> Unfortunately, the best I can point to is a series of blog posts and informal discussions, I'm not aware of any formal published evidence. I remember a blog post on ACX post aducanumab (
https://astralcodexten.substack.com/p/adumbrations-of-aducan...). The "FDA delenda est" catchprase leads to several more posts.
I'm a radiologist by training with an interventional oncology component in my practice so I can really only speak to acute care emergencies and cancer with any degree of expertise.
Cancer, heart attacks, strokes, aneurysms are different because there's a time crunch. In these situations FDA approval comes quickly for new medical devices and imaging tests. New aneurysms occlusion devices, stent grafts, and thrombectomy devices are all quickly approved with shortened review processes. Sometimes this has been to our detriment (e.g. early abdominal aortic/EVAR grafts which all leaked and caused disasters when the patient needed re-operation).
In these cases we did exactly what you're suggesting with:
> One idea is to make trials somewhat less costly by relying more on post-approval monitoring
How this translates to other diseases like Alzheimer's is not in my wheelhouse. I assume the process is more strictly adhered to in these cases, but it presumably should be because the potential harm of delaying is seemingly less important unless we're discussing disease-modifying treatments that require early initiation.
In your post the author mentions COVID-19 vaccinations, these were made available before full FDA approval. COVID-19 was highly politicized and the entire process did not follow typical medical procedures. Honestly the evidence that has come out for them isn't very compelling (omicron and later) and largely why most places have dropped vaccination requirements. I'm not sure that this is a good example of the "FDA's failure".