[gumby]

> It is not just about harm. FDA rules on medical products also in fitness of purpose.

This is because most drugs aren't really that good for you, however in the context of some illness, the disease may be worse than the unwanted effects of the drug.

A good example is methotrexate (MTX): wow, it really clears up its patients' arthritis, but it's so toxic that it's only administered to patients who are more at risk of dying of cancer than of the MTX.

I've appeared before the FDA (in pursuit of drug approval) and in my experience they're actually more than fair. The biggest problem is the assholes who try to game the system, which just gums up the works for everyone.

edit: I'm no longer in that biz so have nothing to gain by praising or condemning the FDA. The approval process is far from perfect but I honestly think it's pretty good overall.