Are you a compounding pharmacist, physician/prescriber, or patient on compounded bioidentical hormone replacement therapy (cBHRT)? You should be aware that the FDA is trying to ban cBHRT, and we need to protect it now.
The FDA recently commissioned the National Academy of Sciences, Engineering, and Medicine (NASEM) to study the clinical utility of compounded bioidentical hormone therapy. There is no standard definition of "clinical utility," and the FDA did not provide one. Therefore, the NASEM committee was faced with preparing their definition. It's interesting that the FDA paid a lot of money to a private organization to do something which they did not define The FDA announced on the report release: “Given the lack of high-quality clinical evidence and minimal oversight of cBHRT, NASEM concluded that their wide-spread use poses a public health concern.”
This has no factual basis. A review of clinical literature concludes 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. Since compounding pharmacies are already required to use FDA-approved ingredients, their products have all gone through the FDA evaluation as drug products and deemed to be "safe and effective"; otherwise, they should not be on the market. The FDA latched onto this false conclusion from a report it commissioned for this purpose, and it is another direct threat to estriol and compounded bioidentical hormones’ future. Because the report frames cBHT as a public health concern, the FDA will likely move fast to ban these critical medicines.
What seems to be happening is an attempt to create drug company monopolies. The FDA has a history of siding with large drug companies against independent compounding pharmacies and their prescriptions. Attacking estriol and compounded hormones is just one of the ways the FDA and the federal government bolster drug monopolies and undermine natural health options. The FDA is trying to create insurmountable barriers to access natural medicines. This is unacceptable. This can result in women not being able to obtain estriol at all, even though estriol has protective properties against cancer. It is imperative that we mobilize a strong grassroot response to meet this threat and save access to estriol with other compounded hormones.
What does the report say?
The report’s conclusion deals a real blow to the future of patient access to cBHRT, but it is hardly a surprise. The FDA stacked the deck against cBHRT as the NASEM committee gathered 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 cBHRT use to patients with a documented allergy to an ingredient in FDA-approved BHRT products or a documented requirement for different dosage form.
- Patient preference alone is not enough to justify cBHRT use.
- cBHRT doses should not exceed FDA-approved product dosages.
- The FDA’s Pharmacy Compounding Advisory Committee (PCAC) should review select hormones for the Difficult to Compound list, including estradiol, estrone, estradiol, progesterone, estriol, and testosterone. As mentioned previously, this will prohibit pharmacies from compounding these medications.
- The federal government and State Boards of Pharmacy should expand and improve oversight of 503A “traditional” pharmacies to ensure quality standards for every cBHRT preparation dispensed, when compounding pharmacies are already over-regulated.
Again and again in the report, members of the NASEM committee acknowledge that many women express a distinct preference for cBHRT, but somehow this isn’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.
To briefly recap: estriol and other bioidentical hormones have been nominated to the FDA’s Demonstrably Difficult to Compound List. Compounding pharmacies cannot make items that appear on the finalized list. The Alliance for Natural Health and other stakeholders forcefully pushed back against the nomination of estriol and other compounded hormones, so the FDA arranged a NASEM committee to, “study,” cBHRT and aid the agency’s final determination. Our interpretation: the FDA wants to ban hormones but knew they couldn’t do it without, “independent guidance,” due to the substantial 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 they issue a ban. 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 cBHRT as outlined by NASEM’s recommendations.
The time to send a clear message to Congress and the FDA is now. We beat the FDA when they tried to ban estriol in 2008, and we can beat them again, but only if the entire community rises up together. We cannot let the federal government interfere with women’s health.
We must demand that Congress reform a healthcare system that not only bars the use, but even the mention, of natural remedies like compounded bioidentical hormones that have not been, and never can be, put through the multi-billion-dollar FDA approval process.
So what can you do?
There are a few easy things you can do!
Click on the link below to write to Congress and the FDA, and tell them that patients have a right to choose the medicines right for them, including cBHRT. Whether you’re a patient, pharmacist, physician, or just concerned about this new overreach, please send your message immediately.
You can also share your story! We need to collect as many positive stories about cBHRT as possible before the FDA decides to ban these crucial hormones and our quality of life! Please send your testimonial right away to us, or to the Alliance for Pharmacy Compounding (A4PC) at email@example.com. A4PC is a trusted organization that represents the needs of compounding pharmacies and their patients. Comments submitted to us will be forwarded to A4PC, to be submitted with other patients’ stories to make the greatest impact possible.
We appreciate your support!
(Thank you Susan Merenstein for writing this blog!)