[otterley]

I’m going to assume the clinical trial bar exists for a good reason unless proven otherwise. The current system is battle tested at this point and is a significant improvement over the situation that predated the current regulations in terms of safety and efficacy.

And, yes, protecting people - both from being injured and from being ripped off - is a feature of modern society, not a bug.

[inglor_cz]

"I’m going to assume the clinical trial bar exists for a good reason unless proven otherwise."

You cannot, nevertheless, assume that its implementation is absolutely optimal.

There already exists a "Right to Try" exemption for terminally ill patients - precisely what the GP was talking about. https://www.fda.gov/patients/learn-about-expanded-access-and...

It was only introduced in 2018 (federally), so it is a relatively recent development, mostly due to pressure from terminally ill patients and their relatives.

Another thing that is being discussed is that the FDA should allow use of drugs that were approved in other developed countries, without requiring separate clinical trials in the US. American patients aren't that different from British or French patients, after all.

[otterley]

I actually agree with the last paragraph. It does make some sense to have some sort of reciprocity with other trusted nation-states. However, there is obviously going to be some forum shopping as a result, and the country with the lowest bar (as opposed to the highest standards) is going to become the one that bears the lion’s share of the evaluation burden.

If we're going to do this, the nations involved should have a rotation, so that 1/you can't predict which nation is going to get a particular evaluation job and 2/to eliminate the "free rider" problem (which exists today in other contexts, such as unfairly burdening the USA with the majority of Western defense spending).

[doe_eyes]

My city has extensive education and occupational licensing requirements if you want to work at a nail care salon. The assumption that bureaucracies left to their own devices always reach an optimum state and then stop expanding is pretty hard to support.

The FDA had 7,500 employees in the 1990s and 18,000 now. Has the world of food and drug gotten 2.5x more perilous? Or is it possible that, just like in tech, every departmental fiefdom wants more resources and more authority with no special regard for what the trade-offs are?

[otterley]

Another plausible (and less sinister) explanation is that pharmaceutical invention and discovery has accelerated since the 1990s and more applications are being submitted to FDA every year that requires more staff to process them in a timely fashion.