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.
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.
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.
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.
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.
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.
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.
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".
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.
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.
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.
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.
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...
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"
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.
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!
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.
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.
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 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.
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.
"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?
“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.
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?
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.
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
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.
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.
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?
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.
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.
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.
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.
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."
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.
"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.
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.
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.
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).
> 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.
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.
> 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.
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).
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.
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!
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.
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.
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.
"… 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
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.
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.
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
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.
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.
Why default to liability on the doctor and not the person making and selling the drug?
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.
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.
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".
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.
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.
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.
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.
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...
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.
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"
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.
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!
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.
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.
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 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.
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.
"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?
“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.
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?
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.
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
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.
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.
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?
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.
Has anything like it been tried anywhere?
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.
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.
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?
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.
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."
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.
"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.
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.
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.
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).
> 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.
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.
> 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.
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).
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.
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.
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.
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.