The Foundation

The entire edifice of evidence-based medicine rests on a research enterprise that, for most of its history, treated the male body as the default human body. Women were systematically excluded from clinical trials — often on the basis of protecting them from research risks that posed no comparable barrier to male enrollment. The result was a scientific literature that described disease and treatment in men and extrapolated to women.

The NIH Revitalization Act of 1993 began to address this. The requirement that federally funded research include women and minorities was a genuine policy achievement, hard-won by advocates who understood that bad data produces bad medicine. The 2016 NIH sex-as-biological-variable policy extended this principle to preclinical research. Both represent meaningful progress.

What Remains Incomplete

Progress has been uneven. Women remain underrepresented in cardiovascular trials, pain research, and many oncology studies. Post-market surveillance systematically under-captures sex-differentiated adverse drug reactions. The FDA does not consistently require sex-disaggregated data in drug approval applications.

The women who experience worse outcomes — because the drugs they were prescribed were dosed for a different body, or the diagnostic criteria applied to them were calibrated to a different physiology — are bearing the cost of this research gap.

The Current Threat

The proposed FY2027 budget’s cuts to NIH, combined with the proposed elimination of NIMHD and the absence of any mention of women’s health research priorities, represent a genuine threat to the infrastructure that has driven progress over the past three decades. Protecting this infrastructure is not a partisan position. It is a scientific one.

What We Track

We monitor NIH funding levels and research priority updates, ORWH activities and funding, FDA regulatory guidance on sex-disaggregated data requirements, congressional appropriations for health research, and the federal legislative agenda for women’s health research.

Next Focus Area

Cancer
Oncology

Cancer

Breast, ovarian, cervical & gynecologic cancers — research, screening & access