NASEM Recommendations to FDA: Compounded hormones are unneeded; have safety and quality concerns. (Wait, what?)
The FDA tasked NASEM to “study” (really do a literature review) the clinical utility of compounded bioidentical hormone replacement therapies. NASEM pulled together researchers, MD’s and PhD’s- none who were familiar with compounded hormones or even compounding- to review the literature. While compounding had no stakeholder involvement in the review process, a former associate director of the FDA now consultant had a seat at the table. After hours of testimony from medical and pharmacy experts and out of hundreds of studies submitted on hormones NASEM said only 13 articles were worthy. The FDA has latched onto this false conclusion from a report it commissioned, and it is another direct threat compounded bioidentical hormones’ future.
The FDA’s announcement regarding bioidentical hormones came just hours after the National Academy of Sciences, Engineering, and Medicine (NASEM) released their report reviewing the “clinical utility” of compounded bioidentical hormone therapy (cBHT). Because the report views the widespread use of cBHT as a public health concern, the FDA will likely move fast to limit these critical medicines. I am actively working on 2 committees, one prescribers/compounding pharmacists and one compounding pharmacists, to develop our plan of response. My committees are working on the gathering the articles that support the use of cBHT and data to show the quality of compounded preparations. The legal committee has already sent a compelling letter 180-page letter to the FDA.
To quote the FDA’s announcement on the report release: “Given the lack of high-quality clinical evidence and minimal oversight of cBHT, NASEM concluded that their wide-spread use poses a public health concern.”
This has no factual basis at all. A 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. What seems to be underway is an attempt to regulate medicine and pharmacy at the federal level. This has long been left to the individual Medical and Pharmacy Boards. The result may be that access to compounded hormones is taken away.
The report’s conclusion deals a real blow to the future of patient access to cBHT, but it is hardly a surprise. We said before that the FDA stacked the deck against cBHT as the NASEM committee was gathering information. It’s no surprise that the recommendations and conclusions of the report mirror the FDA’s interests.
Specifically, the committee’s recommendations include:
- Restricting cBHT use to patients with a documented allergy to an ingredient in FDA approved BHT products or a documented requirement for different dosage form.
- Patient preference alone is not enough to justify cBHT use.
- cBHT doses should not exceed FDA-approved product dosages. (most of our compounded doses are way less)
- The FDA’s Pharmacy Compounding Advisory Committee (PCAC) should review select hormones for the Difficult to Compound list, including estradiol, estrone, estradiol, progesterone, estriol, testosterone, and the pellet dosage form.
- The federal government and State Boards of Pharmacy should expand and improve oversight of 503A “traditional” pharmacies to ensure quality standards for every cBHT preparation dispensed.
Again and again in the report, members of the NASEM committee acknowledged that many women express a distinct preference for cBHT, 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.
To briefly recap how we got here: estriol and other bioidentical hormones have been nominated to the FDA’s “Demonstrably Difficult to Compound List”; items that appear on the list when it is final will no longer be able to be made at compounding pharmacies. Stakeholders pushed back forcefully against the nomination of estriol and other compounded hormones, so the FDA convened a NASEM committee to study cBHT and aid in the agency’s final determination. Our interpretation: the FDA wants 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.
The FDA still has hurdles to overcome before a ban can be issued: the agency has to issue a proposed rulemaking to add these hormones to the Difficult to Compound List. It’s also possible that the FDA issues draft guidance that restricts the use of cBHT as outlined by NASEM’s recommendations.
I need your to do 2 things:
- Submit a testimonial! Please share your story! We need to collect as many testimonials about cBHRT as possible before the FDA decides to ban these crucial hormones and affect our quality of life! Share here www.a4pc.org/cbhtandme We want to be able to have 150,000 + testimonials from women and men who have used cBHT in our packet of information that we submit to the FDA and Congress.
- Second, join the Partnership for Personalized Prescriptions for updates on these hot button issues https://p3rx.org/ They will send a monthly email but if there is a call to action you will be alerted quickly!
Feel free to reach out directly to me if you have questions. My email is: email@example.com
ACT NOW TO PROTECT YOUR ACCESS TO COMPOUNDED HORMONES!!
Jennifer Burch, PharmD, RPh, CDCES