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FDA on Bioidentical Hormones: Myths vs. Facts

There is a lot of confusion surrounding FDA’s recent action to restrict women’s access to bio-identical
hormones that their doctors prescribe for them. In recent months, FDA raised various concerns. For
example, FDA has said that making unsubstantiated claims of safety and efficacy is inappropriate. In
this instance, the FDA may be correct. However, the FDA has made various other statements that
warrant correction.
FDA Myth #1:
The term “bio-identical” is misleading and “there is no credible science to back the claim that compounded hormones are biologically identical to the hormones produced by the body.” Various professional medical societies define the term “bio-identical” as indicating the chemical structure of a hormone drug is identical to that of the hormone produced by the human body. In the cases of estradiol, estrone, estriol and progesterone, the term “bio-identical” accurately characterizes their chemical structure. They are all identical to those found in a woman’s body. In fact, pharmaceutical companies that manufacture FDA-approved bio-identical hormones use the term as well. For example, Prometrium is a manufactured, FDA-approved progesterone drug that is marketed as “bio-identical.” Similarly, Estrogel is an FDA-approved estradiol product also marketed as “bio-identical.”

FDA Myth #2:

It is impossible for FDA to determine the extent of adverse reactions associated with estriol products, but “the Agency does have anecdotal evidence of adverse events.” The FDA has not publically identified a single adverse event associated with the use of estriol in the decades it has been prescribed in the U.S., in spite of multiple requests by Congress and the public to do so. It is appalling that the agency refers to “anecdotal evidence” in an apparent attempt to frighten patients and justify its unsubstantiated claims. Anecdotal is defined as “not necessarily true or reliable” and “based on personal accounts rather than facts or research.” The FDA’s use of this unscientific standard is hypocritical. FDA would never accept decisions or claims based on “anecdotal evidence” from the industries it regulates.
FDA Myth #3
“No ‘BHRT’ product has met federal standards for approval.” Since 1986, FDA has approved at least twelve hormone replacement medications that are bio-identical and are marketed as such. Examples include Prometrium, a manufactured progesterone drug approved by the FDA in 1998 and marketed as “bio-identical” and EstroGel, an estradiol product approved by the FDA in 2004 which is promoted as “an FDA-approved, bio-identical estrogen replacement therapy.”

FDA Myth #4:

It is unlawful for a pharmacist to prepare bio-identical hormones containing estriol because estriol is not a part of an FDA-approved drug. A number of drugs are commonly compounded and prescribed even if they are not components of FDA-approved drugs. This practice is long-standing, well accepted and legal in all 50 states. Additionally, the use of estriol is consistent with U.S. Pharmacopeia (USP) standards for pharmacy compounding in chapters 795 and 1075, and the USP is recognized by Congress as the official standards-setting authority for all prescription medications. The use of estriol is also consistent with the standards of the Pharmacy Compounding Accreditation Board. In addition, the FDA admitted that it has received no reports of adverse events related to use of estriol.
FDA Myth #5:
Compounded bio-identical hormones are unsafe because they are not FDA-approved. Compounded medications are regulated by state boards of pharmacy and are not subject to federal laws designed to regulate mass-produced drugs. This is because they are customized to meet the unique needs of patients based on the specific orders of a physician. The FDA approval process is designed for mass-produced manufactured drugs; it is universally recognized that holding compounded medications to these standards would completely eliminate their availability.
FDA Myth #6:

Bio-identical hormone replacement therapy (BHRT) is unregulated. Bio-identical hormones – like all compounded medications – are made from FDA- and USP-registered materials – the same used by pharmaceutical manufacturers – and their preparation is well regulated by state boards of pharmacy that have responsibility for overseeing all pharmacy practice in each state. Pharmacies that compound medications, including bio-identical hormones, are regulated by state pharmacy boards – similar to the relationship doctors have with state medical boards. In addition, there are also national standards and guidelines for compounded medications. The ingredients and their suppliers are regulated at the federal level by the FDA, with additional oversight provided by the U.S. Pharmacopeia (USP). For more information and resources, visit
Congressional Offices may also contact Jim Rock at (202) 547-4000


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