FACT SHEET: President Biden Issues Executive Order and Announces New Actions to Advance Women's Health Research and Innovation

In his State of the Union address, President Biden laid out his vision for transforming women's health research and improving women's lives all across America. The President called on Congress to make a bold, transformative investment of $12 billion in new funding for women's health research. This investment would be used to 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—which would serve as a national gold standard for women's health research across the lifespan.

It is long past time to ensure women get the answers they need when it comes to their health—from cardiovascular disease to autoimmune diseases to menopause-related conditions. To pioneer the next generation of discoveries, the President and the First Lady launched the first-ever White House Initiative on Women's Health Research, which aims to fundamentally change how we approach and fund women's health research in the United States.

Today, President Biden is signing a new Executive Order that will direct the most comprehensive set of executive actions ever taken to expand and improve research on women's health. These directives will ensure women's health is integrated and prioritized across the federal research portfolio and budget, and will galvanize new research on a wide range of topics, including women's midlife health.

The President and First Lady are also announcing more than twenty new actions and commitments by federal agencies, including through the U.S. Department of Health and Human Services (HHS), the Department of Defense (DoD), the Department of Veterans Affairs (VA), and the National Science Foundation (NSF). This includes the launch of a new NIH-wide effort that will direct key investments of $200 million in Fiscal Year 2025 to fund new, interdisciplinary women's health research—a first step towards the transformative central Fund on Women's Health that the President has called on Congress to invest in. These actions also build on the First Lady's announcement last month of the Advanced Research Projects Agency for Health (ARPA-H) Sprint for Women's Health, which committed $100 million towards transformative research and development in women's health.

Today, the President is issuing an Executive Order that will:

• Integrate Women's Health Across the Federal Research Portfolio. The Executive Order directs the Initiative's constituent agencies to develop and strengthen research and data standards on women's health across all relevant research and funding opportunities, with the goal of helping ensure that the Administration is better leveraging every dollar of federal funding for health research to improve women's health. These actions 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. Agencies will take action to ensure women's health is being considered at every step in the research process—from the applications that prospective grantees submit to the way that they report on grant implementation.

• Prioritize Investments in Women's Health Research. The Executive Order directs the Initiative's constituent 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. These entities are dedicated to high-impact research and innovation, including through the support of early-stage small businesses and entrepreneurs engaged in research and innovation. The Executive Order further directs HHS and NSF to study ways to leverage artificial intelligence to advance women's health research. These additional investments—across a wide range of agencies—will support innovation and open new doors to breakthroughs in women's health.

• Galvanize New Research on Women's Midlife Health.  To narrow research gaps on diseases and conditions associated with women's midlife health or that are more likely to occur after menopause, such as rheumatoid arthritis, heart attack, and osteoporosis, the President is directing HHS to: expand data collection efforts related to women's midlife health; 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. The Executive Order also directs the DoD and VA to study and take steps to improve the treatment of, and research related to, menopause for Service women and women veterans.

• Assess Unmet Needs to Support Women's Health Research. The Executive Order directs the Office of Management and Budget and the Gender Policy Council to lead a robust effort to assess gaps in federal funding for women's health research and identify changes—whether statutory, regulatory, or budgetary—that are needed to maximally support the broad scope of women's health research across the federal government. Agencies will also be required to report annually on their investments in women's health research, as well as progress towards their efforts to improve women's health.

Today, agencies are also announcing new actions they are taking to promote women's health research, as part of their ongoing efforts through the White House Initiative on Women's Health Research. Agencies are announcing actions to:

Prioritize and Increase Investments in Women's Health Research

• Launch an NIH-Cross Cutting Effort to Transform Women's Health Throughout the Lifespan. NIH is launching an NIH-wide effort to close gaps in women's health research across the lifespan. This effort—which will initially be supported by $200 million from NIH beginning in FY 2025—will allow NIH to catalyze interdisciplinary research, particularly on issues that cut across the traditional mandates of the institutes and centers at NIH. It will also allow NIH to launch ambitious, multi-faceted research projects such as research on the impact of perimenopause and menopause on heart health, brain health and bone health. In addition, the President's FY25 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.

