollar lathe with it. Who should be liable?
It's not practical to always put liability on the manufacturer, since there's no way for the manufacturer to anticipate every use case. It *might* be practical for the manufacturer to test the conditions he believes are *likely*, and it's even in his interest to do that and clearly label that it's guaranteed under those conditions so that more customers will believe the product is reliable enough to buy, and it turns out that's what a lot of product manuals say.
This is harder to do with drugs, since the condition is something like "safe in the people we tested it in" and the doctor is considering that drug for his patient who might have some rare condition that makes that drug worse, and given how complicated human bodies are, this is distressingly common.
Which is why clinical trials are so incredibly expensive.
As I understand it, the standard legal strategy is to sue everyone whom you have a vaguely plausible legal theory for suing and see what sticks. Any lawsuit that doesn't immediately get dismissed by the court gives you a chance to win at trial. Also, trials are slow, expensive, uncertain, and tedious, so defendants are very often willing to settle for at least a token amount even if they have a good chance of willing at trial, so more defendants lets you stack up more small settlements. One more factor that seems plausible but I don't know how much it applies in real life is that with responsibility uncertainly divided between multiple defendants, each defendant might make arguments in pre-trial filings that can strengthen the case against other defendants.
My vision of an FDA-less world is one in which all drug companies immediately give up boring and not-so-profitable drugs that actually cure things, and start working on making hyper-addictive narcotics.
You think fentanyl is bad? Wait 'til you see what it looks like when Pfizer, Merck etc have sunk a trillion dollars worth of the best pharmaceutical research into the world to optimise it for addictiveness at the expense of everything else.
Now it's a simple matter of getting the whole world addicted, and gently jacking up the price until your drug is 90% of the global economy.
Abolishing the FDA does not one would presume legalize all controlled substances.
Your ancaps would argue for that as well but your average libertarian would not.
Controlled substance classification and enforcement would still be a thing.
But I agree on the margin they'd be making things more addictive.
I thought the average libertarian was decidedly opposed to the war on drugs and any restrictions on "acts of capitalism between consenting adults"?
As an ex-libertarian who used to roll in such circles, there's a big difference between "end the war in drugs" and "legalize all controlled substances".
Only your proper ancaps and extremists would really hold to the exact line of no restrictions on free trade between consenting adults.
In actual fact the majority of libertarians are some kind of minarchist, (not spelled incorrectly, not monarchist) that is advocated for the minimum possible state. That is, accept immediately and right away the proper place of government as police, military, and court system. And then as far as determining what things are enforceable laws, a _presumption_ away from state action or interference into free trade or association between consenting adults, but not a total unwillingness to do so at all. Basically, the argument is, anything the state does is at the barrel of a gun, so you'd better use it only in extreme circumstances and you'd better be damn sure.
The result in practice is that the majority of libertarians I actually met or heard speak would legalize marijuana, mdma, cocaine, and hallucinogens, but probably not heroin or meth, and wouldn't balk at controlling pharma-optimized-mega-heroin. A lot of libertarians are a short cry away from rugged-individualist-conservatives and would end the war on drugs but not legalize anything except marijuana. That is, leave it illegal and prevent import / export / manufacture / distribution and just not go after users or dealers.
Only a few libertarians really are the recreational mcnukes type.
>"That is, leave it illegal and prevent import / export / manufacture / distribution and just not go after ... dealers."
This strikes me as contradictory, but perhaps there's an elided nuance?
The libertarian is primarily concerned with the liberty of the individual and their right to choose how to spend their days and what to put in their body.
The more you aggregate and create collectives, the less concerned your archetypical conservative libertarian is with freedom of collective action. That's not to say it's not valued, but other things also are valued. He believes in creating and securing borders (as opposed to the archetypical liberal libertarian) and would not balk at preventing international industry from importing things that were very harmful, like explosives, biological or chemical dangers, or addictive drugs. Similarly, as a cultural and social conservative, while he may be okay with an individuals choice to buy and consume a particular drug, as this concerns his direct right to bodily autonomy, this does not equally extend to a right of a mass manufacturer to produce at industrial scale addictive drugs (where the ancaps and extremists differ, as they do extend such personal freedom to essentially all actions)
A small time "dealer" is not meaningfully a distributor. He's some guy in the middle of the chain, not the manufacturer or the mass-quantity-trafficker. You can leave him alone and just prevent anyone from distributing mass quantities like a food or retail company distributes their goods.
I've never heard of a self-described minarchist who wanted to ban recreational drugs. An anarchist wants to get rid of all government, including the "night watchman state". A minarchist wants that state to only police coercion, not engage in any kind of paternalism.
I don't know what to tell you other than that I met em, at Porcfest and at in the formal party. If they were coming from the more conservative side it was pretty common.
I'm not very well-informed about this, but I see a strong case that the vast majority of the harm caused by opioids is caused by their prohibition, rather than the substance itself. As far as I understand, their side-effects aren't all that bad as long as they are manufactured and dosed correctly. But due to their illegality
- People use black market drugs that may not be reliably dosed, may be contaminated, and lack basic quality control (even what would be incentivized by reputation considerations on a free market).
- People use especially potent opioids that are especially easy to overdoes, because they are easier to smuggle in a small space.
- People inject instead of taking it through other routes because a smaller dose is needed for the same effect, and it's very expensive due to the prohibition. Frequent injections of stuff that may be contaminated have bad side-effects regardless of what is injected.
- Some people share needles, which spreads severe diseases like AIDS and Hepatitis C.
- It strengthens criminal gangs, which then commit violence and other crimes besides selling drugs.
- Users may become destitute and commit crimes to get money to pay for the drugs made expensive by the prohibition.
- Imprisonment of drug users and dealers, besides harming the prisoners directly, probably has harmful knock-on effects even after they are released.
- Some people get addicted to legal prescription opiates, and then when prescription rules are tightened, they turn to the black market and suffer or die from any of the above.
Cutting through all of this by making reliably dosed stuff legal and cheap, with a big fat warning that even one try can get you addicted, seems much preferable to this.
China did not have a great time with legalized industrial scale manufacture of opium, famously.
It's famous for going to war to ban opium, but I've no idea how good a reason it had to want to ban it. And that was before the effects of prohibition were seen; alcohol prohibition also looked like a better idea before it was tried.
Seconding this - most of the "deaths of despair" are due to drug prohibition and illegality. The actual drugs cost pennies - if they were legally available at a fair cost+20% or whatever at a known strength and purity, there would essentially be zero overdose deaths, and very little negative physical downsides. With pharmaceutically pure stuff, addicts can live and work and function in society for decades. Just look at William Burroughs or Keith Richards!
And a lot of the deaths are precisely due to strength and purity - the strength varies every time on the street, and with fentanyl a 1mg difference can be the difference between "feel good" and "OD." And contamination is rampant - there are 'zenes that are even cheaper than fentanyl that contaminate most street opiates now. They are cheaper AND more addictive, and they absolutely destroy tolerance in addicted people so they have to do more and more, so it's sort of a double punch in terms of incentives for illegal drug folk to include them. Unfortunately, they are much worse for human biology and orderly function than real opiates too.
And it is exactly a policy of "who cares about drug addicts, they deserve to die" in the USA that leads to these deaths too. It's at epidemic numbers, and lots of the people are people who got addicted to legal pills and then can't get them anymore because doctors are under more scrutiny and negative pressure to not prescribe any actually effective painkillers.
But for every doctor that refuses that script, they're probably killing .1 of a person due to this illegal drug purity / contamination / overdose dynamic. Deny ten scrips and statistically kill somebody! But you know, that's totally in line with Hippocratic Oaths, it would be MUCH worse to prescribe somebody painkillers that work and have very little physical downsides. Really.
> Abolishing the FDA does not one would presume legalize all controlled substances
Who decides what substances are and are not legal in the absence of an FDA?
We could certainly continue to ban already-banned substances, but what about new ones? If Bayer comes along next week with a brand new chemical formulation for a "headache tablet" that's really really good at getting rid of headaches (and also makes you really want to take another one in three hours) then who decides whether or not that's legal to sell, in the absence of an FDA equivalent?
I think you have a misunderstanding of what government agencies do what.
While the FDA is the gatekeeper for food drugs and medical devices for commercialization, it is not the body that decides what is a controlled substance and to what degree.
The CSA (Controlled substances act) empowers the DEA and the Department of Health and Human Services to schedule out drugs, determine their restrictions, and enforce them.
The FDA is intended as a watchdog to prevent patient risk in the course of normal healthcare business, that is, primarily by accident or corporate fraud.
It is not the body intended in any way to police narcotics, recreational drugs, controlled substances etc.
In the absence of an FDA, a company can commercialize a drug in absence of a pre-market approval, but if the department of health and human services or the DEA decides it should be a controlled substance, its a simple matter to schedule and control it.
Fine, but what's the procedure by which the DEA would decide whether or not Bayer's new "headache tablet" should be considered a controlled substance?
The same way they and the DHHS do it now - the FDA is not a part of that chain.
The FDA may decide whether a drug is allowed to be sold or not but them saying it can't be sold doesn't make it a controlled substance. Totally different pipelines
Isn't it a DEA matter if I'm producing and selling prescription medicines without a prescription? And doesn't the FDA decide what is a prescription-only medication versus an unregulated one?
If that goes away, the DEA suddenly has a whole lot of new drugs coming onto the market that they need to decide whether or not to declare as controlled substances. If they choose to say "Meh, if it comes from a respectable company it must be fine" then you get the wirehead pharma-world I descried above. On the other hand, if they decide to look carefully at new drugs before deciding whether or not they should be banned then you've probably just reinvented the FDA as the DEA.
"My vision of an FDA-less world is one in which all drug companies immediately give up boring and not-so-profitable drugs that actually cure things, and start working on making hyper-addictive narcotics."
Zero-sum fallacy.
A new lucrative market doesn't make the existing market unprofitable.
I doubt that it's possible to make all that many novel, hyper-enjoyable recreational drugs, let alone ones where an addition can't be satisfied by different, generic alternatives. As far as I understand, if you get addicted to one opioid, another opioid will satisfy the addiction.
Why would people buy the new hyper-addictive drug, instead of the (sometimes less addictive) existing ones?
I expect that if recreational drugs were legalized, without excessive regulatory burden, the market would look more like the market for aspirin: old, cheap drugs with many competing generic manufacturers.
I suspect that FDA could only (and in the -- however distant -- future, will) be abolished in the exact same way in which e.g. the Praetorian Guard or the Gestapo were abolished.
> Right now your doctor doesn’t worry you’ll sue them, because “the medication was FDA-approved” is a strong defense against liability. But if there are thousands of medications out there, from miraculous panaceas to bleach-mixed-with-snake-venom, then it becomes your doctor’s responsibility to decide which are safe-and-effective vs. dangerous-and-useless. And rather than take that responsibility and get sued, your doctor will prefer to play it safe and only use medications that everyone else uses, or that were used before the FDA was abolished. You might even find it’s even harder to get a medication into common use than it was back when the FDA existed!
This is part of a genre of "we can't do without regulation" arguments that doesn't really work. The hidden premise is that the FDA has always existed.
The reason that other defenses to liability are weak is that it's presumed that only the FDA can make reasonable judgments about what medical treatments are appropriate. In the absence of the FDA, that presumption isn't available, and which defenses are strong will change.
It's true that if you abolish anything, or for that matter establish anything, and then attempt to run every other part of the world as if the change you made had never occurred, those parts of the world that depended on the presence of the thing you abolished, or on the absence of the thing you established, won't work. But that is not actually an argument that the systems they implemented will stop functioning, despite what the people making this observation usually claim.
It does not seem like the quality of food and drugs was great prior to the founding of the FDA was very high, that is in fact the reason why it was created:
https://en.wikipedia.org/wiki/History_of_the_Food_and_Drug_Administration
In the absence of a regulatory body I would generally expect standards to decline, especially so in ways that are hard for consumers to notice.
The quality of food was much higher before the problem period that led to pressure to create the FDA. The low quality was the historically anomalous period.
I think it would be fair to attribute that development of low quality to a disconnect between food manufacturers and food consumers. This made it more difficult for consumers to obtain information about manufacturers, and manufacturers responded, as you note, by becoming untrustworthy in ways that were difficult to assess. (Consumers also responded by shifting their consumption to foods in which defects were very, very easy to assess, such as white bread and large cuts of meat served with very little in the way of flavorings.)
Moving into a much more speculative area, I think it's also fair to observe that the period of low quality essentially coincided with the beginning of the large-scale distribution of food. Systems are more chaotic and display more undesirable behavior when they are new; the problem might have driven itself out of existence given more time. (There is a really interesting piece from Bret Deveraux comparing the social structures of the Mongols with those of the Plains Indians, and noting that in many ways the Mongol structures functioned better. He specifically observes that this is likely due to the Mongol social structure having developed over thousands of years while the Plains Indian lifestyle existed for no more than a few centuries.)
There are several things we might say about this:
1. The same pressure that led to establishing the FDA, if the FDA had instead never happened, would have led to something else. It is not obvious that the FDA is a better solution than the counterfactual one would have been; what we know is that the FDA was a _faster_ solution. (This point is similar to my "speculative" paragraph above.)
2. Between then and now, methods of propagating information at very large scales have come into being, making it much easier for people to obtain good information about manufacturers.
3. A punishment scheme can keep standards consistently high without prospective review. Ron Unz wrote a fascinating piece contrasting the Chinese baby formula contamination scandal with the American Vioxx should-have-been-a-scandal-but-nothing-ever-happened ( https://www.theamericanconservative.com/chinese-melamine-and-american-vioxx-a-comparison/ )
A Chinese formula manufacturer (Sanlu) decided to save costs by cutting the formula with melamine. This killed six babies and hospitalized hundreds. And the result of the state's investigation was that two company executives were executed, one got life in prison, and a handful received shorter prison terms.
By contrast, an American drug manufacturer (Merck) introduced a pain medication that -- as Merck was aware when it introduced the drug -- frequently caused fatal side effects. Vioxx was voluntarily recalled from the market when Merck learned that the FDA had discovered those side effects.
Unz:
> Although the Vioxx scandal certainly did generate several days of newspaper headlines and intermittently returned to the front pages as the resulting lawsuits gradually moved through our judicial system, the coverage still seemed scanty relative to the number of estimated fatalities, which matched America’s total losses in the Vietnam War.
> The circumstances of this case were exceptionally egregious, with many tens of thousands of American deaths due to the sale of a highly lucrative but sometimes fatal drug, whose harmful effects had long been known to its manufacturer. But there is no sign that criminal charges were ever considered.
> A massive class-action lawsuit dragged its way through the courts for years, eventually being settled for $4.85 billion in 2007, with almost half the money going to the trial lawyers. Merck shareholders also paid large sums to settle various other lawsuits and government penalties and cover the heavy legal costs of fighting all of these cases. But the loss of continuing Vioxx sales represented the greatest financial penalty of all, which provides a disturbing insight into the cost-benefit calculations behind the company’s original cover-up. When the scandal broke, Merck’s stock price collapsed, and there was a widespread belief that the company could not possibly survive, especially after evidence of a deliberate corporate conspiracy surfaced. Instead, Merck’s stock price eventually reached new heights in 2008 and today is just 15 percent below where it stood just before the disaster.
> Furthermore, individuals make decisions rather than corporate entities, and none of the individuals behind Merck’s deadly decisions apparently suffered any serious consequences. The year after the scandal unfolded, Merck’s long-time CEO resigned and was replaced by one of his top lieutenants, but he retained the $50 million in financial compensation he had received over the previous five years, compensation greatly boosted by lucrative Vioxx sales. Senior FDA officials apologized for their lack of effective oversight and promised to do better in the future.
We have here a perfect liability shield - the FDA can't be liable for Vioxx because they weren't trying to kill anyone, and Merck can't be liable for Vioxx (in a way that would actually act as a deterrent) because, sure, they were trying to kill people, but they had approval to do that from the FDA!
Which system do you think is likely doing a better job preventing counterfactual decline in manufacturing standards?
Yes, it's large scale commercial and industrialised processes which lead to the worst adulteration scandals (see link below) but even before the "historically anomalous period" food could be contaminated, either through ignorance, the methods used (grinding grain with a quern stone meant grit in the resulting flour) or greed/cheating.
To produce food in the quantities needed for today's population, large scale processes are necessary, and that means the need for oversight. Your mention of "white bread" as one of the foods in which defects were very, very easy to assess is ironic, because adulterating bread - including things to make it whiter - is one of the complaints:
https://www.bbc.com/news/uk-25259505
"When basic staples like bread started to be produced cheaply and in large quantities for the new city dwellers, Victorian manufacturers seized on the opportunity to maximise profit by switching ingredients for cheaper substitutes that would add weight and bulk. Bread was adulterated with plaster of Paris, bean flour, chalk or alum. Alum is an aluminium-based compound, today used in detergent, but then it was used to make bread desirably whiter and heavier. Not only did such adulteration lead to problems of malnutrition, but alum produced bowel problems and constipation or chronic diarrhoea, which was often fatal for children."
And of course, where there is large scale industrialisation, there is both the necessity and the temptation to cut costs and sell at lower prices than the competitors:
https://vichist.blogspot.com/2007/12/adulteration-of-food-and-drink-in.html
"More than a decade earlier [in 1855], in his testimony before a Parliamentary committee, the Select Committee to inquire into the Adulteration of Food, Drinks and Drugs, Arthur Hill Hassall pointed out that the practice “prevails in nearly all articles which it is worth while to adulterate, whether it is food, drink or drugs.” and he went on to point out that
The majority of adulterations consist in the addition of substances of greatly inferior nature, for the sake of weight and bulk. Others consist in the addition of various colouring matters, to conceal other adulterations, or to heighten, and, as it is considered, to improve the appearance. Lastly, a few adulterations are for the purpose of imparting smell, pungency, or taste.
Among the items adulterated and the adulterants used were alum, added to flour in the production of white bread; sloe, ash and elder leaves used to adulterate tea; peas and beans in ground coffee; alum to brighten wine; Brazil wood to colour Port; and sawdust and filbert husks to make red wine more astringent. Just how widespread was the adulteration of food and drink? Certainly it varied from area to area, but it is likely that it was as great or greater in London than in any other part of the British Isles. Writing at the very beginning of the Victorian Era, Theodore Sedgwick commented that it was “difficult to mention a single article of food that is not adulterated.” Some items, he noted, could hardly be found in their genuine state. Even medicines were adulterated and the “quantity of medical preparations thus injured is said to exceed belief.”
https://journals.sagepub.com/doi/full/10.1177/23978473211033034
"In 1820, Frederick Accum published a book, best known by its biblical subtitle ‘Death in the Pot', showing the widespread fraudulent and dangerous adulteration of common foods and drinks bought in London. Despite its brief popularity, there was no effective legislation in Britain until 1875 after more extensive analytical surveys by Hassall and Letheby in 1855 and a parliamentary enquiry had confirmed the frauds and risks to public health. There were similar surveys and legal action against food adulteration in France and Germany towards the end of the 19th century. In the USA, campaigning by Harvey Wiley and others revealed the same risks and frauds and led to the Pure Foods and Drugs Act in 1906 and formation of the FDA. We should have celebrated Accum’s bicentennial in 2020 to recognise his achievement and to remind us of the continuing dangers of food adulteration today."
Case study from Finland today. For context, dog and cat food intended for household pets is minimally regulated. In November, news and social media was filled with reports and videos of pets having deadly paralysis attacks. The cause was quickly pinpointed to a major brand of pet foods, which were recalled, but nobody still knows for sure why and how the dog food was contaminated: the manufacturer (Musti Group) argues that the potatoes they bought from the Netherlands were defectively high in glycoalkaloids (but claims they are not responsible as nobody expects to test dog food ingredient potatoes for that); the Dutch supplier argues the glycoalkaloid content was high but not high enough cause major side-effects.
