I would argue that the FDA is that risk adverse because society is that risk adverse. And while I completely agree that those R&D billions should be compensate

I would argue that the FDA is that risk adverse because society is that risk adverse. And while I completely agree that those R&D billions should be compensated, when the go-to strategy for patents is to do a complete parallel re-invention rather than just pay the inventor, my stance is that the trade offs made by the current system are inefficient and damaging.