"Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace."
I have no personal doubt that the FDA has saved millions of lives in the US and internationally, and the balance of harm/good they have caused would would make the harm side look infinitesimally small.
Also... I be interested in what cases you know that the FDA caused the deaths of people by overaction. There are people out there with axes to grind who thought they were going to get rich with some drug or device, who couldn't subsequently prove the safety and/or efficacy of their product.
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.
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.
The FDA's drug approval criteria are extremely strict. Ask anyone who works in pharma and they can probably name at least a couple of drugs which showed great promise but got axed by the FDA on dubious grounds.
A classic example is Aspirin. We know from over a hundred years of experience that Aspirin is a widely useful and relatively safe drug, but if it were discovered today the FDA would never allow it to market, let alone approve it for OTC sales. Aspirin's mechanism of action is far too broad and the gastrointestinal side effects alone would be considered grounds for rejection.
Perhaps if you dropped a few more specific examples would could talk about their issues instead of in generalities, instead of Aspirin? I was going to reply in my own words, but will instead yield to this retired FDA compliance officer: https://www.quora.com/Would-aspirin-be-approved-by-the-FDA-t...
I have no personal doubt that the FDA has saved millions of lives in the US and internationally, and the balance of harm/good they have caused would would make the harm side look infinitesimally small.
Also... I be interested in what cases you know that the FDA caused the deaths of people by overaction. There are people out there with axes to grind who thought they were going to get rich with some drug or device, who couldn't subsequently prove the safety and/or efficacy of their product.