My opinion about the FDA is that it suffers from two major faults, it is always regulating the "last war" and it has the standard federal government incentive structure for policy making which is "do not do anything that according to civil service regulations can get me fired".

In defense of the FDA, which I promise is not an instituion I have much affection for, they are asked to strike an impossible balance. More or less the same regulatory impulse that allowed Richard Sackler to build an empire on the killing of millions of americans is the same one that allows very sick people to access very, at times dubious, drugs and trials that sometimes save their lives.

Most of medicine is very centrally built around the "first do no harm" approach, even at the cost of lives by non-intervention sometimes. With the FDA most people want a "do some harm, some of the time for the greater good" approach which is a really difficult thing for a federal agency to put into practice. I think they do an especially awful job with it but I appreaciate that it is a really hard balance to strike.