FDA Regulation Must Uphold Women’s Health

Genevieve Grabman & Cara Tenenbaum


Progress in U.S. medical product regulation is not due to a greater understanding of women, their biology, their needs, or their capabilities. Instead, public health tragedy is the historical catalyst for major U.S. legislative and policy changes, and these tragedies unnecessarily harmed women. Congress and the Food and Drug Administration (FDA) have made multiple, often belated, attempts to make medical products safe and effective for women, but more work remains.

FDA created the Office of Women’s Health (OWH) in 1994, but despite OWH’s efforts over the intervening thirty years since its creation, repeated regulatory failures of drugs and devices continue to imperil women’s health. Women remain underrepresented in clinical trials. In addition, labeling of medicines women use is confusing and incomplete. Tests, especially laboratory developed tests (LDTs) for gynecologic cancers and other conditions, have escaped regulation to women’s detriment. Device regulation remains very problematic, with multiple loopholes for contraceptive devices, morcellators, and breast implants and no clear regulatory path for new, digital devices.

To respond to women’s needs, FDA must build and leverage OWH’s expertise to evaluate appropriately the data from pre- and post-market reviews of drugs and devices. These data will inform meaningful and correct sex-specific recommendations and labeling, which will permit consumers of all sex and gender expressions to make informed decisions about their own health. OWH also must step forward to lead on women’s health, anticipating future challenges and using its existing authorities to convene actors across the government to develop strategic responses.