Conflicts of Interest Among Patient and Consumer Representatives to U.S. Food and Drug Administration Drug Advisory Committees

abstract

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 (1). Therefore, patient and consumer representatives are ineligible to receive waivers for conflicts of interest (1). In addition, committee members with more than $50 000 in financial relationships are typically ineligible for waivers regardless of expertise.

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