What would happen if we abolished the FDA tomorrow?
When I wax lyrical about how terrible the FDA is and how we should abolish it, most people react with “but you surely can’t mean we should have no drugs regulation at all can you?”.
I usually respond with explaining some alternative schemes which might work well, but in this post I want to show that completely getting rid of the FDA (or at least the DA part of it) will actually have relatively little impact on drug safety.
The scenario
From some set date (e.g January 1st 2023) the following laws will go into effect:
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By default any drugs become legal for sale without any restrictions.
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For the sake of fighting drug abuse the government can ban or regulate specific drugs or classes of drugs, but the justification can only be due to abuse, not safety or efficacy concerns. There’ll be strict definitions for this and anyone can sue if they think the government is overreaching.
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All drug manufacturers must release all the following information whenever they market a drug: composition, all studies they’ve carried out on the drug, known side effects, known interactions, recommended indications. This will be stored in a central database and be made freely available.
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Much like food manufacturers, drug companies can be sued for poisoning people and false advertising. However, since it’s fairly common for drugs to have side effects, a drug company can only be sued if it can be proven they were negligent or malicious in some way. There will be explicitly listed examples of what non-negligent behaviour is, and the bar will be set very low. The aim of this law is to punish the most egregious violations (e.g. someone marketing bleach as a cure), not to replace the FDA. It’s perfectly acceptable for a company to say “we know it’s got some side effects, but we had enough reason to think it’s got a shot at curing flu that it was worth it for people to use anyway”. False advertising laws will ensure they don’t then claim it definitely cures the flu.
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Drug companies can optionally add restrictions on who can buy their drugs, which pharmacists are legally required to respect. Similarly pharmacists have the right to refuse to sell someone a drug.
And that’s it. Notably drug companies can basically sell anything they want with practically no restrictions.
What would happen?
Immediately
By the time the law came into effect there would be a freely available database of all preexisting FDA approved drugs. Most people would just make sure to only buy these. Doctors will continue to prescribe them.
The main change that would happen at this stage is that people could buy drugs without prescriptions. This will be less cases of buying drugs of abuse (as these are still prescription only), and more cases of self diagnosis. My guess is this will be relatively rare (as a percentage of all drugs sold), since most people tend to be pretty cautious.
For those drugs where this is both common and dangerous, (but not due to drug abuse), drug companies and pharmacies are likely to self regulate sales of these drugs to preserve their good name.
Pharmacists, nurses, etc. might also start diagnosing and prescribing drugs without a Doctor’s prescription.
Medium term
Over the medium term drug companies will continue developing new drugs.
In order to allow people to make informed decisions various websites will advise people on safety, efficacy and indications for drugs.
There will be a number of revenue models for such companies. Some might charge the drug companies to review their drug. Others might charge hospitals and healthcare institution a subscription fee. Others might focus more on the consumer and charge them a subscription or per drug free. Finally there will be advertising funded companies.
There will almost certainly also be open projects doing the same thing. Think Wikipedia, but for drugs.
These different companies will have different focuses and techniques. Some will perform meta-analyses on existing studies, others will carry out their own, and some will simply gather end-user or doctor reviews. Some will be more cautious, others more open. Some will focus on end-consumer drugs, others on hospital and specialist drugs.
With all these options it will be considered wildly irresponsible to buy a drug that is not recommended by any of these websites, but different people will tend to use different websites which fit their budget and appetite for risk.
There will also be websites which rate pharmacies. No pharmacist wants to get a reputation for killing their clients, but neither do they want a reputation for not selling anything to anyone. Pharmacists are likely to start marketing themselves as drug experts who will listen to you describe your symptoms and suggest a good drug to use.
Meanwhile the development process for drugs will change. Drugs no longer need to go through any specific formal process to be sold, but false advertising laws, drug review websites and brand reputation means the company still won’t want to release something dangerous or completely ineffective.
Instead they’ll want to work with doctors to very rapidly get their drugs out to a small number of patients who could get a high benefit/cost ratio from using the drug, and then rapidly scale to larger and larger testing groups until they feel ready to release it. Even when they release it they might initially start with only a limited set of people allowed to buy it, and expand from there.
However, drugs that they’re pretty sure are safe, such as an updated COVID vaccine for omicron, they’re likely to skip straight to the release stage.
Health insurance companies will have their own policies on which drugs they’ll pay for, and maybe even which drugs they’ll allow you to buy—they might say that your medical insurance is invalid if you take specific drugs without first getting approval.
Long term
Over the long term the rate of medical development should skyrocket.
Companies can engage in a very tight develop/test loop without having to engage with huge bureaucratic hurdles that slow everything down every time they make a change.
Drug development is no longer the sole domain of huge enterprises. Even startups can afford to bring new drugs to market, now that they don’t need to go through years of trials and huge costs before they have a chance of maybe turning a profit.
At this rate aims like curing cancer, and even curing aging, start to seem achievable.
This isn’t entirely cost-free.
There’s more ineffective drugs out there, and scam companies that make money by selling nonsense cures. On the other hand it’s not like homeopathy is unheard of today...
There’s also a reasonable number of disasters. Dangerous drugs do on occasion get developed, favorably reviewed and sold. However this is relatively rare—that kind of thing destroys the reputations of both companies and review websites so they try hard not to let it happen. Most review websites are pretty cautious about recommending things until they’ve been out in the wild for a couple of years, so most of the people affected are either initial trial patients or throw-caution-to-the-wind types. The number of negatively affected people pales in comparison to the number of people whose AIDs or cancer has been cured.
