Withholding Good Medication is Worse Than Approving Bad Medication
On why we should reject a cost-benefit analysis to the Food and Drug Administration (FDA)
In the United States, it is the responsibility of the Food and Drug Administration (FDA) to determine when a drug should be made available to the public with prescription. In order to get FDA approval, a drug must first demonstrate safety and efficacy.
If we wanted to maximize human welfare, we would want an FDA that approves a drug if and only if approval of that drug would result in more good than harm. It is likely the case that the structure of the bureaucracy and the incentives in place lead to an FDA which is often overly precautious. Scott Alexander of Astral Codex Ten discusses an example of over-precaution in an article entitled Adumbrations of Aducanumabhe:
A bunch of laboratories, universities, and health care groups came up with COVID tests before the virus was even in the US, and were 100% ready to deploy them. But when the US declared that the coronavirus was a “public health emergency”, the FDA announced that the emergency was so grave that they were banning all coronavirus testing, so that nobody could take advantage of the emergency to peddle shoddy tests. Perhaps you might feel like this is exactly the opposite of what you should do during an emergency? This is a sure sign that you will never work for the FDA.
Even worse than the testing ban was delaying vaccine approval. Alexander published this on August 4th, 2021. The first approval was on August 23rd, 2021.
Although the FDA did kill thousands of people by unnecessarily delaying COVID tests, at least it also killed thousands of people by unnecessarily delaying COVID vaccines. I’ll let you click on links for the details (1, 2, 3, 4, etc, etc, etc) except to remind you that they still have not officially granted full approval to a single COVID vaccine, and the only reason we can get these at all is through provisional approvals that they wouldn’t have granted without so much political pressure.
A person who believes that government should maximize welfare would not want an overly precautious FDA. However, an FDA which faces asymmetric criticism when approvals go wrong might. At the bare minimum, you would want the FDA to perform a cost-benefit analysis. For simplicities sake, imagine the FDA can only consider deaths. You would, at minimum, want an FDA weighing deaths from prohibition and deaths from approval, only to approve in cases when deaths from prohibition exceed deaths from approval. Utilitarians are sympathetic to this approach.
However, I do not think the role of government should involve preventing people from having access to medicine if it could be potentially be life saving. We should consider things beyond mere cost-benefit analysis. I don't think morality is limited to consequences and utility calculation. I am an ethical intuitionist.
I contend that there is a moral asymmetry between acts of omission and acts of commission. Imagine someone has enough money that they could prevent a child from starving to death in a far off country, but they decide that they do not want to donate the money and the child dies as a result. I do not think this is as bad as getting paid money for killing a child in a far off country. They are not equivalent even if both end up with the same consequence of a dead child and money in hand.
Now, imagine a nice guy named Peter who helps his elderly neighbor Betty to make sure she gets her medication when she needed it and doesn't overdose. If Peter ceased helping Betty with her medication, that would be bad. However, it would be worse if Peter were to steal his neighbors medication and withhold it form her. It would be worse even if the probability of her coming into harms way on account of either the lack of medication or inability to properly take her medication was exactly the same.
Similarly, I think it is really bad when the FDA prevents access to potentially life saving medication. It is worse than letting people take a risk and come into harms way. I think that we should legalize drugs and allow people to make their own decisions on the matter. We could leave the FDA in place to provide warnings but still allow people access to the drugs. I believe someone harming themselves is not as bad as someone being harmed by preventing access to medication, and I do not believe that we should treat them as equally morally bad even if they result in nearly identical consequences.
Even for the hypothetical strict utilitarian, the *cost* of the FDA's intervention itself needs to be incorporated in the calculation. FDA investigation and decision making are not free (they are very, very expensive), and have effects on innovation and investment.
FDA delenda est.