The Fact
In 1977, the FDA recommended excluding women of childbearing potential from early-phase drug trials, even women using birth control, single women, and women whose husbands had vasectomies. That policy stood until 1993. In the same era, women were left out of major medical research well beyond drug trials. The Physicians’ Health Study, which tested aspirin for heart disease, enrolled 22,071 men and no women. The MRFIT heart-risk trial enrolled 12,866 men and no women. And the first study of whether estrogen prevents heart disease was done only on men.
What This Means
For a significant period of modern drug development, women of reproductive age were routinely excluded from important phases of clinical testing. That matters because drug safety, dosing, metabolism, and adverse effects can differ by sex.
Sources
- NIH ORWH, History of Women’s Participation in Clinical Research: https://orwh.od.nih.gov/toolkit/recruitment/history
- Schiebinger 2003, J Clin Invest: https://www.jci.org/articles/view/19993/version/1/pdf/render.pdf
- FDA, Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-and-evaluation-gender-differences-clinical-evaluation-drugs