Biotech Values

[AlpineBV_Miller]

I’ve seen cogent arguments by intelligent posters that the FDA ought not to be in the business of evaluating drug efficacy in the first place—just have the Agency rule on safety and let physicians and patients figure out the rest.

This is actually the core idea behind the advisory panels. The FDA is responsible for making sure regulations have been followed, data collected, and interpretations of those data are done correctly. The advisory panels should be for making clinical judgments about risk and benefit (note I did not use "safety and efficacy").

Unfortunately, this process is corruptable when division heads get to choose their own advisory panels. If the division head has his/her own "unique" ideas about risk and benefit on a drug, then he/she can construct a panel that rubber-stamps their point of view.

Frankly, I'd trade ACs with moderate conflicts of interest that are centrally chosen over "conflict-free" ACs that are chosen by division heads. I think the process would be much more thoughtful, particularly if an AC panel member rotated to be available throughout the FDA staff discussion and briefing document prep stages as an observer/advisor.

Finally, I think the central problem with the FDA right now is ruling on safety with not enough consideration of the benefit the drugs provide. Politically that's very difficult with clueless groups like Public Citizen running fundraising campaigns based upon the false idea that drugs are "safe" in the first place. Having the FDA focus only on safety likely exacerbates that problem.