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
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.