Abolish the FDA


Another article that came up on my feed, said that it’s time to do away with the FDA.

The late Milton Friedman argued in “Free to Choose” that the FDA does more harm than good and the problems aren’t just a matter of poor execution but are inherent in the very concept.

There are two forms of “failure” in bringing a new drug or treatment to market: the first is bringing out something that doesn’t work (or worse, is actively harmful). The second is not bringing out something that does work.

When a drug that’s actively harmful is released that’s a bad thing. People point to the folk harmed (or killed) by the drug. Drug manufacturers are sued but that doesn’t undo the suffering or bring back the dead.

When a drug that’s beneficial is not brought out, that’s also a bad thing. The difference is that most people don’t even notice. People are still suffering, still dying as they were before. The new drug would have alleviated some of that suffering, saved some of those lives, but since it’s not a change most people don’t notice.

Thus, the incentive for folk like the FDA is to reject. When in doubt, reject, or at least delay. This is why it took so very long for propranalol, the first beta blocker drug, took so long to be approved in the US. Beta blockers are able to go a long way toward preventing deaths following a heart attack, to the tune of saving 10,000 lives a year in the US. That’s 10,000 people who need not have died for every year that the FDA delayed the approval of propranalol. Now multiply that by every other life saving drug that cranks through the long, slow process of approval.

But nobody notices. Whereas they do notice the other class of failure. So the incentive remains delay, check and recheck again and, when in doubt, deny. Stop a new thalidomide and you’re a hero. Delay on propranalol and nobody notices (even though as many people died in just a single year that could have been saved by propranalol than all the children affected by birth defects from thalidomide combined). Yeah, that’s an easy choice for a bureaucrat to make…and feel virtuous about it. He’s preventing another thalidomide.

And even with all that, the FDA still occasionally approves something that later turns out to be harmful so even with all that you’re not assured at least of safety.

Without the FDA companies would still have a strong incentive to ensure their medications are safe and effective. They would still be liable in lawsuits if they are not. No, the lawsuit does not bring back the dead or alleviate the suffering but the primary purpose is to provide an incentive not to release harmful medicines.

The FDA, then, gives us little that torts and the courts do not already provide, but instead costs in delays in new, effective medications being delayed or outright rejected with the attendant cost in human suffering and death.

Abolish the FDA.

4 thoughts on “Abolish the FDA”

  1. I’d say make the FDA advisory, like the Union of Orthodox Rabbis for people who keep kosher.
    If you want to try a drug that doesn’t have the FDA stamp on it, go ahead. If you want to sell one that doesn’t have that stamp, you might have to charge a lower price for it, depending on how many people demand that stamp as proof of safety and/or effectiveness.


  2. Thalidomide is the big success story of the FDA. It was in the ’50s. That’s over 60 years ago. That even the big success is so long ago points out how useless the FDA is.
    The other thing is that when an approved drug is found useful to treat some other condition, the FDA requires a new round of testing. The fact that much of the testing has already been done does not count.


  3. You can use a medicine for things for which it has not been approved, “off label” uses, but you cannot advertise it for such uses. The catch there is that they can sometimes be very expansive in what they consider “advertising”.


  4. I was wrong on that, then. Sounds like it would be difficult to communicate a new use for an existing medicine to doctors and the public. While some advertising practices are probably listed, drug companies probably have to guess as to what else would be ‘advertising’ to the FDA. I’m certain the FDA would at least be consistent in that determination (NOT).


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