In this case, some pets died. Yet we are not in the 19th century early industrialization information environment. Turns out, despite the internet, the assessment of quality in dog foods comes down to (a) avoiding food that obviously gives your pet a deadly seizure (b) trusting the brand you've previously bought and hoping they have not changed manufacturing process. Modern information environment makes information about (a) spread a little faster, but it helps only if the harmful effect is obvious and already killed someone else's pet.
If the regulation of human foodstuffs were reduced to similar level as dog foods, it seems likely that we'd have similar cases with bad or adulterated human foodstuffs are noticed only after someone dies after eating a product that turned out to be clearly poisonous ... coincidentally similar to the Chinese melamine adulteration case. If one compares melamine and Merck, Merck was not stupid enough to sell a product that contained large amount of chemical that is known to kill your baby just to make it look like it passed quality control; they sold a painkiller that sort-of did what it promised but also had known prevalent but not ubiquitous harmful effects. The Chinese melamine milk producers had been going unnoticed and unpunished for years as long the producers added amounts of melanin that was still harmful but didn't obviously kill babies. Nobody went prison or was executed for killing babies slowly, their mistake was increasingly adding it so much that many babies started dying immediately, which couldn't go unnoticed.
The part in the Merck case that appears the largest injustice to me has nothing to do with the existence of FDA or its regulatory tasks, but the feature of the US legal system where the executives who make money killing people can often escape unscathed with minor personal consequences by having the corporation to pay large monetary settlements (I don't think such cases are limited to FDA only, American system is famous for out-of-court settlements and plea deals).
> The part in the Merck case that appears the largest injustice to me has nothing to do with the existence of FDA or its regulatory tasks, but the feature of the US legal system where the executives who make money killing people can often escape unscathed with minor personal consequences
I did explicitly make the argument that that feature of the US legal system is due to the existence of the FDA.
> If the regulation of human foodstuffs were reduced to similar level as dog foods, it seems likely that we'd have similar cases with bad or adulterated human foodstuffs are noticed only after someone dies after eating a product that turned out to be clearly poisonous ... coincidentally similar to the Chinese melamine adulteration case.
That is also what we have right now. Do problems occur with the dog food in Finland more often than they do with the human food?
(Compare this relatively recent American scandal involving human food: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/chipotle-mexican-grill-agrees-pay-25-million-fine-resolve-charges-stemming-more-1100-cases-foodborne . Nobody died, but that's just a coincidence.)
I'm not sure what you're trying to tell me with the example of the dog food. If it had been regulated more heavily, what would have happened differently?
Honestly, I think "Carve up the FDA" is a better plan than "Abolish the FDA". Remove more and more of their control over medicine, starting with the easiest stuff.
Step 1: Remove AI tools and medical devices from their regulation.
The argument here is simple, the FDA is not competent to regulate AI in healthcare. A ton of new "AI" medical devices have been approved, per Wu ~500, and I'd bet that 80% of them are crap because, well, reality. But there's a ton of AI products that are going to hitting hospitals over the next 5-10 years. And the FDA, to the best of my knowledge, has nowhere near the technical capacity to understand these tools or regulate them in a meaningful sense. With all due respect, at worst they're bureaucrats and at best they're pharmacists, neither of which qualifies them to regulate AI or, frankly, even read some simple Python code.
And we had a perfect example of this with the Epic EMR and their Sepsis prediction model v 1.0. It came out, lots of hospitals adopted it, some ran their own numbers to check their effectiveness, found out Epic significantly overstated it's effectiveness, Epic went back and came out with a new version that genuinely seems better, various hospitals are still evaluating it, and at no point was the FDA involved because....why would you? If a new "AI" device drops and it tries to alert a nurse when a patient at home is potentially having heart problems, whether that's effective or not, especially when faced with an exasperated nurse and 20 false alarms, is a decision for the hospital.
So keep the FDA out of field it's, with all due respect, not qualified to regulate.
Second, cut out medical devices in general:
My CPAP probably isn't going to kill me and doesn't need to cost $3k...this is pretty settled technology. And, again, the FDA isn't engineers, it doesn't build stuff, why are they regulating this?
Now I'm more hesitant here, because there have been a number of dangerous medical devices and there's real danger here and legitimate problems. And I pretty clearly want some sort of regulation of pacemakers, for example. But it sure seems like there's a lot of easy money to be saved in removing regulation from...non-surgical medical devices, for example.
Finally, tackle drugs. Which, ick, for reasons laid out above.
But I should stick up "Abolish the FDA" a bit here by suggesting that politics in the US might...not allow us to pursue our policy goals in as sensible and circumspect a manner as we might ideally like. And while it pains me to suggest that our noble civil servants might undermine or ignore any laws or executive orders they personally disagree with, I think any Libertarian president might want to consider simple and easily verifiable plans rather than detailed and surgical ones. In an ideal world you might want to slowly carve away at the authority of the FDA, and you might even find that their performance improves as their mission gets smaller and more coherent, but in our fallen world of...not ideally functioning politics, we may be left with "Abolish the FDA" or "status quo".
(Im in the med devices industry)
The FDA already has in place a classification system for the risk profile of a medical device (class 1 2 or 3 (or "not a medical device))
To be honest cutting out the class 1 devices from their purview entirely would be pretty risk free. - but it nearly works this way already. To commercialize a class1 requires paperwork and a promise that you have a system for hearing about it if people use your device and have complaints. There's no approval process. (requires registry only)
More generally, and this is commonly misunderstood, In the med devices space the FDA are NOT the arbiters of whether a device is safe and effective. They are actually just an organization that sets a standard of due diligence and checks whether you followed it.
(Clarification edit for wording. The FDA is not a panel of technical experts that themselves evaluates the safety and efficacy of a device. They are a panel of regulators that sets standards for what it means to be safe an effective, tell industry to do the work proving it, and check their work)
They are not engineers or even doctors really and they know this - they make no attempt to "understand" the technology such that they could decide whether it's risk benefit profile is acceptable (though contrary to popular belief, risk benefit analysis is baked into the regulation at all levels, it's cost / benefit that isnt)
Rather, the FDA requires you to make a clinical trial, do your own testing, with competent third parties and doctors, and _they_ are the ones who say whether it's safe and effective, and the FDA just needs to be able to trust their credentials. They will look at your study design and data and see if they agree, and ask questions where they don't. In practice this still ends up cumbersome because they can ask about any kind of data and halt you til you get an answer and trials themselves are difficult and time consuming.
But, the one elegance of the system is that it can actually do it's job explicitly without the FDA needing to be subject matter expert or understand the treatment or modality. They just need to understand study design.
It's really great to have a comment from someone with actual experience in the field. For me, one comment like that is worth 10 or 100 from theorizers. Similar kudos to the fecal transplant post above.
Agreed, comments like the one above are the main reason I even read the comments section.
Thanks for the response, that was very insightful.
I find myself confused though. So the FDA just...double checks the study, at least for medical devices? Like, all the testing and analysis comes from reputable third parties and the FDA just double checks their credentials?
Is this similar for drugs? Does the FDA do more for drugs, do they have actually specialists or is it also just reputable third parties?
Because two notes:
First, this kinda makes abolition sound...sensible. Like, if all the FDA is doing, fundamentally, is double checking qualified third party experts, it doesn't sound that crazy to just abolish the FDA and hospitals and doctors judge off the third party experts. Not that this sounds faultless but, I mean, as far as I can tell the bond markets are based on independent third party experts like the S&P rating agency. Which is far from ideal but if we abolished the FDA, what's the prevent the expert market from consolidating into a few medical device "rating agencies"?
Second, genuine question, does anybody know who and how the FDA is approving these new medical devices? Because ML prediction algorithms don't...work fantastically with standard studies. I don't want to step too heavily here, I'm not that much of an expert, but I know plenty of ML prediction algorithms have had ugly failure modes because their training data was limited to 2-3 hospitals and so those algorithms don't generalize to the wider population, or more appropriately, other niche populations. Any links would greatly be appreciated.
Okay, a bunch more detail.
1. I'm really familiar with medical devices but not at all familiar with drugs and from what I hear that's a different animal altogether. So, can't say anything about how the FDA does drugs.
2. So, you want to commercialize a new medical device? Here's what happens.
A. If your device is simple and non-critical and has a low risk profile, like a laparoscopic grasper or chest retractor or blood pressure cuff, your device is a class 1 device. You will create a "Design History File" which includes the user of the devices needs from the device, the engineering requirements that satisfies those needs, a set of drawings and specifications that fully define a device that meets those needs, and then probably only one kind of testing which you will run yourself, checking that a device made to your drawing meets your specifications, in an objective manner.
Then youll have a way to prove that the manufacturer is building that same device. You do a pre-market registration with the FDA, where you notify them you are selling this and where it's being manufactured, and you're done.
All of this has to be well documented with traceability. If your device has complaints the FDA may look into it.
For class 1 devices a lot of this can be left out and does based on the size of the company but if you do at least the above you're in good shape if the FDA checks and it's usually just good practice engineering anyway.
B. Your device is potentially critical and could be risky, but it's based off something that already exists and so you can make pretty good guesses about it's risk profile. This can include basic implants, monitors, surgical devices, etc. Your device is class 2.
You will be using the "510K" submission pathway, where you demonstrate that your new device is substantially equivalent to a device or combination of devices that already exists.
Your design history file will include all of the same as before, with the addition of the following: documented design reviews at a minimum of 3 defined stages in the product design. Documented "risk evaluation" where you assess what the likely failure modes are, what happens if they occur and how bad it is and develop a semi-quantitative sense of risk level, and then implement risk controls to address each until they are acceptable.
A second kind of testing, where a licensed clinician uses your device in a simulated use environment and agrees that the device made to your drawing meets the needs of the user.
Statistical process qualifications of the manufacturing process by which the manufacturer will make.
A clinical registry, where once you start selling the device you'll be carefully tracking the first physicians who use it and checking their outcomes.
A few other documentation requirements but this comment is already too long.
C. Your device is critical to the patient, risky, and brand new. Your device is class 3 and you will need a pre-market approval, i.e., a clinical trial.
You'll do all the same documentation and testing as in (B), plus a bit more, but the big difference is that you run a clinical trial before you can sell anything.
The results of the clinical trial are outcomes and judgements made by clinicians. Typically you run these with a third party who specializes in doing so.
So the FDA receives your submission and reviews it. The first thing they do is check your argument for classification. If they disagree with the device class your submission is DOA. A lot of new devices get held up here - tiny companies who have sold a class 1 and the FDA scrambles to tell them no that's a class 2 stop, or much more frequently someone trying to say something is class 2 and the FDA is t convinced and says it's class 3.
This is a partially expert opinion call, but they have some fairly objective ways of making it that are honestly pretty decent: devices are the same if they have the same intended use on the same patient population and use broadly the same modality.
Usually the disagreements are when there's different intended uses but sometimes the FDA won't buy that the modality is similar enough.
The FDA then goes through your submission, checks all your documentation and testing and data and the outcomes of the data.
If they're confused or disagree with something, they will ask you for additional information, and possibly data.
If youve answered all their questions to their satisfaction, and in the case of class 3 completed the trial, congratulations you can sell a medical device.
But we're not done yet
In addition, the FDA also audits you on an irregular basis, to check whether you have a defined procedure in place for creating all that documentation and running the testing etc and for capturing that it happened and that it happened the way you said it did. If you fail an audit you may have to make corrections or may have to not sell devices.
They also perform inspections in manufacturing facilities and audit them similarly but with experts on manufacturing facilities. Here they really do have subject matter expertise.
They also are tracking the healthcare space and looking for complaints or devices creating bad outcomes, and require you to do this as well. If the device is not performing, they are the watchdog for when you have to recall your device. (In practice no one let's it get so bad that the FDA has to tell them to recall, they do it themselves first because if mom has to tell you to stop you're in trouble).
3. For the review of special cases, the FDA does keep on staff some genuine technical and medical experts. But for the review of business as usual submissions, they are not involved.
4. The FDA typically leaves the design and performance of a device totally up to the designer, but they do have in place a list of industry standards for basic and very quantifiable things that your device is required to meet (things like biocompatibility of materials, sterile barrier packaging tests, etc)
5. Honestly the main risk o see of dissolving the FDA specifically in regard to medical devices is a lot of companies commercializing devices made to varying engineering standards, that have only been tested internally, manufactured in facilities that are poorly controlled, especially ones that really should have had clinical trials.
There is a lot of pressure for this in the space already. I absolutely do not believe companies would perform this testing if they were not required to.
6. In regard to AI, the big fight that's going on right now is companies trying to make an AI based device and arguing it's a physician _aid_ and not an alarm or diagnostic modality, and therefore class 2, and the FDA saying look we all know damn well they are going to just trust the machine or they wouldn't use it and you wouldn't sell it, it's class 3, and imo both arguments have merit. That pushes the AI algorithms into clinical trial land. And until they can consistently get good outcomes they won't be approved. Tbh the FDA doesn't need to understand AI, if you can demonstrate your device achieved good outcomes with low risk according to the defined statistical practices, they will let you. But nobody wants to run an AI trial.
On the bright side, after a bunch of AI class 3s HAVE been made, someone will be able to claim equivalence and then some of them will start being class 2s.
Finally, admittedly, the FDA can be pretty arbitrary with what they ask for in a submission. We've never been able to predict what things they'd be confused about and ask for more data on ahead of time. And for anything shiny and new (AI) they are much more inclined to ask to show more work and data regarding risks. This can really bog things down and make it take a long time and a lot of money.
Nobody wants to run an AI trial because they don't think it'll be successful?
Depends on the particular use of AI. But mostly nobody wants to run an AI trial because it's cumbersome and impractical to set up. (Read: expensive and time consuming)
In the case of a hospital alarm system like mentioned before somewhere, to have a proper control and experimental group would probably involve a dozen hospitals and hundreds of patients. Or in the case of using AI to interpret some kind of massive diagnostic data set, the trial required to properly vet that might demand enormous numbers of samples, especially if no one can tell you how the AI works under the hood.
To a first order, whether you have to do a trial for an AI or not is a difference of at least one and probably 2 orders of magnitude in terms of cost to actually release your device.
Where did you get the idea that the FDA isn't the arbiter of whether a device is safe and effective? How, then, did the FDA stop 23andme from helping people interpret their genotype? (Answer: They claimed that a microarray was a medical device, and that it needed to go thru the full approval process.) How has the FDA managed to block the introduction of broad-spectrum genetic pathogen-detection tests for decades? I've spoken to several companies who sell such tests overseas, and all said they will never sell them in the US, because of the FDA.
Hey, the wording was unclear, ive added the following edit to the top level:
(Clarification edit for wording. The FDA is not a panel of technical experts that themselves evaluates the safety and efficacy of a device. They are a panel of regulators that sets standards for what it means to be safe an effective, tell industry to do the work proving it, and check their work)
They dont scientifically evaluated whether a particular device is safe or effective, they are a group that makes sure you proved it before you sell anything. Sorry for the poor choice of the word arbiter (since that word has such strong associations / connotation with gatekeeper)
Does that answer your question?
My question was rhetorical. Your post suggests that the FDA doesn't have the power to keep "medical devices" off the market for stupid reasons, and to apply the term "medical devices" outrageously broadly. Yet they have done so, over and over again.
23andme takes your saliva and runs it on a microarray that detects 640,000 different SNPs (single nucleotide polymorphisms). They used to have software which then checked the disease risks associated with all those SNPs, and provided the user a summary showing which diseases they had an elevated risk for.
The FDA declared that this constituted a medical device, and that 23andme needed to go through the approval process for EVERY ONE OF THOSE 640,000 SNPs. That's 640,000 different approvals.
It was stupid to pretend that the microarray is a dangerous medical device, and it is stupid to demand going thru a regulatory process on literally every nucleotide in the human genome before you can tell a patient anything about it. And this kind of abuse of power is not the exception, but the rule. The business with banning broad-spectrum pathogen tests is far worse, and has probably killed millions of Americans.
I dont think my post suggests that at all, in fact its exactly for the reasons im trying to describe that such a thing as the above can happen - The FDA are not scientists, doctors, or engineers. They are regulators working within a constrained definition of what a medical device is, and if something meets that definition they expect an approval process, and they arent capable of understanding the technology scientifically in order to know when to make an exception or change their protocol.
They are the gatekeeper, but not because they do the math, because they make you do it.
I dont disagree that this results in a lot of stupid things. Im just explaining how it works.
Frankly, such a product really _does_ seem like a medical device, but one that should probably have a single submission altogether. But like I said in my later post, most of the sticking points on a project is the FDA disagreeing with the classification and requiring arbitrary things.
Ah, sorry. I interpreted "the FDA are NOT the arbiters of whether a device is safe and effective" as "the FDA doesn't regulate devices". I didn't interpret your statement within the context of the comment you were responding to, which said the FDA doesn't have the expertise to do so, but instead only in the context of Scott's post.
Banned for this comment.
As a libertarian who wants to abolish the FDA (and every other government agency), my answers to your questions are:
1. Are we also eliminating the concept of prescription medication?
Yes, in the sense that people should be free to put whatever they want into their own bodies. If patients, doctors, pharmacist, pharmaceutical companies, insurance companies, or others find the concept of prescription medication useful, they can recreate it for those who want it while leaving the rest alone.
2. Are we also eliminating factory inspections to make sure drugs aren’t contaminated?
My answer is essentially the same as to the previous question.
Factory inspections are probably useful, and could probably be even more useful if done by people with better incentives than the FDA.
Factories could be inspected and certified by organizations created for that purpose. These could be anything from for-profit companies to non-profit patient organizations.
3. How do we deal with the fact that many doctors are dumb?
Certainly not by replacing them with even dumber bureaucrats. At least the good drug is also available in your scenario. In the equivalent scenario with the FDA, only the bad drug would have been approved.
No system can create the optimal outcome every time. The FDA certainly doesn't. Sometimes doctors make mistakes or act maliciously, but the harm caused by such events is smaller and easier to deal with than when bureaucrats and politicians do the same. When a doctor is malicious or incompetent, the only challenge is finding out and convincing everyone else. That may be a big challenge, but even that's not enough when the FDA is malicious or incompetent because the FDA doesn't need the consent of the people it has the potential to harm.
4. How will the smart doctors get the data they need?
I don't share your confidence in the FDA reliability. The FDA's ability to enforce its decisions creates bad incentives because it means that it doesn't need the trust of patients. I think that also makes the agency easier to manipulate compared to a voluntary organization because there is no counterweight to the individual decision makes' incentives to maintain good a good relationship with the large pharmaceutical companies that they often end up working for once they leave the FDA.
Regarding supplements, I would assume the reason there are not as many studies into their safety is that unsafe supplements are a relatively small problem. How likely are people to die or suffer serious injury after consuming supplements compared to FDA approved drugs? What are the consequences of the average supplement not doing anything compared to the average FDA approval drug not doing anything? I don't know the answer to those questions and I could be wrong, but I suspect they explain the lack of large scale studies.
5. What would insurance cover?
That should be decided by patients, doctors, insurance companies, mutual aid organizations, etc., not by government agencies.
However, if you don't want to reform the healthcare system, I assume there is already a system in place for determining what insurance companies have to cover when it comes to procedures such as surgery, physical therapy, etc. that is outside the FDA's remit. That system could perhaps be extended to cover drugs as well.
While I would abolish the FDA in a heartbeat if I could, making the FDA advisory and voluntary by removing their enforcement powers as DavesNotHere suggests would be an acceptable compromise. Almost all harm caused by the FDA comes from their monopoly and their ability to enforce their decisions by force.
Thanks for providing actual answers!
