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The 130th Annual Meeting of APHA |
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The 130th Annual Meeting of APHA |
Emily J. Rowe, MA, Lisanne Bradley, JD, MA, and Martin T. Gahart, PhD. Health Care, U.S. General Accounting Office, 441 G Street, NW, Room 5A14, Washington, DC 20548, 202-512-2809, rowee@gao.gov
A recent U.S. General Accounting Office (GAO) study of drug safety found that eight of the 10 prescription drugs withdrawn from the U.S. market since January 1, 1997 posed greater health risks for women than men. Such demonstrated differences in men and women’s responses to some drugs underscore the importance of including both sexes in all stages of drug development and analyzing the resulting safety and efficacy data for potential sex differences. Although the Food and Drug Administration (FDA) has taken steps to increase women's participation in drug trials, concerns remain that women are underrepresented and that sex differences in responses to drugs go unexamined during drug development. In this session, the GAO will discuss findings from our review of a sample of new drug applications (NDA). In this review, we tabulated the number of men and women included in clinical drug trials at each phase of drug development, evaluated NDA compliance with the regulations to present drug safety and efficacy data by sex, and investigated FDA’s oversight of the presentation and analysis of drug safety and efficacy data related to sex differences. We will also provide an update on actions taken by FDA to improve compliance with the regulations. At the conclusion of the session, participants will be able to recognize the importance of analyzing drug outcome data for potential sex differences and to discuss progress FDA has made in ensuring women’s participation in drug trials.
Learning Objectives:
Keywords: Clinical Trails, Drug Safety
Related Web page: www.gao.gov
Presenting author's disclosure statement:
Organization/institution whose products or services will be discussed: U.S. General Accounting Office
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.