If the FDA is not dissuaded, millions of women will lose access to life-saving hormones that are often safer than the alternatives currently on the market.
Want more information or to find out how you can help? Contact Jo Twombly at [email protected] or 240-345-1510.
How is Access to Bioidentical Hormones Threatened?
In implementing the Drug Quality and Security Act of 2013, FDA began accepting nominations to the “Difficult to Compound List.” When finalized, compounding pharmacies will no longer be able to make items that appear on this list. Bioidentical estriol, estradiol, and progesterone are crucial hormones women need when going through menopause or fertility challenges, or when struggling with other hormonal imbalances. All three are currently nominated for the “Difficult to Compound List.” In the case of compounded bioidentical estriol, which has no FDA-approved alternative, consumer access would be eliminated if the agency places it on the list.
Estriol’s nomination is especially concerning given the FDA’s demonstrated hostility toward this hormone. In 2008, the agency ruled that pharmacies could not compound medicines containing estriol without first obtaining an investigational new drug authorization.[1]The FDA remains unconvinced of estriol’s safety despite acknowledging that the agency is unaware of any adverse events associated with estriol[2]in addition to the fact that this hormone has a USP monograph.[3]The FDA’s position on estriol could be influenced by a 2005 Citizen’s Petition from a major drug manufacturer that urged the FDA to undertake enforcement actions against pharmacies producing bioidentical hormone products that competed with the drug maker’s own products.[4]
FDA action on these three bioidentical hormones – estriol, estradiol, and progesterone – could come as early as March 2018. That is when the FDA’s Pharmacy Compounding Advisory Committee (PCAC) is next expected to meet. PCAC has the responsibility of considering FDA staff recommendations concerning all substances nominated for the “Difficult to Compound List.”
What are Bioidentical Hormones?
Unlike conventional hormone therapy that uses synthetic and animal-derived hormones that are slightly different from a woman’s own hormones, bioidentical hormones are biochemically the same as those made by the ovaries during a woman’s reproductive years. Bioidentical hormones are used chiefly to relieve and control the symptoms of menopause.
Custom-made bioidentical hormones are extremely popular with patients: up to 2.5 million US womenaged 40 years or older may use compounded hormone therapy annually, accounting for 28% to 68% of hormone therapy prescriptions.[5]
Are Bioidentical Hormones Safe?
Yes, especially relative to some of the FDA-approved products on the market. 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.[6]
On the other hand, studies have consistently demonstrated that synthetic hormones are associated with an increased risk of breast cancer.[7],[8],[9]Synthetic and animal-derived hormones have also been shown to produce negative cardiovascular effects and to negate the cardio-protective effects of estrogen.[10],[11], [12]
Are Bioidentical Hormones Difficult to Compound?
No. The arguments used to support the notion that bioidentical hormones are difficult to compound do not hold up to scrutiny. Extensive internal testing by pharmacies as well as third-party testing ensure that compounded hormone preparations are homogenous and reflect dosages and strengths found on the product labels. Ingredients purchased by compounders are guaranteed by the manufacturer to adhere to certain specifications. The increasing popularity of compounded hormone medicines also attests to patient and doctor satisfaction with the efficacy of these products.
Estriol in the Crosshairs
Access to estriol is particularly threatened, as there are no FDA-approved drugs for bioidentical estriol—meaning that if the FDA decides that estriol is on the “Difficult to Compound List,” patients will lose access to this hormone. Estriol has proven benefits beyond treating postmenopausal symptoms: it has been shown to reduce cardiovascular risk, help with osteoporosis, and reduce brain lesions in individuals with multiple sclerosis. Studies have also shown estriol to be safer compared with more potent estrogens.[13]
What is ANH Seeking?
The Alliance for Natural Health (ANH) asks members of Congress send a letter to FDA directing the agency to preserve consumer access to compounded hormones that do not present safety concerns.
Want more information or to find out how you can help? Contact Jo Twombly at [email protected] or 240-345-1510.
[1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3127562/
[2]https://www.researchgate.net/publication/23959867_The_Bioidentical_Hormone_Debate_Are_Bioidentical_Hormones_Estradiol_Estriol_and_Progesterone_Safer_or_More_Efficacious_than_Commonly_Used_Synthetic_Versions_in_Hormone_Replacement_Therapy
[3]http://www.pharmacopeia.cn/v29240/usp29nf24s0_m30840.html
[4]https://www.law.uh.edu/healthlaw/perspectives/2008/(BP)%20compounding.pdf
[5]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4547729/
[6]https://www.researchgate.net/publication/23959867_The_Bioidentical_Hormone_Debate_Are_Bioidentical_Hormones_Estradiol_Estriol_and_Progesterone_Safer_or_More_Efficacious_than_Commonly_Used_Synthetic_Versions_in_Hormone_Replacement_Therapy
[7]https://www.ncbi.nlm.nih.gov/pubmed/15908197
[8]https://www.ncbi.nlm.nih.gov/pubmed/12419080
[9]https://www.ncbi.nlm.nih.gov/pubmed/15551359
[10]https://www.ncbi.nlm.nih.gov/pubmed/9012659
[11]https://www.ncbi.nlm.nih.gov/pubmed/6596830
[12]http://equimed.com/news/general/research-reveals-dangers-of-conjugated-equine-estrogens-for-women
[13]http://www.lifeextension.com/magazine/2008/8/Estriol-Its-Weakness-is-its-Strength/Page-01