What happens in a situation where a drug has good effects for most people but unexpectedly causes death to a few? While the FDA frustrates a lot of beneficial medical innovation I worry that without it private lawsuits could have an even bigger chilling effect.
That's a good point. Lawsuits could definitely lead to a chilling effect that limit access to drugs even without the FDA if pharmaceutical companies are forced by law to accept liability. That wouldn't be a problem if liability was regulated by contract rather than law.
The amount of liability that it makes sense for a patient to expect and a pharmaceutical company to accept would probably vary wildly depending on the drug and the context in which it's used. A patient probably wouldn't care nearly as much about the chance of getting compensation if something goes wrong if they take the drug in a last-ditch attempt to save their life compared to if they take the drug to treat something less serious or if there are other treatments options.
The amount of liability a pharmaceutical company is willing to accept for a drug when there are multiple competing drugs available can also serve as an indication of how safe the drugs are, as a compliment to independent certifications and studies.
So you'd need to sign a contract with each customer? I... don't actually see major problems with that. Obviously creates a bit of a transaction cost but eh. Prescription meds are already transaction costed out the wazoo.
I kind of expect that pharma companies would just waive all liability as a default though. Even if you're selling basic ultra-safe paracetamol, the cost of one random person dying and their family trying to blame your pill for it could easily be high enough that it's just easier to say "buyer beware".
There should be some default, but it should be alterable in contract.
One possible default is that the manufacturer is only liable for whatever they explicitly state on the box or in the leaflet. Then the "contract" doesn't need signatures, so it has little transaction cost.
If the box only states that it contains 30 pills of 5 mg fluxomoxacil each plus these-and-these excipients, they have fulfilled their duty as long as they actually give you 30 pills of 5 mg fluxomoxacil and excipients, regardless of what effects that has on you. You probably shouldn't take this unless it's recommended by a doctor who knows what fluxomoxacil does.
If they state that here is the list of side-effects and their prevalences, they are liable for any side-effect that's not on the list or more prevalent than that. If they also say that they limit their responsibility to no more than $100,000 per patient, that applies.
If they state that they have done FDA-standard clinical trials (or some FDA-equivalent if the FDA is not preserved even in an advisory role), and here is the list of *known* side-effects and their prevalences, they are responsible for that being true, but not for any unknown rare side-effects.
If there are many scandals of people dying from unsafe drugs, people will pay more for drugs that make stronger promises.
This is my preferred system too. It almost seems like common sense to me.
This is definitely what I expected the lib answer to be: liability law makes all the above manageable.
But thats where they lose people, who respond have you actually SEEN liability law? Its insane.
For my part I could believe liability law is the lesser of two evils, but would appreciate more effort showing its not quite as terrible as everyone thinks it is.
Started fine, but I felt Scott had already done other - dare I say: better - suggestions for reform, didn't he? With a four star system of FDA approval, I vaguely remember. Not just: new supplements - experimental - the ol' stuff. On SSC I a quick search only turned up https://slatestarcodex.com/2013/11/26/a-letter-i-will-probably-send-to-the-fda/
which is a fine but different story. Was it on ACX?
That said, the new supplements should make all libertarians happy enough. Though I wonder: Won`t many of the bad outcomes described for an "FDA deleted" still apply?
I agree with you that making the FDA optional (which is sort of what legalizing artificial supplements would do) is a better solution that abolishing it. Selective deregulation is not the same thing as a free market, at all.
I don't think your "abolition would be bad" arguments are quite as strong as they appear, though. I don't think supplements are the only relevant comparison. Their high degree of safety and low price (for the most part) goes a long way to explaining the paucity of evidence. I also think the existence of the FDA drives more dubious claims into the supplement market. Take the personal computer market for example. There is reliable evidence about performance and reliability characteristics which experts (e.g. system integrators) can reliably interpret to recommend things to lay clients, sort of like doctors do for medicines. There's no compelling case for a regulator here. It is not the case that a PC hardware company can make a terrible product and make billions in sales anyway with slick marketing.
I think the ideal starting place for reform is insurance, not drug approvals. Meaningful price signals are necessary for a functioning market.
Tired: Abolish the FDA.
Wired: Reform the FDA.
Inspired: Develop really good drug-evaluation AI that does the FDA’s job super fast.
So instead of infinite paper clips killing us all, we’ll have an AI torture us to death with medication „studies“ GlaDOS-Style, because the best representative study is of course testing everyone on every drug. For science!
Nope. It works just as well to test using a good large representative sample, and AI would know that.
I thought it’s going to be too intelligent for us to comprehend. How can *you* know what AI is going to know and derive to be best?
I like your two proposed solutions, but I disagree with your assertion that "if you throw the average 2023 American into the jungle, they will die within days." People would certainly be unhappy and uncomfortable, but I think humans are far more resilient than you give them credit for. When push comes to shove and a human's life is on the line, they have a strong tendency to get over themselves and figure things out.
The jungle is harsh, and survival is hard, and your life expectancy is certainly going to go down. But you aren't going to just lay down and fail to find water or stand by while a tiger gnaws on your leg. Take a look at Uruguayan Air Force Flight 571 for an extreme example of how modern humans will "figure it out" when they need to.
I think if we remove this assumption that humans are incapable of "figuring it out" without the state telling them how to live, then the "just delete the FDA and DEA" solution becomes "viable" (for some definition of viable) and at least worth considering IMO. Your alternative solutions may come up superior depending on how you measure success, but I don't think they are automatic wins no matter what metric of success you choose.
"Throw us into the jungle 2024" is not a great election campaign slogan, irrespective of whether the average person would eventually learn to eat a raw jungle mouse!
If the goal is "to get votes" we have strong evidence that "regulate more" is the optimal strategy (because people that advocate for that historically get elected, while people who advocate for any regulatory reduction don't).
If the goal is to have a plan that may plausibly work over the long term, then Scott's suggestions or the "just delete them" fulfill this requirement.
It would be cool if Scott's plans were sufficiently friendly to the average voter to get them to vote in a direction of such things, but I'm quite skeptical on that.
A plan that would work long-term while causing its implementers to lose elections is like an airplane that would fly if there was air but no gravity.
By that metric, I think both of Scott's proposals are out as well. This is a serious problem with current US politics IMO; there is no "political will" to remove/reduce regulations, only to increase them.
So either we are discussing options that could solve the problem, regardless of whether they are something a politician could run their platform on, or we accept that for now there is no viable path to significantly reducing regulations and we discuss how we change that.
I’m ideologically opposed to almost all consumer protections of which the FDA is maybe the best example. So let me tell you about my libertarian fantasyland, in which consumer protections have been eliminated. People prefer safe food, drugs, etc; so let the free market figure out how best to meet their needs. I imagine that a complicated mixture of partial solutions would emerge:
Liability is one important solution. Even without the FDA, you should still get sued if you lie about your drug and it makes people sick. Maybe drug vendors are still required to purchase liability insurance. This should cover a lot of concerns about potential harms, e.g. “Are we also eliminating factory inspections?” Answer: yes, as long as you can afford the insurance!
How do we deal with BadCorp? Maybe I’m naive but I am a lot more optimistic about certification than you seem to be. “NEVER RECOMMEND UNCERTIFIED DRUGS” is exactly the sort of simple norm which I suspect would be very easy to install in the medical establishment. Similarly, I think it would be easy to establish a protocol where certification bodies publish whatever data the smart doctors need in a standardized format.
> you should still get sued if you lie about your drug and it makes people sick.
Correct me if I'm wrong, but your comment seems to be treating "lie" and "makes people sick" as if observers can easily reach consensus on when these occur. If a company promised that e.g. bleach injection was a safe cure for COVID-19, and most bleach-injectors died rapidly, then that would probably work.
The more likely scenario in FDA-free libertarian fantasyland is that no new drug is rapidly fatal as often as bleach injection would be, and thus it becomes hard for observers to reach consensus without... studies.
But what sort of studies?
As Scott wrote,
> The only reason we have big, less-than-completely-manipulated studies is that the FDA demands it, and employs lots of experts to figure out which studies have been manipulated or not.
Why should the judicial system take over the FDA's role in mandating big, less-than-completely-manipulated studies? Why would we trust judges and juries with data analysis more than we trust FDA bureaucrats?
If that's not what you're proposing, then how are the lawsuits resolved? On the basis of small, completely manipulated studies?
For all its faults, one of the benefits of the tort system over a bureaucracy like the FDA is that if nobody with standing objects, then the former does nothing. The FDA will prevent dying patients from using experimental drugs, even though these people would never bother suing the company for selling them experimental drugs.
" Even without the FDA, you should still get sued if you lie about your drug and it makes people sick."
So how libertarian is this fantasy land? As libertarian as Negidius describes above, where you can put whatever you like into your own body, and same with factory inspections? Or some at least requirement that hey, test this first to make sure it isn't likely to kill people?
You could sell a drug in good faith and it turns out that for the 1 in 100,000 people it has very severe side effects. Is that lying? What happens to the people who do get very sick or even die once your drug is being sold to millions, so the 1 in 100,000 figures add up to 'quite a few'?
We've historically had the environment where "sell what you want, take what you want, and buyer beware", and that's how we ended up with the FDA and similar bodies. Maybe we could go back to "let's put substances in beer to make it even more intoxicating*, and if by selling hundreds of millions of pints of it, it turns out to kill quite a few people, okay now we know", but would the public accept the chance that "today it might be *you* who dies from an additive or sloppy manufacturing"?
And if it's "contracts and lawsuits all the way!" then manufacturers are going to stick to making very, very safe and anodyne products, and so not much in the way of innovation in drugs. Yes, you might get a new drug that does in fact treat Alzheimers if you start people on it aged 50 before any symptoms, but maybe it could be useless (but harmless), or maybe it could produce very bad side effects. Then you get sued for breach of contract and go bankrupt and lose everything. Better to stick to making indigestion remedies, those are a sure-fire money spinner what with people putting lead in the bread and chalk in the milk.
* https://en.wikipedia.org/wiki/Anamirta_cocculus
"Anamirta cocculus is a Southeast Asian and Indian climbing plant. Its fruit is the source of picrotoxin, a poisonous compound with stimulant properties.
...Although poisonous, hard multum is a preparation made from Cocculus Indicus, etc., once used (by 19th century brewers) to impart a more intoxicating quality ("giddiness") to beer than provided by the alcoholic content alone. Charles Dickens referred to those engaging in such practices as "brewers and beer-sellers of low degree,... who do not understand the wholesome policy of selling wholesome beverage." Although appearing in many homeopathic volumes and at least two brewers' guides, the use of such preparations was outlawed in England, during the mid-19th century, with fines of £500 for sale and £200 for use of the drug."
Government outlawing and fining usage? How unlibertarian of them!
Yeah that's one of my many problems with libertarianism in general: it's entirely reactive. Ultimately the only check on any kind of behaviour is reputation, so if you're a careless or malicious actor without an established reputation, then you can spread careless malice to your heart's content. Sure, millions of people might die eventually, but you'll rack up megabucks (or megagold, I suppose) in the process, so it's still totally worth it.
If that actually becomes a problem, people won't buy from companies without an established reputation (or perhaps a company with liability insurance from an established insurer).
Beer is a serious issue. I grew up believing the "Commandment of Purity", otherwise translated as "Order of Purity" (https://en.wikipedia.org/wiki/Reinheitsgebot) was an old and universal german law. In fact there were many beer regulations and practices in Germany even after it had become something like one state. The history of beer regulations goes to show people have struggled about their choices of poison for many generations. And there have been quite interesting poisons in ancient beers.
I don't know. I'm a metallurgist (sort of) in industry, and considering the insurance, third party verification, etc involved, se still find fake mill certs and weld consumable certs. The industry is known to literally fly our own people to the manufacturing yard to work there full time just to check that they're doing exactly what they're saying they are, for the duration of the project (1 -3 years).
This works for fabrication of large metallic structures because you can catch any issues before you put people on the structure and it collapses. I don't see how you'd reasonably manage this for drugs, which is a continuous manufacturing environment, where you'd have to manufacture millions of tiny things perfectly for decades unto decades, AND THEN also oversee the entire supply chain.
Even with regulations I know a dumpling store that's been fined for health and cleanliness violations like 3 times. I've eaten there and I was fine, but I didn't consent to the 1/500 chance of getting whatever foodborne illness I was risking to eat there. I have absolutely no doubt that restaurants would be regularly serving food dropped on the floor if there wasn't an authority to shut them down. Maybe an independent outlet that audits the kitchens and publicises the findings, including refusal of inspection?
Nothing wrong with a bit of reform on the margin - but I'm left somewhat puzzled, since the usual contexts in which I've heard cries of FDA Delenda Est...wouldn't seem to have been much ameliorated by the given proposals? The baby formula thing, covid tests, ERB tribulations, perennial skirmishes over stuff like insulin and EpiPens, bioethics, and so on. (Plus the governmental medical hydra having too many overlapping heads, not just the FDA but also the CDC, DEA, WHO...) I guess I always took the slogan to be, let's think harder about tradeoffs and what we really want to accomplish, rather than "literally abolish the FDA". But maybe I'm making the same category error as happened with "Defund the Police" and similar...
So 'abolish the FDA' is the libertarian 'defund the police'? Yeah, I could see that.
People With Incurable Diseases with Promising Drugs Held Up in Testing's Lives Matter! Yeah, not as catchy.
Regard medicines as approved by FDA if it's already approved by the regulatory bodies of any of the other G7 members? That would be a nice patch.
I don't think you want approval to be automatic, because then you only need to suborn one G7 regulatory agency to effectively suborn them all. But there should absolutely be a fast-track process which usually requires no further clinical trials.
that's why I suggested G7 regulatory agencies, I don't think it's easy to bribe the health agencies of either of EU, Japan, UK or Canada.
A better approach IMO would be to not automatically approve anything, but not forbid such medicines either.
To the consumer, this would look like "This $Medicine is approved in the EU, but not the other six, so I could get it in the US, but I've heard some sketchy things about EU approval, so I dunno...". Or "$Medicine was approved by three G7 agencies; pretty good chance it's legit". To the FDA, it would look like they no longer can gatekeep medicines, but they do still hold value in that if they're one more agency that approves $Medicine, that many more people will accept $Medicine. To a pharmaco, it looks like the more agencies approve, the better their sales, provided they don't bribe any of those agencies and get caught and cause consumers to balk at an agency approval that subsequently doesn't count.
Not easy, sure, but there would be trillions of dollars at stake.
I take your meaning as that there's enough money there to motivate someone to actually try and bribe all G7 agencies.
I don't think there's *that* much money in getting any one drug approved, but even if there were, there's also money / fame in uncovering that level of bribery, which is why this is offered as a remedy. Try to bribe one G7 agency and you *might* manage not to get caught. Try to run the table and it's too likely that someone will notice.
> I take your meaning as that there's enough money there to motivate someone to actually try and bribe all G7 agencies.
No, or pharma companies would already be doing it. But there might be enough money there to try and bribe *one* G7 agency, in a world where they all auto-approved each others' decisions so you only needed to bribe one. Also, I don't expect anything so crass as outright *bribery*, just extensive lobbying and an understanding that whichever country's agency manages to be the most... *flexible and responsive to the needs of the industry* will reap rewards in the form of increased investment, more competitive drug costs, all that sort of stuff that nation-states care about.
If you're worried about auto-approval, then check my response to E Dincer; you and I are in the same camp. I also agree that influence would more take the form of bribery's little brother.
This specific exchange all started with your last reply to E Dincer. Maybe I misread what you meant. I thought E Dincer was saying it'd be too hard to influence four G7 agencies at once, and you countering that there's enough incentive for someone to try.
Now, it sounds like you're saying there's incentive for one G7 to be more flexible and thus get a lot more investment. In that case, I notice there's a risk. People aren't obsessed with getting any drug at all costs; rather, they want the drug *that will make them healthier*. If one G7 decides to approve nearly everything in exchange for investment, it risks being seen by the public as exactly that. The public will see a drug approved by one G7 as maybe not that great. Many of them will not be convinced, which means that G7's approval will not be worth that much to investors. Knowing this, G7s will be less likely to certify everything unless they are certain it will meet a consumer need.
There is a case that at the moment the balance is sufficiently far in the direction of safetyism from the optimum that "most lenient and corruptible regulator in the G7" is probably still too strict.
Certainly possible, but it's a moving target and there are trillions of dollars at stake. Recall the Pentagon's definition of trust: a trusted component/system/person/organisation is one that can unilaterally break your security.
The FDA like other regulators is the way it is in response to government demands. So the practical solution is lobby representatives, executive branch and public opinion so the balance of incentives is less in favor of "avoid approving anything because it's a scandal if anything mildly bad happens" to "approve things because it's a scandal if medications aren't approved"
Abolishing an agency seems more practical than trying to lobby it so it acts like a rubber-stamp.
Trying to shift the public opinion in that direction is one of the things we do when we assert that in its present form the FDA is so bad that it would be better to abolish it.
Ah, in the same way that we shift public opinion towards creating more competent and higher paid police departments with the slogan, "Defund the Police."
Yes. The reason I oppose that slogan is case-specific, namely that I think that defunding the police would be worse than the status quo.
Exactly my point. A slogan for something worse than the status quo doesn’t help sell measured reform to much of anyone.
Yes, but (some) people saying "abolish the FDA" think the status quo is actually worse than abolishing the FDA, even if they might agree that an FDA reformed in a particular way would be better than either. I was responding to a comment by Randomstringofcharacters which argued that lobbying to reform the FDA was preferable to abolishing it, not that the status quo was better than abolishing it. If you are arguing that the status quo is better than abolishing it, then that's another discussion.
I do happen to think the status quo is better than abolition. But you seemed to be asserting that “abolish FDA” was going to sway people “in that direction.” My point is that, like “Defund,” you are far more likely to sway most people in the other direction. “Defund” and “Abolish” are both poor slogans as a measured approach fuels less anxiety which fuels much of people’s decision-making.
Primarily, your prior seems to be that the FDA is more or less working (if not necessarily working optimally), wheras the libertarian prior is that is not. There are other comments around here that address that already.
With regards to the liability issue, this is a total red herring. If doctors had concern about liability on perscription, they would form agreements with drug companies that the drug companies would assume liability when the drug was prescribed. If they would refuse, the doctors would refuse to prescripe their drugs. This would have the advantage of drug companies refusing to sell drugs they assumed liability for - a superior situation to now where nobody has liability for bad drugs that are none the less approved.
Some libertarians' view is that the FDA works very well to eliminate unsafe drugs (not always 100% perfectly but that's impossible); the enormous harm they do is in being too strict, not in not being strict enough.
(Actually, even in the current system, nothing prevents a drug manufacturer from accepting more liability than required by law; if unsafe drugs were a major problem even with the FDA existing, people would pay a premium for a drug whose manufacturer accepts more liability than required.)
I don't understand why all the dangers of unregulated drugs that you're worried about don't also apply to unregulated supplements? And why, in spite of those working largely all right, you still think that there's something special about drugs that the FDA solves?
I'm pretty disappointed – not with you but with the post. That's probably because of the shadow cast (in my mind) by the alternate 'full-on Scott Alexander effort post' I know you *could* have written!
Some 'glaring' absences from this post (at least as compared to the post I expected):
1. Prediction markets!
2. David Friedman
3. Robin Hanson
4. Kosher certification agencies
5. The history of the FDA
6. The history of 'food and medicine' *before* the FDA
7. Differences between the FDA and its cousins around the world
One concept that's helpful when 'refactoring' parts of a big/complex/complicated software system is 'backwards compatibility', i.e. preserving the 'public interface' of a part (as much as possible). That's definitely something that would be at the top of my mind were I to be charged with abolishing the FDA.
Responding to some of your points or questions:
> Do you also want all medications to be available without a prescription?
All medications are *already* available without a prescription – we're just 'talking price' as Zvi likes to write.