This coordinated, NIH-wide effort will be co-chaired by the NIH Office of the Director, the Office of Research on Women's Health, and the institute directors from the National Institute on Aging; the National Heart, Lung, and Blood Institute; the National Institute on Drug Abuse; the Eunice Kennedy Shriver National Institute of Child Health and Human Development; the National Institute on Arthritis, Musculoskeletal and Skin Diseases.

• Invest in Research on a Wide Range of Women's Health Issues. The bipartisan Congressionally Directed Medical Research Program (CDMRP), led out of DoD, funds research on women's health encompassing a range of diseases and conditions that affect women uniquely, disproportionately, or differently from men. While the programs and topic areas directed by Congress differ each year, CDMRP has consistently funded research to advance women's health since its creation in 1993. In Fiscal Year 2022, DoD implemented nearly $490 million in CDMRP investments towards women's health research projects ranging from breast and ovarian cancer to lupus to orthotics and prosthetics in women.  In Fiscal Year 2023, DoD anticipates implementing approximately $500 million in CDMRP funding for women's health research, including in endometriosis, rheumatoid arthritis, and chronic fatigue.

• Call for New Proposals on Emerging Women's Health Issues. Today, NSF is calling for new research and education proposals to advance discoveries and innovations related to women's health. To promote multidisciplinary solutions to women's health disparities, NSF invites applications that would improve women's health through a wide range of disciplines—from computational research to engineering biomechanics. This is the first time that NSF has broadly called for novel and transformative research that is focused entirely on women's health topics, and proposals will be considered on an ongoing basis.

• Increase Research on How Environmental Factors Affect Women's Health. The Environmental Protection Agency (EPA) is updating its grant solicitations and contracts to ensure that applicants prioritize, as appropriate, the consideration of women's exposures and health outcomes. These changes will help ensure that women's health is better accounted for across EPA's research portfolio and increase our knowledge of women's environmental health—from endocrine disruption to toxic exposure.

• Create a Dedicated, One-Stop Shop for NIH Funding Opportunities on Women's Health. Researchers are often unaware of existing opportunities to apply for federal funding. To help close this gap, NIH is issuing a new Notice of Special Interest that identifies current, open funding opportunities related to women's health research across a wide range of health conditions and all Institutes, Centers, and Offices. The NIH Office of Research on Women's Health will build on this new Notice by creating a dedicated one-stop shop on open funding opportunities related to women's health research. This will make it easier for researchers and institutions to find and apply for funding—instead of having to search across each of NIH's 27 institutes for funding opportunities.

Foster Innovation and Discovery in Women's Health

• Accelerate Transformative Research and Development in Women's Health. ARPA-H's Sprint for Women's Health launched in February 2024 commits $100 million to transformative research and development in women's health. ARPA-H is soliciting ideas for novel groundbreaking research and development to address women's health, as well as opportunities to accelerate and scale tools, products, and platforms with the potential for commercialization to improve women's health outcomes.

• Support Private Sector Innovation Through Additional Federal Investments in Women's Health Research. The NIH's competitive Small Business Innovation Research Program and the Small Business Technology Transfer Program is committing to further increasing—by 50 percent—its investments in supporting innovators and early-stage small businesses engaged in research and development on women's health. These programs will solicit new proposals on promising women's health innovation and make evidence-based investments that bridge the gap between performance of basic science and commercialization of resulting innovations. This commitment for additional funds builds on the investments the Administration has already made to increase innovation in women's health through small businesses, including by increasing investments by sevenfold between Fiscal Year 2021 and Fiscal Year 2023.

