Meanwhile, medicine is a lot less forgiving of wild goose chases, and requiring that the taking of risks is soundly justified seems pretty reasonable, as exciting as the idea of unrelenting research sounds.
—Dr. E. E. Peacock, Jr., University of Arizona College of Medicine;
edit: of course I agree that the new way is not necessarily better, I'm just saying that the old way is also not necessarily better.
The FDA approval process is slow partly because it is bureaucratic, but largely for two very important reasons: 1) because it is easier to prove effectiveness than safety (i.e. Easier to prove a positive than a negative), FDA requires rigorous standards to ensure drugs are safe (many FDA rules came into existence because people died from taking approved drugs) and 2) to prevent snake oil sales
It is difficult to imagine how pervasive and socially detrimental "snake oil salesmen" are (i.e. People who sell useless products to vulnerable sick people by taking advantage of their need for care), but without regulations this would be a huge problem
According to the people who actually work on these drugs, the FDA is neither excessively or insufficiently bureaucratic. It's worth remembering that only about 10% of the drugs that start the process actually finish it, and half of the submissions turn out to fail at the final, expensive step because they don't work.
Accelerated approval actually does reduce the number of studies you need to do to get approval. One of the reasons cancer is such a hot space is that FDA has been lettingamy drugs get accelerated approval from phase 2 studies looking at tumor response endpoints or progression free survival, rather than overall survival, which is a more relevant endpoint but one that takes longer to measure
I work in the field and find FDA is generally ok but I've been in situations where FDA used its power to enforce its will based on internal politics rather than scientific evidence. Very discouraging but that isn't the norm