It's already the case that there are many many ways for people to kill themselves, or die accidentally. A perhaps shocking number of people *currently* die from overdoses of Tylenol (acetaminophen/paracetamol), let alone the consequences of alcohol.
> But if we don’t eliminate prescriptions, how do you protect prescribers from liability?
In the hypothetical world where the FDA *is* abolished, the U.S. Congress would of course pass some sort of (short, readable) bill protecting prescribers as they are now – for drugs already approved by the FDA – and create/fund some new system for new 'drugs'.
> But if there are thousands of medications out there, from miraculous panaceas to bleach-mixed-with-snake-venom, then it becomes your doctor’s responsibility to decide which are safe-and-effective vs. dangerous-and-useless.
I don't think the world as it is now versus one in which the FDA has been abolished is that different. Some people, including doctors – that are not employees or contractors of the FDA – are already deciding these questions, even given the existence of the FDA.
> Are we also eliminating factory inspections to make sure drugs aren’t contaminated?
The 'private FDA alternatives' could do this – or test the drugs afterwards instead. I'm not *definitely* sure that the current inspections 'turn a cost-benefit profit' now.
> How do we deal with the fact that many doctors are dumb?
Presumably, we'd use our abilities/affordances/etc. that we're currently using to deal with the fact that 'the FDA is dumb'.
> How will the smart doctors get the data they need?
It's already *terrible* epistemic practice for pharmaceutical companies to be responsible for studying whether their products are safe and effective. Insurance companies are one good alternative candidate!
What's extra surprising to me is that he writes about an adjacent market - supplements - that has all the basic potential for harm that drugs might, acknowledges that it largely works, but doesn't factor this into the anti-FDA abolition argument a few paragraphs earlier at all
I think his point about supplements – with which I mostly agree – is that there is no useful/practical 'epistemic consensus' regarding supplements, and there is a reasonable worry that 'treating everything like supplements' would be worse, at least along that dimension.
I am – personally – more along the 'think for yourself' end of the 'epistemic status' spectrum. I feel too strongly that doctors and medical researchers just don't grok statistics really at all. I also have had a recent vivid demonstration of the efficacy of concerted 'medical advocacy' – even in an area of medical practice that is, apparently, actually really pretty good nowadays.
The useful consensus is that there are a lot of substances that have the potential to be dangerous, that are marketed for benefits, with largely no regulation, and there are no massive problems of the nature that he's envisaging with drugs
Sure – that's the tradeoff that exists under the current equilibrium, which includes the FDA. I think it effectively relies on the approximate fact that supplements just mostly don't do anything, unlike many many prescription drugs.
I was hoping Scott would write about the _additional_ arguments that, even for drugs that ARE significantly dangerous, evidence from, e.g. people in other countries in the world as it is today, point towards people being MOSTLY responsible still. There are also lots of weaker wonkier arguments about reasonable changes that could be made on the way towards the 'libertarian extreme'.
Supplements just mostly don't do anything is an emergent fact about the kind of supplements that are marketed, not an absolute fact about all the supplements that are possible! There are plenty of risky substances out there that could theoretically be marketed as supplements but aren't, without any thing like the FDA being needed to prevent it.
That's true (or so I think as well)! I'd love to read what Scott has to write about this.
Regarding elimination of prescriptions - there are certain countries (such as Russia), where most non-narcotic medications (including warfarin, for example) can be purchased without any perscription.
The Russian population does not seem to be bleeding to death in large droves yet.
Though it is not a fountain of health and prosperity either (admittedly, probably not because of available-for-all medication).
Do you know about a lot of grey or black importing of harder to get drugs to Europe? It seems to be the obvious corollary.
It does lead to overuse of antibiotics, because a lot of people think you can treat flu with them. Recently, I think, most antibiotics became prescription.
Antibiotics is actually an interesting case that is not mentioned in the article (or most comments). By taking antibiotics when they are not needed, you might not harm yourself (so lawsuits, either against producer or doctor!), but you make everyone's life a bit worse by possibly contributing to rise of resistant bacteria. To me, this is clearly a "tragedy of commons" type scenario, because effects of abuse are removed in time and space, and therefore market cannot respond to them well.
Yes, antibiotics are a special case where regulation may be justified.
Thank you! I can't believe you're the first person to point out that there are a BUNCH of countries that let any non-fun meds be had over the counter with no prescription. Just off the top of my head and based on my own personal experience, Russia, Philippines, Colombia, Costa Rica, China, and more.
I actually assumed that MOST non-western countries don't require prescriptions based on my experiences.
I can only find a source from 2012 with cursory searching, but going by the countries of the world graphic here, that's largely true:
https://www.motherjones.com/kevin-drum/2012/03/lots-countries-dont-require-prescriptions-oral-contraceptives/
So if that map is still accurate, indeed MOST countries in the world don't require prescriptions for non-controlled drugs, and they're not all bleeding to death from recreational Warfarin abuse and such - why is it so much to expect that richer, more educated (by % of college degree and HS graduation) Americans can't handle the same degree of freedom that the great majority of the world enjoys?
That map is not about non-controlled drugs in general, but one particular (class of) drugs, contraceptives. That those are available without prescription doesn't mean warfarin is.
Oh my! How shameful for my reading comprehension.
Thanks for pointing that out, I hadn't realized and thought it was more general. I'll leave it up without editing so your comment continues to make sense in context.
I just spent another 15min or so trying to find some sort of list or map that's more comprehensive, and it's just a mess of standards and arbitrary dividing lines for prescription / non-prescription, dangerous / non-dangerous / household remedies and more across every country.
Given my own personal experiences, I still think the default in non-western countries is "most non-fun / non-dangerous US prescription meds are over the counter," but I can't find any cite that rigorously supports that, so I'll just have to cite my own anecdata for now.
A suggestion from the land of socialised medicine: split the safety-monitoring agency from the recommendation agency. In the UK these jobs are done by the Medicine and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) respectively. You can tell they were created by doctors, because neither of the abbreviations work. MHRA tests drugs for safety and basic efficacy and operates a side-effect monitoring system for licensed drugs; NICE decides which drugs are cost-effective enough to be available by-right on the NHS and publishes clinical guidelines. Both of these should still be government bodies, because that creates a useful Schelling point. But right now the stakes for the safety half of FDA are very high: they know that if they approve a medicine then everyone and their dog will start prescribing it. A two-step "yes, this is safe", "yes, this is recommended" lowers the stakes considerably, and allows for some time to gather real-world effectiveness data before advancing a drug to "recommended". Basic insurance could cover only drugs recommended by USA!NICE, less-basic insurance could cover all drugs licensed by USA!MHRA, gold-plated insurance could cover only drugs rated as safe, etc.
Also, USA!MHRA should fast-track approval for drugs approved by MHRA, EMA and other peer-nations' regulatory agencies, none of this "very nice, now do the trials again but in America" nonsense (and the other nations should reciprocate). It's a trillion-dollar bill lying on the ground.
Incidentally, it turns out (https://www.nhs.uk/conditions/medicines-information/#how-new-medicines-become-available) it's not illegal to prescribe an unlicensed (not MHRA-approved) drug in the UK! In Soviet Britain, everything that is not forbidden is permitted. I don't know how that works in practice - you might need to pay for the drug privately.
Originally the FDA did just verify that factories weren't contaminating their outputs. But you can't trust a government agency to stick to its original justification.
Weren't those changes due to new legislation, and emerging problems?
Legislation was new, problems were not.
The FDA does seem to be unusually bad among G7 medical regulatory agencies, though.
That's interesting. What metrics are you using?
Purely vibes, I'm afraid - AFAICT Americans complain a lot more about the FDA than Brits complain about MHRA or mainland Europeans complain about EMA.
How many people do you know from each region?
Rather more Brits and Europeans than Americans :-) Though my information diet does contain a lot of American sources, especially when you restrict to the libertarian-inclined outlets: libertarianism is much more niche over here.
I have thought of a concrete example, though! Remember how there was a delay of several extra weeks before the FDA approved the first Covid vaccine? That didn't happen here because the MHRA did a "rolling review" process, where they started the review as the trials were still going on: https://nibsc.org/about_us/latest_news/c-19_vaccine.aspx That suggests to me that the MHRA has its shit at least somewhat more together than the FDA.
I'm wondering if there's issues like this with other major libertarian policies I like. Would straight up ceqa/NEPA or JA repeal remove any load bearing pieces of policy?
I assume so - all those agencies were established for reasons, and it would IMHO be surprising if they have *no* effect on the thing they were established to combat. Simply abolishing NEPA would probably result in a bunch of environmental damage; simply abolishing the Jones Act would wipe out the existing US shipbuilding industry and put a bunch of American sailors out of work. The benefits may be worth it, but the costs would not be zero.
IIUC NEPA isn't the main barrier to real environmental damage (which is covered by other laws - it's noteworthy that fossil fuel projects are already exempt from it anyway). It's possible that this is a bigger problem than I realize, but if so I'd like to see some stronger more specific example of something that would go wrongs.
Re Jones act, that's the expected effect (which I think is fine in the context of the national economy). The question is whether there's unexpected effects that would be bad.
I don't think the argument about them being established for reasons necessarily holds water - they were established in a very different context (and are specific laws, not major agencies with multiple responsibilities.
Good catch on the agency vs law distinction, thanks.
I think we're mostly arguing about priors here: my prior is "sure, the context may have changed enough such that the law/agency no longer helps with whatever caused it to be established, but you need to do work to show that".
> Re Jones act, that's the expected effect (which I think is fine in the context of the national economy). The question is whether there's unexpected effects that would be bad.
You don't think that ensuring the continued existence of a shipbuilding industry is load-bearing? I'll happily agree that the Jones Act does a very bad job of ensuring the continued existence of a *competitive* shipbuilding industry, which was presumably the original intention. And it's effectively failed at maintaining a Merchant Marine that can be called upon in times of war, because the US Merchant Marine is tiny. But (AIUI) it does succeed at keeping shipyards open for the Navy's use. If you abolished the Jones Act overnight you'd either need to pay even more astronomical costs for warships (since now the US Navy is bearing the entire burden of keeping those shipyards open) or buy warships from elsewhere and suck up the increased scope for supply-chain attacks. I don't know how you could repeal the Jones Act (which I agree would be positive EV) without that problem - perhaps some kind of subsidy for the industry coupled to export discipline?
And to be clear, the US Navy is load-bearing: it (with some help from allied navies) ensures the Pax Americana on which global shipping relies.
If shipyards were kept around via the government paying whatever it costs to build warships, and at that point the *marginal* cost of building commercial ships as well is competitive with foreign builders, then they would build commercial ships. If even the marginal cost of building commercial ships is uncompetitive, then it shouldn't be done.
The government *would* have to pay more for warships, but paying for it explicitly like that, via broad-based taxes, would probably cause less deadweight loss than paying for it via the implicit taxes created by the Jones Act.
Yep, fair. It's not an insuperable problem, but it *would* be politically challenging.
There's actually an amusing situation where Terraform Industries has an immensely easier time getting solar-powered CCS approved by sort of pretending it's a fossil-fuel plant for regulatory purposes.
I think one outcome of this change would be a big resurgence in brand names in pharma. Without the FDA, consumers would turn to big pharma brands and manufacturers to be drugs that they can trust. So, they might start to ask their doctor “is it made by Pfizer?”
Another thing the FDA regulates is the advertising on drugs. We would start seeing a lot more “generous” ads for all the wrong drugs - but eventually the big brands would own this space
But, that’s only the people that won’t take the first med they see a $1 Facebook ad for that’s targeted on their condition. There’s a solid 10% of people that would be really missing FDA protections. But, those are the same people eating a ton of weird supplements.
Soon - life would stabilize. Just like how there’s no agency running what programs are safe for our computers, people generally would be very cautious and employ blockers/expensive services that would sometimes be counterproductive. But eventually we humans would find a system that just works for 90% off decisions. Probably a regulatory board the big manufacturers sign on to or something in collaboration with each other.
In fact - “big manufacturers create a safety board to regulate each other and scale up all their collective appearance of safety”… might solve most issues and questions?
Two reforms I'd like to see: (1) FDA recognizes other first world country approvals of drugs, and (2) for approval in the U.S., safety is required but not efficacy. Do those two things and maybe I won't want to abolish the FDA anymore.
Wouldn't that lead to big pharma companies jurisdiction shopping for the most lenient regime recognized by the FDA, and then that in turn motivate some jurisdictions to become "drug approval" havens?
Of course if you don't require efficacy jurisdiction shopping is less of a problem, but I find that I do think efficacy is pretty important.
> Wouldn't that lead to big pharma companies jurisdiction shopping for the most lenient regime recognized by the FDA, and then that in turn motivate some jurisdictions to become "drug approval" havens?
Yes. There might also be downsides!
Joking aside, I think the FDA ought to un-recognize any jurisdiction that has a history of shenanigans like this.
Yes, and there might even be upsides as well!
Joking aside, what would happen regarding the, possibly thousands, of drugs that were previously recognized on the basis of being approved by the now disavowed jurisdiction? Would they be 'grandfathered' in even though we now know they never went through a rigorous approval process? Would they become unobtainable possibly leaving many patients in the lurch? Would they receive some sort of special status until the studies were redone in a still recognized jurisdiction?
Also wouldn't the FDA be reluctant to un-recognize any jurisdiction whose approval process was the only basis for any substantial number of FDA drug approvals even if the approval process was inadequate, because of the chaos and PR disaster that would cause?
Hmm... I suppose one mitigation might be to simply stipulate that you need at least two trusted countries to approve the drug, rather than just one.
I make the responsible libertarian case for abolishing the FDA in my latest book: https://www.cato.org/sites/cato.org/files/ebookfiles/michael-f-cannon-recovery.pdf
My colleague Jeff Singer and I address specifically ending the FDA’s power to require prescriptions here: https://www.cato.org/white-paper/drug-reformation-end-governments-power-require-prescriptions
I'm maybe onboard with the second idea. But, practically, every drug manufacturer or marketer will maneuver through this experimental category first for access reasons. They will point to their products' successes as experimental drugs as proof that they're fine, and seek (or possibly require) testimonials from doctors and patients using these drugs as a means to convince more doctors and patients to use their products. It would not take long at all for an experimental drug ghetto to form. Heck, that could be the business strategy of several companies.
If we also manage to get IRBs up to a level of sanity where they don't consider it unethical to study the results of something that's already in widespread practice, that wouldn't be a "ghetto" drugs get trapped in, just an important stage in the development process. People willing to try experimental stuff contribute to datasets on efficacy and subtler or longer-term risks, which then eventually lead to enough formal confidence for full approval or rejection.
"Even those tiny handful of bad outcomes mostly involve a few well-known chemicals like caffeine and other stimulants."
Sorry for my ignorance. Is Scott referring here to consumers OD-ing on caffeine, or is there some well known manufacturer malfeasance that I am unaware of and that escapes my ability to Google?
Not an true overdose, but in the sense that excess consumption triggered something bad that they happened to be susceptible to (probably deadly heart rhythms or heart attack)
Thanks!
“But if you throw patients and doctors - fat and lazy from decades of trusting other people to do their thinking for them - into the unregulated medical jungle, it will take a generation before they’re able to do anything except flail and die.”
Well, I think it will take forever before they do anything besides flail and die. It’s not a matter of being fat and lazy; knowledge about modern complex systems is too massive for anyone to master. Descartes tried to do this in the 17th century—refuse to believe anything that he personally hadn’t derived from first principles—and failed. When a world-historical genius like Descartes couldn’t pull it off in a simpler time, we’ve got no hope. ClinicalTrials.gov says there are close to half a million registered studies this year alone. Patients can’t understand the dosing instructions on a bottle of pills and practicing doctors would have to read [checks notes] a thousand studies a day. This is why we have a division of cognitive labor built on trusting others.
☝️
You know what's good at divisions of cognitive labor? Free markets. With the FDA, we're forced to "trust" a bureaucracy imposed on us, with the result being people like Jake Seliger not being able to get the medication that could save their lives.
Free markets are good at some things, terrible at others, like solving negative externalities. The lives of people affected by those matter too.
Not opining on how well a free market would work here, but there is no negative externality here, since people taking the drugs are doing so voluntarily.
What negative externalities? Are these drugs causing people to explode, wounding bystanders with human shrapnel?
Suppose we allow everyone to buy hyperheroin all they like. All the subsequent drug addiction leads to others dying by DUI drivers, costs to the economy, and medical costs borne by taxpayers, plus the human cost to their families. These are negative externalities.
Or suppose we have an outbreak of a very contagious and extremely lethal disease, but we also have a highly effective (but not infallible) vaccine. People can either get the vaccine or not on the open market, but there is no mandate. Without a mandate, many more people who were vaccinated (but it didn't take), or wanted the vaccine but didn't get it yet will die. These are negative externalities.
You're right about vaccines having externalities, but heroin is another story. People on heroin tend to nod off rather than engage in activities while high. DUIs are mostly alcohol, which is legal.
Jake Seliger won't get to grow up more once he's dead.
I think the problem there isn't about specific durations, it's the basic assumption of a fixed-term, fixed-price monopoly. Georgist LVT seems potentially applicable - make patents indefinitely renewable, but with a cost set by competitive bidding, so patent trolls can't simply squat in the path of progress and collect rent, they need to be delivering actual value above replacement. That'd still incentivize innovation since the creator presumably has inside info on how well something works which other potential bidders wouldn't.
Better general approach to recouping drug development costs would be something along the lines of posting bounties. "If anyone can provide a treatment meeting such-and-such standards of safety and efficacy, I will buy the first X doses at $Y each." Possibly even with a formally-defined sliding scale of price based on the specific level of performance demonstrated. An escrow agency of some sort could deal with p-hacking shenanigans, and prediction markets or other financial derivatives could cover situations where a particular treatment seems like an obvious winner, but would take an unreasonably long time to technically meet the full criteria, and the researchers need some cash immediately rather than decades down the road.
> "If anyone can provide a treatment meeting such-and-such standards of safety and efficacy, I will buy the first X doses at $Y each."
The term for this is "advance market commitments": https://en.wikipedia.org/wiki/Advance_market_commitment
Banned for this comment.
I'm not for banishing the FDA, but the libertarian idea has some grain of truth at its core (like all of their bad ideas do): Get on the FDA's list of product recalls.
On the one hand, it is good to know something is going on. But once you see the scale, it is clear just how little the FDA is actually doing proactively as opposed to reactively.
The other part of this is the creeping bureaucratic Kafka-esque regulatory creep going on in the US and Europe. Anyone in a remotely consumer consumable industry feels this - the regulations are getting beyond crazy: circular economy packaging documentation. ever more picayune "contaminant" documentation. ever more ridiculous allergy notifications. testing restrictions combined with safety requirements.
It is a wonder that any small companies sell anything at all.
And to be fair, this isn't just the FDA at work. Congress passed a new law requiring new safety overview of cosmetics: MOCRA. The portal is supposed to go online in December - the betting is running heavily that it will not hence the FDA announcing already that it won't enforce for 6 months. But does that mean the ambulance chasers can't sue for 6 months? It does not.The arguments presented above are operational - but the primary reasons to question the FDA are mission oriented.
What exactly is the FDA's mission?
How exactly should the FDA be achieving this mission?
How should the FDA be getting graded in its pursuit of its mission and who would be the oversight authority?
Considering that cosmetics don't actually do anything and it's all a 10000% markup on the cheapest imaginable ingredients, the companies in question could just reduce the ingredient list down to oil and pigment thus avoiding 99% of the regulatory oversight. Had they had the sense to stop including ingredients that they have known full well were cancer causing 10 years ago, then the regulation would likely never been conceived of.
Are you a woman? Do you use cosmetics?
If not, I'd say you have zero basis for commenting on this use case.
