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FDA GUIDELINE ON WOMEN IN CLINICAL TRIALS

 /ADVANCE/ WASHINGTON, July 21 /PRNewswire/ -- The Food and Drug Administration is publishing a guideline calling for better assessment of possible gender differences in responses to new medications. The guideline will be published on July 22 in the Federal Register and is discussed in the current issue of The New England Journal of Medicine. At the same time, FDA revised a 1977 policy that had excluded women of childbearing potential from the early studies of most drugs.
 As Ruth Merkatz, Ph.D., R.N., special assistant to the FDA commissioner-women's health issues, and co-authors point out in a special report of NEJM, the new "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" will help "ensure that the safety and efficacy of drugs are adequately studied in the full range of patients who will receive therapy."
 The new guideline encourages companies to include patients of both sexes in drug development as, in general, they have in the past and to analyze the effectiveness and safety databases to look for significant differences in response between men and women. (For background, see Talk Paper T93-18, April 5, 1993.)
 The guideline directs particular attention to possible pharmacokinetic effects of the phases of the menstrual period, menopause and use of oral contraceptives or estrogens. Elimination of the 1977 restriction on participation of women of childbearing potential in early clinical studies reflects the agency's view that institutional review boards, investigators and patients should play a greater role in determining whether participation of women in trials is appropriate and how best to make sure there is no exposure of a fetus to potentially toxic agents. In its review of the manufacturers' protocols, FDA will continue to evaluate the risks and benefits of drug studies in specific populations, including women.
 FDA and the authors of the Special Report in NEJM -- Merkatz, Robert Temple, M.D., Solomon Sobel, M.D., Karyn Feiden and FDA Commissioner David A. Kessler, M.D. -- believe that the new policy will encourage the collection of better information about the effects of drugs in women and provide women with greater opportunities to participate in drug development and research.
 The general principles about inclusion of women and gender analysis outlined in the guideline also apply to biological products and medical devices.
 Interested persons may submit comments on the guideline to Dockets Management Branch, HFA-305, Rm. 1-23, 12420 Parklawn Drive, Rockville, Md. 20857, by Nov. 19, 1993.
 -0- 7/21/93 1800
 /NOTE: TV broadcasters please use open caption for the hearing impaired./
 /CONTACT: Susan M. Cruzan of the Food and Drug Administration, 301-443-3285/


CO: Food and Drug Administration ST: District of Columbia IN: HEA SU:

KD-IH -- DC036 -- 4034 07/21/93 14:11 EDT
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Date:Jul 21, 1993
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