Women in Clinical Trials of New Drugs -- A Change in Food and Drug Administration Policy

The Food and Drug Administration (FDA) is taking two important steps to ensure that new drugs are properly evaluated in women. First, it is providing formal guidance to drug developers to emphasize its expectations that women will be appropriately represented in clinical studies and that new drug applications will include analyses capable of identifying potential differences in drug actions or efficacy between the sexes. Second, the agency is altering a 16-year-old policy that has excluded most women with "childbearing potential" from the earliest phases of clinical trials. Attention to sex differences is part of a larger effort by the FDA to ensure that the safety and efficacy of drugs are adequately studied in the full range of patients who will receive therapy and that information is obtained that will allow physicians to individualize therapy. These actions are also being taken in response to questions about whether this country's drug-development process produces adequate information about the effects of drugs in women, as well as more general issues concerning women's health.