The FDA’s new, more open tone on compounded bioidentical hormones is a promising shift—but without sustained public pressure, meaningful change is far from guaranteed. Action Alert!
THE TOPLINE
- FDA Commissioner Marty Makary signaled a potential break from the agency’s long-standing, biased hostility toward compounded bioidentical hormone therapy, offering a rare opportunity to push for evidence-based policy.
- Despite this encouraging tone, the FDA could still move to ban key compounded hormones like estriol based on a flawed, industry-influenced NASEM report that misrepresents the science and patient experience.
- Protecting access to cBHRT will require continued advocacy to ensure the FDA rejects the NASEM recommendations and preserves individualized, patient-centered hormone care.
In a surprising turn, FDA Commissioner Marty Makary made a comment recently that may signal a long-overdue shift in the agency’s position on compounded bioidentical hormone therapy (cBHT). During a press conference about removing black-box warnings from hormone products, Makary struck an encouraging tone when asked about compounded hormone therapy, suggesting that under his leadership, the FDA may take a more evidence-based, patient-centered view—unlike the government’s previous position that cBHRT is a “public health concern.”
If Makary’s remarks reflect a shift not just at the head of the agency, but also inside the agency, it could mark a significant victory for patients and practitioners. But we must remain vigilant and continue to make our voices heard. Particularly given that cBHT will be seen by Big Pharma manufacturers of synthetic HRT as direct competition.
How We Got Here
Estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List (under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act); items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. ANH-USA and other stakeholders pushed back forcefully against the nomination of estriol and other compounded hormones, so the FDA convened a NASEM committee to study cBHRT and aid in the agency’s final determination.
It is our view that the FDA wanted to ban hormones but knew they couldn’t do it quietly due to the large consumer response, so they commissioned NASEM to study the matter and give them cover to ban these hormones.
Unsurprisingly, the resulting report was hostile toward these therapies, claiming that their “widespread use poses a public health concern” due to “a lack of high-quality evidence.”
This conclusion ignores scientific literature showing that bioidentical hormones—when prescribed and compounded appropriately—can offer lower risks of breast cancer and cardiovascular disease and better symptom relief than synthetic or animal-derived hormones. It also ignores decades of clinical experience of tens of thousands of American women.
NASEM, it must be recognized, is not the objective, neutral body it purports to be. For example, conspicuously missing from the committee was anyone with an expertise on how compounded bioidentical hormones are used to treat patients. Further, a review of NASEM’s financials shows that they accept millions in donations from Big Pharma—that is, the very players that stand to gain from the elimination of cBHRT, which competes with pharmaceutical menopause products.
It’s also clear that the FDA was heavily involved in the development NASEM’s final report, all but guaranteeing that it reached the “proper” conclusions. The most glaring example of this is the FDA’s insistence that Jane Axelrad, former associate director for policy at the FDA’s Center for Drug Evaluation and Research and the agency’s lead on compounding issues, help develop the NASEM committee’s final report. In her work overseeing the compounding industry, Ms. Axelrad on numerous occasions stated publicly her opposition to compounded medicines.
The point is, this was not an unbiased analysis of the facts. From the beginning, it was a carefully managed process to arrive at the desired conclusion: a ban on cBHRT.
What’s at Stake
To be clear, the FDA has not yet moved forward with a ban, which would require a formal rulemaking. We emphasize yet.
But when the FDA finalizes this ban, countless patients will lose access to the personalized hormone therapies that have improved their quality of life—sometimes after years of trial and error with commercial products that didn’t work or caused side effects.
By eliminating competition from compounded products, the FDA effectively hands the market over to a few large pharmaceutical manufacturers. Women lose, patients lose, and innovation loses.
A Chance to Change Course
Commissioner Makary’s recent comments give us a rare opening. They suggest that he recognizes the need to take a fresh look at compounded hormones based on real-world evidence and patient outcomes—not bureaucratic bias or industry pressure.
For years, ANH-USA has submitted data, practitioner testimony, and patient experiences to the FDA showing that compounded bioidentical hormones are safe, effective, and essential for individualized care. Makary’s remarks could mean that work is finally being heard.
But make no mistake: until we see concrete policy changes—such as the FDA rejecting NASEM’s conclusions and ensuring estriol remains available—this fight isn’t over.
Tell the FDA and Congress: stop the attack on compounded bioidentical hormones, listen to patients—not industry—and preserve access to individualized, evidence-based care.
Action Alert!