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WOMEN IN DRUG STUDIES: FDA NEEDS "MORE EXPLICIT" POLICY GUIDANCE

Executive Summary

WOMEN IN DRUG STUDIES: FDA NEEDS "MORE EXPLICIT" POLICY GUIDANCE on the inclusion of women in clinical trials for new drug products, an Oct. 29 General Accounting Office report recommends. GAO says FDA's revised guidance should instruct pharmaceutical manufacturers on how to determine "when enough women are included in drug trials to assess potential differences in safety and effectiveness by gender." The report also notes that FDA should require industry to analyze clinical trial data by gender. Entitled "Women's Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing," the GAO report was requested in February 1991 by House Energy and Commerce/Health Subcommittee Chairman Waxman (D-Calif.), and Reps. Schroeder (D- Colo.) and Snowe (R-Maine), chairwomen of the Congressional Caucus for Women's Issues ("The Pink Sheet" March 4, 1991, T&G-3). The study, which examines the participation of women of childbearing years in clinical trials conducted by FDA-regulated drug manufacturers, reviews clinical information on 53 prescription drugs approved by FDA over a recent three-and-one-half year period. The latest report follows a 1990 GAO investigation of the inclusion of women in trials sponsored by the National Institutes of Health that also was requested by Reps. Waxman, Schroeder and Snowe. One outcome of that study was the creation of the NIH Office of Research on Women's Health and the strengthening of NIH requirements for the inclusion of women in clinical trials ("The Pink Sheet" Sept. 17, 1990, T&G-3). In recent months, FDA has given closer scrutiny to women's participation in clinical trials. FDA is considering sending a letter to drug manufacturers reminding firms that NDA applications should include analyses of gender-specific safety and efficacy data. Responding to GAO's call for more explicit language in FDA's guidelines on gender-specific data analysis, FDA maintained in the report that its guidelines on analyzing efficacy data on men and women are "clear"; however, the agency concedes that its guidelines for analyzing safety data by gender are "not clear." FDA also agreed with GAO that manufacturers should evaluate, and possibly study in clinical trials, drug interactions with women's hormones and oral contraceptives. GAO based its recommendations on a number of findings. For example, the study determined that clinical data for over one-half (53%) of the drugs surveyed were not analyzed for gender-response differences, although all had included some women in clinical trials. The lack of analysis may be due in part to the fact that some of the analysis was done before FDA issued its 1988 guidelines. More recently, an FDA survey of pending NDAs found that drug safety data were analyzed by gender for 54% of the drugs, while efficacy was analyzed on the basis of gender in 43% of the applications. The GAO report states that FDA's 1988 guidance on women in clinical trials leaves pharmaceutical manufacturers "unclear" about how to determine "when there are enough women in a clinical drug trial to detect gender-related differences in drug response, and when it is appropriate to study specific physiologically induced drug interactions in women." Noting that the FDA guidance recommends testing new drugs on representative populations, GAO said that the agency does not define the word "representative." On the other hand, FDA asserted that specific guidance on the representation of women "is not needed because drug manufacturers generally include enough women in their trials," the report says. GAO maintains that for 60% of the 53 drugs reviewed in the survey period, the representation of women in the test population was less than the representation of women in the population with the corresponding disease. In addition, 24% of drug manufacturers report that they do not deliberately recruit representative numbers of women for their trials. For cardiovascular disease, the leading cause of death in women, a "low" representation of women was reported for one-half of the cardiovascular drugs in the study. That finding "is of particular concern" because drug companies have detected that men and women can respond differently to cardiovascular drugs, GAO said.
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