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 $100 M 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. One 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, so along with 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 $100 M 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.

I didn’t want to rely on my own bias to call out these “hey, take a look at this!” items. So, once again, I called on some very smart women to ask which of these excited them. I’m hoping that this list — though random — will inspire more allies, innovators, and researchers to dig into the list of 23 EO initiatives. This is undoubtedly the largest expression that anyone has seen of what the Federal Government could do to improve women’s health — and possibly the largest we will EVER see.

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 invest 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; Liz Powell, founder of G2G Consulting; 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.

• The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh?
• The year we found the hormone causing acute morning sickness?
• Impressive and large funding rounds despite a bleak funding environment?
• “Birth control for men” makes it to the clinical trial stage?

…..Was 2023 actually a GOOD year in women’s health?

In the shadow of one very, bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.

My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got to add observations from Dr. Barbara Levy; from CEO/Founders Somer Baburek (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada Hanafi; investors Jessica Karr, and Susan Solinsky; and Ayse McCracken, Director and Founder of Ignite Health, an Accelerator supporting female founders and executives creating life science companies.

What did we miss? A lot, certainly. Please add your “bright spots of note” to comments. And then if insult gets added to injury in 2024 (upholding the Texas decision overturning the FDA approval of the Plan B pill? PLEASE TELL ME NO!) we can have something to look back at to cheer us up.

BRIGHTSPOTS IN WOMEN’S HEALTH FROM THE YEAR 2023

Gaslighting no more? Attention, Support, and validity

“I think one of the most compelling things has been the publicity around gaslighting women — dismissing and refusing to treat our symptoms of menopause, endometriosis and highlighting the embarrassing inequities in maternal health outcomes” Said Dr. Levy, OB/GYN, former head of research for ACOG (the American College of Obstetrics and Gynecology), currently co-chair of the AMA CPT board and Medical Director for Versana Health and Sola Pelvic Therapy. Contributors Robers and Salenger also called out the sea change in tone, with Salenger adding: “While Gaslighting is still a huge issue, the publicity the subject has attracted has helped create awareness.”

Also in this category: The White House Initiative on Women’s Health Research (nominated by Hanafi, Baburek, McCracken and others; The first comprehensive review of investment in women’s health by Silicon Valley Bank highlighting that investment into companies innovating in women’s health has “flourished in the past five years” (and noted by Solinsky, Karr and others); the work of the NIH, among others, to put a focus on ghastly rates of maternal morbidity in the US (noted by Hanafi and myself.)

Hanafi,in particular, pointed out that these efforts often highlighted “the health crises disproportionately disadvantageing black and brown and LatinX women in the US ‘’ and the need to address systemic racism.

The first OTC birth control pill; a path towards contraception for men

In a year where developments in government policy often ran counter to women’s reproductive rights, the FDA’s decision in July to allow for some birth control pills to be sold over the counter was a significant move to get contraception into the hands of all women, and earned Karr’s nomination. Now the fight is happening to make sure that pills bought this way will still get insurance reimbursed with no out of pocket, as specified for contraception under the Affordable Care Act.

And this just in: in December, YourChoice Therapeutics began clinical trials in the UK of the first hormone-free reversible male birth control pill, creating a new path for men to take part in reproductive decisions.

Funding yes. But with some significant improvements.

The year 2023 was something of a car wreck for private investment in general but in contrast, according to the SVP report, “women’s health is seeing more of a speed bump.” Looking at the five year trends in funding of this sector, in 2023 there were some differences. Somer Baburek noted that big later stage raises are happening (I.e. Maven’s $90 M raise.) And while the early funding focus was on digital health innovations particularly in fertility and maternity, now companies born of solid advances in life science research are breaking through.

