Biden Signs Sweeping Executive Order To Advance Women’s Health

Earlier this week, President Joe Biden signed an executive order aimed at enhancing women’s health research. The White House said these directives will ensure women’s health is integrated and prioritized across the federal government.

The signing of the executive order comes on the heels of Biden calling on Congress to allocate $12bn for women’s health during the State of the Union earlier this month — an investment the White House said would create a fund for women’s health research at the National Institutes of Health (NIH) to advance “a cutting-edge, interdisciplinary research agenda and to establish a new nationwide network of research centers of excellence and innovation in women’s health.”

It also follows First Lady Jill Biden announcing a $100m investment into the Advanced Research Projects Agency for Health (ARPA-H) for “transformative research and development in women’s health.” (Also see "News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance" - Medtech Insight, 23 Feb, 2024.)

The executive order directs federal funding for research into a wide range of women’s health topics, including midlife health. That funding will go to “narrow research gaps” on diseases and conditions associated with women at midlife or more likely to develop after menopause, such as rheumatoid arthritis, heart attack, and osteoporosis.

“My Administration is committed to getting women the answers they need about their health. For far too long, scientific, and biomedical research excluded women and undervalued the study of women’s health,” Biden said. “The resulting research gaps mean that we know far too little about women’s health across women’s lifespans, and those gaps are even more prominent for women of color, older women, and women with disabilities. “

To that end, the order directs the Department of Health and Human Services (HHS) to expand data collection efforts related to the health of women at midlife; launch a comprehensive research agenda that will guide future investments in menopause-related research; identify ways to improve management of menopause-related issues and the clinical care that women receive; and develop new resources to help women better understand their options for menopause-related symptoms prevention and treatment.

“Through the discovery of genetic factors that increase the risk of breast cancer and innovations in mammography, we have transformed our approach to prevention, early detection, and treatment, and have improved outcomes for women facing a breast cancer diagnosis.” — President Joe Biden

Further, the order directs the Department of Defense (DoD) and VA to study ways to improve treatment of menopause for women veterans.

The order also directs various agencies to prioritize funding for women’s health research and encourage innovation in women’s health, including through ARPA-H and multi-agency initiatives such as the Small Business Innovation Research Program and the Small Business Technology Transfer Program. It also orders HHS and the National Science Foundation (NSF) to study ways to leverage artificial intelligence to advance women’s health research.

In addition to the executive order, various federal agencies have announced initiatives to promote women’s health as part of the administration’s broader initiative to boost women’s health research, according to a White House fact sheet.

For example, the FDA said it plans address gaps in research and availability of products for diseases and conditions that primarily impact women — or impact them differently — and is committed to research and regulatory initiatives that facilitate “the development of safe and effective medical products for women.”

The FDA further also plans 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.

Additionally, the NIH has launched an initiative to close the gap in research focused on women’s health with $200m in funding beginning in fiscal year 2025.

NIH said this will allow for research into the impact of perimenopause and menopause on heart health, brain health and bone health. In addition, NIH said the president's 2025 budget request would double current funding for the NIH Office of Research on Women's Health “to support new and existing initiatives that emphasize women's health research.”

Further, the bipartisan Congressionally Directed Medical Research Program (CDMRP), which is based at the DoD, funds research on women’s health encompassing a range of diseases and conditions that affect women uniquely, disproportionately, or differently from men.

For instance, CDMRP allocated $490m in 2022 in women’s health research — including for projects aimed at breast cancer, ovarian cancer, and lupus as well as orthotics and prosthetics in women. In Fiscal Year 2023, DoD anticipates implementing approximately $500m in CDMRP funding for women’s health research, including in endometriosis, rheumatoid arthritis, and chronic fatigue.

The National Science Foundation (NSF) is also calling for new research related to women’s health. The foundation recently invited applications for proposals that would improve women’s health through a wide range of disciplines, which represents the first time the foundation has called for novel and transformative research focused entirely on women’s health topics.

“We have also identified some of the most characteristic symptoms of heart attack in women, which are different from those in men. This is what we can achieve when we invest in women’s health research.” — President Joe Biden

The Environmental Protection Agency (EPA) is also taking part by updating grant solicitations to prioritize women’s exposures and health outcomes. These changes, according to the EPA, will help ensure that women’s health is better accounted for across the agency’s research portfolio and increase its knowledge of women’s environmental health.

In announcing the executive order, Biden pointed to prior federal policies that have resulted in “significant increases” in women’s participation in clinical trials, and ongoing investments in biomedical research have supported breakthroughs in women’s health.

“Through the discovery of genetic factors that increase the risk of breast cancer and innovations in mammography, we have transformed our approach to prevention, early detection, and treatment, and have improved outcomes for women facing a breast cancer diagnosis,” Biden said. “We have improved access to life-saving treatments for women with severe heart failure by ensuring that the devices they need are the right size for a woman’s body. We have also identified some of the most characteristic symptoms of heart attack in women, which are different from those in men. This is what we can achieve when we invest in women’s health research.”