Biden-Harris Administration to Establish Landmark Initiative on Women’s Health Research

In a bold move to close glaring research gaps in the underfunded area of health study, President Joe Biden is establishing a new White House Initiative on Women’s Health Research, helmed by First Lady Jill Biden and the White House Gender Policy Council.¹

“Every woman I know has a story about leaving her doctor’s office with more questions than answers, not because our doctors are withholding information, but because there’s just not enough research yet on how to best manage and treat even common women’s health conditions,” said First Lady Jill Biden in a news release, nodding to the timely and critical nature of the Initiative.¹

The President outlined key steps that the Initiative will take during its initial launch and explained how congressional leaders, the private sector, research institutions, and philanthropists are being called on to support its mission.

The Initiative will consist of representatives from executive departments and agencies across the Federal government, including the US Departments of Health and Human Services, Defense, and Veterans Affairs, as well as the Office of Management and Budget, and the Office of Science and Technology Policy.

Once established, Initiative members will be given 45 days to form recommendations about concrete actions that the Biden-Harris Administration can take to advance, improve, and maximize investments in women’s health research. Initiative members will mark priority areas of research that, if given additional investments, could lead to major breakthroughs. As they affect women, these areas include Alzheimer’s disease, endometriosis, menopause, and more.

By forging new public-private partnerships and combining the power of scientific, private, and philanthropic sectors, the Initiative will work toward further accelerating innovation in the field of research on women’s health.

The Initiative will be chaired by active clinician, professor, and NIH-funded researcher Carolyn Mazure, PhD, a professor in women’s health research and of psychiatry and psychology at the Yale School of Medicine, and the creator of Women’s Health Research at Yale, the university’s interdisciplinary research center on the health of women.¹

Women have historically been understudied and underrepresented in health research despite representing more than half of the nation’s population, painting a dangerously incomplete picture of women’s health and causing serious consequences for the wellbeing of women across the country.¹ The lack of data collected on women’s health stems partly from participatory restrictions placed on clinical research in the twentieth century: in 1977, the FDA recommended that women of “childbearing potential” be excluded from phase I and phase II drug trials.²

Coming off the heels of the thalidomide tragedy, the recommendation to exclude “premenopausal females capable of becoming pregnant” was made under the claim that it was protecting a vulnerable population.² Evident by the implementation of the Biden-Harris Initiative, however, the health sector is still grappling with its effects; although eventually reversed in 1993, the recommendation created a vacuum of women’s research spanning more than 15 years.

The focus on childbearing and fertility associated with women’s health has persisted even in recent times, creating a narrow view of the woman, rather than the ‘prepregnant mother’, as a topic of study.³ Although the National Institutes of Health now requires the participation of women in research it funds, women only make up between 29% and 34% of participants in early-phase trials sponsored by the pharmaceutical industry due to concerns about potential harm dealt to future children.^4,5

The dearth of knowledge on women’s health issues has had a profound impact on the overall health of the population, the effects of which have been illustrated in prior research. One study found that the historical underrepresentation of women in clinical trials, paired with the application of a one size fits all approach between the 2 sexes, has contributed to an increased risk of adverse drug reactions among women.⁶ Other research found that women are more likely than men to have their heart attacks initially misdiagnosed due to the lack of data on their unique presentation among members of the sex.⁷

Inequities caused by the undervaluation of women’s health are exactly what the Initiative spearheaded by the Biden-Harris Administration hope to address.

“If we act swiftly, we can pioneer the next generation of discoveries in women’s health–improving the lives of millions of women,” the Administration said in statement.

References

1. FACT SHEET: President Joe Biden to announce first-ever White House initiative on women’s health research, an effort led by First Lady Jill Biden and the White House Gender Policy Council. News release. The White House. November 13, 2023. Accessed November 17, 2023. https://www.whitehouse.gov/briefing-room/statements-releases/2023/11/13/fact-sheet-president-joe-biden-to-announce-first-ever-white-house-initiative-on-womens-health-research-an-effort-led-by-first-lady-jill-biden-and-the-white-house-gender-policy-council/

2. Gender studies in product development: historical overview. Article. FDA. February 16, 2018. Accessed November 17, 2023. https://www.fda.gov/science-research/womens-health-research/gender-studies-product-development-historical-overview

3. Waggoner MR. Motherhood preconceived: the emergence of the Preconception Health and Health Care Initiative. J Health Polit Policy Law. 2013;38(2):345-371. doi:10.1215/03616878-1966333https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3656594/

4. Cottingham MD, Fisher JA. Gendered logics of biomedical research: Women in U.S. phase I clinical trials. Soc Probl. 2022;69(2):492-509. doi:10.1093/socpro/spaa035https://academic.oup.com/socpro/article/69/2/492/5920830?login=true

5. Chen A, Wright H, Itana H, et al. Representation of women and minorities in clinical trials for new molecular entities and original therapeutic biologics approved by FDA CDER from 2013 to 2015. J Womens Health (Larchmt). 2018;27(4):418-429. doi:10.1089/jwh.2016.6272https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7001461/

6. Zucker, I., Prendergast, B.J. Sex differences in pharmacokinetics predict adverse drug reactions in women. Biol Sex Differ 11, 32 (2020). https://doi.org/10.1186/s13293-020-00308-5https://bsd.biomedcentral.com/articles/10.1186/s13293-020-00308-5

7. Wu J, Gale CP, Hall M, et al. Editor's Choice - Impact of initial hospital diagnosis on mortality for acute myocardial infarction: a national cohort study. Eur Heart J Acute Cardiovasc Care. 2018;7(2):139-148. doi:10.1177/2048872616661693https://academic.oup.com/ehjacc/article/7/2/139/5932651?login=true