The FDA is ill-equipped to provide such oversight. The problem is political. Once the FDA evaluates a thing, then it has been approved by the gov, and if any negative thing happens we blame the gov for being too lax.

but we rarely blame the gov for being cautious. (even when caution costs many lives).

The result is massively biased towards deaths and damage by in action.

If there were a way to balance risks on both sides…. but I don’t see it. we humans naturally want to assign blame when a pill CAUSES harm, but rarely even take an accounting of the number of deaths that occur or would occur if we slows medicine down by many factors.

if you cannot balance these factors, then just leave well enough alone.

— dan