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Beyond “Abolish the FDA”

“Abolish the FDA” has become a popular slogan in libertarian circles. I’m sympathetic to the spirit of the demand. But a slogan isn’t a plan, and this one is even less of a plan than usual.

I used to think that since libertarians always lose, there was no point in having a real plan for what to do if they won. But now that they’ve gone from “literally always lose” to “only lose 99.9% of the time” . . .

. . . it’s probably worth having a plan ready just in case.

Here are some issues any would-be-FDA abolisher would have to address:

Are we also eliminating the concept of prescription medication?

There are two different legal barriers to getting a prescription medication in the US. First, the medication must be approved by the FDA. 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?

If we eliminate prescriptions, then how do you get Adderall and painkillers? Remember, the FDA doesn’t fight the War on Drugs – that’s the DEA, a different agency. Many recreational drugs (including dangerous ones like methamphetamine, cocaine, and fentanyl) have accepted medical uses. Right now, you’re allowed to use those drugs with a prescription, but not otherwise. If there’s no prescription system, can everyone buy these drugs at the corner store? Can nobody buy them?

(on a federal level, marijuana and LSD officially have no medical uses, and are not available even with a prescription. The most embarrassing way this could end would be the legalization of all drugs except marijuana and LSD.)

And if we eliminate prescriptions, are all medications freely available at the corner store? Does this include warfarin, where getting the dose slightly wrong makes you bleed to death? Does it include MAOIs, where eating cheese after use makes your blood vessels explode? Obviously you put these things on the label, but is it in bigger or smaller print than “this blood-vessel-exploding medication contains chemicals known to the state of California to cause cancer”? Don’t all reasonable people ignore labels because they’re useless? And who decides what side effects are so bad you need to put them on the label? (right now it’s the FDA)

But if we don’t eliminate prescriptions, how do you protect prescribers from liability? Even the best medications sometimes cause catastrophic side effects. 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!

Are we also eliminating factory inspections to make sure drugs aren’t contaminated?

Right now the FDA does this too. Should somebody else do that after the FDA is abolished? The FDA sure seems to close down factories for being contaminated pretty often, so it’s not obvious that the free market has this one under control.

How do we deal with the fact that many doctors are dumb?

Suppose GoodCorp puts a lot of effort into making (let’s say) a revolutionary new Alzheimers drug that really works. They conduct a great study, and get it certified by whatever voluntary certifying organization replaces the FDA. Their drug costs $10,000.

BadCorp takes whatever was in their fridge, blends it together, calls it “a revolutionary new Alzheimers drug”, conducts a bad study which they manipulate, and does a great advertising blitz. Their drug costs $50. Which one does your doctor prescribe you?

I don’t know: which company has more attractive sales reps distributing pens? Which pens are nicer and shinier?

How will the smart doctors get the data they need?

Maybe your doctor isn’t dumb. Maybe they could look over the studies themselves just as well as the FDA can. That doesn’t help, because without the FDA, the studies won’t be done.

Or rather, there will be studies, but they’ll be much smaller. And the pharma companies will figure out ways to manipulate them. The only reason we have big, less-than-completely-manipulated studies is that the FDA demands it, and employs lots of experts to figure out which studies have been manipulated or not.

Like you, I can think of many clever institutions that could overcome these problems. You could imagine competing voluntary certification agency which all employ experts just as qualified as the FDA’s experts are now; doctors would decide which ones to trust and only prescribe medications certified by a credible agency.

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.

And even if such organizations existed, unless they had FDA-like levels of power and monopoly rule, they wouldn’t be able to force pharma companies to give them all their data, or to demand big ironclad studies in the first place.

Also, I can’t stress enough how many doctors would never look into any of the certifying agencies, and just go off of the free pens.

What would insurance cover?

Right now (to vastly oversimplify) insurances have to cover all FDA-approved medications if patients can prove they really need them (insurances are allowed to make the proving process inconvenient, which is how they gate access in practice). Insurances don’t have to cover any non-FDA-approved treatments, and often don’t.

Without an FDA, we would have to completely reform the health insurance system. If you’re a libertarian, maybe you already want to do this. You can imagine a world where health insurance was a real insurance – each company chooses what drugs to cover and what price to charge, and consumers choose whichever one makes the best offer. Maybe there’s some trusted NGO that sets a general formulary of safe and effective medications, and your insurance promises to follow that formulary.

