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Executive Summary

FDA GENDER DIFFERENCES PROPOSED GUIDANCE ELIMINATES EXCLUSION OF WOMEN of childbearing potential from Phase I/II testing. The proposed "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" will be published in an upcoming issue of the Federal Register. The proposed guideline would supersede a 1977 policy statement made in the "general considerations" guidelines for clinical studies. That policy stated that women of childbearing potential should be excluded from Phase I and Phase II trials until the toxicology studies and teratogenicity studies showed that a drug had no potential of affecting the development of a fetus. FDA now feels that women of childbearing age can be adequately monitored for appropriate contraception and through informed consent for participation in early clinical trials for new therapies. The importance of evaluating gender differences prior to new drug product approval also receives emphasis in the proposed guideline. The document states that adequate numbers of women must be included in the clinical trials to assess gender differences. NDAs should include appropriate analyses of gender differences, such as differences in pharmacokinetics between women and men for the new drug. Additional studies evaluating the potential of a new drug to interact with women-specific drugs such as oral contraceptives should also be included in an NDA submission, the guideline notes. There is a suggestion that FDA will not approve an application if it does not contain sufficient numbers of women in the trials and gender-specific analyses. The guideline concurs with recommendations made by the General Accounting Office in a report released in October ("The Pink Sheet" Nov. 2, 1992, T&G-4). The report found that only 54% of NDAs were analyzed by gender for safety and only 43% for efficacy. The report also noted that, for 60% of the 53 drugs surveyed for the report, the representation of women in the test population was less than the representation of women in the population with the corresponding disease. The issue of strategies to increase recruitment of women in clinical trials is slated to be discussed at a March 29 public hearing sponsored by the National Institutes of Health Office of Research on Women's Health. ORWH will sponsor a scientific hearing on the kinds of parameters needed to assess women's reactions to pharmaceuticals; the hearing is scheduled for July 12 and 13 in Bethesda, Md.

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