except that people are already dying. it is not the case that nobody dies now and only this newfangled method has some chance of people dying. people are dying now, and the faster we can make fewer people die, the better. even the notoriously slow and bureaucratic US drug approval process recognizes that sometimes new drugs are discovered that are so much better than the status quo that is is unethical to check if there are unknown side effects; it doesn't really matter if someone gets kidney disease ten years down the road if they have advanced cancer right now.
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.
It isn't true that the FDA recognizes that some drugs are so beneficial it is unethical to check for side effects
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
The FDA does have a fast track process, but it's more of a "we'll review your submission in two months instead of a year" kind of deal. You still have to do all the clinical trials, although in a few cases (e.g., the ebola vaccine during the recent epidemic), it is possible to overlap the trials a bit.
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.
Yes fast track and breakthrough destination and priority review allow you to cut review time down and get more FDA input on your dev plan, but none of them allow you to ignore getting safety data as the person I responded to said.
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
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.