The ‘Monumental’ Step Forward for Women’s Health
All the buzz around the White House’s executive order to advance women’s health research is simply excitement over what the future holds.
Last week, when President Joe Biden signed a sweeping executive order to expand and improve women’s health research, it was only a matter of hours before health professionals responded to the magnitude of the action.
“This is a monumental step forward for women and for advancing our health equity,” says Nicole Woitowich, executive director of the Northwestern University Clinical and Translational Sciences (NUCATS) Institute and a research assistant professor in the department of medical social sciences at Northwestern University’s Feinberg School of Medicine. “This is really the work of advocacy that’s been done over the past several decades by myself, and many others who’ve highlighted the fact that women are underrepresented, understudied and our research underfunded.”
Women have historically been underrepresented in medical research. In February, the first lady and her husband launched the first-ever White House Initiative on Women’s Health Research, which Dr. Jill Biden heads. It aims to fundamentally change how women’s health research is approached and funded in the United States.
The executive order signed March 18 is far reaching and will direct the most comprehensive set of executive actions ever taken to expand and improve research on women’s health, according to the White House. Indeed, the executive order is designed to ensure that women’s health is integrated and prioritized across the federal research portfolio and budget. The move came after President Biden called on Congress during the State of the Union to make a $12 billion investment to create a Fund for Women’s Health Research at the National Institutes of Health (NIH).
Again, Woitowich stressed to East Wing Magazine in a phone interview that the White House initiative is “gigantic” especially because of the amount of funding behind it. She speculated that outcomes from the executive order may not be immediate, but depending on what is being looked at, it could take a few months to a few years. Critical for the executive order, Woitowich says, was the creation of infrastructure for the research.
“A lot of this data exists,” she says. “If we can have the infrastructure and the resources to examine what data we might already have collected about women’s health that perhaps might not have been analyzed, that might be done sooner.”
Outcomes from additional research that may need to get started, she adds, may take quite a few years.
The president and first lady also announced more than 20 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). It also includes the launch of $200 million in 2025 to fund new, interdisciplinary women’s health research, the first step to establishing the Fund on Women’s Health.
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 research and development in women’s health.
“I am passionate about women’s health and making sure that we consider sex in biomedical research instead of continuing along with the assumption that everything works exactly the same in men and women, despite so many very obvious differences in health and disease,” said Barbara Stranger, associate professor of pharmacology at Feinberg who appeared in November 2023 in a virtual panel, “Sex as a Biological Variable,” convened by the NIH Office of Research on Women’s Health.
Additionally, Woitowich hopes that the spirit of funding for Women’s Health Research extends into her area of biomedical research that focuses on females—not just women, but also mice, rats and even cells.
“It will help us make significant improvements in this area and, perhaps in some cases, push folks to be doing the sort of data analysis and collection that we should have already been doing,” she says.
In other more obvious areas of women’s health, Woitowich hopes the focus will look specifically at maternal morbidity and mortality rates. The Centers for Disease Control and Prevention (CDC) reports that maternal mortality has been rising in the United States with 1,205 women who died of maternal causes in 2021, compared with 861 in 2020 and 754 in 2019.
“It is just unconscionable to have that sort of high level of morbidity and mortality rate, especially for women of color, who have the highest rates of morbidity and mortality related to pregnancy,” Woitowich says. “I’m hoping we can start to make some advances in that space.”
“It is just unconscionable to have that sort of high level of morbidity and mortality rate, especially for women of color, who have the highest rates of morbidity and mortality related to pregnancy,” Woitowich says. “I’m hoping we can start to make some advances in that space.”
Furthermore, Woitowich says women’s health has been considered just obstetrics and gynecology. But, it's so much more.
“There’s so much we don’t know about women’s health because we simply have not been studied at the same level that male cell animals and humans have,” she says. “This is really a period of time where we’re going to be able to make new discoveries about women’s health across all body systems and not just our reproductive health.”