Nor is the rest of your comment based on any form of reality.
Are you aware that animal testing is no longer allowed? So how exactly should any products be verified as safe for humans?
Nor does having a "simple" ingredient list, sufficient for "avoiding 99% of the regulatory oversight" - you have no idea what regulatory regimes are these days.
VOCs - i.e. the evaporated ingredients are now controlled.
Labeling on packages to comply with individual national and state regs is a thing, so are language support and adverse effect reporting. The packaging itself is required to undergo all manner of disposal, content, circular economy type reporting.
It is not and never has been primarily about safety.
For example: Japan has a limit of 0.0% formaldehyde in cosmetics. The US doesn't even test to that level. But formaldehyde is literally CH2O - it is a water atom with a carbon atom added on. Or in other words, naturally occurring, meaning "organic" products will often have it in them in a very small amount.
So is formaldehyde safe?
In reverse: natural food colorings are effectively banned in the US in candy. All US foods have to use artificial colorants. Is that safer?
For perspective on the safety/freedom tradeoff question, it's helpful to expand your analysis to areas outside of healthcare. Consider, for example, power tools. You can walk into your local Home Depot, slap some money on the counter, and walk out with a chainsaw or a 24"-diameter concrete cutting saw. No forms to sign, no questions asked, no licenses required. Then you can bring these tools home and get to work.
Depending on what you do, there may be building code or zoning restrictions on modifying your property. But, assuming you have any approvals you need for that, there are essentially zero restrictions on your ability to actually use a wide array of power tools to do it. This area of activity is nearly as unregulated as it was in the 19th century.
Is a large chainsaw more dangerous in the hands of an untrained person than many healthcare products regulated by the FDA and available by prescription only? Yes, definitely. But the healthcare industry is better at using the regulatory system to defend its turf than the logging industry is.
Devil's advocate:
A large chainsaw or concrete cutting saw's dangers are obvious and easily understood. There are well-known safe techniques for using them. The guy that decides to use a chainsaw to cut down a tree isn't going to fell his tree, walk away in one piece...and then five or ten or twenty years later find out that that tree felling he did a decade ago is causing serious lifelong impact. Those things that DO have effects like this have mostly been eliminated due to the industry banning the practice or regulation. Power tools are more intuitive and easily understood than many pharmaceuticals.
I think the dangers of putting random exotic chemicals into your body is pretty obvious and well understood. As is the well-known "ask your doctor or pharmacist..." technique for doing so safely.
However, we have spent a few generations teaching people that if a drug is available OTC, it is known to be so safe that you don't need to bother asking a doctor or pharmacist. In the short term, there would be a lot of problems if we made all the drugs OTC overnight.
Maybe as an interim, anything that doesn't meet approximately today's OTC drug requirements, has to be bought from a pharmacist who will explain the safety implications and any safer alternatives? This could be viewed as an extension of current warning-label requirements, to a case where the "label" would be impractically large and detailed.
Possibly nuclear plants can be regulated like commercial ships, and if they can then possibly drugs can be regulated like commercial ships
- The edge case navy large landing craft (and its 8 sister ships) cost $1.7 billion and were in service 50% of the year
- The average Very Large Crude Carrier costs $80 million and runs 95% of the year.
(https://jackdevanney.substack.com/p/a-tale-of-two-ships?utm_source=%2Fsearch%2Fships&utm_medium=reader2)
Commercial ships are regulated by Underwriter's Certification. It's a market system where insurance agencies specify what regulation the shipyard must adhere to in order for the agency to insure that ship in operation. The shipyard can choose between agencies if it thinks one agency is overregulating. But, it has to choose and adhere to one in order to get insurance. I assume they can sell without insurance if they want to but either they don't or none of their buyers does
Commercial ships are regulated by performance based metrics, guarantees, and critical component inspection - particularly on welding. Navy and nuclear regulation are prescriptive. Rather than inspect dimensions and welding quality in real time, nuclear plants get to have fun things like screws that cost 100x as much as other screws from the same assembly line in order to fund the paperwork for the nuclear screws. I'm less familiar with the FDA but this sounds similar to what I read here
This sounds like it would work well for safety, and that might be enough, while I'm not sure it can work as well for efficacy since whether a crude carrier operates 95% of the year is easily observable compared to drug efficacy. This suggest to me a halfway house regulation starter compromise. The market based system can be used for the 'experimental drug' category and we can see how we like it
Not that I necessarily disagree, but if you're referring to the littoral craft, that program was a notorious disaster. Nuclear powered aircraft carriers might make a better comparison?
Not the littoral craft, the San Antonio is an amphibious transport dock (vessel that launches and retrieves amphibious craft while also being a smallish helicopter carrier).
That being said, a warship and an oil tanker aren't really comparable at all, even when the tanker is bigger physically. Whereas an oil tanker is essentially a floating empty space, the cost of a warship comes from what's inside the hull. For one thing, weapons. The RIM-116 air defense missiles the San Antonio class carries are about a million dollars a piece, and the ships carry two launchers that each hold 21. Even if they carry no reloads (which I doubt), that's half the cost of the VLCC just in missiles.
Then of course you have fire control radars, electronic warfare systems, hangar and helicopter maintenance facilities. Accommodations, food storage, and water generation for about 1,000 people (a cargo vessel generally has a crew of 15-30). A 124 bed hospital with 2 operating rooms. Stealth measures which are classified but presumably expensive. The ability to take extensive battle damage and survive. Not even to mention that a warship is expected to be both faster and more maneuverable than any commercial vessel.
And yes, all of that is certainly subject to the cost disease that impacts all government (and especially military) projects. But an LPD will be a few orders of magnitude more expensive than a VLCC even in an ideal world.
Thanks-I really appreciate hearing from someone with expertise!
> But an LPD will be a few orders of magnitude more expensive than a VLCC even in an ideal world.
Pet peeve: how many orders of magnitude? Based on smopecakes' numbers, they are currently about 1.3 orders of magnitude (10¹·³ times) more expensive.
Yes that's on me, I should have said "an order of magnitude". And honestly that's probably not the best way to phrase the difference here to begin with. I'll say "over 10 times the cost".
I'm a big believer in stepwise change, and there's two big strategies that tend to seem appealing: one, making things marginally more like your eventual target, and two, creating alternatives to whatever system you want to do away with so they're already ready to go when you finally remove it.
Your two proposals both do #1. Honestly making the FDA judgment of "this is safe" distinct from "this really works" seems like a great idea. For #2, we have to really beef up the reputations of expert-run NGOs that make recommendations about supplements and/or experimental drugs.
And then, after more steps like that which we haven't yet mapped out, we can eventually actually abolish the FDA without chaos because it will have become a vestigial agency while the functions we needed it for were being performed in parallel in ways that don't suck.
There are a couple more possibilities, my favoured one though the one we do in Prospera that is basically "start from scratch & first-principles" that looks something like:
- Create voluntary FDAs, with a certificatory approach under competitive dynamics
- In practice still follow the same safety standards, innovate conservatively - the much bigger regulatory hurdle is efficacy trials, much less safety; I feel comfortable with efficacy just going out the window and for other market solutions to emerge just like that (e.g. consumer reports)
- There is still medical freedom, if you want to take it - you can take it (in Honduras limited by criminal law, e.g. for psychedelic drugs, but not for most other areas); have strong liabilities in case things like "informed consent" are violated, so providers make extra-extra sure there's informed consent
Within the existing system any reform proposal is a theoretical possibility and tetris-playing exactly like you suggest. If I had to pick two possibilities that are promising it would be:
a) Expand "right to try" laws as much as possible
b) Abolish not to the whole FDA, but start with abolishing efficacy trials
The consequences of abolishing the FDA needs to be weighed against the harm the FDA does.
Government isn't a magic wand. There are no solutions, only trade-offs.
I do think (2) would be a huge improvement. If you really want to get crazy, add a standardized-but-optional data collection method to make the new pathway a way to provide an automatic, IRB-less, Phase 4 trial on efficacy, like a discount for providing feedback.
Could make "collect relevant data from willing patients and make it available to all public-sector researchers" an explicit condition of the safe-but-not-proven-effective status. Ongoing compliance cost would help motivate drug companies to push toward formal efficacy certification sooner rather than later, even though they're already collecting revenue without it, whereas if it's optional they'd avoid or obfuscate in order to deny intel to their competitors. When some random grad student can potentially get a cash-cow drug's license suspended just by complaining that data is being shared in an inconvenient format, hopefully some vast engine of bureaucratic ass-covering will focus its terrible gaze on the task of best-practices UI design, making the scientist's job easier.
What about little things like reciprocal approvals with the EU's EMA, the UK's MHRA, Japan's PMDA or other qualified groups?
I would also like to see a radical reduction in which medicine requires a prescription. I think the experience in moving allergy medications like Allegra, Claritin and Zyrtec to over the counter reduced prices 90% has shown this can be done safely.
In terms of overall coverage of the FDA, having a much more open supplement level, where things are not approved for insurance coverage, but are freely available would be helpful. The FDA's recent moves against nootropics like the racetams are a net negative, and then they are trying to take away anti-aging supplements like NMN just because someone starts a trial for it as a drug.
Essentially, keep the FDA as a body that serves as approval for government insurability processes, but don't let them restrict the sale of chemicals that haven't been able to afford a study. (Although the FDA still should be involved in verifying they contain what is on the label)
The real question here is why doctors are so influenced by free pens. Further research is needed. A role for the FDA?
The world of supplements seems far from ideal, but...arguably better? You get a lot less certainty in knowledge, but a lot more affordability and convenience. If there are two systems and one costs orders of magnitude less, you can’t just assume the more expensive one is preferable because it delivers higher quality.
Most supplements in the mainstream supplement market aren't particularly new and innovative, though, are they? Old, established generic drugs are cheap too.
One way to ground a discussion of how an alternative regulatory system could work is to look at the existing regulatory systems in the 200 other countries where things function differently.
I haven't *done* that work, but I know India and Mexico have *much* freer drug prescription regimes, and Americans travel to Thailand for procedures that are illegal in the US.
Anyone have more concrete insights in other existing system to learn from?
My brother works in biotech venture capital, often dealing with vaccine development, and he told me there are basically three medical oversight systems that matter: the US, European and Chinese systems. Other countries either accept the results of one of these systems, or have markets too small to matter.
US system has regulatory capture issues where no new regs have passed in a long time due to industry pushback. FDA can no longer govern via new regulations but relies on enforcement actions (warning letters, inspections observations) to address evolving situations.
EU has been the core (European Medicines Agency). EU is universal healthcare. If they approve a drug, they have to pay for it. So they are serious about approvals.
China is becoming a major player recently. Money and lots of potential customers. Now we have three regulatory regimes to appease....
> EU is universal healthcare. If they approve a drug, they have to pay for it.
That's not true. Approval decisions and funding decisions are made separately in the EU, rightly. Approval is mostly made at the EU level, funding decisions are made at the member country level. So there are drugs that are legal to buy but aren't subsidized. (And even when subsidized, what percentage the subsidy is varies widely between countries and drugs.)
And even in the UK, where we do have universal healthcare, approval decisions and funding decisions are made by separate bodies.
+1
As a small step in the right direction, we might allow patients with terminal illnesses to take drugs that have passed phase II trials. I'll just admit that I'm not sure how to handle the larger issues of informed consent, insurer duty to cover treatment, and liability for doctors and pharm companies.
Realistically, this will lead to a lot of desperate patients with slow-motion diseases like cancer paying a lot of money for plausible but unproven treatments. But I think I'm ok with that.
“Compassionate Use Exemption”. For conditions with no approved treatment.
Organizations start out full of competence and energy. Then devolve into bureaucracy and fiefdoms over a few decades. Private companies are no exception, but the old and tired companies get out-competed and replaced by new ones regularly, keeping the herd relatively healthy.
Government agencies don't have many forces working in that direction. NASA had a typical life span. Went to the moon in a decade. A generation later, they could barely keep the deeply flawed space shuttle running. I've talked to a few people who worked with FDA and other TLAs, and their anecdotes confirm my prejudices.
So what if, every few decades, you don't *abolish* the FDA, but replace it with a new one? Give every FDA employee a $1M severance package, and start FDA2 from scratch in another city.
Has anything like it been tried anywhere?
This could even pair well with the approach described in the post.
You could have FDA2: Experimental get started with some energetic, competent leadership. They could instantly recruit the handful of people from FDA1 that are really good and want reform, as well as all the people who would work in FDA1 one in the ideal world but find the culture/rot intolerable.
Then, maybe you start giving FDA2 the right to do full approval, maybe in some easier categories to start. Companies can choose which to pursue. Eventually they can do everything, and FDA1 will reform due to pressure, or (more likely) can be safely closed.
Go to the moon, and then repeat as needed a generation from now.
In concept, I think this is interesting. The problem is standing up an 18,000 person agency. Have you ever started even a 1,000 person organization? 100? It's really, really hard.
Harder or easier than getting ambitious reform through the existing, entrenched 18,000 people?
One of the advantages of the new, focused agency is that you actually *could* start with 100. Yes, building something like that from scratch is still hard. But it does happen!
Assuming you want reform, what's the next best alternative?
Whoops-this content was supposed to go here. Sorry for double-posting.....
vorkosigan1
just now
It depends on your metrics, I think. I think that starting and hyper-rapidly growing a new organization of that scope is likely to fail. If it does succeed, it's more likely to give those reforms, true. But I think success is unlikely.
In my dream world, you provide the existing leaders with better incentives to change. There is already a lot of change going on at FDA, but not on the scale you're talking about.
So I think it's not hard to get FDA to change; I think it's hard to get Congress to change the laws that give FDA its incentives. ANd I think it would be a lot easier to get Congress to pass reform legislation of the kind I'm talking about than "FDA 2".
It's not about being entrenched, it's about incentives. And governing laws. And it's like any other organization-while there are some stick-in-the muds, most of the people at FDA, especially at the higher levels, are highly motivated and value improving health for Americans.
So the first thing I look at is changing incentives for the existing organization.
That makes sense! So how do you, in practice, change the incentive?
You need legislation from Congress. Congress says "jump", and FDA will say "how high?"
One more thought on "FDA2"--the way to make that work would be start with with some sub-office of one of the FDA Centers (so like 4 levels down from the FDA Commissioner, but still sizable), and apply FDA2 reforms at that level as a pilot. See what happens, and when you have something that works, expand it.
Oh, and one more thing-it seems like there are really only two areas folks are complaining about-drug (and maybe biologics?) approvals, and ability for people to assume the risk when the alternative is death or disability. Maybe focus the legislative reforms on those two areas, which seems much more doable, than "BRAND NEW FDA" or "NO FDA".
Lastly, I'm not comfortable with assuming that EMA drug approvals are as good as in the US. I vaguely recall seeing some problems with EMA drug approvals....
I have never worked in government, but my experience of coding against Microsoft APIs tells me that the old agencies will never, ever die, and the new agencies will never take the last handful of responsibilities off them, so in practice you'll have to deal with *all* the agencies to get anything done.
Yes for this to work you'd need the will from above to protect FDA2 from FDA1's meddling -- FDA1 will absolutely kill it if they can.
I don't know enough about the politics involved to know how practical this is, but I would be surprised if it's not more practical than "just abolish the FDA and don't replace it" or "actually accomplish meaningful reforms in the existing FDA, without any lever that prevents them waiting you out"
Are there other options I'm missing?
Good point about air cover - AIUI the UK's Government Digital Service (GDS) was very successful in modernising UK government web services in the early days, but then the politicians who supported it moved on and it hasn't been nearly so effective since due to bureaucratic turf wars.
I believe there have been a few cases where a police force has been rebooted successfully: the Republic of Georgia, Northern Ireland, and Camden, NJ. I don't know of any successful hard reboots of other types of government department.
How do you deal with the loss of institutional memory and expertise?
So, if the problem is bureaucracies getting to blotted and self serving (ie, Zvi's Immoral mazes), is there any solution that works from within? Not having to tear the whole thing down. Maybe like monopolies (I'm thinking Ma Bell) can we break it into parts. Have smaller FDA's in the north, south, east and west. And then maybe you get some competition? IDK it seems like a hard problem.
I prefer the option of shutting down the FDA and immediately replacing it with a new agency with the same responsibilities.
Sometimes the only way to fix the incentives for a bureaucracy is to start with a clean slate when the organization ossifies too badly.
If the criteria for a doctor being "dumb" is that they don't use critical thinking when they prescribe medication, then I've got news for you....
I think the straightforward approach is to take away the FDA's licensing powers and replace it with certification. Insurance companies would be unlikely to pay for drugs that have not been certified as effective, so there would be strong incentive to conduct major phase 3 studies and little change to consumption in practice.
I would definitely let any drug be legally sold anywhere. That said, private pharmacies may still only choose to dispense certain drugs with a prescription, so not everything is likely to be as widely available as alcohol. For the minority of people who want to self-medicate with therapeutics, as long as no one else is forced to pay if it goes wrong, I don't see the problem. People are free to mutilate their bodies or destroy their lives with bad choices.
On liability, I favor laws that create liability multipliers or divisors for failing to or scrupulously complying with industry best standards, respectively. Inspection would be voluntary and opt-in, but any business of size would have a strong legal incentive to get certified as in compliance. This could ultimately replace almost all regulation. No need to punish people for harm they have not actually caused, but if something happens, then negligence would be ruinous. This could work for doctors writing prescriptions as well as companies manufacturing generics. Ultimately, it would be better to see competing private organizations that certify, but government could still play that role.
Never use "complying with industry best standards" as a criterion, because it creates a ratchet. There is an incentive to be at least as good as the industry average, preferably better, and a strong incentive not to ever be worse than the average. That means standards can only ever go up, not down, even when they are well beyond what's worth the cost.
It's interesting that Scott thinks that libertarians always lose, and that apparently this isn't just casual hyperbole but something that until recently was _literally_ true (and now is merely 99.9% true). Off the top of my head:
- The YIMBY movement has been quite successful, and although it doesn't identify in a partisan way, it seems pretty clearly libertarian-aligned.
- There has been some recent bipartisan support for reducing the carceral state, and Trump himself signed a meaningful prison reform bill. Although prison reform may not be the top of the libertarian wishlist, it is definitely an issue that I have heard some libertarians talk about.
- The Niskanen Center is a new-ish think tank that is punching above its weight. Its politics can be a little hard to characterize (in a good way), but to me they basically seem like good government libertarians.
- Matt Yglesias just wrote an interesting piece about bipartisan efforts to decriminalize mobile homes. This issue is more important than it sounds, as it deeply affects housing affordability.
- One could point to the dismantling of Jim Crow as a general victory for freedom. Libertarians (correctly) don't take credit for this or, you know, seem to care about it generally, but the general arc of the last century was toward much greater freedom for really broad swathes of America.
- My impression is that there has also been some bipartisan energy around dismantling rent-seeking occupational licensing regulations, but I'm not really up on the details. This is another issue that some libertarians have talked up a good deal.
This is just off the top of my head, and it would be pretty easy to come up with a much longer list. Perhaps the more interesting question is why libertarians think they always lose. I have a number of theories here, some of them honestly pretty obvious, but if I were to mention them the comments section would probably lose its mind, so I will mostly hold off. The only one I will point out is that the best source of actual libertarian energy in government is probably centrist Democrats, but libertarians for a variety of reasons can't or won't accept that.
Most cities still have zoning. 99% perhaps?
What has Niskanen actually accomplished?
> why libertarians think they always lose
Government keeps growing as tech improvement (largely in communications) enables this.
This comment could be exhibit one in a list of libertarian pathologies that make libertarians think they always lose. Actually, it could be exhibits two and three as well, as it manages to convey in compressed form a number of terrible ideas about what success in politics means.
Apologies if that reads as snark. I mean it seriously.
