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:
By default any drugs become legal for sale without any restrictions.
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.
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.
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.
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.
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:
By default any drugs become legal for sale without any restrictions.
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.
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.
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.
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.