Following his 2024 State of the Union address calling for a $12 billion investment in women’s health research and the release of the fiscal year 2025 President’s Budget, President Biden on Monday, March 18 released an Executive Order directing “the most comprehensive set of executive actions ever taken to expand and improve women’s health research.” The directives are aimed at integrating and prioritizing women’s health across the federal research portfolio and spurring new women’s health research.
The Executive Order calls for change in four key areas:
- Integration of Women’s Health Across the Federal Research Portfolio: The administration says that it “will build on the NIH’s current policy to ensure that research it funds considers women’s health in the development of study design and in data collection and analysis” and that agencies will consider women’s health at every step in the research process.
- Prioritization of Investments in Women’s Health Research: The order encourages innovation in women’s health research through the Advanced Research Projects Agency for Health (ARPA-H) and multi-agency initiatives, such as the Small Business and Innovation Research (SBIR) Program; calling on HHS and the National Science Foundation (NSF) to study ways to leverage artificial intelligence to advance women’s health research.
- Galvanization of New Research on Women’s Midlife Health: The administration identifies the need to look at diseases and conditions associated with women’s midlife health or that are more likely to occur after menopause (e.g., rheumatoid arthritis, heart attack, osteoporosis). To close these research gaps, the Executive Order directs HHS to take actions, including expanding data collection efforts related to women’s midlife health; launching a comprehensive research agenda to guide investments in menopause-related research; and identifying ways to improve the clinical care that women receive. The order also calls on DoD and VA to study and take steps to improve the treat of, and research related to, menopause for Service women and women veterans.
- Assessment of Unmet Needs to Support Women’s Health Research: The administration directs the Office of Management and Budget and the Gender Policy Council to assess gaps in federal funding for women’s health research and identify policy changes needed to support women’s health research across the federal government and, to improve visibility, calls on federal agencies to report annually on their investments in women’s health research and progress made.
Within the Executive Order, the President and First Lady also announced more than 20 new actions and commitments by federal agencies, ranging from the U.S. Department of Health and Human Services (HHS) to the Department of Defense (DoD) and the Department of Veterans Affairs (VA) to promote women’s health research. These actions and commitments include the following:
- $200 million from the National Institutes of Health (NIH) beginning in fiscal year 2025 for an NIH-wide effort to close gaps in women’s health research across the lifespan, particularly on issues that cut across the traditional mandates of the Institutes and Centers at NIH
- Dedicated call (the first of its kind) for new research and education proposals to advance discoveries and innovations specifically related to women’s health from the NSF
- Updated grant solicitations and contracts from the Environmental Protection Agency (EPA), which will ensure that applicants prioritize the consideration of women’s exposures and health outcomes
- 50% increase in investments from the SBIR Program and the Small Business Technology Transfer Program to support innovators and early-stage small businesses engaged in research and development on women’s health
- Plans from the U.S. Food and Drug Administration (FDA) to issue guidance for industry that relates to the inclusion of women in clinical trials and conduct outreach to stakeholders to discuss opportunities to advance women’s health across the lifespan as well as to update FDA’s framework for women’s health research
- A new NIH initiative on biomarker discovery and validation on endometriosis
- An NIH effort to identify and develop new common data elements related to women’s health
- A new joint Women’s Health Research collaborative between DoD and VA to explore opportunities to advance women’s health research and improve evidence-based care for service members and veterans
The full list of actions and commitments can be found here.
Following these announcements, SWHR sent a letter to First Lady Dr. Jill Biden thanking her for championing and leading this first-ever White House Initiative on Women’s Health Research. SWHR noted the great need for these investments and how this initiative is helping to chart a path forward for changing the women’s health research landscape in the United States and is bringing us one step closer to achieving equity and parity in the health of women. Read the letter here.
For questions about the White House Initiative on Women’s Health Research and SWHR’s involvement, please email our Policy Team.
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