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I think you have an overly sunny view of how effective the FDA is. (leaving aside the question of cost effectiveness and the opportunity cost of the delays and even outright prevention of useful drugs getting to market and their effect on the cost of drugs)
There are plenty of cases of the FDA being hoodwinked by drug companies. Regulatory capture is always a concern.
Statistical incompetence is very common. I still cannot believe that they let Vioxx on the market when the fourfold increase in heart attacks had a P value of about 10-11%. . This is the sort of stupidity that would (or should) get you as F in Statistics 101.
My experience over many decades is that over time the benefits of drugs often turn out to be way overstated and the dangers greatly underestimated.
I stand by my narrow claims. Here is another narrow claim: you are wrong about what happened with Vioxx.