The White House Champions Women’s Health with Initiative for Women’s Health Research and Groundbreaking Executive Order

The recent surge in interest in women’s health research and innovation in the United States has been near impossible to ignore. FemTech companies are disrupting the market (or in some instances, creating markets) for women’s health-focused products. Star-studded conferences focus on women’s health issues, such as the May 2024 Women’s Health Health Lab featuring celebrities and policymakers, as well as the 2024 Women’s Health Summit that took place in the same month and was packed with presentations by CEOs, authors, and journalists. Yet, more than thirty years after the United States Congress passed a law requiring the inclusion of women in clinical research, many are concerned that the understanding of and research into women’s health remains neglected. The Biden Administration is doubling down on efforts to change that with its November 2023 announcement of the Initiative for Women’s Health Research led by the Office of the First Lady and the White House Gender Policy Council, the February 2024 $100M Sprint for Women’s Health Research, and the March 2024 Executive Order on Advancing Women’s Health Research and Innovation.

This article focuses on the history of research related to women’s health while exploring the latest efforts to expand women’s health research through the Biden Administration’s Executive Order on Advancing Women’s Health Research and Innovation. It will examine how the Executive Order will integrate women’s health into the federal research portfolio, prioritize investments in women’s health research, and foster innovation through exploring the current unmet needs in women’s health.

A Look at Women’s Health Research Over Time

In the 1960s and 1970s, the goal of the Women’s Health Movement was to improve healthcare for all women and eliminate sexism from the healthcare system. However, these efforts were halted by the increasing concerns about the safety of drugs and drug trials during pregnancy. In 1977, a policy from the Food and Drug Administration (FDA) recommended excluding women of childbearing age, considered a vulnerable population, from the early stages of drug trials. These recommendations stemmed from certain drug-related incidents regarding thalidomide, which caused severe birth defects for women who took this medication while pregnant. The large number of women and babies who were impacted led researchers to adopt a cautious approach to participation in clinical trials. This exclusion resulted in a severe shortage of data on how drugs affect women.

In 1985, a report by the Public Health Task Force on Women’s Health Issues concluded that excluding women from clinical research was detrimental to their health and recommended the needed expansion of research to include conditions or diseases that disproportionately affect women of all ages. In 1986, the National Institutes of Health (NIH) provided a notice that researchers should include women in clinical studies; however, it was not required. In 1990, the NIH established the Office of Research on Women’s Health. The NIH Revitalization Act of 1993 included new requirements for NIH-funded research, aimed at expanding the inclusion of women and minorities in clinical research. These requirements specified that any trials including women should be designed and carried out in a way to make it possible to analyze whether the variables being studied affected women differently. In 1994, the FDA established the Office of Women’s Health to address sex-based variances in biomedical research.

In 2016, NIH committed to improving health outcomes of women through the “Consideration of Sex as a Biological Variable” policy. That same year, the 21^st Century Cures Act addressed reporting of the proportion of female clinical research subjects in NIH-funded studies and created a task force to explore research as to pregnant and lactating women. “Only in 2019 were pregnant women no longer presented as an example of a vulnerable population,” said a Milken Institute report on the Act, “having been labeled as such and restricted from participating in clinical trials since 1975 due to concerns about potential teratogenic effects and adverse pregnancy outcomes.”

Despite these advances, the historical and persistent exclusion of women in clinical trials has caused significant gaps in data, funding, and innovation in women’s health research. The effects of the disproportionality of women in clinical trials continues to be apparent in most aspects of human health. For the past 24 years, women in the United States have reported adverse events from approved medicines 52 percent more frequently than men. Further, the lack of women-specific data and analysis leads to the underestimation of disease severity and health burden, and influences the level of innovation and investment in women’s health. It is estimated that better addressing investing in women’s health could boost the global economy by at least one trillion annually by the year 2040. In efforts to bolster the research and advancement on women’s health, the Biden Administration has launched key initiatives to fundamentally change how women’s health is approached and funded.

Women’s Health Research as a “First-Thought” and Not an “Afterthought”

In November 2023, the President and First Lady launched the White House Initiative on Women’s Health Research, with the goal of transforming women’s health. On February 21, 2024, First Lady Jill Biden announced funding as the first major deliverable of the White House Initiative on Women’s Health Research through the Advanced Research Projects Agency for Health (ARPA-H). ARPA-H introduced the “Sprint for Women’s Health,” which committed $100 million towards development and transformative research in women’s health. First Lady Jill Biden expressed that the ARPA-H would close gaps, accelerate new ideas, and “build a health care system that puts women and their lived experiences at its center…” To further expand the White House Initiative, President Joe Biden announced the Executive Order on Advancing Women’s Health Research and Innovation, on March 18, 2024. It is the most comprehensive set of executive actions ever taken to enhance women’s health research.

