Conflicts of interest among patient and consumer representatives to U.S. Food and Drug Administration drug advisory committees

Background: Drug advisory committees provide independent advice to the U.S. Food and Drug Administration (FDA) on policy matters. Committee members are special government employees and are subject to federal employee conflict-of-interest guidelines under 18 U.S.C. § 208 and § 712 (1994). Although these regulations prohibit actual or apparent conflicts of interest, regulatory policy allows waivers to be issued when the participant's expertise is deemed essential to evaluating a specific matter before the advisory committee. The issuance of waivers can be complicated, but the FDA is clear that relevant scientific expertise is a necessary and primary criterion. Therefore, patient and consumer representatives are ineligible to receive waivers for conflicts of interest. In addition, committee members with more than $50, 000 in financial relationships are typically ineligible for waivers regardless of expertise. During the past decade, financial conflicts of interest in health policy have raised important concerns. For example, a growing body of scholarship has documented that some drug manufacturers enlist patient advocacy organizations to influence federal policy. Objective: To examine financial relationships between drug manufacturers and patient and consumer representatives serving on FDA drug advisory committees.