Improving transparency and strengthening the science at the FDA

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.