[anewhope]

I’m not an expert, but I’ve worked with the FDA. In my experience they’re pretty reasonable and motivated by mission. I suspect it’s simply really hard and risky to come up with new therapeutics and make sure they work in a reasonable amount of time. Diminishing returns.

I don’t know anything about the generic drug marketplace. I’d guess the issues are more complicated than what you describe. The FDA’s mandate is safety, not anticompetitive practices.

One surprising takeaway from working with our regulatory consultants is that apparently many actors try to game the crap out of the FDA’s processes. The FDA is really the only wall between shenanigans and consumers.