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Sunday, March 21, 2010

FDA Advisory Committee Conflict of Interest

Erin D. Williams
Specialist in Public Health and Bioethics

The Food and Drug Administration (FDA) regulates a wide variety of products, including foods, cosmetics, drugs, medical devices, biologics (e.g., vaccines), tobacco, and radiation-emitting devices. Advisory committees play a role in this regulation, enabling the agency to obtain specific recommendations from external experts on the various products. An understanding of the mechanisms FDA uses to manage conflicts of interest on its advisory boards is informative not only for FDA-specific policy discussions, but also as a reference when considering how to 

As described herein, the way that FDA recruits and vets advisory committee members, and the circumstances under which conflict-of-interest exceptions may be granted, are governed by a combination of laws, one presidential statement, and several FDA guidance documents. Relevant laws include Title VII of the Food and Drug Administration Amendments Act of 2007 (FDAAA; P.L. 110-85); the Federal Advisory Committee Act (FACA; 5 U.S.C. Appendix); the Ethics in Government Act of 1978 (EGA; 5 U.S.C. Appendix); and Acts Affecting Personal Financial Interest (AAPFI; 18 U.S.C. 208). 

This report analyzes the laws and other documents that articulate FDA's policies and activities for addressing conflicts of interest in its advisory committees.


Date of Report: March 8, 2010
Number of Pages: 9
Order Number: RS22691
Price: $19.95

Document available electronically as a pdf file or in paper form.
To order, e-mail congress@pennyhill.com or call us at 301-253-0881.