The move comes, partly, in response to a citizen's petition filed by Wyeth, which wants to stop compounding pharmacies from making bioidentical versions of Prempro. In doing so, however, Wyeth caused a bit of a ruckus among women who oppose the use of the synthetic med, which has been the subject of lawsuits over ties to breast cancer.
However, the FDA says these seven pharmacy operations improperly claim their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and has not been proven safe and effective for any use), are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat such diseases as Alzheimer's, stroke, and various forms of cancer, according to the FDA.
[UPDATE: This arrived at 5:30 PM EST: For its part, a trade group for compounders expressed anger. "Under this policy, patients will suffer while Wyeth profits," L.D. King, executive director of the International Academy of Compounding Pharmacists, says in a statement. "Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth's products are found to be ineffective or produce side effects. This is a decision that should be left to doctors."]
But in its statement, the agency notes that compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
The pharmacy operations receiving warning letters use the terms "bio-identical hormone replacement therapy" and "BHRT" to imply that their drugs are natural or identical to the hormones made by the body, according to the agency The FDA says it regards the use of "bio-identical" as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.
The FDA goes on to say that the pharmacy operations also make unsupported claims their drugs are better than FDA-approved menopausal hormone therapy drugs and can be used to prevent and treat serious diseases such as Alzheimer's disease, stroke, and various forms of cancer. The pharmacy operations compound hormone therapy drugs that contain estriol as well as progesterone and estrogen. No drug product containing estriol has been approved by FDA and the safety and effectiveness of estriol is unknown.
[UPDATE: The IACP, however, fired back that: "Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors' prescriptions for women suffering from symptoms of menopause. Like many commonly prescribed drugs (e.g, Phenobarbital, quinine, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.
The FDA also stated in its letters that pharmacies may not use the term "bio-identical" to characterize compounded hormone therapies, even though the chemicals used in such compounds are chemically identical to what is produced by the human body. Furthermore, manufacturers of drugs containing the same bio-identical hormones commonly use the term to characterize their products. The chemical structure of these drugs is indisputable.]
The FDA stressed, however, that its action doesn't target pharmacists who practice traditional compounding and who don't make false or misleading claims about compounded products.