Apparently school choice in the USA is gaining ground
It is certainly the case that home schooling is at an all-time high and experiencing a long-term upward trend due in part to legalization and deregulation. This seems straight down the middle for libertarianism. Yet another item for the 0.1% side of the ledger.
https://www.economist.com/the-world-ahead/2022/11/18/americas-school-choice-movement-is-gaining-steam
It's not clear that self-identified libertarians had anything to do with the legalization of homeschooling. (AFAIK it was 100% from the efforts of religious fanatics, who neither identify as "libertarians", nor support anything else the latter advocate.)
It is my contention that most (but not all) self-identified libertarians have very little to do with meaningful political change, for reasons of self-selection. But libertarian ideas more broadly do have some purchase across the political spectrum. Not a lot of purchase, because libertarianism in general isn't very popular and self-identified libertarians seem mostly allergic to doing the kinds of things that might make it more popular. But definitely some purchase.
Yes, home schooling as a movement originally drew most of its energy from religious people. It has broadened out a bit since then. I was technically a homeschooler during Covid, although we hired a teacher with some other families. And we crammed our kindergartners full of Darwin and Nietzsche.
While parts of Jim Crow were enforced by laws (eliminating which increased freedom), parts of it were enforced by private decisions and contracts, and outlawing that reduced freedom (and did so nationwide, while the previous laws that were struck down only applied in a part of the USA). There wasn't a second when US governments (federal and state governments combined) didn't intervene on the matter in either direction.
I don't think that Scott meant that everything in the US in maximally opposed to liberty, such that some things having been worse the better part of a century ago would be any sort of rebuttal, or that every new law necessarily takes the US further from liberty. In the context of abolishing the FDA, his reference to libertarians never winning seems to be to policies that are *unique* to libertarians, like abolishing the FDA.
A couple of comments:
1. "FDA" has multiple functions: it deals with food safety (especially for imports), medical devices (hip joint replacements, for example, X ray machines, etc.), pet food and medicine, and tobacco products, beyond just "drugs" which I think includes biologicals, etc.). If you're going to "abolish FDA" (which I do not favor), then you need to think about all those functions.
2. FDA already are various fast-track provisions, which to some perhaps limited extent address some of the points Scott raises: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
Great piece. You bring up a lot of good questions.
My own opinion is that the Covid response in particular clearly demonstrated that the FDA is seriously "bent" like many other government agencies. At some point more and more people just throw up their hands in frustration and call for abolishing such an agency rather than continuing to beat their collective heads against the wall trying to reform it.
I am somewhat familiar with the public health system in Taiwan. With the exception of what we call "controlled substances", you can buy most medications without a prescription, including all antibiotics and antivirals. If you go in for a doctor visit and are prescribed a medication, it is provided at nominal cost at the hospital. If you don't have a prescription but want to use it anyway, you can purchase it at a somewhat higher price at any pharmacy. Note here that even when self-purchased, the prices are still vastly lower than here in the US for most meds.
Wasn't there a documentary called "Idiocracy" that described when the Brawndo Company ("it's got electrolytes!") bought the FDA and the FCC and thus was able to sell and print anything it wished?
It’s what plants crave!
The president was a professional wrestler. And don’t forget the hooker whose customers paid her to not have sex with them.
Electricity is incredibly dangerous (far more dangerous than all but the most dangerous drugs) and yet we all have a zillion electrical devices, made by thousands of nearly unregulated factories all over the world. I suspect if we had a Federal Electricity Administration that got to decide what electrical devices could be sold, first off we’d just be getting home PCs now. But there would also be articles like this asking how we could ever function without such an agency and speculating about the hundreds of thousands of electrocutions we’d have.
The solution is simple – you can sell any chemical for any use to anyone you want, same as for any other product. And as with any other product, the seller is liable for any undisclosed harms. That liability will cause sellers to be clear(ish) about harms, and also to be choosy about what they sell and how they sell it. Some may choose to only sell some drugs to doctors, to offload the liability. Private insurers (like UL) will offer to test drugs and protect doctors or sellers. Some drugs might simply be too dangerous to even sell, or to only sell (with very detailed contracts) to highly trained specialists.
And an agency like the NHTSA could be setup to identify undisclosed problems and go after manufacturers, as we do with autos. But that would be very different from an agency that must sign off on all new products.
Yes, some additional people will abuse painkillers but many who are currently living in pain will get painkillers they need. Yes, some people will overdose, or take meds that are unhelpful. But in exchange, many people currently suffering may find treatment and/or relief from drugs that are blocked by fda approval.
Aren’t there in fact safety regulations for electrical devices? But of course such regulations are a simple matter since electricity’s effects on the body are not complicated. New chemical compounds *can* have quite unpredictable effects on the body, particularly in combination with others: if I buy Drug A from you and Drug B from someone else, and they interact badly, who is liable, you or the other seller, or both?
Medical devices are regulated by the FDA under 21CFR820 and require extensive testing of both drug and mechanical components, very similar to what is required of finished pharmaceuticals.
I was talking about electrical devices generally; JG seemed to be making an analogy between selling drugs and selling electrical devices.
At least in the US, safety of consumer electrical devices is mostly handled by a private organization, https://en.wikipedia.org/wiki/UL_(safety_organization) , which was originally funded by a consortium of insurance companies that were sick and tired of paying for buildings that burned down because some resident installed a newfangled electrical doohickey.
There's also some statutory regulation, but UL's success in keeping Americans from electrocuting themselves or burning down their homes is frequently cited as one of the strongest existence proofs of "we don't need government regulation to get this right". But, as always, you don't want to extrapolate too much from one data point.
The most obvious answer to "why don't we take supplement certification seriously now?" seems like it's obviously that supplements don't deserve to be taken seriously. If they had a major impact on the body then the FDA would be regulating them, just like what happened with Red Koji.
I think there is one more item that needs to be addressed and I think it is the most important one.
Most drugs have obvious effects on the folks taking them (e.g. fentanyl) and the libertarians are pretty consistent about letting people make their own choices and suffering the consequences. If you make fentanyl not require a prescription then some people will die because they purchased it and they overdose. Their call as long as the fentanyl wasn't labeled as aspirin.
But ... some drugs, specifically drugs that fight bacterial infections (?), can make things worse for everyone if not used judiciously. Over use just creates bacteria that is immune to the drug and then we don't have working drugs for those infections. This is a classic "tragedy of the commons."
Maybe this isn't handled by the FDA today, but any much more laissez-faire approach needs a position on this, even if that position is "we will wind up with drug resistant bacteria and no effective drugs because it is wrong to limit people's choices."
> we will wind up with drug resistant bacteria
This already happened, and continues to happen, on account of FDA being entirely ok with the practice of feeding antibiotics to livestock by the megatonne.
Yes the last of the universal anti-bacterials have all been cannibalized to the point that there is no more universal anti-bacterial.
Has there ever been one?
Fire tends to work pretty well, although with some nasty side effects...
If the "Federal Death Administration" were abolished, and nothing else changed, predatory tort lawyers will simply fill the power vacuum. A replacement, if you will, of "dragon" with "plague of locusts".
re: "Second, a doctor must prescribe you the medication. “Abolish the FDA” gets rid of the first barrier, but doesn’t specify the status of the second. Do you also want all medications to be available without a prescription?"
There's (maybe?) a partial answer here inasmuch as a) what constitutes a prescription drug can be codified by law either explicitly (X drug requires a prescription) or by defining what fits in the class of "prescription drug" and/or this policy development can be handed off to someone who isn't tied up in also deciding what drugs are effective and b) what requires a prescription is, in practice, generally decided by state Boards of Pharmacy anyways. BoPs typically punt this definitionally backwards though; CA pharmacy law defines "dangerous drug" as "Any drug that bears the legend: 'Caution: federal law prohibits dispensing without prescription,' 'Rx only,' or words of similar import", but I get the sense you could probably appeal to their ego by telling them they get to pick a more specific definition.
Also, where you describe independent accrediting organizations (competing to be) taking the place of the FDA, that's supposed to be what health insurers/PBMs are doing--they're supposed to be deciding what gets covered/how well based on the available evidence, we just already know where that tends to break down.
In Puerto Rico you can already buy any(?) prescription medication over the counter without a prescription, so that probably wouldn't be apocalyptic if you included a carve-out for dangerous or even "dangerous" drugs remaining illegal unless prescribed by a physician.
It is worth noting that millions of people (even if only speaking of USA) already have no serious difficulty at all in regularly obtaining the most dangerous and illicit drugs without any paperwork whatsoever.
"The only problem is that this hasn’t happened with supplements (examine.com, LabDoor, etc, are nowhere close to this level, sorry), even though there are some of the same incentives there today that there would be for medications in a post-FDA world."
Are they the same incentives? I think right now the FDA pushes out what would be good alternatives because it has legal force. Very rarely is anyone going to pay a second, private company after going through the FDA's process, because the FDA is already expensive and cautious, and gets you everything you need (insurance *must* cover it, doctors can prescribe it, etc).
"But if we don’t eliminate prescriptions, how do you protect prescribers from liability?"
The way liability works in the US is an unmitigated disaster. (The way tort works in general is a separate disaster). Reforming it is especially hard because, as Colorodans found out last year (https://kdvr.com/news/local/access-to-14ers-at-risk-after-bill-protecting-landowners-fails/#:~:text=The%202023%20amendment%20to%20CRUS,be%20found%20as%20%E2%80%9Cmalicious.%E2%80%9D), a lot of legislators are lawyers. We probably only have a medical industry at all because of specific carve-outs for things like the FDA approval shield that you mention here. You probably could preserve the carve-out by specifying some comparable liability shield... but how does that work? Saying that specific orgs can "approve" drugs just replicates the FDA's monopoly. Providing for a government bureaucracy that certifies other organizations does the same.
I know that "well just reform the entire legal system alongside getting rid of the FDA" isn't much of an answer, but I do think that we should switch to loser pays and have a reasonable liability system regardless. Ditto for all of the other things you mentioned--we should have legal weed and LSD, we should have a sane health insurance system, etc.
I suppose an intermediate point would be to make FDA approval optional. I expect most doctors and most drugstores would continue to only prescribe/sell approved drugs, but it would allow people with terminal conditions or something particularly resistant to existing drugs to seek out experimental drugs or alternatives that didn't work for most people or that have big risks. We already have clinical trials, and I don't know how liability works in those cases, but presumably it could cover these situations as well.
Part of the libertarian solution to liability is to make all tort liability waivable in contract. The law should set some defaults—I have some ideas what they should be—but whatever they are, it should be possible to override them in a contract in the direction or either less or more liability. A waiver, if made in the right form, should be enforceable, no exceptions. (There can be rules about the form of a waiver, like certain waivers have to be prominent and can't be hidden in the fine print, but there should always be a reliably valid way to waive liability.)
That's true; we should have greater ability to remove liability with explicit agreement. But our current liability law faces serious issues even outside of that: You can trespass on someone's property, get yourself hurt doing something you're not supposed to be doing, and successfully sue them for failing to do more to prevent you from trespassing or for failing to fix a dangerous thing that no one is supposed to go near.
This point isn't so relevant to medicine, since your doctor and pharmacy can always make you sign paperwork before prescribing/selling you medicine. But I'm still not sure if this would work--make the waiver too short and broad, and the courts will say it doesn't cover things; make it too long and detailed, and they'll say it's not reasonable for people to read it. Plus, how many people will be willing to sign their life away every time they need a prescription? Would this substantially impact people's willingness to take important medications? This is where the above point becomes relevant again, because it would be really nice if the standards for being liable in general were somewhat stricter than "did not move heaven and Earth to prevent any negative outcome."
(Except when it comes to driving, for some reason. You can drive like an absolute cretin, break a dozen laws, mow down a child on your way to running a station wagon of nuns off the road, and just go "oops! it was an accident" and suffer minor consequences.)
I definitely agree that there should be saner, stricter (towards the plaintiff), more predictable defaults.
But this: "make the waiver too short and broad, and the courts will say it doesn't cover things; make it too long and detailed, and they'll say it's not reasonable for people to read it" shouldn't fly either. At least one form should be predictably valid.
There *should* be, yes. I just don't know what you would have to write the law as to get US courts to follow it.
I don't think this would actually work in practice - for one thing, every EULA and forced clickwrapper will have maximally liability avoidant conditions immediately added.
For another, any business with any history or potential to be tortiously sued will immediately require you to sign maximally liability avoidant participation waivers.
Your employer, as a condition of employment, will force clickwrapper maximal liability avoidance.
Hell, I'd even personally craft a maximally liability avoiding EULA and force anyone who tries to talk or interact with me to click "Agree" before being able to do so, and I'd imagine every single politician or person with assets would do the same.
How does your suggestion not end in a world where everyone is forced to clickwrapper "Agree" for every business transaction or interaction everywhere in a way that maximally absolves the other party of any liability?
In many cases, that would happen—if the default liability that applies isn't also significantly curtailed—, and that's fine. (Btw I think many kinds of liabilities *can* be waived even today, this would just be extending that.)
In cases where the liability is actually important, where there are many well-known scandals of companies hurting their counterparties (like the ones that prompted the creation of the FDA, workers' compensation laws etc. in the first place), people would be willing to pay more, or accept a lower salary, in exchange for the company accepting more liability; it would be a selling point for a company, sort of like extended warranty can be.
For instance, if there are scandals where pharma companies sell ineffective or harmful drugs, people would have no reason to trust that a new, expensive drug is any better than an old, established, cheap generic; if anything, the old drug is safer. So they would buy the old, cheap drugs if they buy any at all. That would be disastrous for pharma companies' profit, and they know it. So they would either proactively make sure no such scandals happen in the first place via some sort of self-regulation, or they would try to regain people's trust by making strong, legally binding promises.
"In many cases, that would happen—if the default liability that applies isn't also significantly curtailed—, and that's fine."
Imagine a Eula clickwrapper, stomping on a face, forever!
I mean props for being internally consistent, but I'd happily become an expat if this happened here, I think that would be a strong net negative and a much worse status quo. And I'm definitely of the opinion that 99% of lawyers and legal cases are entirely useless to net-negative for the average person, so it's not love of litigation or the legal system, or indeed of current liability standards, which I think are ridiculous.
I don't think forced clickwrappers and EULA's should even be legally enforceable today as they stand, just imagine having every possible transaction or person-to-person interaction EULA'd - hell would be upgraded from being other people...at that point, hell would be their EULAs.
But if the inconvenience of signing waivers exceeds the cost of the liability to the two parties summed, then they won't make people sign waivers, because people are willing to pay more for a service if they don't have to sign a waiver. There is no reason to expect the free market wouldn't find the optimal solution here. (Nitpick: EULAs are a kind of license for copyrighted software, what we're talking about are waivers, not EULAs.)
Yeah, I even used "waiver" appropriately in my original post, I was using EULA as a synecdoche of the cluster of things like waivers, forced clickwraps, EULA's, mutual contracts, insurance waivers etc.
I still think we would end in ubiquitously forced EULA / waiver hell if that were passed, due to the hugely assymetrical risk / reward for most companies and people - all it takes is one lawsuit to cost you millions, compared to the not-even-an-inconvenience-to-you of forcing somebody to take 30s to click / sign. But of course in the aggregate, those 30s add up to heinously huge amounts of wasted time, cumulatively many lifetimes worth, for incontrovertibly negative benefit to the people being forced to click / sign.
So the proposal is to waste many cumulative lifetimes, incinerate this huge pile of QALY's, just to feel that we're a solid contractually-savvy country that is smarter than most western countries about liability and litigation? The price isn't worth the reward.
It is not an inviolable law of nature that clickwrap EULAs must be legally binding. If Congress (Parliament, whatever) passes a law saying that people can waive liability to any degree they want, it can just as well say that waiving liability beyond some set standard requires a written contract - or written and notarized. Which would be enough of an inconvenience to drive away more than a few customers, particularly in the age of e-commerce, such that nobody would do it unless they expected to be sued a *lot* if they didn't.
After the apocalypse, as we get used to the burning corpses and the roving gangs of pre-verbal waifs swarming anything that moves, there will be a second great die-off as the billions of us who only survive by taking a cocktail of a few dozen different malady reducers three times a day are rather quickly Darwined into oblivion.
Over a quarter century I’ve plied my trade for Big Pharma (technology auditor) and it is easy to lose track of the fact that medicines are getting developed that do allow people to live fuller and healthier lives. But it is a business and a powerful one with huge (huge!) amounts of capital at its disposal and the ability to push back against the regulators with a fair amount of weight. Money gets what money wants.
A good justification for gatekeepers: antibiotics. Go to a place like Phnom Penh and you'll see locals buy one or two tablets of Cipro from a corner shop thinking it will fix their common cold or sore arm. Over-prescription undermining antibiotic effectiveness is an issue in the U.S., but developing world casual overuse really exacerbates the problem.
The ideal solution is probably some combination of self-regulatory organizations, Consumer Reports-type reviews, and tort reform that protects drug makers and MDs who do their due diligence while exposing those who do not. The real world solution is probably some combination of your arguments re: supplements and experimental drugs plus downgrading lots of medicines to over-the-counter status.
I'd just like to see the FDA reworked into a label enforcing and data gathering institution. Report the patient/user data to the FDA and you get told what sort of labels have to appear on your product. Don't report any data to the FDA and you get some very scary labels. Falsify data and you get to go to prison for the foreseeable future. Drug and food companies have liability for unadvertised product harms (either through neglect or withholding the data).
Ideally, FDA would have open and anonymized medical datasets. As a user/consumer, you get to avoid taxes on medications and foods if you register your national, digital, medical profile with the FDA and buy drugs and food through that profile. Then the FDA and independent researchers could run ML across those datasets to look for correlations and bad interactions between drugs and so forth, which then informs what sorts of labels get applied to products.
Is there any country where this is handled better? If so, how do they handle it?
Abolish-lite idea 2 (experimental drug category) is the inverse of the reform I want. I would prefer a regime where the FDA regulates for efficacy, and does not regulate safety per se, but rather safety labeling, by which I mean when you buy a drug it would say “taking this drug raises your risk of heart attack by 10%”, and you know that a) it meets the normal FDA threshold of efficacy and b) the FDA thinks the level of risk on the label is truthful. Basically the idea is the FDA makes sure drugs do what they claim to do but is leaving it to patients and doctors to decide what level of risk they are comfortable with for a given treatment.
This idea is mostly motivated by some personal experience - my grandfather had Parkinsons, got on some drug trial, saw a massive improvement in his symptoms, and then was told “sorry, turns out this elevates your risk of heart attack or something by x%, so we have to end the trial.” He wanted to be able to continue using the drug - he felt that the massive improvement in quality of life from the drug was well worth an x% higher chance of heart attack, but some bureaucrat decided that no, he was wrong, he is better off suffering but safe. I have had a burning hatred of the idea the FDA gets to decide what level of risk is ok ever since).
The solution to this has always seemed obvious to me: drugs would be approved for safety, not effectiveness; and any drug with well-understood safety could be sold (if the known safety risks were disclosed on the label).
In this hypothetical universe, the FDA still exists, but only regulates information about safety on drug labels. So, for example, the label for any product containing acetaminophen would be mandated to include that, if you take more than 1000mg in any 6 hour period, or 4000mg in any 24 hour period, then you will have permanent liver damage; that it increases the risk of stomach ulcers; that it increases the risk of hypertension; that it can cause kidney problems; etc. The FDA would still require manufacturers to get their proposed labelling approved before bringing a drug to market.
This is essentially the situation for off-label prescribing: drugs can be used for uses where effectiveness hasn't been shown, but there's still comprehensive information about safety on the label (granting that safety information for one indication could in principle not generalize to another indication). Perhaps off-label marketing would be legalized, or perhaps it would still be illegal to market drugs for unapproved uses, but drugs on the market wouldn't need to be approved for any uses in order to be sold as long as the manufacturer didn't make any particular claims about effectiveness.
