[jashephe]

For lack of a rebuttal to the FDA dissolution comment, which I'm sure others are more qualified to respond to, I wanted to address the efficacy/safety remark:

A growing number of people have voiced objections to the burdens of the FDA's efficacy testing requirements, but it's worth at least thinking about why they're in place. The main issue is that "safety" in the context of pharmaceuticals doesn't mean "perfectly safe" or even "non-lethal" — it really means, "safe enough, given the benefits". Side effects of a chemotherapy drug that can completely eliminate a tumor, for instance, could be acceptably substantial, because it cures an otherwise terminal illness. Side effects of a drug mildly lowering cholesterol levels, by contrast, must be strictly limited, because many Americans may take such a drug for much of their adult lives, sometimes in combination if the effects of a single drug are too weak.

It's hard to know if the benefits outweigh the risks if you don't know what the benefits are. Obviously, this efficacy testing carries a huge time and monetary burden, but without it, contextualizing acceptable risk would be difficult, if not impossible.