165823 Improving transparency and strengthening the science at the FDA

Tuesday, November 6, 2007: 11:10 AM

Susan F. Wood, PhD , George Washington University School of Public Health and Health Services, Washington, DC
Abstract Text: The Food and Drug Administration currently gets major funding from regulated industry, primarily to increase premarket review of products. It has become clear over past years that this has driven priorities of the agency toward review and approval decisions, with lesser resources available for postmarket safety, inspections, and other aspects of its mission. At the same time, FDA recently proposed stricter conflict of interest policies for Advisory Committee Members, and Congress considered even stronger provisions as part of the FDA Revitalization Act of 2007. Aspects of these proposals should be considered for other agencies beyond the FDA. This presentation will review the impact of this negotiated user fee system, as well as discuss recent efforts to improve transparency, access to clinical study data, reduce conflicts of interest of advisory committee members and ensure FDA scientific staff the right to publish freely.

Learning Objectives:
Articulate the impacts of user fee programs and restricted resources on the US Food and Drug Administration. Discuss Conflict of Interest Policies. Identify key areas for strengthening the use of science at FDA.

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.