The Nonlinear Library LW - Contra Scott on Abolishing the FDA by Maxwell Tabarrok
Dec 15, 2023
10:23
Welcome to The Nonlinear Library, where we use Text-to-Speech software to convert the best writing from the Rationalist and EA communities into audio. This is: Contra Scott on Abolishing the FDA, published by Maxwell Tabarrok on December 15, 2023 on LessWrong.
Scott Alexander's
recent post on the FDA raises the average level of discourse on the subject. He starts from the premise that the FDA deserves destruction but cautions against rash action. No political slogan can be implemented without clarification and "Abolish the FDA" is no different, but Scott's objections aren't strong reasons to stop short of a policy implementation that still retains the spirit behind the slogan.
Scott's preferred proposal is to essentially keep the authority and structure of the FDA the same but expand the definition of supplements and experimental drugs. This way, fewer drugs are illegal but there aren't big ripple effects on the prescription and health insurance systems that we have to worry about.
The more hardline libertarian proposal is to restrict the FDA's mandatory authority to labeling and make their efficacy testing completely non-binding. This would turn the FDA into a informational consumer protection agency rather than a drug regulator. They can slap big red labels on non-FDA approved drugs and invite companies to run efficacy tests to get nice green labels instead, but they can't prevent anyone from taking a drug if they want it.
Let's go through Scott's objections to the hardline plan and see if they give good reasons to favor one over the other.
Are we also eliminating the concept of prescription medication?
I can see some "If I were king of the world" overhauls to the health system that might do away with mandatory prescriptions, but I think the point of this exercise is to see if we can abolish the FDA without changing anything else and still come out ahead, accounting for costly second-order effects from the rest of the messed up health system. So no, the hardline "abolish the FDA" plan would not remove the legal barrier of prescription. Here is Scott's response:
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.
This is a reasonable concern, litigation pressure is a common culprit behind
spiraling regulatory burden. But in this case we can be confident that turning the FDA into a non-binding informational board won't turn prescriptions into an even higher legal hurdle because doctors already prescribe far outside of FDA approval.
When a drug is tested by the FDA it is tested as a treatment for a specific condition, like diabetes or throat cancer. If the drug is approved, it is approved only for the outcome measured in efficacy testing and nothing else. However, doctors know that certain drugs approved for one thing are effective at treating others. So they can issue an "off-label" prescription based on their professional opinion.
Perhaps 20% of all prescriptions in the US are made off-label and more than half of doctors make some off label prescriptions.
So doctors are clearly willing to leave the legal umbrella of FDA approval when they make prescription decisions. There are lots of high profile legal cases about off-label prescriptions but they are mostly about marketing and they haven't dampened doctor's participation in the practice. If doctors were comfortable enough to
pres...
Scott Alexander's
recent post on the FDA raises the average level of discourse on the subject. He starts from the premise that the FDA deserves destruction but cautions against rash action. No political slogan can be implemented without clarification and "Abolish the FDA" is no different, but Scott's objections aren't strong reasons to stop short of a policy implementation that still retains the spirit behind the slogan.
Scott's preferred proposal is to essentially keep the authority and structure of the FDA the same but expand the definition of supplements and experimental drugs. This way, fewer drugs are illegal but there aren't big ripple effects on the prescription and health insurance systems that we have to worry about.
The more hardline libertarian proposal is to restrict the FDA's mandatory authority to labeling and make their efficacy testing completely non-binding. This would turn the FDA into a informational consumer protection agency rather than a drug regulator. They can slap big red labels on non-FDA approved drugs and invite companies to run efficacy tests to get nice green labels instead, but they can't prevent anyone from taking a drug if they want it.
Let's go through Scott's objections to the hardline plan and see if they give good reasons to favor one over the other.
Are we also eliminating the concept of prescription medication?
I can see some "If I were king of the world" overhauls to the health system that might do away with mandatory prescriptions, but I think the point of this exercise is to see if we can abolish the FDA without changing anything else and still come out ahead, accounting for costly second-order effects from the rest of the messed up health system. So no, the hardline "abolish the FDA" plan would not remove the legal barrier of prescription. Here is Scott's response:
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.
This is a reasonable concern, litigation pressure is a common culprit behind
spiraling regulatory burden. But in this case we can be confident that turning the FDA into a non-binding informational board won't turn prescriptions into an even higher legal hurdle because doctors already prescribe far outside of FDA approval.
When a drug is tested by the FDA it is tested as a treatment for a specific condition, like diabetes or throat cancer. If the drug is approved, it is approved only for the outcome measured in efficacy testing and nothing else. However, doctors know that certain drugs approved for one thing are effective at treating others. So they can issue an "off-label" prescription based on their professional opinion.
Perhaps 20% of all prescriptions in the US are made off-label and more than half of doctors make some off label prescriptions.
So doctors are clearly willing to leave the legal umbrella of FDA approval when they make prescription decisions. There are lots of high profile legal cases about off-label prescriptions but they are mostly about marketing and they haven't dampened doctor's participation in the practice. If doctors were comfortable enough to
pres...