There’s a lot to be said about the seemingly overbearing nature of the majority of FDA/ISO standards that result in the mass amount of hurdles that need to be jumped before a treatment is available, but that’s mainly due to institutional trauma from past events (thalidomide, primarily) as well as the fact that treatments are not simply binary. The options are not just “does not work” and “makes patient better,” there’s also “makes the problem worse.” These additional tests and trials are to catch and prevent adverse effects just as much as they are to ensure the drug or treatment actually works.
During covid, the FDA testified to congress that they were putting the vaccines on an approval fast track that would not reduce safety or efficacy. Why is this not the standard approval track?
For example, running very large trials in a short time is very high effort.
Worth it
For patients. But maybe not to the companies which would have to pay for these large expedited trials
It's a trade-off: better info versus handling an immediate crisis. If it's not an immediate crisis, you can take more time.
Engineering is trade-offs.
People are dying of these diseases every day
Because it's inordinately more expensive.
We're computer people, so we have a good analogy here; the COVID vaccine did speculative branch prediction. They basically operated _as if_ they would get approval at all stages where they could, parallelizing much more of the process at the cost of a _very_ expensive branch fail if something went wrong.
a) Risk vs. reward -- not that I'm saying we're making the right balance decisions, but the correct speed depends on that balance in general.
b) The current administration is extremely unlikely to make vaccine approvals faster. If anything their instincts are the other way around.