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Historical background of changes in FDA policy on the study and evaluation of drugs in women

The Food and Drug Administration (FDA) has recently made two important changes in its policy for the study and evaluation of drugs in women: (1) sex-specific analyses of the safety and efficacy of drugs will be required as part of all new drug applications, and (2) it will no longer be recommended that women of childbearing potential be restricted from participating in the earliest phases of drug trials. These changes have come about as a result of continuous efforts to individualize therapy, to improve upon the safety and efficacy of drugs, and to respond to important questions about whether the drug development process produces adequate information about the effects of drugs in women. In turn, these efforts are the outgrowth of a long history in the United States of changes in the clinical care for women, changes in the use of women as research subjects, changing attitudes about the balance between protection and risks for women in clinical trials, and national movements by women to focus on issues of their health care and to transform the male-oriented model of clinical research. The new FDA guidelines, published in July 1993, will provide guidance to researchers on accumulating valuable information on how drugs work in women and will help make it possible for physicians and other caregivers to consider the effects of gender on health and treatment.