AOA DX’s $17 M 2023 seed raise, for instance, will bring its liquid biopsy-based diagnostic for #ovariancancer closer to market. With this raise, AOA Dx has received a total of $24 M in seed funding. This may, in itself, be a record for a company innovating in women’s health. Another breakthrough diagnostic is coming: Hera Biotech, the company founded by Barburek, is completing its first round of clinical trials for a tissue-based diagnostic for endometriosis. With a tool that diagnoses with more certainty than saliva or blood-based attempts to test for endo, pharma companies will be better able to look for therapies and fertility clinics can identify the 50% of their patients for whom endo may be the root cause of their infertility.

And YAY for Science!

This one’s from my list: In 2023, we learned that the HPV vaccine may be lowering rates of cervical cancer by 65%. In fact, the vaccine has been so effective that the lower incidence of cervical cancer brought down the overall US cancer rate. We know the vaccine deserves the credit because 2023 was the year the first cohort who got vaccinated could be looked at from a 10-year perspective.

This bodes very well for other advances that are just now coming to market.

“The approval of an oral, at-home treatment for severe postpartum depression, zuranolone (despite its $15,000+ price tag) is a brightspot. (It) allows a woman to remain home with her newborn and family,” noted Dr. Levy. Karr also named this as one of her “bright spots.”

And when funding is there for science, it turns out that “mystery ailments” have a cause. In another win for 2023, in December the journal Nature reported that the cause of acute morning sickness turns out to be a hormone — GDF15. With the cause known, the therapies can be developed.

The Embrace of Doulas

Maternal mortality in the US tops that of any developed economy and the rates are greatest among disadvantaged populations including black, brown, Indian, and low-income women particularly living in a rural area. Sadly, 2023 was not a year that saw any movement in that sad statistic.

But, as noted by Melissa Bowley, CEO and Founder of Flourish Care, 2023 IS the year that both government and private insurers began paying for one of the things — Doulas — that can make a difference. Evidence shows that when a Doula is involved, NICU rates, C-section rates, and postpartum depression rates go down — dramatically — and breast-feeding rates go up among other benefits.

Just in November, the nation’s largest private employer, Walmart, said it would reimburse employees who use a doula up to $1K per birth, joining companies like Microsoft and CVS who have similar policies. On the medicaid side — which covers 42% of the country’s births — the US Department of Health and Human Services announced in December its Transforming Maternal Health (TMAH) initiative which includes doula care as a component of personalized care for mothers it will help fund in 15 states. At this point, with lots of activity taking place in 2023, nearly half of states’ Medicaid programs are either providing reimbursement for Doulas, or in the process of making laws that will have that result.

At the root of progress: Better definitions

The brightest spot in 2023 may be that the common understanding of what constitutes “Women’s Health” is changing, a development nominated by Solinsky. It can be argued that all advances — diagnosis, funding, the development of therapies — depend on solid data collection that shows the breadth of problems (and the opportunity inherent in addressing them) as well as provides the quantitative understanding that can lead to therapies.

So the broadening of “women’s health” beyond a focus on women’s reproductive and “women only” diseases to include the fast panarama of “mostly women” or “different in women” makes a difference. In April, McKinsey issued this report (brought to my attention by Salenger) documented just how big a difference this change makes, and also chronicling the data gaps, their consequences, and where progress can be made. brightest spot in 2023 may be that the common understanding of “Women’s Health” is changing. It can be argued that all advances — diagnosis, funding, the development of therapies — depend on solid data collection that shows the breadth of problems (and the opportunity inherent in addressing them) as well as provides the quantitative understanding that can lead to therapies.

A Solid and Collaborative Community

Each accomplishment noted above — and others that I know will be added in comments — was born of a community of scientists, private and governmental funders, start-up founders, authors and policy makers who have spent the last few years (and sometimes the last decades, looking at you, WHAM) fighting for improvements in women’s health. So I’ll end this list of “Bright spots” in 2023 with a profound thank you to this community. It’s been hard and frustrating. But take a moment to note what happened this year and take a bow.

Please contribute

This is a partial list and I’m truly counting on the readers to help make this more complete. Please take a moment: what happened in Women’s health in 2023 that you think deserves noted?