It depends on your metrics, I think. I think that starting and hyper-rapidly growing a new organization of that scope is likely to fail. If it does succeed, it's more likely to give those reforms, true. But I think success is unlikely.
In my dream world, you provide the existing leaders with better incentives to change. There is already a lot of change going on at FDA, but not on the scale you're talking about.
So I think it's not hard to get FDA to change; I think it's hard to get Congress to change the laws that give FDA its incentives. ANd I think it would be a lot easier to get Congress to pass reform legislation of the kind I'm talking about than "FDA 2".
It's not about being entrenched, it's about incentives. And governing laws. And it's like any other organization-while there are some stick-in-the muds, most of the people at FDA, especially at the higher levels, are highly motivated and value improving health for Americans.
So the first thing I look at is changing incentives for the existing organization.
On the same topic, Scott, you may find this Cato piece of interest: https://www.cato.org/white-paper/drug-reformation-end-governments-power-require-prescriptions
There's an old saw "Don't take down a fence until you know why it was put up." In regard to the FDA, the reason it was installed was because businesses had learned how to effectively market completely quack medicines. You can look this up; the modern media documented all of it. A pure libertarian doesn't care, but in practice, once you reach the outer bounds of the effective rationality of the average person, society can (in aggregate) lose a fantastic amount of productivity based on mass poor decisions, and a society that isn't pure libertarian can out-compete one that is.
As I age, I'm less and less interested in libertarian ideas. I still respect and enjoy Heinlein's visions of perfect society, but I fully understand that I would probably die, or at least suffer in such society. I'm too lazy and stupid to be a libertarian. Really, all I want from life is to concentrate on a few things that matter to me, and let the nanny state, or world AI, or whatever take care of the rest, preferably without me needing to pay any attention.
We already live in world where everyone is trying to cheat everyone. I don't feel that relaxing government protections will make it any better, but rather at least more confusing, if not outright worse.
I mean, right now, if I want to check information about a drug, I can go to FDA site and see if it is deemed safe. But if there are multiple voluntary certification agencies? I have to decide which ones I trust. It makes me think of anti-virus software. Even in 90's, I had to run at least two AV programs to check if an executable was safe, because each had its own database. Now? There are dozens of them, so you really can't decide anything without looking at VirusTotal.
For drugs, that means if a company wants its drug to reach the widest possible audience, it must get certification from ALL major agencies. Who will have different processes, different requirements and different outcomes (it's a known problem in software world - sometimes you have to modify your program just to make that one AV shut up, because its heuristics think your little game is a virus). Come to think about it, it would make sense for a certification body to warn consumers about any drug that didn't tried to get its certificate in Big Red Scary Letters on some kind of meta-information site.
Also, what would prevent existence of rubber-stamp certificate mills? Libertarian answer is reputation, but I don't think it works well enough. An enterprising person might set up a network of such companies, to give any drug a feel of substance approved by multiple sources. Even if one of his companies is compromised and sued into oblivion, it doesn't mean the whole network goes down. This probably wouldn't work on a canny consumers who do through research before committing to buying stuff (I would guess some kind of meta-checking site I mentioned above would probably only use results from most trusted sources), but most of us don't do that.
And of course people will self-prescribe anything they see in an ad, without consulting their doctor (this costs money, why would you pay for doctor to say you need exactly the same thing a TV ad said you need?!). This actually already happen with supplements. I don't know the situation in US, but in Russia, supplements already became synonym for snake oil. People, especially old people, spend their last money to buy the latest miracle supplement, and then die of preventable problems, because taking supplements is psychologically easier than going to doctor.
What protects you from government and bureaucrats cheating you?
Mostly wishful thinking that the government should have longer-term vision than business. It's mostly an illusion, but a nice one to have. Also, governments are less competent at cheating, so it's easier to see through.
'Mostly wishful thinking that the government should have longer-term vision than business. It's mostly an illusion, but a nice one to have. '
Congratulations on self awareness. It's not a nice illusion though - it's a very dangerous one. I say that as a citizen of a country where the government does far more damage than business, by several orders of magnitude. And, if you look at human history, political power has tended to be a far more pernicious force than business, until it was (relatively) tamed, relatively recently, and in very few places
This suggests there is a market for businesses that will tell you everything is going to be fine, in return for a subscription fee. That fee will likely be even less than the tax you currently pay to the government to tell you the same thing.
Good writeup.
I've been Libertarian-adjacent for decades. Have voted for Libertarian candidates, am a past Reason subscriber, etc. "Abolish the FDA" though is always a good reminder that I would not want to live in, and would do whatever it took to avoid raising children in (!), a society run by real-life Libertarians.
The usual American thinking pitfall is refusing to look elsewhere (Scott had a post about it) for alternatives. What kind of FDA-like agencies work elsewhere in the (Western) world, and work better than the FDA?
In my opinion, if people were at risk of dying from drinking a Coca-Cola, the market would react in a matter of hours to minutes, not days. I have a general thought about this problem, which is that we seem to much prefer it if people die for the right official reasons than if they die for 'morally unsanctioned' reasons. People are dying right now because of the FDA/drug laws. That seems to be agreed upon. But if a libertarian says, 'legalize and privatize all drugs and drug safety, and let God sort the rest', the costs of that somehow come off as more heinous, even if the grand utilitarian calculus should ultimately improve. It seems especially heinous, because the costs would cluster among the less-intelligent and agentic. So I can't help but read into this as another question about the goal of equality.
I feel like this whole issue maps onto sending resources to the under-performers in school instead of prioritizing the potential of the gifted. Or moreover, the redistribution of resources generally. Doctors suck. People who rely on them are and will always be behind the curve. That is in my mind the essence of the libertarian position; these institutions don't just fail to work now, they never worked and will never work by their design (being statist/moralistic).
These institutions are designed for the inept, who are now and will always be subject to higher predation anyway. No amount of educational intervention will raise these kids' IQ, and no amount of medical regulation will make people who rely upon the medical system healthier. If ancapistan comes tomorrow, the doc-in-the-box will still exist, and still prescribe largely the same stuff, and they'll still be horrible. But the inept have one thing in their favor, and that's numbers. There are millions, billions of low-agency people, and so their collective intelligence/economies of scale tend to give them at least a stably mediocre product. Yes, that will take some sorting out. But it's not my problem if some people can't handle freedom. Objectively, the costs of ineffective people falling through the cracks is ALWAYS less than the benefits of smart people having more options and using them. That's self-evident, just morally verboten to say.
Maybe I just live in the state with the worst healthcare in the nation, but everyone I know who is healthy, especially those who are aging well, avoid the doctor at all costs. Without exception, they have been better off solving any problem they can outside the state's purview. And if they do go in, it's only to tell the doc exactly what medication they want. "Give me an antibiotic for my strep throat". It's a five-minute visit to a deadweight middleman.
I could tell you a lot of stories, including my own about only being alive because I ignored doctors and followed my own, well-informed senses. But the point is, if you're inclined like I am, you already have a notion of just how much deadweight there is in the system on education, healthcare, hiring, everything because of the dead-end goal of low-IQ-proofing these systems, rebranded as 'safety'. Nothing is safe. You should already be checking all your labels, avoiding baby formula if you can, importing certain ingredients. Meanwhile there's trillions of dollars on the table and futures we can't even imagine.
Just let me buy some coke for my exams, a cocktail of anti-aging drugs on the side, and the 10k Toyota truck. I can handle the freedom, and oh well to those who can't.
> Just let me buy some coke for my exams, a cocktail of anti-aging drugs on the side
This is why the future (to the extent there is a future(tm)) is in... smart people secessionism. Leave the dimwits to the mercy of their bureaucracies, they deserve them.
I am intrigued by your ideas, and wish to subscribe to your newsletter.
But really, how would even a weak version of smart people secessionism actually work? Are you reinventing Prospera and charter cities?
I mean, obviously when we're able to effectively genemod our kids this will happen naturally (a worldwide 20% subpopulation who is literally much healthier, more intelligent, more attractive etc would obviously want to join together in a more exclusive social / legal demesne somehow), but I'm actually pessimistic about genemodding being legal / available anywhere that matters even when the technical capacity is there. I mean, we've been able to substantially genemod human embryos for 7+ years, but you literally can't get it done anywhere.
As I was towards the beginning of this piece, I was on the verge of eye-rolling because I thought that this would just be another take completely ignorant of the alternatives proposed within the libertarian sphere, but then you mentioned a voluntary certifying organization, and from there it just kept on getting better.
Q: "But if we don’t eliminate prescriptions, how do you protect prescribers from liability? Even the best medications sometimes cause catastrophic side effects."
A: I don't know whether we'd have a non-monopolized justice/courts system, but in either scenario I would imagine that legally binding waivers would become commonplace just like what are already presented at hospitals/clinics. It just might shift to having the doctor have you sign it after having discussed the pros and cons of a particular course of treatment and answering any questions that you might have — an informed consent waiver of sorts. Also I highly doubt that prescriptions would be done away with entirely because of their genuine utility to insurers. Rather, non-prescribed medications may just remain prohibitively expensive to those who don't have a prescription.
Q: "And rather than take that responsibility and get sued, your doctor will prefer to play it safe and only use medications that everyone else uses, or that were used before the FDA was abolished. You might even find it’s even harder to get a medication into common use than it was back when the FDA existed!"
A: With waivers, I'm not sure that this would be the case, but it's certainly a feasible behavior for the type of more conformist doctor that we have so many of today. As for common use, my impression is that medications with more side effects will take longer to find sufficient demand while others that are less risky will be more readily tried out by patients with their doctors' monitoring. It might sound bad given how risk-averse the current regulatory regime is, but perhaps a certain amount of the testing would be done by releasing the medication to doctors under agreement that they will order whatever labs/monitoring for patients who decide to try the new medication (and liability waivers for patients of course). Of course there will be some minimal testing beforehand to ensure that certain acute side effects rarely materialize, but beyond that this approach would have the benefit of providing more data for more use cases and also being cheaper since it could actually be sold (albeit at a lower price) during these real-world trials.
Q: "Are we also eliminating factory inspections to make sure drugs aren’t contaminated?"
A: I actually hadn't thought about that. In a regime composed of competing certifying agencies, I would hope that one of the demands upon pharmaceutical producers would be to submit to spontaneous batch testing in order to be bestowed with a seal of approval. If some agencies didn't do that, ones that did could just advertise that they do and tar those that don't for being soft on producers.
Q: "How do we deal with the fact that many doctors are dumb?"
A: This is a tough one that I think most lucid people are coming to grips with ever since COVID, though there were of course those who were ahead of the curve (e.g., AIDS). On the one hand, we hope to build institutions which are trustworthy enough that even the "dumb" doctors will not do too much harm in following guidance they receive from their institutions. However, there is likely a cyclical nature at play, where the reputation of previously reputable institutions shields it from criticism long enough that it can be corrupted or co-opted by special interests. Only when there is a critical mass of individual professionals who sound the alarm will there be either reform or collapse and rebirth/innovation. That said, I would be remiss to not place any blame with the AMA. Not only have they been controlling the number of doctors for the sake of controlling wages, but also they seem to select for and inculcate values of obedience within graduating cohorts of doctors — not to mention their enforcement of conformity by reserving the right to yank medical licenses. Just as this post was about alternatives to the FDA, I think alternatives to the AMA are sorely needed.
Q: "Again, I can imagine mechanisms that could solve a lot of these problems. They’re just the kinds of mechanisms that have never worked in real life. Why aren’t there mechanisms like this for supplements now?"
A: On the one hand, bringing up supplements is an excellent counterargument and serves well as food for thought. On the other, I don't know how old the supplement industry is in its current form, and perhaps as it attracts larger demand there will be sufficient desire for such certifying agencies. Then again, I'm not sure it would be a positive development if the average person moved further towards supplements instead of moving more towards good/healthy eating to get all their dietary needs met. Beauty products are similar in that there's an absolute wealth of options all claiming their own benefits but usually without robust evidence for/against certain effects. This makes me think that it's bound to stay as it is, with marginal improvements because of sites like LabDoor and Examine, simply because they're not as risky and so fundamentally different from pharmaceuticals. I read and shared your fish oil and melatonin posts, so thanks for that; my life is brighter now that I know about the Ambien walrus.
Q: "All of these other things are terrible and should probably be reformed anyway. But you’d have to do it all at the same time, and get it all exactly right."
A: I really don't like sounding like a naive radical, but I think that's what we need to risk. Since all of these systems have developed over time concurrently with state interventions, which inevitably have left us with a whole host of unintended consequences and perverse incentives, it's no surprise that radically rehauling one sector would have significant downstream effects for everything else. My only objection is that we don't need to get it "exactly right" because we don't really know what that even means. Markets and liberty are good means, not necessarily ends, but the results that we get will only sometimes look like what we could have imagined.
As for your suggestions, they're definitely worth trying. As long as we're moving in the direction of liberty — which is to say one where people see voluntary solutions as at least compatible with human nature and flourishing, if not an outright facilitator — then I'll be happy. Also given how fraught any of these issues is, even in the coveted world of ancapistan, I hope people will see that voluntaryism/anarcho-capitalism isn't at all utopian but rather an order permitting maximal association/dissocation, favoring low time preference, and pressuring people to align their actions with their sentiments (putting your money where your mouth is).
> Rather, non-prescribed medications may just remain prohibitively expensive to those who don't have a prescription.
They may not be covered by insurance, but that doesn't necessarily mean prohibitively expensive: many drugs (primarily old ones) are cheap even at the full price.
> Does it include MAOIs, where eating cheese after use makes your blood vessels explode?
One of the two main components in ayahuasca is an MAOI, and people eat cheese after ayahuasca sessions on the regular with nothing bad whatsoever happening, so I suspect this story needs a little qualification.
IIRC the problem was strictly in the "moldy" type of cheese (and certain other foods, e.g. aged sausage), rather than cheese per se.
Yeah, I don't doubt there are particular interactions, but I'm quite sure it's not "cheese."
Apparently it's tyramine, which is found in a wide variety of foods including aged cheeses, smoked or cured meats, pickled or fermented foods, and beer: https://en.wikipedia.org/wiki/Monoamine_oxidase_inhibitor#Hypertensive_crisis
Correct, but often in low concentrations. I'd like to see reliable statistics on actual incidence of interaction of tyramine from common foods and MAOIs, with a breakdown of which food and which MAOI.
Hard-line, probably psychotic libertarian position:
The flailing and dying that occurs during the transition period is a feature, not a bug. It means that our tax dollars will have propped up the individuals that can survive in an environment with regulated drugs but not in an unregulated environment or in the transition period. Afterwards, much less will be spent on healthcare and the survivors would be better adapted to life in modernity.
Also, most of the gains from what we call "healthcare" come from vaccines, germ theory, and antibiotics, plus the diligent work of obstetricians and to a lesser extent, pediatricians. 1950 USA wasn't some kind of hellhole full of children dying left and right to entirely preventable conditions, and life expectancy there was very similar to modern-day Mexico. And far, far higher than any of the great and powerful civilizations that existed before 1900. Yes, even for royalty. Infant and youth mortality used to be incredibly high.
> ...the survivors would be better adapted to life in modernity
This is precisely the doctrine that was pushed (successfully; by US puppets) in 1990s Russia, under the nickname "Shock Therapy". Perhaps it would be only historical fair play for Americans to experience its "joys" first-hand.
> So what does the FDA gain from carving out natural products?
It's worth noting that this is not at all something that the FDA did voluntarily. Quite the contrary, DSHEA was passed in 1994 over strong FDA objection. If it were up to the FDA, there would be no separate category of "supplements." They would all be regulated exactly as are drugs.
https://en.wikipedia.org/wiki/Dietary_Supplement_Health_and_Education_Act_of_1994
At a high level, we can decompose the FDA's function into two components: coordination and application of the precautionary principle. It sounds like Scott fundamental does not object to the coordination component, only to the application of the precautionary principle. So a practical proposal would be one that retains coordination while relaxing the filtering criteria into something weaker than the precautionary principle.
Every day on the internet, I see a reasonable author writing a logical, thorough response attacking a completely bonkers idea that I had literally never heard of before. There was a time when I would have assumed that the otherwise reasonable author was just fighting straw men. But almost every time that I've looked up the bonkers position, I've found that there were, in fact, real people supporting it.
Which brings me to my favorite centrist complaint: "the Republicans and Democrats never agree on anything." It turns out, they agree about tons of stuff! They agree that 99.9% of the madcap stuff flying into the Overton Window like so many sun-blinded birds should get swatted down. That might seem trivial. Yet, as Scott's opener suggests, if we don't swat down the madcap stuff and it makes it in to normal politics, the effects on ordinary people could be awful.
How do you draw the line at what ideas are so stupid as to be not worth considering? I actually disagree pretty strongly that Republican and Democrats agreeing on an issue means that they are correct. Republicans and Democrats agree on quite a few policies that I think are terrible.
Perhaps the clearest example is the Foreign Dredge act of 1906, which forbids any dredging in the US except by boats which are built, flagged and crewed by Americans. This law is pretty blatantly just rent seeking by American dredging companies for the purposes of keeping the price of dredging high. American dredging costs are 10-20 times higher than the Netherlands per unit volume. If the law were to be repealed, the price of dredging would decrease substantially and many more dredging projects would happen that are currently not feasible due to cost.
Just to clarify, I did not say that Republicans and Democrats agreeing on an issue means that they are correct. Republican and Democrat unity keeps out lots of bad ideas, but also keeps out lots of good ideas. It does seem to be most pernicious on issues where a law creates a clear rentseeker class like American dredging companies, and where the people paying off the rentseekers are too diffuse to rally.
So to answer your question, bipartisan unity is just one small sanity-check when assessing whether an idea is stupid. What I usually do is hunt for the part of the proposal where they wave away the downsides rather than address them. As Scott nicely demonstrated, Abolish-The-FDA features a lot of waving-away of problems, some of which are even bigger problems than the problems that the FDA itself is causing.
If you think abolishing certain kinds of regulatory powers (like the FDA) is a completely bonkers idea, I would recommend keeping a more open mind. There are several very good reasons that should make you think why it might not be bonkers, just in this thread.
There are plenty of regulatory powers worth trimming. I get skeptical when entire agencies are being destroyed, because every agency has a chunk of the economy that has arranged its business around that agency continuing to exist. Yes, that is unsavory, but it's the reality we're stuck with. A plan that abolishes an entire agency needs to deal with that reality.
I think the difference is concept vs. execution. Abolish the FDA is a concept that is not necessarily bonkers. If you think of it as a plan, then yes it might be. The plan should have detail and steps, including what and how the ecosystem is going to adjust. But that only comes if as an objective we can find agreement on the nature and level of regulation.
My ideal solution would be to treat medicine like any other consumer good and provide federal support for the development of Consumer Reports-like outfits for medical products. ConsumerLab is an indispensable example of the needed type of testing watchdog on the current supplement market. Federal matching funds could be distributed to competing testing companies based on the number of paid subscribers the company is able to attract. With adequate matching funds, testing companies would have enough resources to independently conduct clinical trials.
The FDA doesn't do product testing. If the current model were applied to, say, refrigerators we'd have a situation where Whirlpool would be required to test the safety and effectiveness of its own refrigerators. Then, if a secretive FDA star chamber decides they're not absolutely convinced by Whirlpool's self-testing data everybody is forbidden to buy the refrigerator. Even if the FDA approves the refrigerator your doctor might still tell you no because she thinks you'll be better off without a refrigerator. I don't think anybody would put up with a refrigerator marketplace that starts with corporate self-dealing and then proceeds through two layers of unchecked veto authority. I'm mystified by the fact that people blithely put up with it for medicines.
