george, I strongly suspect that he was on the panel because he had AIDS, not because he was a scientist/doctor. I think that he was representing the "end user" or impacted population, and his panel membership was mandated.
I used to be on an institutional review board for certification of Scripps' animal facility. The composition of the board was dictated by the certifying agency, and in addition to a veterinarian and scientists who used the facility, there was a lay person appointed to represent the community (and he had no advanced degree or experience with animal experiments).
I believe the the composition of the FDA advisory committee is similarly mandated (with representatives from industry, academia, government, and targeted population).
Moreover, it is my understanding that the FDA Modernization act did away with rejections based on market conditions. The risk/reward ratio is supposed to be calculated on safety, and the marketing aspects are supposed to be left to the marketplace. If patients and doctors do not find value in the drug, then it will not be used, even though an approval had been granted.
As I said earlier, of those following FDA guidelines, the approval vote for Panretin was really unanimous (8-0). |
