FDA Guidelines on Women in Clinical Trials

NEWS 07/21/1993 FDA Guidelines on Women in Clinical Trials
EMBARGOED UNTIL 6:00 P.M. 

Note To Correspondents                           Susan M. Cruzan
July 21, l993                                    301-443-3285

            FDA Guideline on Women in Clinical Trials

     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 l977 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, l993.) 
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                                   Page 2, Women in Clinical Trials
     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 l977 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 -- Dr.
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 Mangagement Branch, HFA-305, Rm. 1-23, 12420 Parklawn
Drive, Rockville, Md.  20857  by Nov. 19, l993.  
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