On Jul. 20, 1988, the U.S. Food and Drug Administration (FDA) announced that the Modernization Act of 1997 (FDAMA) Sec. 115 Clinical Investigations. (b) Women and Minorities. — Section 505(b)(1) 21 U.S.C. 355(b)(1) was amended by adding at the end the following: “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials . . .”

The Center for Drug Evaluation and Research (CDER) has been assigned the responsibility for reviewing and implementing this section for the Agency. To accomplish this task, CDER established an ad hoc working group, “FDAMA Women and Minorities Working Group” with representation from the Agency and the National Institutes of Health.

The Center is submitting for your review and consideration the recommendations of the FDAMA Working Group, which have the concurrence of CDER’s Medical Policy Coordinating Committee (MPCC) and are contained in the enclosed report. These recommendations also were discussed with representatives of the pharmaceutical manufacturing industry, as required by section 115(b) of FDAMA. They are in agreement that no additional guidance is needed at this time and offered to confer with the Agency if this should change in the future.

In 1977, the agency issued a guideline for the clinical evaluation of drugs that called for the exclusion of “women with childbearing potential,” from the early phases of most clinical studies. The phases of drug development, when basic issues of safety, dose ranging, and efficacy were evaluated. The exclusion was applied broadly to include premenopausal women capable of becoming pregnant, except women with life-threatening diseases.

This ban was implemented in the protectionist climate that had developed and subsequently prevailed after birth defects were found to be associated with the maternal use of certain drugs, such as thalidomide. The consensus of ethical opinion at the time was that the potential for any fetal risk was unacceptable in studies that might not have important direct medical benefits to the participating subjects.