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Women's Health |
U.S. Food and Drug Administration • Center for Drug Evaluation and Research |
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Women's Health |
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CDER Women's Health SubcommitteeCDER strongly supports activities on women's health issues through the Women's Health Subcommittee of the CDER Medical Policy Coordinating Committee. This subcommittee is responsible for developing policy related to women's health issues. Over the past several years, its members have worked to draft new legislation and guidance documents that address issues related to the inclusion of women in clinical trials and to the analyses of efficacy and safety data by gender. In addition, the subcommittee developed tools for reviewers so that they would be knowledgeable about CDER policies related to the analysis of gender differences, and incorporate gender-related information in their reviews of regulatory submissions. A web-based course entitled, “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs – Self-Learning Course” was developed in 2001 in collaboration with the Office of Training and Communications (OTCOM) and provides four hours of continuing medical education credit. In July 2002, the subcommittee developed a demographic worksheet for inclusion in approval action packages for new molecular entities (NMEs). The worksheet captures the numbers of subjects exposed to drug by gender, age and racial subgroups in the primary safety database, reasons for omitting demographic analysis and implications, if any, on labeling. The subcommittee is composed of physicians, statisticians and other scientists representing all parts of CDER, as well as the Centers for Biologics Evaluation, Devices and Radiological Health, and Food Safety & Applied Nutrition. Primary among CDER's initiatives is the FDA Pregnancy Labeling Task Force which CDER co-chairs with FDA and manages. This task force was organized to review pregnancy labeling and to explore how the pregnancy category information could be presented to clinicians, reviewers and other interested parties in the most effective manner in order to provide the greatest possible usefulness to the public. The long term goal is to determine how animal toxicology information contributes to clinically meaningful information. A major task of this group will be the reassessment of Category "C". Because there are often no studies conducted in pregnant women, most drugs have been placed in this category. This has resulted in the erroneous appearance that there are few drugs which can be safely given to women of childbearing potential. Other women's health projects in which CDER is participating are the Pregnancy Registry Working Group, the Pregnancy Drug Use Survey, rewriting of the Institutional Review Board regulations to foster studies in which women of child-bearing potential are included, and gender-related bioequivalence issues. Women's Health Subcommittee Membership 1/2005 CHAIR:
Julie Beitz, Medical Officer, CDER Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Food Safety and Applied Nutrition Office of Special Health Issues Office of Women's Health Susan Wood
FDA/Center for Drug Evaluation and
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