Conclusion
For most people things would remain pretty much the same as before. You’d go to a doctor, they’d prescribe something, and you’d buy it.
This story is meant to point out that free markets have their own ways of regulating things. Getting rid of government regulation doesn’t turn a market into the wild west—it just moves regulation down into the private sphere. And the advantage of private regulation is it tends to be far more adaptable. Nobody will pay for a drug recommender that waits 10 years before recommending a new drug, but we just don’t have a choice with the FDA.
If you want to actually understand what would happen in such a case, it makes sense to look at empirical reality.
When it comes to nutritional supplements we frequently see independent labs testing supplements that are sold and finding that those supplements don’t contain what the manufacturer claims. Most people neither understand that this is the case nor are willing to pay for information about supplement testing.
People are much more likely to take a supplement because an influencer recommended it than because it had a good review on ConsumerLab.
Doctor review websites also seem to be currently ill-equipped to actually say more than whether or not a doctor is friendly to his patients. Patients generally don’t consume the available data about outcomes for medical interventions by different doctors.
Similarly, CVS currently sells homeopathic ‘medicine’, marketed exactly as if it were real medicine. https://www.cvs.com/shop/content/homeopathic-remedies If you didn’t know what “homeopathic” meant, could you tell that these were fake medicines? They say things like “The ONLY clinically proven cold shortening nasal swab” on them. I think some of these might also contain real medicine at normal doses, but I frankly can’t tell for certain. So why do we expect CVS to become more benevolent when all the regulations are gone than it currently is?
https://astralcodexten.substack.com/p/how-trustworthy-are-supplements discusses supplements and concludes the issue is nowhere near as bad as claimed.
There are two main issues here:
It makes sense to update on supplement actually containing what they claim they contain
The information landscape is very bad and reading newspaper articles does not allow a normal person to understand whether or not claims about what supplements contain are true or false. Marketing from the review companies further muddies the information landscape so that a lot of people who think they know what’s going on don’t
One very interesting tale of a regulation failure was the Ranbaxy saga. The FDA already was pretty bad at the case, but it shows the kind of problems that a regulatory agency is supposed to solve.
There is one other important difference between drugs (as currently regulated) and supplements: insurance doesn’t pay for supplements. Insurance companies today frequently refuse to pay for drugs they claim are ineffective or unnecessary. While they typically rely on FDA recommendations, privately controlled pharmacy benefit managers set criteria which can differ from the FDA’s. Insurance companies have an incentive to find reasons to refuse to pay for some, but not all, drugs, and deciding based on whether the drug is actually useful is a Schelling point. Big insurers and PBMs could conceivably afford to test new drugs, if sufficiently motivated.[1] To be sure, there are numerous opportunities for companies to profit by lying, colluding, and making decisions that are less than medically sound, but the market is still far from unregulated even without the FDA.
This isn’t to say unscrupulous drugmakers won’t market useless or dangerous products directly to consumers—of course they will. Nothing stops a manufacturer from releasing completely untested drugs onto the market and then waiting for someone else to study them. Any controls would have to move farther up the food chain. A big pharmaceutical company that doesn’t want to get its hands dirty could buy the rights to a new drug once it starts to gain acceptance.
Assuming drugs cannot be evaluated by some other reputable group. In the event the FDA is abolished, I expect regulatory requirements for drug approval would persist in other countries, and any interested party could benefit from the information, so most insurance companies likely would not do their own testing.
I think there are arguments you can make a system without the FDA would still work. This particular post however additionally makes predictions about how the resulting system would look like that I find unlikely.
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Companies that sell tobacco knew that tobacco is dangerous, and did not self-regulate sale of tobacco enough to stop people from dying from it.
Homeopathy exists today because the FDA has a specific exception for homeopathy baked in, because Senator Copeland, who helped create the Food, Drug, and Cosmetics act in 1938 which gave authority to the FDA, was a homeopath and wrote the exception into the FDCA. The FDA is barely starting to remove the exception in modern times.
We also have the supplement market to judge how such a market would work. They’re not subject to FDA approval, and are subject to false advertising laws. Websites can catalog and evaluate efficacy. So do they?
No. The market is a wild west of unsubstantiated claims, impure product, and (at the margin) unrestrained fraudsters.
The market for supplements is way smaller than medicines, has low risk, and pretty much only carers to suckers since they’re mostly useless. The few that are useful are easy to discover, and commonly prescribed. As such there’s no market for high quality reviews.
If you want a preview of what this ratings-website environment will look like, Google “best cat food” and then try and figure out which advice is best.
There’s a lot more money in medicine than cat food. There’s already a plethora of really high quality sites offering medical advice, plus high quality catalogues of drugs, such as the BNF.
Chances are, there are also good cat food ones, it’s just without being an expert yourself, it probably close to impossible to pick them out of the sea of bad ones. What do you think is preventing those good medical advice ones from being drowned in the sea of terrible ones? Presumably, bigger market provides about the same extra insentives for creation of misleading advice as it does for creation of good advice?
The US nutritional supplements market is worth about $50B/yr (source: North America Dietary Supplements Market Report, 2021-2028 (grandviewresearch.com)). No website is even suggesting they perform evidence-based efficacy analyses. At what market size do you expect to see that?
Correction: originally gave global market size
You have examine.com for the general question of what substances are effective and then ConsumerLab for the lab evaluation of individual market products.
Suing somebody requires that they are still around, can be found, and have money. Nothing in your proposal would prevent unscrupulous people selling all kinds of miracle cures to desperate people. By the time somebody can get around to suing, the website is gone, the money is gone, and good luck finding whom to sue and recovering any money.