Re-Visiting the Executive Order on Women’s Health Research

It’s been two weeks since President Biden signed the Executive Order (EO) to advance women's health research and innovation. That action complemented an announcement made at the end of February that ARPA-H (a federal agency within the US Health and Human Services Department) would allocate $100M of its funding to transformative research and innovations in Women’s Health.

?Together these initiatives represent a historic investment and commitment with impact beyond the funded projects.? An executive at one of the nation’s largest health providers told me privately “Our executive team believes this gives our work on projects aimed squarely at women’s health credibility. And we believe it’s about damn time.”

But following the initial celebrations, I’ve heard a lot of questions. As an ally and observer (not by any means an official spokesperson) I thought some context about what happened as well as an update on activity would be valuable. Additionally, the more I read the EO (which is easiest to digest via the Fact Sheet)? the more I am struck by some of the extraordinary and consequential items tucked amongst the 23 (23!) actions that federal agencies promised to undertake. Taking advantage of the expertise of some of the smartest women I know in this domain, I’m going to highlight some items that might have otherwise been missed.

Question #1: Is this going to Happen? Even beyond the Presidential Elections?

Watching the ceremony and signing happen in the White House produced a spasm of joy among allies. Beneath the glee, however, some worried that everything could come undone if the Bidens leave the office or if Congress doesn’t act. In large part, those fears are unfounded.?

It’s true that Biden’s call for $12 Billion to fund women’s health research on a national scale, which would include the creation of a new nationwide network of research centers, will only happen if approved by Congress. I think I’m pretty safe in predicting that won’t happen unless Congress gets overhauled in the November elections.

However, both the Arpa-H $100M commitment and the 23 actions promised by the federal agencies utilize dollars already approved and in the agencies’ budgets. With the signing of the order, Biden moved these items from “could be dones” to “will be dones.” The only threat to these dollars and commitments is that future Administrations cut the overall budgets of the institutes (or cut the agencies themselves.)

…And Action is Happening

First steps have been taken on at least three of the promised initiatives. To help you correlate the item I’m referencing to what’s in the fact sheet, I put a number next to each bulleted initiative.

• #3. On March 18th, the National Science Foundation (NSF) Issued a “Dear Colleague Letter” essentially making clear the NSF’s intent to fund research and education proposals in the areas of women’s health. The letter is especially notable in its listing of projects of interest which specifies it welcomes proposals across the gamut of digital and wearable innovations, computational and other models, and proposals to create intra-organization partnerships that could further research (to name just a few.)?
• #6. Arpa-H is speeding towards April 15th, the deadline for submissions for projects across six identified tracks. The timeline will allow for proposals utilizing the $100 M commitment to be funded in September.?
• #5 On March 26th, The Office of Research on Women’s Health (ORWH),? issued a Notice of Special Interest (NOSI): Women’s Health Research pulling together the funding opportunities of 26 Institutes and Centers that are part of the National Institutes of Health (NIH.) This pulls together all of the current, open funding opportunities across institutes and health conditions -- and the ORWH will build on this to fulfill another of the Executive Order actions: The creation of a dedicated one-stop shop on open funding opportunities related to Women’s Health.?

It is possible that other actions have already been taken. If I’ve missed something, please bring it to my attention in notes!

Notable “Bright Spots” within the 23 Executive Actions

The Executive Order lists 23 initiatives from different federal agencies - most prominently the National Institutes of Health (which is part of Health and Human Services) - but also the Department of Defense, the Environmental Protection Agency, the Centers for Disease Control and many others. Two things about these promises: 1) They were pulled together fast because the Administration only asked for commitments from Federal Agencies on November 18th and gave just 45 days for response. 2) They are all funded by dollars already in the budget, so either dollars were moved to make these actions possible or they were largely underway.?

Not surprisingly, operating with that speed and scope, the initiatives themselves feel a bit fragmented, lacking in detail about how they’ll be executed or results implemented, and - in some cases - underfunded. However, within the list of actions there are some that will create meaningful results, and some that represent exciting starts.?Here's where I called on a "kitchen cabinet" of clinicians, researchers, lobbyists, entrepreneurs and investors and asked them to the initiatives they thought were most notable and to explain why.

Responding to my call were: Dr. Barbara Levy, OB/GYN, former head of research for ACOG, current co-chair of the AMA CPT board, Chief Medical Officer for start-ups Dorsata, Uroshape, and VisanaHealth; Dr. Divya Balasubramanian, Staff Physician Department of Emergency Medicine at the Veterans Administration Healthcare system, Palo Alto California; Elizabeth Bailey, Managing Director of RH Capital, one of the most established and influential funds investing in women’s health; Somer Burbarek, CEO of Hera BioTech, a company establishing the first tissue-based diagnostic for endometriosis; Trish Costello, CEO and Founder of the Portfolia Funds, which through it’s FemTech funds has invested in 44 women’s health startups; Vanessa Villaverde, California Health Care Foundation Innovation Fund Investor, and of course, myself, Anna Zornosa, investor, advisor, and mentor focused on women’s health.?

?So, referring to my hand-numbering of the fact sheet so you can cross-reference the quotes to the initiatives, here goes:

#1 A Cross cutting effort across the National Institutes of Health to transform women’s health throughout the lifespan. The action will be supported by $200 M from the NIH in FY 2025, and would potentially include dollars from the President’s FY 2025 budget aimed at doubling the current funding of the NIH’s Office of Research on Women’s Health. The description includes specific language about women’s mid-life issues “such as research on the impact of perimenopause and menopause on heart health, brain health an bone health” and this caught Balasubramanian’s attention: “With women facing increased risks for conditions like cardiovascular disease, Alzheimer's, and autoimmune diseases post-menopause, this (action) addresses the need for better early detection markers, treatment options, and education to promote prevention and recognition,” she wrote.?

