5 ms·
Just to be a pedant the FDA doesn't consider the value of a drug to society, just if it is safe and effective. It is up to the pharmaceutical company to decide
by danieltillett 8y ago
Just to be a pedant the FDA doesn't consider the value of a drug to society, just if it is safe and effective. It is up to the pharmaceutical company to decide if it is worth developing and selling a new drug.
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.
- andyferris 8y agoA agree, that's totally true. That "exercise" was just my thought experiment about what might be for "the greater good" (whatever that might mean, precisely).
- 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