A history and update of the FDA's current challenge to cBHRT.
If we lose Compounded Bioidentical Hormone Replacement Therapy
The NASEM Report concluded that the FDA should:
- “Restrict the use of compounded bioidentical hormone therapy preparations. Prescribers should restrict the use of bioidentical hormone preparations to the following situations:
– documented allergy to an active pharmaceutical ingredient or excipient of an FDA-approved drug product, or a documented requirement for a different dosage form … “
This regulation directly has the FDA determining how a healthcare professional should practice medicine. This overreach goes beyond the mandate and authority of the FDA and like violations have been successfully challenged in the past.
– “Patient preference alone should not determine the use of bioidentical preparations.”….
This overreaches into the freedom of women and men patients to freely and privately choose their healthcare providers and, according to the modes of therapies and expertise offered.
- “Review select bioidentical hormone therapies and dosage forms as candidates for the U.S FDA Difficult to Compound List, [including]: estradiol, estrone, estradiol cypionate, estriol, pregnenolone, dehydroepiandrosterone (DHEA) progesterone, testosterone, testosterone cypionate, and testosterone propionate…”
This recommendation is potentially devastating to providers and patients. No drug can be compounded, if it is on the “Too Difficult to Compound List.” 13 If these bioidentical products are put on this list, that would be the immediate end of all bioidentical hormone therapy.
This regulation would destroy the present ability of physicians and patients even to access bioidentical hormone treatments, at all. Such undue limitation will impact millions of patients (both women and men) who are living fulfilling, productive lives, thanks to these currently legal bioidentical hormone treatments.
There are other alarming recommendations in the NASEM report:
“A state-level certification program for providers seeking to start or continue to prescribe bioidentical hormones.”
Professional societies (which are often supported by money from the pharmaceutical industry) will promote “best practices” guidelines, stating when a provider should consider using a bioidentical hormone in lieu of an FDA-approved drug- essentially telling doctors when, how, and which formulations they could even think about using.
“Additional federal and state-level oversight.” This expansive recommendation includes new mandates, inspections, paperwork, reporting requirements, and other onerous restrictions on compounding pharmacies.
The robust response of cBHRT professionals and the public to these challenges has been inspiring. Coming forward are millions of American women, and many men, that are being treated with compounded bioidentical hormones. Along with them are thousands of physicians, nurse practitioners, and physician’s assistants that are treating these women, as well as thousands of compounding pharmacies that are dispensing these hormones.
Memorandum to the FDA report. An immediate response to the FDA report came from Rachel Pontikes, an attorney with Reed-Smith, a prominent international law firm.) Supported by several compounding pharmacies, she issued a profound legal memorandum to the FDA that has been published in the FDA docket.14 It contains many points of contention:
- The FDA is overstepping its mandate and is interfering with the rights of women to choose which methods of treatment they want for their health care.
- The FDA is also exceeding its legal authority and is overreaching by dictating to medical professionals how to practice medicine. Again,the FDA has been successfully challenged on this issue, in the past.
APC: The Alliance for Pharmacy Compounding has mounted a phenomenal and multifaceted response. We recommend that you visit their website, and, participate in their calls to action (https://www.a4pc.org). Their commitment is prodigious and determined.
We the Women. One of many organizations devoted to protecting the healthcare rights of women, and, deeply committed and involved in this bioidentical hormone challenge.
ANH The Alliance for Natural Health Always a major player in the protection of our healthcare rights.
We invite all of you to join us We are a central focus of much-needed synergy, energy, expertise, creativity, and co-ordination! Please send us your email and/or other contact information, so we can inform you about upcoming events, strategies, conference calls, campaigns, etc., and, also crucial, to be deployed at the best-coordinated timing. There are specific actions you can take to protect our personal and professional health care rights and freedoms. Join us.
NASEM = National Academy of Science, Engineering and Medicine’s Committee on the Safety and Efficacy of Compounded Bioidentical Hormones
Premarin: estrogens derived from pregnant mares’ urine (hence the name, “Premarin”), and Prempro, which is Premarin combined with a synthetic and problematic progestin.
Premarin had a 0.79 relative risk (less risk if a woman is treated with Premarin than if not being treated. Prempro had a 1.26 RR, which was noted to be “statistically insignificant” in the body of the study.
Hormone therapy prescribing patterns in the United States. 2004 Nov;104(5 Pt 1):1042-50. doi: 10.1097/01.AOG.0000143826.38439Diana S M Buist, et al
Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality. Manson, et al, JAMA. 2017 Sep 12; 318(10): 927–938 https://pubmed.ncbi.nlm.nih.gov/28898378/
Estrogen Matters, Why Taking Hormones in Menopause Can Improve Women’s Well-Being and Lengthen Their Lives — Without Raising the Risk of Breast Cancer, Avrum Bluming, MD and Carol Tavris, PhD, published September 4, 2018. https://www.amazon.com/Estrogen-Matters-audiobook/dp/B07G9JXT1H/ref=sr_1_1?dchild=1&keywords=estrogen+matters&qid=1616341235&sr=8-1
Compounded bioidentical hormone therapy: identifying use trends and knowledge gaps among US women. JoAnn V. Pinkerton, MD1 and Nanette Santoro, MD2. Menopause. 2015 Sep; 22(9): 926–936. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547729/
Compounded non-FDA–approved menopausal hormone therapy prescriptions have increased: results of a pharmacy survey. JoAnn V. Pinkerton, MD1 and Ginger D. Constantine, MD2. Menopause. 2016 Apr; 23(4): 359– 367. https://pubmed.ncbi.nlm.nih.gov/26645819/
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use.https://www.nationalacademies.org/our-work/clinical-utility-of-treating-patients-with-compounded-bioidentical-hormone-replacement-therapy.
National Academies of Science, Engineering, and Medicine (NASEM) Study on the Clinical Utility of Treating Patients with Compounded “Bioidentical” Hormone Therapy. https://www.fda.gov/drugs/human-drug-compounding/national-academies-science-engineering-and-medicine-nasem-study-clinical-utility-treating-patients
The Clinical Utility of Compounded Bioidentical Hormone Therapy: A Review of Safety, Effectiveness, and Use https://www.nationalacademies.org/our-work/clinical-utility-of-treating-patients-with-compounded-bioidentical-hormone-replacement-therapy, Section 9, page 217
See 21 US Code 353a(b)(3) and 353b for verification. https://www.law.cornell.edu/uscode/text/21/353a
Reed, Smith: Rachel Pontikes https://www.regulations.gov/comment/FDA-2015-N-0030-8335
Supplemental Report from Reed, Smith: Rachel Pontikes. https://a4pc.org/Common/Uploaded%20files/Advocacy/2021-03_cBHT-Supplemental-Comment-and-Exhibits.pdf
In an attempt once again to eliminate cBHRT, the FDA funded and tasked the National Academy of Science, Engineering and Medicine to form a Committee to Examine the Safety and Efficacy of cBHRT and issue a report of their findings.
What is the NASEM Study About Bioidentical Hormone Replacement Therapy?
The NASEM committee essentially determined that women and men don’t need compounded alternatives to drug-company hormones. As a result, this highly prejudiced and likely illegal study could become the basis for FDA moving to outlaw most if not all cBHRT.