Number: RS22691
Title: FDA Advisory Committee Conflict of Interest
Authors: Erin D. Williams, Specialist in Public Health and Bioethics 
Abstract: On September 27, 2007, a comprehensive law reauthorizing existing Food and Drug Administration (FDA) programs and expanding the agency's authority to ensure the safety of prescription drugs, medical devices, and biologics was signed into law: the Food and Drug Administration Amendments Act of 2007 (FDAAA; P.L. 110-85; H.R. 3580). FDAAA Title VII focused on the topic of conflicts of interest. It was added following some negative publicity about the FDA's process for addressing conflicts of interest within its advisory committees. FDAAA requires changes in the way that FDA recruits and vets advisory committee members, and in the circumstances under which conflict of interest exceptions may be granted. This report details FDA's new policies for addressing conflicts of interest in its advisory committees.
Pages: 5
Date: January 2, 2009