• Advance Initiatives to Protect and Promote the Health of Women. The Food and Drug Administration (FDA) seeks to advance efforts to help address gaps in research and availability of products for diseases and conditions that primarily impact women, or for which scientific considerations may be different for women, and is committed to research and regulatory initiatives that facilitate the development of safe and effective medical products for women. FDA 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. And FDA's Office of Women's Health will update FDA's framework for women's health research and seek to fund research with an emphasis on bridging gaps in knowledge on important women's health topics, including sex differences and conditions that uniquely or disproportionately impact women.

• Use Biomarkers to Improve the Health of Women Through Early Detection and Treatment of Conditions, such as Endometriosis. NIH will launch a new initiative dedicated to research on biomarker discovery and validation to help improve our ability to prevent, diagnose, and treat conditions that affect women uniquely, including endometriosis. This NIH initiative will accelerate our ability to identify new pathways for diagnosis and treatment by encouraging multi-sector collaboration and synergistic research that will speed the transfer of knowledge from bench to bedside.

• Leverage Engineering Research to Improve Women's Health. The NSF Engineering Research Visioning Alliance (ERVA) is convening national experts to identify high-impact research opportunities in engineering that can improve women's health. ERVA's Transforming Women's Health Outcomes Through Engineering visioning event will be held in June 2024, and will bring together experts from across engineering—including those in microfluidics, computational modeling, artificial intelligence/imaging, and diagnostic technologies and devices—to evaluate the landscape for new applications in women's health. Following this event, ERVA will issue a report and roadmap on critical areas where engineering research can impact women's health across the lifespan.

• Drive Engineering Innovations in Women's Health Discovery. NSF awardees at Texas A&M University will hold a conference in summer 2024 to collectively identify challenges and opportunities in improving women's health through engineering. Biomedical engineers and scientists will explore and identify how various types of engineering tools, including biomechanics and immuno-engineering, can be applied to women's health and spark promising new research directions.

Expand and Leverage Data Collection and Analysis Related to Women's Health

• Help Standardize Data to Support Research on Women's Health. NIH is launching an effort to identify and develop new common data elements related to women's health that will help researchers share and combine datasets, promote interoperability, and improve the accuracy of datasets when it comes to women's health. NIH will initiate this process by convening data and scientific experts across the federal government to solicit feedback on the need to develop new NIH-endorsed common data elements—which are widely used in both research and clinical settings. By advancing new tools to capture more data about women's health, NIH will give researchers and clinicians the tools they need to enable more meaningful data collection, analysis, and reporting and comprehensively improve our knowledge of women's health.

• Reflect Women's Health Needs in National Coverage Determinations. The Centers for Medicare & Medicaid Services (CMS) will strengthen its review process, including through Coverage with Evidence Development guidance, to ensure that new medical services and technologies work well in women, as applicable, before being covered nationally through the Medicare program. This will help ensure that Medicare funds are used for treatments with a sufficient evidence base to show that they actually work in women, who make up more than half of the Medicare population.

• Leverage Data and Quality Measures to Advance Women's Health Research. The Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) are building on existing datasets to improve the collection, analysis, and reporting of information on women's health. The CDC is expanding the collection of key quality measures across a woman's lifespan, including to understand the link between pregnancy and post-partum hypertension and heart disease, and plans to release the Million Hearts Hypertension in Pregnancy Change Package. This resource will feature a menu of evidence-informed strategies by which clinicians can change care processes. Each strategy includes tested tools and resources to support related clinical quality improvement. HRSA is modernizing its Uniform Data System in ways that will improve the ability to assess how women are being served through HRSA-funded health centers. By improving the ability to analyze data on key clinical quality measures, CDC and HRSA can help close gaps in women's health care access and identify new opportunities for high-impact research.

Strengthen Coordination, Infrastructure, and Training to Support Women's Health Research

• Launch New Joint Collaborative to Improve Women's Health Research for Service Members and Veterans. DoD and VA are launching a new Women's Health Research collaborative to explore opportunities that further promote joint efforts to advance women's health research and improve evidence-based care for Service members and veterans. The collaborative will increase coordination with the goal of helping improve care across the lifespan for women in the military and women veterans. The Departments will further advance research on key women's health issues and develop a roadmap to close pressing research gaps, including those specifically affecting Service women and women veterans.

