I take your broader point but personally I feel like it’s ok if the FDA is cautious. The incentives that bias towards rejection may be “not killing people”.
What about the people who die because a safe and effective drug that could have saved their life got rejected? The problem is that there's a fundamental asymmetry here - those deaths are invisible but deaths from a bad drug that got approved are very visible.
I mean drugs are different than consumer technology. Instagram isn’t great but it doesn’t cause birth defects. Also things like the compassionate release of hiv drugs in study show the govt can see the nuance here with enough pressure.
I deliberately chose the FDA here specifically because of this. The problem here is that on a societal level, we have to be willing to tolerate some risk. If a drug could have saved many, but is rejected because of occasional complications, that sounds like a poor cost benefit analysis.
