The Food and Drug Administration in draft guidance is proposing to tighten its approach for considering potential financial conflicts of interest for advisory committee members.
The agency screens all prospective advisory committee participants before each meeting to determine whether the potential for a conflict of interest exists, and may grant a waiver in cases where an individuals expertise outweighs the potential for a conflict of interest. A previous guidance attempted to address the waiver criteria, but it was deemed too complex.
The new guidance seeks to streamline the process for recommending waivers, and would tighten eligibility for participation. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members.
FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees, said Randall Lutter, FDAs acting deputy commissioner for policy. The draft guidance document should provide more consistency in the consideration of who is eligible to participate in advisory committee meetings and would simplify the process.
The proposal will be subject to a 60-day comment period. -- by Jennifer Lubell