Last year the FDA commissioned the National Academies of Science, Engineering, and Medicine (NASEM) to make a report on the safety and efficacy of Compounded Bio-identical Hormone Replacement Therapy (cBHRT). Please note that the FDA has been directed and staffed by influencers in the pharmaceutical industry as well as lobbied over the years by pharmaceutical companies to put limits on compounding pharmacies. Conveniently the report was returned stating that there is not enough evidence to prove the safety and efficacy of cBHRT and so they recommended restriction of compounded hormones. The FDA is considering such restriction and possibly even banning it’s use altogether.
There are a number of ironies in the report and in the concerns of the FDA.
The following is an abbreviated review by the Alliance for Pharmacy Compounding:
- The NASEM study committee was populated by healthcare professionals, but not a pharmacist with patient-facing experience, much less a pharmacy compounder, in their number. Nor was there a physician with experience in BHRT — but did include one former FDA employee (who was opposed to BHRT
- Although compounded drugs are exempt from the new drug approval process because of being individualized for each patient…The report makes an illogical leap by effectively deeming cBHT unsafe unless it can mirror drug manufacturing in terms of safety and effectiveness data, labeling, AE reporting, pharmacokinetic data, and scale of clinical trials.
- NASEM said it based its recommendations in large part on a review of literature, but identifies only 13 studies as having, in the judgment of the committee, suitable “rigor and relevance” — these, out of literally hundreds of studies out there, not to mention abundant patient outcomes data that could and should have been considered and weighed.
- The report calls for restricting use of cBHT to patients with allergies to FDA-approved drugs, despite the fact that many FDA-approved therapies may not meet the dosing needs of patients — a point not addressed by the report’s recommendations.
- The recommendations seem to suggest that a prescriber’s medical judgment and a patient’s preferences should play no role in determining a proper course of treatment — a stunning assertion that is applied to no other aspect of medicine or pharmacy care. Hormone needs are more complex than the cookie-cutter approach offered by current FDA-approved drugs. Individualized therapy is the result of a balanced approach between prescriber and patient assessing each patient’s unique needs.
- The NASEM provides no evidence of patient harm that has resulted from widespread use of cBHRT.
- The report cites concerns over bioavailability. However, many prescribers perform testing to confirm cBHT is appropriate therapy. Yet how many prescribers routinely check levels of FDA-approved products?
- The report sends mixed messages. Individualized therapy is a part of FDA’s newly established goal of creating personalized therapies to target each patient. Factors such as age, weight, genetics, past medical history all contribute to appropriate treatment and dosage selection. Yet these NASEM recommendations seem to assert that FDA-approved drugs are always superior to compounded therapies.
That’s not to say that NASEM gets everything wrong in its report. While it’s acknowledged that claims of superiority of compounds over FDA approved therapies should not be made, millions of people have quality of life and even life because of their use.
The APC is gathering data for a more balanced perspective for the FDA.
I have sent them my perspective as a prescriber because I don’t want to lose access for me and my patients to compounded HRT, including hormone pellets. I encourage you to use this form https://form.jotform.com/202306121452035 and share your story too.
We need to keep the option of compounded hormones alive!