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So, the food regulation side of the FDA's activities have certainly saved millions of lives and probably swamp what the FDA does in terms of drug regulations.

So, the food regulation side of the FDA's activities have certainly saved millions of lives and probably swamp what the FDA does in terms of drug regulations. But generally new drugs tend to be rolled out gradually, doctors hear about disasters, and I'd be surprised if the FDA saved more than a thousand lives a year at most. On the other hand a bad call in disallowing new medicines can have very bad consequences. The FDA only allowed the use of beta blockers in the US about a decade after they came into use in Europe which probably cost something on the order of 100,000 excess deaths. Those early beta blockers did have serious problems and the FDA's decision also probably saved 1,000 people from liver failure after taking those drugs but I don't think that justified withholding the category until a liver-safe version was made. These days the FDA is less strict than it was in the 1960s and has certainly improved. But we can still do better to move more in the direction of European style regulation where they have a dozen competing EpiPen equivalents.

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throwaway5752 8y ago
You had to go back 60 years. You didn't even mention Fast Track. You are ignoring device, test, and implant categories.
- Symmetry 8y ago
  I didn't mentioned Fast Track specifically but it was one of the things I was thinking of when I said the FDA had "certainly improved." A large part of the credit for that should go to AIDS activists but Reaganite Republicans also deserve a lot of credit. I'm not sure the FDA of the 1960s/70s was a net positive in its drug regulating role on human health. I'm almost certain the FDA of the 2010s is a good thing on net but I'm pretty sure it's bad on the margin, compared to the EMA which I think gets things more or less right. I'm not particularly conversant in how FDA regulatory behavior is different across product categories but it sure looks like it's the FDA's role as a device regulator that causes the differences in the market for epinephrine injectors in the US versus EU.

deleted 8y ago

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throwaway5752 8y ago

You had to go back 60 years. You didn't even mention Fast Track. You are ignoring device, test, and implant categories.

Symmetry 8y ago
I didn't mentioned Fast Track specifically but it was one of the things I was thinking of when I said the FDA had "certainly improved." A large part of the credit for that should go to AIDS activists but Reaganite Republicans also deserve a lot of credit. I'm not sure the FDA of the 1960s/70s was a net positive in its drug regulating role on human health. I'm almost certain the FDA of the 2010s is a good thing on net but I'm pretty sure it's bad on the margin, compared to the EMA which I think gets things more or less right. I'm not particularly conversant in how FDA regulatory behavior is different across product categories but it sure looks like it's the FDA's role as a device regulator that causes the differences in the market for epinephrine injectors in the US versus EU.