Issue 183  /  October 20, 2026  /  Feature

$5B Less For NIH and A Seat For the FDA

We read the new order against the one it revoked. The market already showed which lever works.

$5B Less For NIH and A Seat For the FDA

The Luteal read Monday's executive order on women's health against the 2024 order it revokes, section by section, then checked both against what federal agencies have measurably done in the category over the past year.

The comparison shows where the administration expects women's health to move.

The market data shows it already has.

President Trump signed Advancing Women's Health to Improve Outcomes in All Phases of Life on October 19, alongside First Lady Melania Trump, who led the effort.

It directs NIH to establish a Women's Health Division inside an existing institute or center within 90 days, which lands around January 17, 2027. It creates a White House Women's Health Task Force co-chaired by HHS Secretary Robert F. Kennedy Jr. and Chief of Staff Susie Wiles. HHS covers the task force's administrative costs. Everything else runs subject to the availability of appropriations, the same clause the 2024 order carried.

Executive Order 14120, signed in March 2024, told the Office of Management and Budget to calculate federal funding for women's health research every year and feed the gaps into the budget process. It named Small Business Innovation Research and Small Business Technology Transfer grants, ARPA-H, the Congressionally Directed Medical Research Programs, and innovation funds and prizes as routes to commercialization. It ordered a review of the state of menopause science within 90 days and set reporting deadlines at 30, 90 and 180 days, then every year after.

None of that language survives in the new order.

What does survive is the commitment to including women and girls in clinical trials and holding NIH grantees to the agency's policy on sex as a biological variable.

The new order adds a seat for the regulator and the payer. The Commissioner of Food and Drugs, the CMS Administrator and the ARPA-H Director are among 11 named members of the task force besides the two co-chairs. The task force can advise agency heads on pilot programs that change incentives around prevention, early intervention and treatment, and on keeping a reliable supply of providers and medical products. The 2024 order's agency roster named the secretaries of Defense, Agriculture, HHS and Veterans Affairs, the EPA Administrator and the NSF Director. It did not name the FDA or CMS individually.

Kennedy described the direction to Senate appropriators in April. "We are compressing the pathways to approval and compressing clinical trials," he told the committee.

The clearest evidence of what that lever can do is already in the market. In November 2025 the FDA asked manufacturers of menopausal hormone therapy to remove boxed warnings about breast cancer, cardiovascular disease and probable dementia. No new trial preceded the request.

The agency based it on a review of the existing literature, a July 2025 expert panel and a public comment period. On February 12, 2026 it approved the first six relabeled products, out of 29 manufacturers that had submitted changes.

On September 3 the FDA said the supply of approved estradiol patches had nearly doubled over the previous year, and attributed the rise in demand to its November labeling action. That is the agency's own figure and it gives no base number. This month the Association for Accessible Medicines, the generic drug trade group, published a count. Its analysis of IQVIA data shows dispensed estrogen patch prescriptions rising from 1.8 million to 3.6 million between January 2025 and June 2026. The figure is aggregator-computed by a trade association whose members supplied most of the increase. AAM does not state the counting period behind each figure, and it notes that its Amneal data covers estradiol products that may include more than patches.

Truveta, a health data company, found estrogen hormone therapy prescribing rose from 11.5 to 23.5 per 1,000 women between January 2018 and February 2026, and kept climbing after the July 2025 panel. Truveta's figures come from a subset of its own records rather than a national sample. The label change accelerated a trend already underway.

A regulatory action with no new evidence behind it was enough to move a market that was already moving.

Six companies make estradiol patches for the US market, and the FDA says larger expansions take time because the product needs specialized equipment and manufacturing processes.

The agency maintains that patches remain available, while noting that brands vary by pharmacy and location. Bayer has said it expects periodic supply shortfalls of its Climara patch until at least early 2027, a company-stated timeline, and Viatris has added a shift at its Vermont facility. The bottleneck in menopausal hormone therapy has moved from the prescriber to the production line.

The administration's FY2027 budget request for NIH is $5.0 billion below the FY2026 level, according to NIH's own budget office. The House Appropriations Committee rejected that cut in June and proposed $100 million above FY2026 instead, and full-year funding has not been enacted. At the same April hearing, Senator Susan Collins, who chairs the Senate Appropriations Committee, pressed Kennedy on a decline in NIH-funded women's health projects and said grants were "being scanned for the word 'women.'" NIH Director Jay Bhattacharya said Monday that the new division would "bring discoveries closer to patients."

It will sit alongside the NIH Office of Research on Women's Health, which Congress funded at $106.48 million in FY2026, according to the Congressional Research Service.

The field's main research groups welcomed the order.

The Society for Women's Health Research, the American College of Obstetricians and Gynecologists and the Women First Research Coalition issued a joint statement supporting it and tied it to their own framework calling for $20 billion in women's health research and care over 10 years, as reported by Healio.

CMS already runs a women's health payment experiment the task force inherits. The Transforming Maternal Health model is the first CMS Innovation Center model focused only on maternal care. It runs from 2025 to 2034 across 14 states and the District of Columbia, each eligible for up to $17 million in cooperative agreement funding. A three-year pre-implementation period is followed by seven years in which states move maternity providers onto value-based payment. It covers Medicaid and CHIP only, and its terms were set before Monday's order.

The two orders describe different theories of how women's health improves. The 2024 order treated it as a research deficit and built machinery to count the deficit and close it. The 2026 order treats it as a translation problem and puts the agencies that set labels and payment rules in the room. The hormone therapy record is the clearest market test either theory has had this year, and it favors the second.

Within a year of the label request, patch supply nearly doubled.

A research division funded from existing appropriations has no mechanism to produce a comparable signal on that timeline.

FDA labeling actions and CMS payment terms now say more about where the category is going than NIH program announcements. The order sets one date, the NIH division by mid-January. Nothing else on the task force's list has a deadline, so the first real signal of its intent will come from what the FDA and CMS do next rather than from anything the task force publishes.

Most of the evidence behind the label change already existed.

What the market was waiting for was permission.

This article is for informational purposes only and is not medical advice.

---

Sources

Primary

Aggregator-computed

Company-stated

Secondary

— Keisha, Editor of The Luteal