> I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while yo

> I suppose only things that definitely cause harm, because otherwise why not just ask for the same deal that Biogen got, and go out and prove efficacy while you turn a profit? In a sense, this is how it's sort of always worked. The approval process is about protecting investors. If a drug is good it's usually pretty obvious. When it's not obvious, efficacy in a more abstract sense must account for cost, which is out of the FDA's jurisdiction. The real problem with its organization is that it is, as you're saying, Medicare's procurement agent. But it is not empowered to consider cost.