Number 93-4

(Human Subject Protections)


August 13, 1993

Subject:  Food and Drug Administration Guideline for the Study and Evaluation of Gender Differences in the Clinical
Evaluation of Drugs 

Dear Colleague:

This letter is being forwarded to Institutional Officials and Institutional Review Board (IRB) chairs throughout the country to notify you of the issuance of the Food and Drug Administration (FDA) "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs." A copy of the Notice of the Guideline published in the Federal Register on July 22 (58FR39406) is enclosed. This guideline sets forth FDA's expectations regarding inclusion of both genders in drug development and revises the section "Women of Childbearing Potential" in the 1977 guideline entitled, "General Considerations" for the Clinical Evaluation of Drugs" (HEW Publication No. (FDA) 77-3040].

There are two major changes addressed in this guidance. First, FDA is withdrawing the restriction on the participation of women of childbearing potential in early clinical trials, including clinical pharmacology studies and early therapeutic studies. Second, FDA is formalizing expectations regarding inclusion of subjects of both genders in drug development; analyses of clinical data by gender; assessment of potential pharmacokinetic differences between genders; and, where appropriate, assessment of pharmacodynamic differences and the conduct of specific additional studies in women.

A major effect of the new guideline is to give more flexibility to IRBs, investigators, and subjects in determining how best to ensure the safe participation of women of childbearing potential in clinical studies. Changes in FDA policy reflected in the new guideline remind us of the importance of the IRB deliberative process, the informed consent document and process, and the necessity for attention to the completeness and accuracy of information conveyed to potential and enrolled subjects. Women must receive adequate information and opportunity for discussion regarding, for example, potential risks to their fertility and possible teratogenic potential of the drugs and biologics. Your attention to this important matter is greatly appreciated.

  Gary Ellis, Ph.D.
Office for Protection from Research Risks