Are the Estriol Ban Rumors True?

A rumor on the FDA’s estriol ban reminds us that the axe could fall on these hormones at any time, and we have to be ready. Action Alert! 

Estriol and other bioidentical hormones that millions of women rely on are in dire threat of being banned. The FDA is working to clear the market of non-FDA-approved hormone products to eliminate competition for approved hormone drugs. The agency has doubled down on its rejection of the science on the safety and benefits of compounded bioidentical hormone replacement therapy (cBHRT), so it is up to consumer advocates to make our voices heard and protect access to these crucial medicines. 

There was an uproar in our community when a rumor circulated that the agency had set a firm date to move forward with the ban on estriol and other hormones. These rumors about timing appear to be false, but it was a good reminder that the FDA can act swiftly, and with little notice, to start the process of removing these hormones for good. To be clear: we know the agency wants to ban compounded bioidentical hormones, it’s just a matter of when.

The FDA’s intentions to ban hormones were made clear in a letter responding to 22 members of Congress who expressed concerns that the agency is eliminating access. In its response, the FDA doubled down on every aspect of the flawed report from the National Academies of Science, Engineering, and Medicine (NASEM). The FDA convened the NASEM committee to assess cBHRT after the natural health community and other stakeholders pushed back against several bioidentical hormones’ nomination to the Difficult to Compound List (items that appear on this final list will be banned from compounding). The final NASEM report was written by non-experts in pharmacy compounding and marred with bias. You can read our previous coverage for more details, but the facts clearly show that the FDA managed the process from the start to ensure that the NASEM committee reached the “proper” conclusions. Unsurprisingly, NASEM’s report concluded that cBHRT was a “public health concern.”

This has no factual basis at all. A more recent and comprehensive review of the clinical literature found cBHRT is not associated with adverse events and further concluded that cBHRT is effective in the treatment of certain peri-and post-menopausal conditions. NASEM’s report examined only 13 studies, whereas this review looked at 40 articles covering 29 trials comparing cBHRT to conventional hormone products.

Another review of the clinical literature concluded that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more effective than synthetic or animal-derived hormones. Many studies have shown that estriol offers many potential health benefits—for urinary tract and bone health, for example—without some of the dangers that accompany higher-potency estrogens, such as cancer. This is likely because bioidentical hormones are, as the name suggests, chemically identical to those used in the human body. Other hormone products are not identical, like Premarin, which is an estrogen made from pregnant horse mares’ urine.

What seems to be underway is an attempt to create drug company monopolies; banning compounded hormones gives Big Pharma the green light to create more expensive hormone drugs. The result would be that women will not be able to obtain estriol at all, even though estriol protects against cancer.

Case in point: we reported in 2016 that a drug company, TherapeuticsMD (TMD), was moving in on the bioidenticals market. TMD has gotten two products approved, an estradiol and progesterone combination product in oral pill form, and an estradiol vaginal insert. TMD has been working for years to penetrate the compounded hormone market and to get compounding pharmacies to distribute their FDA-approved hormone products. A ban on cBHRT would serve TMD’s interests by eliminating competition.

If the FDA goes through with a ban of cBHRT, patients will still have access to bioidentical hormone products that are FDA-approved. There are, however, no FDA-approved estriol products, so a ban would mean complete loss of access to estriol. While access to some bioidenticals would remain, patients would not be able to receive customized dosages, nor would they be able to choose the route of administration they prefer.

What is even more maddening about this entire FDA process is that the agency is fully aware that patients prefer these medicines. Again and again in the report, members of the NASEM committee acknowledged that many women express a distinct preference for compounded BHRT, but that this wasn’t enough to justify its use. We can only expect the FDA to parrot this message. It’s a clear signal: we know better than women and their doctors. This is government paternalism at its worst, and it cannot be allowed to stand.

Action Alert! Write to the FDA and Congress, telling them that patients need access to compounded BHRT! Please send your message immediately.