FDA Orders Pharmacies To Stop Making False Claims About Custom-Made Hormones To Treat Menopause

Main Category: Women's Health / Gynecology
Also Included In: Seniors / Aging;  Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 11 Jan 2008 - 5:00 PDT

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FDA on Wednesday sent letters to seven pharmacies that sell custom-made "compounded" hormone products over the Internet to menopausal women and ordered the companies to stop making false and misleading claims about the compounds' benefits, the Wall Street Journal reports (Wilde Mathews/Rubenstein, Wall Street Journal, 1/10).

The so-called "bioidentical hormones" are synthesized chemically but have the same structure as natural hormones. Supporters of compounds say they are safer than other forms of hormone replacement therapy because they imitate women's hormones (Daily Women's Health Policy Report, 8/28/07). However, the American College of Obstetricians and Gynecologists and the North American Menopause Society have said there is no evidence the compounds are safer than other types of HRT (Wall Street Journal, 1/10). The pharmaceutical company Wyeth -- which reported $791 million in HRT sales in the first nine months of 2007 -- filed a petition with FDA about the pharmacies' practices, and the agency received more than 70,000 comments about the petition (Wall Street Journal, 1/10).

FDA in the letters ordered the pharmacies to stop claiming that the custom-made hormones are better than approved menopause therapies and that they can prevent and treat other conditions -- including Alzheimer's, strokes and cancer, Reuters reports. The agency also objected to the term "bioidentical," saying it incorrectly implies the hormones are natural or identical to the ones made by the body. FDA also said there is no evidence the custom-made hormones are safer than approved versions of the hormones estrogen and progesterone. The letters also said that the pharmacies cannot sell hormone mixtures containing the ingredient estriol, which has not received agency approval (Richwine, Reuters, 1/9). In the letters, FDA said the pharmacies' false and misleading claims violate federal law, adding that the agency is concerned the claims could mislead patients, physicians and other health care professionals (Schmid, AP/Google.com, 1/9).

According to USA Today, the use of bioidentical hormones increased following a 2002 study that found brand-name drugs produced by pharmaceutical companies increased the risk of breast cancer, heart attack and stroke (Appleby/Szabo, USA Today, 1/10). FDA is being sued by compounding pharmacies, which argue that the agency doesn't have authority to regulate compounded drugs, and an appeal in the case is scheduled to be heard on Thursday, the Journal reports (Wall Street Journal, 1/10).

Comments

Janet Woodcock, FDA's chief medical officer, in a statement said, "We want to assure that Americans receive accurate information about the risks and benefits of drug therapies" (McClain, Arizona Daily Star, 1/10). L.D. King, executive director of the International Academy of Compounding Pharmacists, said the agency has gone beyond its authority in attacking the use of estriol, adding that the majority of his members' compounded hormone mixtures include the drug. King said the group will seek to meet with FDA officials (Wall Street Journal, 1/10). "Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate," King said, adding, "This is a decision that should be left to doctors."

Wulf Utian, executive director of the North American Menopause Society, supported the decision to send the letters. "If there is a reason to be on [HRT], there are more than enough approved products out there," Utian said (USA Today, 1/10). Wyeth spokesperson Doug Petkus said the company supports FDA's action, adding that the company is "pleased" with the agency's formal response to Wyeth's petition (Wall Street Journal, 1/10).

The letters are available online.

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