On March 18, the Biden Administration announced that it is doubling down on its commitment—previously announced during President Biden’s State of the Union address—to transform women’s health research and improve the lives of women across the United States.
During the State of the Union address, President Biden called for an investment of $12 billion in new funding for women’s health research. In an Executive Order issued on March 18, President Biden directed “the most comprehensive set of executive actions ever taken to expand and improve research on women’s health.” These directives aim to ensure women’s health is integrated and prioritized across the federal research portfolio and budget and build the foundation for new, innovative research on health topics impacting women across their lifespans.
To carry out these directives, the Biden Administration established the White House Initiative on Women’s Health Research (the “Initiative”), which will contain representatives from over 20 executive departments and agencies, including the Department of Health and Human Services (HHS), the Department of Defense (DOD), Food and Drug Administration (FDA), the Department of Veteran Affairs (VA) and others.
Specifically, the Executive Order directs:
- The Initiative to integrate women’s health across the federal research portfolio by developing and strengthening research and data standards on women’s health across all relevant research and funding opportunities. This is meant to build on the National Institutes of Health’s (NIH) current policy of ensuring that the research it funds considers women’s health in the development of study design, data collection and analysis.
- The Initiative to prioritize investments in women’s health research and innovation through the Advanced Research Projects Agency for Health (ARPA-H) and multiagency initiatives and further directs HHS and the National Science Foundation (NSF) to study ways to use Artificial Intelligence to advance women’s health research.
- HHS, DOD and VA to narrow research gaps on diseases and conditions associated with women’s midlife health, or that are more likely to occur after menopause, and take steps to improve the treatment and research of menopause for service women and women veterans.
- The Office of Management and Budget (OMB) and the Gender Policy Council to assess unmet needs to support women’s health research by leading a robust effort to assess and identify gaps in federal funding for women’s health and determine changes that can be implemented. These agencies will also be required to report annually on their investments of women’s health research.
President Biden’s Executive Order is another recent activity aimed at improving women’s health through work in the public and private sectors. To name only a few of these initiatives:
- NIH launched an effort—initially funded with $200 million by FY2025—to close gaps in women’s health research. As part of this effort, NIH will launch research projects studying topics such as the impact of perimenopause and menopause on heart health, brain health and bone health. NIH is also launching a new initiative dedicated to research on biomarker discovery and validation to help improve prevention, diagnosis and treatment of conditions, such as endometriosis, that affect women. In addition, NIH is debuting its first-ever Pathways to Prevention series on menopause and the treatment of menopausal symptoms. Finally, NIH announced that it is planning a 50% increase in its investment in private-sector innovators and small businesses engaged in research and development related to women’s health.
- The First Lady announced ARPA-H Sprint for Women’s Health, which commits $100 million towards transformative research and development in women’s health. The Sprint for Women’s Health will use two funding tracks to foster transformative research and development efforts. One for early-stage research, or “Spark” solutions, and the other for later-stage development, or “LaunchPad” solutions. Grant applications are due this month.
- The Centers for Medicare & Medicaid (CMS) Innovation announced a new voluntary model for state Medicaid agencies aimed at addressing the stark, maternal health inequities and profound maternal morbidity and mortality experienced across the United States.
- NSF is calling for the submission of new research and education proposals to advance discoveries and innovations related to women’s health through a wide range of disciplines—from computational research to engineering biomechanics.
- The United States Department of Agriculture (USDA) announced that it will fund research to help recognize early warning signs of maternal morbidity and mortality in recipients of Special Supplemental Nutrition Program for Women, Infants and Children (WIC). USDA anticipates awarding up to $5 million in FY2023 to support this research.