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The problem is that as a regulator, the FDA declares what constitutes legal use.

Consequently, if they make over-prescribing legal, then it is.

Similar problem with the EPA chemical safety division: https://news.ycombinator.com/item?id=28092336

The general problem is there's not enough basic funding to fund quality safety trials. Which are still run, but by the manufacturers themselves.

What probably should happen is more pushback from agencies with downstream remits like the DEA once statistically durable negative effects are observed on the ground.



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