When Jill Biden announced the White House’s Women’s Health Research Initiative in February scholars also recognized the effort as historically significant. Anita McBride, director of American University’s First Ladies Initiative and former chief of staff to former First Lady Laura Bush, told East Wing Magazine that the first lady’s influence with the initiative “is important not only for the White House, but it is important for those organizations that are her partners in this [initiative] that are invested in these issues, whether it's health research centers, whether it's university research centers that are maybe going to get some of this money.”
McBride, co-author of Remember the First Ladies: The Legacies of America’s History-Making Women, also added, “There are a lot of people invested in making sure that this is staying front and center as much as possible.”
Presidential executive orders don’t guarantee forever funding for initiatives when new administrations transition into the White House. While Woitowich admits she is no policy expert, she says with an election year upon us she would be concerned if a different administration would not seek to advance women’s health research in the same way the Biden Administration has.
“They see a renewed focus, a renewed energy and the nudge to get us going in the right direction.”
— Nicole Woitowich, executive director of the Northwestern University Clinical and Translational Sciences (NUCATS) Institute and a research assistant professor in the department of medical social sciences at Northwestern University’s Feinberg School of Medicine.
The action has set off a flurry of excitement, she says, and has gotten people in the healthcare field talking.
“This was coming up at nearly every meeting or call I have on the topic,” Woitowich says. “They see a renewed focus, a renewed energy and the nudge to get us going in the right direction.”
Here’s how the executive order breaks down:
Women’s health, as directed by the executive order, will be integrated across the federal research portfolio. Building on current NIH policy, federal agencies have been given the directive to ensure women’s health is being considered at every step in the research process from prospective grant applications to the way agencies report on grant implementation.
Agencies have been directed to prioritize funding for women’s health research and encourage innovation through ARPA-H and multi-agency initiatives such as the Small Business Innovation Research Program and the Small Business Technology Transfer Program. It further directs HHS and NSF to study ways to leverage artificial intelligence to advance women’s health research.
The executive order directs HHS to expand data collection efforts related to women’s midlife health; launch a comprehensive research agenda guiding future investments in menopause-related issues; and develop new resources to help women better understand options for menopause-related symptoms prevention and treatment. The order also directs the DoD and the VA to study and take steps to improve the treatment of and research related to menopause for service women and women veterans.
The Office of Management and Budget and the Gender Policy Council have been directed to assess gaps in federal funding for women’s health research and identify changes that are needed to support women’s health research across the federal government. Agencies will also be required to report annually on their investments in women’s health research.
In tandem with the executive order, several federal agencies also announced new actions they are taking to promote women’s health research that include the following:
Beginning in 2025, the NIH has $200 million set aside to allow the agency to catalyze interdisciplinary research that cut across the traditional mandates of the agency. It will allow the NIH to launch multi-faceted projects such as research on the impact of perimenopause and menopause on heart health, brain health and bone health.
The NSF is calling for new research and educational proposals to advance discoveries and innovations related to women’s health.The NSF is inviting applications that would improve women’s health through a range of disciplines from computational research to engineering biomechanics. This is the first time NSF has broadly called for novel and transformative research focused entirely on women's health. Proposals will be considered on an ongoing basis.
The Environmental Protection Agency is updating its grant solicitations and contracts to ensure that applicants prioritize the consideration of women’s exposure and health outcomes.
The NIH will create 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 the cumbersome search of each of NIH’s 27 institutes.
The NIH’s Small Business Innovation Research Program and the Small Business Technology Transfer Program is committing to increase by 50% its investments in supporting innovators and early-stage small businesses engaged in research and development on women’s health.
The FDA seeks to advance efforts to help address gaps in research and availability of products for diseases that primarily impact women. The agency also plans to issue guidance on the inclusion of women in clinical trials.
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.
The 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.
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.
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.
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.
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 responsible for identifying research gaps, fostering collaboration, and coordinating and a unified response.
The 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 focusing on environmental factors and women’s health, including maternal health.
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.
The 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.
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.
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.
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).