The Executive Order seeks to integrate and prioritize women’s health across the federal research program. It directs agency members of the Initiative (including the Secretary of Defense, the Secretary of Agriculture, the Secretary of Health and Human Services, the Secretary of Veteran Affairs, the Administrator of the Environmental Protection Aency, and the Director of the National Science Foundation) to develop and strengthen research and data standards for all relevant federally funded research and other federal funding opportunities. Agency members shall consider issuing new guidance, application materials, reporting requirements, or strategies on research dissemination. This will include requiring eligible applicants to explain how the proposed study designs will advance women’s health, improving accountability for grant recipients by requiring reporting on their implementation and compliance with standards related to women’s health, and enhancing efforts to recruit and retain women in clinical trials.

The next major goal of the Executive Order is to prioritize investments and funding for women’s health research. The Executive Order declares that agency members of the Initiative shall identify and prioritize grantmaking and other awards to advance women’s health research. Members may accomplish this through a variety of means that include, but are not limited to, promoting collaborative and interdisciplinary research, addressing health disparities and inequities that mainly affect women, and translating research advancements into improved health outcomes. There is also a call for agency Members, along with the Director of the National Science Foundation, to consider the opportunities and challenges that may affect women’s health research in the context of implementing artificial intelligence technologies. These funding efforts are to be accompanied by a call to advance women’s health innovation in order to fully evaluate the needs of women.

The Executive Order establishes plans to assess and address the unmet needs of women. The Director of the Office of Management and Budget will work alongside the Assistant to the President and the Director of the Gender Policy Council to lead an effort that will identify current gaps in federal funding for women’s health research. These gaps will be turned into recommendations describing the additional funding and programming necessary to catalyze research on women’s health. Furthermore, these recommendations shall identify potential statutory, regulatory, budgetary, or any additional changes that may be necessary to ensure that federal law, policies, and programs are more effective in supporting women’s health.

Federal Agencies Commit to Women’s Health

There are numerous initiatives, including the “Sprint for Women’s Health,” to support the Executive Order’s efforts to enhance innovation and new discoveries in women’s health. The NIH committed to increasing funding for innovative and early-stage small businesses engaged in women’s health research and will be launching a new initiative dedicated to conducting research on biomarker discovery to improve the ability to prevent, diagnose, and treat conditions that primarily affect women. The FDA is seeking to address gaps in research and availability of products for diseases and conditions that primarily impact women and is committed to research and regulatory initiatives that will drive the development of safe and effective medical products for women. Lastly, the NSF Engineering Research Visioning Alliance is launching initiatives to identify high-impact research opportunities in engineering that can improve women’s health.

The NIH plans to identify common data elements that will help researchers share data sets to improve accuracy when it comes to women’s health. The Centers for Medicare & Medicaid Services (CMS) is introducing guidance to ensure that new medical services and technologies work well in women. The Centers for Disease Control and Prevention (CDC) along with the Health Resources and Services Administration are building on existing datasets regarding women’s health to improve the collection, analysis, and reporting of such data, which includes expanding quality measures across a woman’s lifespan.

Additionally, agencies are dedicated to strengthening the overall coordination, infrastructure, and training to support women’s health research. The Department of Defense will invest in the Military Women’s Health Research Partnership, which will provide research on a wide range of health issues affecting women in the military. The Environmental Protection Agency plans to direct the Board of Scientific Directors to advance research with consideration of the intersection of women’s health and environmental factors. The CDC and the American Board of Obstetrics and Gynecology will expand training, allowing clinicians to gain health research skills needed to improve the health of women and children exposed to or affected by mental health, substance use disorders, and infectious diseases.

Several agencies have dedicated efforts to improving health during all phases of a woman’s life. NIH will be launching a first-ever “Pathways to Prevention” series, an independent, evidence-based process to synthesize current data, identify gaps and develop a roadmap to guide the field forward in regard to menopause and treatment of menopausal symptoms. The Agency for Healthcare Research and Quality will build evidence about elements of primary care that influence patient outcomes and health equity to shed light on the vital targets for improvement in the delivery of primary healthcare to women. These agency efforts will be vital to the success of the executive order and in moving the needle on women’s health.

Conclusion

The White House Initiative on Women’s Health Research along with the Executive Order on Advancing Women’s Health are poised to lead to innovation that has long been needed to improve women’s health. The ARPA-H seeks to tackle health challenges faced by women through investments to advance medical treatments for conditions and symptoms that are unique to women. The Executive Order bolsters these efforts by directing agencies to develop and strengthen research data standards, with the goal of ensuring that federal funding improves women’s health. The intended breadth of these efforts is undeniable. Given the timing of the announcement during an election year, however, it remains to be seen to what extent the 2024 Presidential elections (and a possible change in Presidential Administration) may impact progress toward the goals set forth in the Executive Order.