Drug Topics - February 11, 2008 - (Page 17) www.drugtopics.com FEBRUARY 11, 2008 DRUG TOPICS 17 Rx Care FDA’s crackdown on bio-identical hormones sparks controversy Heidi Belden, Pharm.D. hen the Food & Drug Administration recently announced an enforcement action against pharmacy operations that compound bioidentical hormone drugs, compounding pharmacists, physicians, and representative organizations have been up in arms over the development. In early January, the FDA sent warning letters to seven pharmacies that made unsupported claims that their prepared hormone therapies were “bio-identical” to those FDA-approved treatment options for menopause symptoms, in some cases referring to them as superior products. Bio-identical hormone replacement therapy (BHRT) often involves use of estriol, a drug that has never been approved by the agency. The FDA stated that pharmacies wishing to use estriol as an ingredient in any product must now submit either an investigational or a new drug application (NDA), and undergo a formal review. Wulf H. Utian, M.D., Ph.D, D.Sc., executive director of the North American Menopause Society (NAMS), concurs with the FDA action. “I believe that women will be better off in the long run if they are using products that have undergone review and that we know are safe,” Utian said. He pointed out that the FDA has said that it is not against the practice of compounding pharmacy in general, and that is something with which NAMS agrees. “The purpose of today’s action is not to put an end to traditional compounding pharmacy,” said FDA’s Deborah Autor, Esq., director of the Office of Compliance, Center for Drug Evaluation and Research (CDER), at the agency’s telebriefing. But compounding pharmacy groups think otherwise. The International Academy of Compounding Pharmacists’ (IACP) executive director, L.D. King, said that the majority of the members of his group use estriol in the products they compound. IACP argues that estriol, although not officially FDA-approved, has a U.S. Pharmacopeia (USP) monograph from prior to 1997. After the FDA Modernization Act of 1997, Congress indicated that unapproved drugs with a USP monograph could still be compounded when prescribed by a licensed medical practitioner. Making matters even more controversial was the fact that FDA simultaneously responded to a citizen’s petition filed in 2005 by Wyeth Pharmaceuticals, makers of W Premarin and Prempro, which asked the agency to take action against pharmacies that used unapproved hormones in their products. “The FDA has succumbed to pressure from Wyeth in its attempt to clear the market of safer alternatives to its unsafe products,” said Erika Schwartz, M.D., cofounder of the Bio-identical Hormone Initiative (BHI), a group of practicing physicians who treat patients with bio-identical hormones and believe that BHRT is a safe and effective treatment option for patients with hormone depletion. Schwartz and other BHI members contend that the FDA should protect the interest of women and not the profits of Wyeth. “Under this policy, patients will suffer while Wyeth profits,” agreed IACP’s King. He fears that the FDA warning will have a chilling effect on the compounding of BHRT. In addition, some argue that Wyeth is attempting to save already plummeting sales of its HRT drugs, which have dramatically fallen off since results of the Women’s Health Initiative (WHI) in 2002 showed use of HRT led to an increased risk of stroke, myocardial infarction, breast cancer, and blood clots. Still, Wyeth report- L. D. King objects to FDA’s estriol ed $791 million in revenue for its hormone proddecision. ucts in the first nine months of 2007. To date, BRHT has not demonstrated the same dangers outlined by WHI; however, the studies have not yet been performed. The bottom line, according to NAMS’ Utian, is that “there is no evidence that compounded hormones are better or safer than commercially available drugs.” Even so, hundreds of thousands of women are seeking treatment with bio-identicals when their need cannot be met by conventional HRT. “Until the courts give us the final word on this subject, I will continue to prescribe estriol as an important part of the total hormone replacement therapy for my patients – whom I have found to benefit from its use,” said Cheryle R. Hart, M.D., a Mayo Clinictrained and board-certified gynecologist who promotes her BHRT business, Hormones by Hart, online. Hart, who had originally said she would stop prescribing therapies containing estriol when the FDA took action, has since changed her tune after discussing the issue with IACP. “I want my patients to know that all of their prescription hormones are still going to be available,” she said. DT http://www.drugtopics.com
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