August 3, 2011
Margaret A. Hamburg, M.D.
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002
Dear Commissioner Hamburg:
We are writing to make very clear that there is a significant element of the public health community that includes patient, consumer and scientific integrity advocates that strongly oppose any efforts by the FDA to loosen the current conflict of interest rules for members of FDA advisory committees. In fact, it has been our position that the agency’s management of such potential conflicts of interest needs to be made stronger.
Over the past several years, organizations that are members of the Patient, Consumer, and Public Health Coalition have consistently raised concerns that advisory committee member conflicts of interest, both disclosed and undisclosed, continue to raise the specter of bias in the advice that advisory committees provide the agency. The perception and reality of conflicts of interest seriously undermines the public’s faith in the integrity of recommendations made by advisory panels to the agency.
Earlier this year, in the context of our public comments on proposals regarding renewal of Prescription Drug User Fees, we once again brought up the issue of conflicts of interest and our belief that FDA must do more to manage potential conflicts in order to keep the public trust. We understand that there are differences of opinion on this issue. However, your suggestion that most patient and consumer stakeholders want to loosen the rules is truly disappointing and puzzling to us.
We respectfully request an opportunity to discuss our concerns with you as soon as it is possible to schedule a face-to-face meeting.
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Consumer Federation of America
Jacobs Institute for Women’s Health
National Consumers League
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
National Women’s Health Network
THE TMJ Association
Union of Concerned Scientists
For more information, contact Paul Brown at (202) 223-4000 or email@example.com