3 ms·
> One thing the FDA doesn't consider that I think they should is the cost of not approving a drug. Safety and effectiveness is not black and white when faced wi
by nordsieck 8y ago
> One thing the FDA doesn't consider that I think they should is the cost of not approving a drug. Safety and effectiveness is not black and white when faced with uncertainly.
There is an excellent lecture by Richard Epstein on this topic [0].
tldr: The FDA doesn't allow pre-stage 3 access to drugs because it would, in part, reduce demand to be part of stage 3 trials. However, it's much more complicated than that.
[0] Chicago's Best Ideas: "Clinical Trials on Trial: How Should the FDA Do Its Job?" https://www.youtube.com/watch?v=IEhzoh86N9M https://www.youtube.com/watch?v=IEhzoh86N9M