Abstract

This project investigates the extent to which conflict-of-interest considerations influence the perceived credibility of the Food and Drug Administration (FDA) advisory committees, as well as the credibility of ensuing FDA decisions.

Issue

For several decades, advisory committees have offered valuable assistance to the FDA by helping the agency make sound policy decisions about food, drug, biologics, and medical device issues. Advisory committees are comprised of scientists, professionals, and researchers from private and public sectors who are considered experts in their fields. Because these experts are typically pre-eminent researchers, they are often recruited by the regulated industries to assist in product development or may work for universities or centers that receive funding from regulated industries. As a result, many of the experts or the places where they work have grants from or contracts with the regulated industries, which may give rise to potential conflicts of interest. In short, the expertise that makes these individuals so valuable to the FDA also makes them more valuable to the regulated industries. This project investigates the extent to which conflict-of-interest considerations influence the perceived credibility of FDA advisory committees, as well as the credibility of ensuing FDA decisions. In addition, this project examines the degree to which knowledge of the waiver process influences perceptions of impartiality. Finally, this project examines the extent to which conflict-of-interest considerations influence satisfaction with advisory committee meetings as techniques for helping FDA obtain the best scientific advice on policy decisions.

Response

The study included audience participants, as well as advisory committee members. From March to July 2003, we distributed questionnaires on audience members' chairs at 11 FDA advisory committee meetings held in the Washington D.C. Meetings were selected to represent the four largest FDA centers: the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), and the Center for Food Safety and Applied Nutrition (CFSAN). Each questionnaire contained a letter describing the research and soliciting participation and a business reply envelope. The questionnaire distributed to audience members involved 273 that were returned and included in our data analysis. In addition, at each of the meetings, the advisory committee executive secretaries permitted us to distribute questionnaires at the advisory committee member's seat. Each questionnaire included a letter describing the research and soliciting participation, as well as a business reply envelope. Of questionnaires distributed to advisory committee members, 92 were completed and returned.

We conducted data analysis on each of these subgroups and have presented our findings at several conferences. In addition, we have several articles either under review or in press at academic journals.

Impact

The FDA posted the project's final summary report on its advisory committee web site. At present, we do not know of any substantial impact on how the FDA organizes its advisory committee meetings.

Funding Sources

• Other Federal non-USDA (e.g., NSF, NIH, DOA, DOD)

Topic Description

• Credibility of federal advisory committees

Collaborators

• U. S. Food and Drug Administration
• University of Maryland, College Park

Key Personnel

• Linda Ann Sherman, M. D., Director, Advisory Committee Oversight and Management Staff, U.S. Food and Drug Administration
• Leah Simone Tuite, doctoral candidate, Department of Communication at the University of Maryland
• Leah Waks, Ph.D., Director of Undergraduate Studies, Department of Communication, University of Maryland,