#3? The National Science Foundation’s call for new research and education proposals to advance discoveries and innovations related to women’s health was called out by Powell. ? “The Executive Order takes immediate action by ordering the NSF to implement sex-based initiatives now and to create interagency collaboration around women’s health and sex-based data. This starts driving change in how we approach and implement research impacting the health of women,” she said.?

#4 and #17 - Substantial actions by the Environmental Protection Agency (EPA). Nominated by both Levy and myself. The EPA is updating both grant solicitations and contracts so that, where appropriate, applicants prioritize consideration of women’s exposures and outcomes. It will also establish a Women’s Health Community of Practice to coordinate research and data dissemination. This excited me because it’s long been understood that women’s workplace exposure to toxins - for instance, the chemicals widely used in beauty and nail salons - are impacting health in ways for which the EPA has not required measurement. For Dr. Levy “The potential of these actions are huge. Will we get a better understanding of chemicals' impact on menstrual cycles, the age of menopause, and perhaps their role on the escalating rates of PCOS? Will we get insight into how the endocrine modulators in ‘forever chemicals’ are affecting women’s hormones, their fertility and childbirth?”

#6 The Arpa-H (Health and Human Services)? #sprintforwomenshealth initiative, mentioned above but also singled out for comment by Levy. “This is substantial. The dollars allocated - $100 Million - are sufficient to launch numerous projects, the inclusion of companies as potential applicants, and the focus on visionary statements - couched as “what if” scenarios - all allow for something more than incremental change,” she said.

#7 - The commitment from the National Institutes of Health to support private sector innovation by increasing by 50% awards given through the SBIR and STTR grants to women’s health. This caught Bailey’s eye: “I'm excited to see the recognition of the role of the private sector in this initiative.? A leading advocate in women's health recently said to me, ‘What's different in this moment compared to other initiatives over the years, is that we now have venture capitalists and entrepreneurs as part of the equation.’” Bailey said. “We have to leverage the engine of innovation with venture capital and startups to benefit women's health, and government support will surely turbocharge some of those existing efforts.”

#9 - A new NIH initiative to use biomarkers in the early detection and treatment of conditions such as endometriosis. This caught the eye of Barburek whose company looked beyond blood and saliva, both of which have not yielded a stable endo diagnostic, to tissue. “This disease requires significant attention and funding in order to understand its molecular underpinnings.We look forward to seeing this funding used to further the development of diagnostic biomarkers that are definitively and causatively related to the disease, like those in the Hera diagnostic, which are the only means to? drive better understanding of disease development, progression, and mitigation,” said Barburek.?

#12 Standardize data to support research on women’s health through an NIH effort to identify common data developments. With these, researchers can share and combine datasets, promote interoperability, and improve the accuracy of datasets. This effort captured Costello’s attention: ?“Of particular note is the administration's emphasis on improving research and data standards, exemplified by the establishment of a dedicated subgroup aimed at enhancing agency research to better understand and address women's health issues. This strategic focus on research infrastructure is crucial for driving meaningful progress in the field.”

#13 The Centers for Medicare and Medicaid Services (CMS) pledged to wield its formidable power to approve products applying? for coverage (payment) in the Medicare program to require applicants to prove that their services and technologies work well in women, where applicable. Bailey noted the significance of this initiative:? “CMS looking more closely at how new products affect women specifically, and reimbursing appropriately, will ideally incentivize companies to run studies analyzing and reporting any differences across gender.? I hope this piece of the initiative will be expanded to look more generally at reimbursement rates for women's health products and services with an eye toward achieving reimbursement parity as well,” said Bailey.?

#19 Create a comprehensive research agenda on menopause. The NIH will launch a Pathways to Prevention series, meaning an independent, evidence-based process to synthesize what is known today, identifying gaps in research, and developing a roadmap for the future. This report will guide innovation and investments in menopause-related research and care across the federal government and research community.?

Bailey also hailed this ambitious effort. “It's about time that business, healthcare and government acknowledge the needs of women around menopause!? There is so much that we don't know, and much more research is needed,” said Bailey. “By calling menopause out specifically in the research agenda, and directing funding to it, a bright light is being shined on the massive gap in menopause care for women and highlighting the opportunities as well.”

#21 and #23 Two different but important initiatives focusing on the health of underserved communities. The first is an initiative by The Indian Health Service launching efforts including focus groups to understand tribal beliefs related to Menopause. The second is new funding the USDA pledged to recognize early warning signs leading to maternal morbidity and death in recipients of WIC (Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Villaverde applauded the timing of these efforts: ?“Despite impressive reductions in maternal mortality for all racial/ethnic groups in California, Black mothers / birthing people are four to six times as likely to die from pregnancy/birth-related causes and twice as likely to suffer a maternal morbidity (such as hemorrhage and infection) than those in all other racial/ethnic groups.”

I hope this article inspires more innovators and researchers to dig into the Executive Order to explore which initiatives might support their work.? This is the largest effort the Federal Government has ever made to bring attention and funding to diseases that occur only, mostly or differently in women. And, depending on what happens in November, may be the only one we’ll see.