I didn't mentioned Fast Track specifically but it was one of the things I was thinking of when I said the FDA had "certainly improved." A large part of the credit for that should go to AIDS activists but Reaganite Republicans also deserve a lot of credit.
I'm not sure the FDA of the 1960s/70s was a net positive in its drug regulating role on human health. I'm almost certain the FDA of the 2010s is a good thing on net but I'm pretty sure it's bad on the margin, compared to the EMA which I think gets things more or less right.
I'm not particularly conversant in how FDA regulatory behavior is different across product categories but it sure looks like it's the FDA's role as a device regulator that causes the differences in the market for epinephrine injectors in the US versus EU.