Here's a little story to illustrate the problem. I'm a big fan of the FDA-approved Lucira molecular Covid test. In my experience, Lucira is way more sensitive than the rapid antigen tests the government doles out for free. It's important to detect Covid infections early:
https://cbuck.substack.com/p/product-review-lucira-covid-test
There's a new molecular test on the market called Metrix, but the fact that it's FDA approved doesn't really tell me whether the new test is more or less sensitive than the familiar Lucira. I know a ton of people who currently have Covid so we were able to do some DIY community testing. Our casual results suggest Lucira is *much* more sensitive than Metrix. Consumer Reports for medical products would have been an overwhelmingly better approach to this type of problem.
I think it would be best to begin by removing those FDA powers which (A) were never authorized by Congress, but simply claimed by the FDA because no one will stop them, (B) are not critical to protecting people from harm, or (C) hold new drugs up to a standard that nothing else we eat is held up to.
In the 'A' category we have medical tests. About 270,000 Americans die every year of sepsis, and most of these deaths might be prevented by using DNA-based tests which would almost instantly identify every species of pathogen in a sample. I've spoken to several companies who manufacture such tests, and none of them plan to ever sell them in the US, because of the FDA. But these tests are both known to be extremely accurate--far more accurate than the current immunological tests--and are completely harmless. There is no way that putting your blood or tissue on a microarray can hurt you. There is no need for the FDA to be involved. And there is no Congressional mandate, either; the FDA's claim to be allowed to regulate these things is based on very old legislation which speaks of "medical devices", by which they meant things like X-ray machines and pacemakers.
In the 'B' category we have the FDA requirement to prove not just safety, but efficacy. I think we should settle for safety. You might think that a study of safety could just as well prove efficacy, but the problems are that (A) most medical studies are terrible, and (B) a lot of drugs work well for some people but not for others, so when you pick the Z-value you need to pass a t-test at 95% confidence for the entire population, you're screwed.
In the 'C' category we have for instance artificial sweeteners which kill some people, but a whole lot fewer than sugar does. A lot of things we consume regularly--sugar, butter, caffeine, alcohol, Big Macs--are far more-lethal than the FDA would allow. I argue we also here have phentermine, which is very effective at helping people lose fat, and non-addictive (as every study so far has shown, despite what Wikipedia and your doctor will tell you). Current policy is to only allow people phentermine as long as they're obese. As soon as they get down to just plain-old "fat", they're cut off until they get obese again. I don't know if the FDA is responsible for that policy. There's a similar policy governing the use of Ceftriaxone for Lyme disease: as soon as you start to get better, they cut you off, guaranteeing that you're just building up the resistance of your Lyme.
I think I can boil this down to a single sentence:
"The FDA does a bunch of things it would be catastrophic not to have done; replacing it with a functionally near-identical body (possibly with a different institutional character) might conceivably work, but just getting rid of it is a fundamentally unserious suggestion".
And even "replace it with an equivalent body" seems like a pretty terrible idea - you'd lose an awful lot of valuable institutional expertise.
"Keep requiring prescriptions from MDs for everything that might be the least bit dangerous" and "let everyone buy anything they want at the corner store with zero gatekeeping" are not the only options. You could for example make it legal for consenting adults to buy now-prescription-required drugs from a licensed pharmacist, who is required to explain the dangers and/or possible ineffectiveness to them before they buy it, but who cannot actually make a discretionary refusal to sell it. I think I would support having a policy like this for almost everything and reserving MD prescription requirements for things that have serious and unusual externalities, like antibiotics.
"Require a huge study to be completed and painstakingly approved before you can sell it to anyone" and "let anyone sell it with no study at all" is a similarly false dichotomy. You could for example make it legal to start selling after Phase I/II trials, with the proviso that the Phase III trial has to be completed on time and to FDA standards of soundness/non-manipulated-ness in order to keep selling. If the Phase III doesn't meet its endpoints, you can still sell it but with a big red warning label; but if you don't finish the Phase III process in good faith in a timely manner, *then* it's banned outright. This would retain a strong incentive to generate the information the public needs to make good decisions, while avoiding delays for people who want to try the new experimental thing asap.
Why not allow the same substance to be sold both as a supplement and as a drug? Effectively that would mean you can buy any substance without prescription as a supplement, but perhaps doctors would continue to only recommend, and insurance to only cover, approved drugs.
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Re: fish oil and Alzheimer drugs: Aren't these precisely examples that work poorly in the current, non-libertarian American system?
I expect that, on a free market, most people would only have catastrophic health insurance. If people pay for most of their healthcare out of pocket, and their doctor recommends a $300 fish oil capsule, they will ask if there is a cheaper alternative.
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I read drug leaflets, and I don't think they are useless. In Europe they include order of magnitude estimates of the prevalence of side-effects.
Once people get used to Dad^Wthe state no longer watching out for their safety, once there are stories of people dying from taking drugs irresponsibly, they'll read warning labels. It's just that in a non-libertarian society, the government usually steps in faster than people would learn from other people's mistakes. That means somewhat fewer people initially dying from the risk in question, but a lot of harm (in lives, money, convenience and freedom) from excess safetyism.
i know you consider yourself a libertarian, but the first section of this post is as excellent argument for why libertarianism is wrong as i've ever read. going through all the market failures--stemming from asymmetric information, missing markets, limited attention, externalities--that would come roaring out of the "pandora's box" that FDA regulation has them trapped in is a great demonstration of the value of regulation. if the FDA didn't exist, we would have to invent it.
in the second section you suggest the problem is one of path dependence. that in a new equilibria without the FDA, doctors would have to "think for themselves" and critically evaluate the safety of drugs. you seem to suggest that this equilibria is preferable to our current one, but the transition path would be too painful, so we will never cross it. but the "doctors and patients think for themselves" equilibria seems kind of inefficient, right? even if all unthinking doctors get competed out of existence (which seems unlikely--just about all existing markets have both good and bad sellers coexisting in equilibrium), the remaining smart doctors would have to allocate a substantial amount of time and resources to thinking, which all else equal would reduce the number of patients they can treat. reducing the inefficient duplication would require re-inventing the FDA (in part).
'going through all the market failures'. This is not the only relevant thing to think about! Have you gone through all the 'government failures' - and weighed the harms and inefficiencies against those of market failures?
luckily we don’t have to choose between extremes of “no regulation” vs “maximum/current regulation.” scott’s post is convincing to me that non-zero level of regulation is desirable, and a full repeal would be very bad.
That's surprising because as with many other people in the comments thread, it's surprising that Scott's post is convincing even to himself, given that all the points he raises about the 'dangers' of unregulated drugs are very strongly moderated by the example he gives later of the unregulated supplement market
i didn't read the comments, but i personally wouldn't be very confident extrapolating from natural supplements. a salient difference is that they're neither effective nor harmful--for the most part they have no discernible effect. many of the scenarios scott describes (people suing doctors for prescribing something that killed/hurt them) don't really apply in that case.
As I've noted elsewhere, unless your contention is that harmful supplements are physically impossible to create, the fact that they're not harmful is not a given - it's an emergent property of an unregulated market.
we want a system that makes drugs that are effective. harmful is ok as long as when it's consumed in the right quantity and under appropriate circumstances and the benefit outweighs cost. a market for supplements that are ineffective yet harmless is not the gotcha you think it is; the market seemingly has no incentive to develop supplements that are effective. it's good that the drugs that scott describes that make you bleed internally if consumed in the wrong quantity etc exist.
This seems like a strong point to make about the supplement market where ineffectiveness and the attendant safety profile are a feature.
Thank you for reminding me that there is a strain of libertarianism that conceives of freedom solely in terms of government regulation and not the broader set of human institutions that shape or constrain us, and therefore views the abolition of Jim Crow as a net negative for liberty. This would otherwise seem like a bizarre strawman that I hallucinated.
So the idea is that libertarians only win if the win is something that they, and only they, care about? I don't see how that makes any sense, and I think it is a hard proposition to defend. What is special about FDA reform that distinguishes it from occupational licensing reform, housing reform, prison reform, or zoning reform? These aren't things that happened the better part of a century ago. They are happening now.
Also, I fully understand, as I said, that (most not all) libertarians generally don't think or care about things like Jim Crow. But this wasn't just "some things" being worse 70 years ago. It was a major, major upheaval of American society that resulted in major, major advances in liberty.
But sure, if you ignore all the advances in liberty, libertarians always lose, I guess.
As I recall, one of the things the FDA does is define and enforce truth-in-labeling laws. Your product label has to say what's in it, and the label has to be correct. Before the Pure Food & Drug Act of 1906 there were a lot of shams and fraud that outright lied about the contents of the product. So, that's another thing that would have to be addressed by any plan to fully abolish.
The laws against e.g. selling aspirin laced with fentanyl are not the ones anyone, AFAIK, is proposing to abolish. Nor is FDA the only ministry that enforces such laws in the US.
I think a good small-c conservative solution could be to turn back the clock to some tried-and-true solution rather than diving head first into terra incognita.
What about the pre-1962 FDA? The approval process is perfunctory, but disastrously bad drugs were recalled ex-post anyway. And the power to shut down contaminated plants was already there. Basically a very specialized police force rather than a regulatory agency (you can go before 1938 if you want to do away with the approval process anyway, but courts will keep discussing liability of course).
Or, if we insist to abolish the FDA altogether, let be noted that the pre-1906 US was not Galt's Gulch: while the Federal Government did not regulate pharma, the states surely did. Harmful chemicals could be, and were, forced to be sold with a label reading "Poison" or outright banned. This would ameliorate the effects of regulatory capture (it would be discussed democratically rather than among bureaucrats), leave some opening for people who really really want a drug (I trust NH or some other state to scarcely use such powers), while creating some safety for the average patient.
Of course, we are not limited to domestic examples: pretty much any polity in the world regulated pharma one way or another, there must be many example of models more successful than the FDA. The possibilities are nearly endless!
If it's legal to buy rat poison, it should be legal to buy warfarin.
Maybe we could have a 1 to 5 scale, from totally safe to totally poisonous.
The (US; but this is quite universal) legal system is not (and does not aim to be) logically consistent from a "mathematical" POV. "Justice is incidental to law and order" (J. E. Hoover). See also the famous "What colour are your bits?" essay: https://ansuz.sooke.bc.ca/entry/23
For a concrete example: the poppy plant is legal to grow in your garden in most of USA, while refined and properly dosed opiates are regulated to the point where not all chronic pain sufferers can reliably buy them on the open market.
To take another: the psychedelic DMT is prohibited in USA. Even though it is purportedly found, at all times, in small quantities, in a healthy human brain.
Believers in the logical consistency of law sometimes have interesting misadventures in USA. There exists an entire subculture of "sovereign citizens" -- mentally-touched people who search for what they believe to be logical inconsistencies in the US legal system, and believe that they can make use of them to get out of paying tax, debts, legal judgements, etc. Often, their arguments look superficially correct to the uninitiated. What they don't realize is that "Western democracy" and "rule of law" are simply a fiction used by the powerful to dress up their master-slave relation to the plebes in flowery jargon, strictly to make for cheaper and more effective plebe management. When the "logicians" end up in court, the judges sometimes "let the mask slip" and helpfully remind them of this fact. Such cases very often make for interesting reading.
>What they don't realize is that "Western democracy" and "rule of law" are simply a fiction used by the powerful to dress up their master-slave relation to the plebes in flowery jargon, strictly to make for cheaper and more effective plebe management.
I disagree. Democracy and rule of law are a pseudoformalized agreement. Pseudoformalized in the sense that formal rules are written, and if those rules turn out to have weird edge cases, people go with common sense over the letter of the rules. But none the less, they are rules. And one of their functions is some partial protection against abuse of power. And also some protection against thieves. Which indeed makes people less likely to revolt.
Scott, your questions invite thoughtful contemplation, as do the comments it's received.
It is interesting that underground drug markets like we see within bodybuilding, which exists largely outside the FDA's purview, offers a glimpse into a potential scenario where the FDA is absent.
The underground bodybuilding community operates on a market-driven basis, heavily reliant on reputation. Trust and product efficacy, rather than government regulation, guides consumer choice.
This model isn't flawless, and perhaps those interested in bodybuilding may do a tad more research (though not nearly enough) than an average Joe looking to correct his blood pressure, but it's a representation, albeit an extreme representation of a government-less drug market.
I'm not going to pretend to be naive to the issues such underground markets create, or the damage that has been done as a result of it. But there are lessons learned (in some cases intentionally, by human test subjects trying to inform their peers) from the bodybuilding community which would never get approval in a moral system.
It's a world I both love and hate. I'm glad it exists, to educate others (including medical professionals), but would hate to see such risks adopted by my grandmother.
You can make similar arguments for regulation in any economic sector. For example, suppose software was as heavily regulated as prescription drugs; where any new program would be vetted by an FDA-like agency before its public release. If someone called for deregulation, people would object in a very similar manner: bad actors would publish malware, they'll infect our computers, steal our money, and all kinds of horrors will ensue. They would predict that the entire technological civilization would come crashing down without federal bureaucrats carefully approving each program through rigorous testing.
Since in our world software is deregulated we can understand the folly of this argument. Malware and hacking definitely exist but their negative effects are overwhelmed by the enormous benefits provided by deregulated software. That's why a cost-benefit analysis is necessary concerning any proposal of regulation or deregulation. You don't attempt to do that at all. You list some benefits that FDA provides but you should have also considered the costs that it imposes. FDA's existence can only be justified if the benefits exceed the costs. I don't believe it does; the opportunity costs of delayed or nonexistent drugs vastly outweigh whatever benefits FDA provides.
You also make up imaginary scenarios where BadCorps rule the market absent enlightened bureaucrats. This assumes that every other market participant is a fool. Consumers care about quality too. In a free market, competition will ensure that BadCorps will go out of business. However, there will be tradeoffs between quality and price. IMO that would be an improvement over the status quo.
It's easy to imagine scary scenarios in the absence of regulation. However, such scary scenarios are often less likely than they seem and market competition works to remove them.
Proposals of deregulation are always greeted with predictions of disaster. People predicted disaster when airlines and railroads were deregulated by Carter, or when telecommunications were deregulated by Clinton. The results instead were a wealth of innovation that led to huge efficiency gains and falling prices. I'm sure that deregulating medicine will have the same effect.
The cause of the opioid epidemic was the patent and not the drug that has been around for thousands of years that everyone knew was addictive. So the reason Oxy was pushed by the Pharmaceutical Industrial Complex was because of the huge profits…take away the profits and then the PIC loses interest in pushing the drug.
"“Natural” doesn’t mean “safe” - nature includes venomous snakes, poisonous mushrooms, and produces some of the most dangerous drugs in the world (eg opium, cocaine, digoxin, certain chemotherapy agents)."
I would have to assume that supplement companies are still subject to legal liability, and stand to get sued if they kill or sicken too many people (also, good chance your supplement gets reclassified as a toxin, which might be a challenge for the marketing department).
Would this system continue to work if the FDA were abolished? The prospect of an overloaded court system trying to regulate drug safety gives me pause.
"Natural" does skew towards "has been around long enough for people to understand what it generally does". "Natural" plus "We don't have a gigabuck drug-discovery budget", mostly means stuff that the supplement-peddlers have been cued to look at because some culture's ancient tribal wisdom says its a medicinal herb. And the witch doctors, wise old ladies, etc, were generally smart enough to stop advising their patients to eat the outright poisonous stuff and to advertise the seriously mind-altering stuff as being seriously mind-altering if you're into that sort of thing.
So far, this inherent filtering (plus fear of liability) has worked pretty well to keep the natural-supplement industry reasonably safe, even if it is often nothing more than a safe way to produce expensive urine. If we start allowing synthetic compounds, that might not hold and we'd need to find another path to the same level of safety.
Reminds me of how we regulate pet food.
I expect this has already been said to death in the comments, but a practical abolition plan would just make the FDA voluntary, and whoever seeks to have an FDA-approved drug could choose to pursue the exact same process as today.
On day one, no changes due to liability fears. On day 10000 maybe people juts stop paying attention, who knows.
People always complain about comparing an idealized version of the new system to known realistic failures of the old system. But the actually existing system keeps getting worse and people refuse to acknowledge how bad it is. I have about a 10% rate of having my prescriptions refused. We just don't have a system any more.
Is that what they’re teaching in H.S. Chemistry these days? If it’s just one letter away from something familiar, you don’t have to worry about it? So, no need to worry about cyanide (CN) or hydrogen peroxide (H2O2 and at full strength, it will eat your face).
If we had no FDA, wouldn't the covid vaccine have been available 6 months earlier, I have heard, maybe longer. That would have saved a lot of lives, and shortened the lockdown period, maybe kept covid from becoming a pandemic. If that is correct, wouldn't that alone tell us that the FDA had caused more harm than good over the time it existed?
For the experimental drug category, we would possibly have a situation where a medicine would be cheaper as an experimental drug (I assume demand for them at this stage would be lower), but their price increases, possibly by orders of magnitude, at the point where they are FDA approved. This feels like it could lead to all sorts of weird things. A concrete example is the uninsured patient (or a patient in a developing country, where medical insurance could function differently or be non-existent). Here, a drug they had access to suddenly becomes out of reach. This feels like an edge case, but it seems plausible there are other more significant impacts from a drug suddenly shooting up in price, especially in a healthcare system as convoluted as the states'.
Could you force drug companies to fix the price upon FDA approval? Perhaps, but this introduces another layer of regulation. It could be fixed at the final post-FDA price, in which case few patients would be able to benefit from it as it is uninsured. Alternatively, you could fix it at the pre-FDA price, in which case the pharma company could never make the money back from the expensive FDA approval.
I propose one simple reform: “The FDA shall not prevent market access for any claim." This keeps the FDA in it's current form, but removes it's 'monopoly on violence' by taking away it's monopoly power to prevent a drug or device from reaching the market for any reason. This will open the market to other standards like the EU's CE Mark and to new competitive nongovernmental standards. Hospital purchasing departments and Payers will likely still want to see FDA approval for high risk, highly invasive drugs/devices, but may find FDA approval excessive for low risk interventions and look to less burdensome standards for approving those. This one reform will create a competitive landscape for new standards and this will bring more innovation to the marketplace most efficaciously.
Defang the beast and you starve the beast. Time to defang the FDA and make it compete in an open marketplace of standards.
The late, great Steven B Harris proposed simply rolling back the FDA to the powers it had in the early 1960s, before thalidomide. That is, get rid of mandated efficacy studies and keep everything else. Under the old system, the FDA was in charge of ensuring a drug was safe rather than safe *and* effective. Efficacy was a matter for the medical community to decide organically.
When you change the rules, you change the game. It seems that Scott is making a mistake of assuming that when you change the rules, the equilibrium remains the same.
To give an example of this mistake that nobody would make, imagine a city with 2 routes into downtown, with traffic split 50/50 between the routes. One day, the city decides it needs to shut down route A, and leave route B open.
Nobody would assume that the folks who typically take route A would just give up and go home, leading to a 50% reduction in downtown workers that day. Instead, the equilibrium would shift - many of those formerly route A drivers would now take route B (and some would indeed stay home, as the marginal cost of going to work is too high).
Regarding this post - one mistake I see relates to people's habits reading pill bottles. Yes, few people read them today, for two main reasons:
1. Information density - very little of the information is value add; most of it is boiler plate.
2. Incentives - with the FDA, doctors, and pharmacies all warning you of any dangers of your meds, people feel no need to do it for themselves.
When my daughter crosses the street, she looks both ways before crossing. But, when she's with me, she doesn't.
If we were to abolish the FDA and prescription requirements, I can't promise it would be amazing. But at a minimum, I'm pretty sure people would read and understand the nature of the medications they were going to take before taking them.