• Coordinate Research to Advance the Health of Women in the Military. DoD will invest $10 million, contingent on available funds, in the Military Women's Health Research Partnership. This Partnership is led by the Uniformed Services University and advances and coordinates women's health research across the Department. The Partnership is supporting research in a wide range of health issues affecting women in the military, including cancers, mental and behavioral health, and the unique health care needs of Active Duty Service Women. In addition, the Uniformed Services University established a dedicated Director of Military Women's Health Research Program, a role that is responsible for identifying research gaps, fostering collaboration, and coordinating and aligning a unified approach to address the evolving needs of Active Duty Service Women.

• Support EPA-Wide Research and Dissemination of Data on Women's Health. EPA is establishing a Women's Health Community of Practice to coordinate research and data dissemination. EPA also plans to direct the Board of Scientific Counselors to identify ways to advance EPA's research with specific consideration of the intersection of environmental factors and women's health, including maternal health.

• Expand Fellowship Training in Women's Health Research. CDC, in collaboration with the CDC Foundation and American Board of Obstetrics and Gynecology, is expanding training in women's health research and public health surveillance to OBGYNs, nurses and advanced practice nurses. Through fellowships and public health experiences with CDC, these clinicians will gain public health research skills to improve the health of women and children exposed to or affected by infectious diseases, mental health and substance use disorders. CDC will invite early career clinicians to train in public health and policy to become future leaders in women's health research.

Improve Women's Health Across the Lifespan

• Create a Comprehensive Research Agenda on Menopause. To help women get the answers they need about menopause, NIH will launch its first-ever Pathways to Prevention series on menopause and the treatment of menopausal symptoms. Pathways to Prevention is an independent, evidence-based process to synthesize the current state of the evidence, identify gaps in existing research, and develop a roadmap that can be used to help guide the field forward. The report, once completed, will help guide innovation and investments in menopause-related research and care across the federal government and research community.

• Improve Primary Care and Preventive Services for Women. The Agency for Healthcare Research and Quality (AHRQ) will issue a Notice of Intent to publish a funding opportunity announcement for research to advance the science of primary care, which will include a focus on women's health. Through this funding opportunity, AHRQ will build evidence about key elements of primary care that influence patient outcomes and advance health equity—focusing on women of color—such as care coordination, continuity of care, comprehensiveness of care, person-centered care, and trust. The results from the funding opportunity will shed light on vital targets for improvements in the delivery of primary healthcare across a woman's lifespan, including women's health preventive services, prevention and management of multiple chronic diseases, perinatal care, transition from pediatric to adult care, sexual and reproductive health, and care of older adults.

• Promote the Health of American Indian and Alaska Native Women. The Indian Health Service is launching a series of engagements, including focus groups, to better understand tribal beliefs related to menopause in American Indian and Alaska Native Women. This series will inform new opportunities to expand culturally informed patient care and research as well as the development of new resources and educational materials.

• Connect Research to Real-World Outcomes to Improve Women's Mental and Behavioral Health. The Substance Abuse and Mental Health Services Administration (SAMHSA) is supporting a range of health care providers to address the unique needs of women with or at risk for mental health and substance use disorders. Building on its current efforts to provide technical assistance through various initiatives, SAMHSA intends, contingent on available funds, to launch a new comprehensive Women's Behavioral Health Technical Assistance Center. This center will identify and improve the implementation of best practices in women's behavioral health across the life span; identify and fill critical gaps in knowledge of and resources for women's behavioral health; and provide learning opportunities, training, and technical assistance for healthcare providers.

• Support Research on Maternal Health Outcomes. USDA 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), and anticipates awarding up to $5 million in Fiscal Year 2023 to support maternal health research through WIC. In addition, research being conducted through the Agricultural Research Service's Human Nutrition Research Centers is focusing on women's health across the lifespan, including the nutritional needs of pregnant and breastfeeding women and older adults.