The FDA is tightening up its conflict-of-interest rules for those expert advisory panels that often get involved in the most contentious drug safety decisions (and approvals, too). For years, consumer advocates and others have argued that panel members shouldn't have any financial conflicts. Arguing back, the agency would say that limiting committees to experts without conflicts would exclude many if not most top docs and researchers.
But now FDA has given in--at least a little. If an expert or anyone else in his immediate family has financial conflicts of more than $50,000, he can't participate in that meeting. Also, four specific kinds of conflicts won't be allowed, period. And any conflict waivers--required for people with less than $50,000 at stake and without those four disqualifiers--would have to be absolutely necessary for the committee to have "essential expertise."
Already some are saying that $50,000 is too high a threshold--but FDA types said they're pushing to find advisers with "minimal or no conflicts." We'll see how that effort plays out.
- see the FDA release
- read the post at Pharmalot
- check out the Wall Street Journal Health Blog's item