Tougher restrictions sought for FDA advisory committees

The FDA has developed a new guidance that will make the screening process for choosing advisory committee members more stringent, thereby minimizing potential conflicts of interest. Currently, the agency screens prospective committee participants before each meeting to determine their conflicts of interest. However, the FDA may grant a waiver when it believes the individual's expertise outweighs the conflict. Under the new proposal, if an individual has disqualifying financial interests exceeding $50,000, he or she would not be allowed to participate in the meeting, regardless of expertise. If below $50,000, an individual may be allowed to participate as a non-voting member, and only those without potential conflicts would be eligible to attend meetings as voting members. The FDA is accepting public comments on the draft guidance for the next 60 days. Electronic comments can be submitted to