…or maybe your insurance covers BadCorp’s $50 Alzheimers drug and not GoodCorp’s $10,000 Alzheimer’s drug, and you buy that policy anyway, because nobody looks into the details of Alzheimers drug coverage when they’re buying an insurance policy unless they have Alzheimers (and if they do, it’s too late). And even if they did look, BadCorp would have a smokescreen of well-done fake studies such that it was hard to tell they were worse than GoodCorp.

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?

(before answering, read my posts on fish oil and melatonin)

Conclusion: What would a practical abolish-the-FDA-lite policy proposal look like?

Full abolition of the FDA would have domino effects on every other part of healthcare. You would have to reform the insurance system, the War on Drugs, the medical evidence system, the malpractice system, and the entire role of doctors. 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.

And even if there’s some design that we should have gone with from the start, the transition will be terrible. The anarcho-primitivists say mankind should never have left the jungle. Whether or not they’re right, if you throw the average 2023 American into the jungle, they will die within days. In the same way, maybe we never should have created the current health system. 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.

What policy proposal closest to abolish-the-FDA would I feel comfortable supporting in the real world?

1: Legalize artificial supplements. There’s already a parallel universe where the FDA has (almost) been abolished. This is the world of supplements. Companies are allowed to design and sell supplements after only quick and minimal safety testing (and no efficacy testing).

In some ways, this world looks like abolish-the-FDA libertarians would expect. Supplements are very cheap, easy to get, and full of innovation, with thousands of different chemicals and (usually) many competing producers for each. There’s also shockingly safe – 50 – 70% of Americans take supplements regularly, and there are only a tiny handful of negative outcomes nationwide (though, like terrorist attacks and other low-frequency events, the media over-reports them in a way that keeps most people afraid). Even those tiny handful of bad outcomes mostly involve a few well-known chemicals like caffeine and other stimulants. Otherwise, the situation seems surprisingly good and stable.

On the other hand, there’s little agreement on which supplements work, or whether any of them work at all. Most doctors ignore the whole field rather than try to sort through the competing claims, and studies are few, dubious, and often contradictory.

So why isn’t that mission-accomplished? Supplement companies (extreme oversimplification) are only allowed to sell natural products. If you can derive it from a plant, you’re good. Otherwise it’s illegal and has to get FDA approval.

How much work does the natural product rule do? “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). So what does the FDA gain from carving out natural products? I think it’s a combination of two things. First, usually if something’s being considered for a supplement, it’s because someone (maybe a traditional culture) has used it as a medication for generations, and this means it’s pre-tested. Second, this constrains drug developers’ ability to optimize and slows them down so much they can’t do too much damage. But these are pretty weak justifications, and there are exceptions to both.

So why not scrap that rule and allow synthetic chemicals to be sold as supplements? This would fulfill abolish-the-FDA-ers goal in making it legal for someone with an innovative medical treatment to sell that treatment. But it wouldn’t add any extra confusion for doctors or insurance companies (who are already confused by supplements and mostly ignore the whole space). It wouldn’t prevent a pharma company with a new blockbuster drug from going the usual FDA route and getting all the usual studies. And it would piggyback on the existing supplement system, which seems to have good norms for keeping things safe and balancing patients’ desire for choice with their need for information.

The main potential problem is that a company might release a great new drug as a supplement instead of seeking FDA approval, and then doctors might stay lazy and never think about it or prescribe it. In a perfect world, the company could use the revenue it makes from supplement sales to sponsor the FDA approval process. But in practice, if it switches from a supplement to a drug, that makes life worse for patients (they’ll need a prescription and lots of money for something they used to get cheaply and conveniently) and those patients would probably resist. So supplement status might end up as a ghetto that drugs stay in forever. There are ways around this – traditionally the pharma company creates a new drug that’s almost exactly the same, pretends it’s better in some way, and everyone else goes along with the ruse (1, 2, 3). But this is already embarrassing, and basing even more of the medical system on it would be more embarrassing still.

2: An “experimental drug” category: The FDA creates some alternative pathway where they test for safety (maybe more stringently than supplements are currently tested), but don’t test for efficacy. Any substance that passes this pathway can get approved as an “experimental drug”. This isn’t real FDA approval. Insurances aren’t forced to cover it. It says “EXPERIMENTAL” on the box in big red letters, and doctors won’t be tempted to conflate it with all the other fully-approved drugs. But they can prescribe it if they want. It’s not illegal.

Here more than in the supplement route, companies would be encouraged to use the revenue they get from selling it to eventually apply for full FDA approval. Since it’s already (presumably) expensive and prescription-only, this wouldn’t inconvenience anyone too badly.

These two proposals won’t satisfy hard-liners. But they’re the closest things I can think of to radical abolish-the-FDA that have any chance of getting adopted in the real world.

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