Group Launches Letter-Writing Campaign To Protect Custom-Made Hormones For Menopause

Main Category: Menopause
Also Included In: Seniors / Aging;  Endocrinology;  Pharmacy / Pharmacist
Article Date: 31 Jan 2008 - 6:00 PDT

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More than 4,000 people during the last three weeks have taken part in a Patients and Professionals for Customized Care letter-writing campaign that urges members of Congress to protect the right of pharmacies to sell custom-made hormone products to treat symptoms associated with menopause, a spokesperson for the International Academy of Compounding Pharmacists recently said, CongressDaily reports. According to CongressDaily, the campaign was launched in response to FDA's orders that required seven pharmacies to stop making false and misleading claims about the compounds' benefits and to stop selling hormone mixtures containing the ingredient estriol, which has not received agency approval (Edney, CongressDaily, 1/29).

FDA sent letters to seven pharmacies earlier this month. The agency 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. The agency also objected to the companies using the term "bioidentical" to describe the hormones, saying it incorrectly implies the hormones are natural or identical to the ones made by the body. In addition, FDA said there is no evidence the custom-made hormones are safer than approved versions of the hormones estrogen and progesterone. 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 (Daily Women's Health Policy Report, 1/10).

Kathleen Yule, FDA's assistant commissioner for women's health, said, "Women should be aware these products are not safer just because they are natural." Debbie Autor, FDA's compliance director, said other pharmacies conducting operations similar to the companies that received the letters should take note and adjust their practices.

According to a spokesperson from IACP, advocates of custom-made hormones are targeting lawmakers such as Senate Aging Committee ranking member Gordon Smith (R-Ore.). A Smith spokesperson said the senator is looking into the issue and anticipates a Congressional Research Service report next month that will compare state compounding regulations. An IACP spokesperson said that an estimated 90% of compounding pharmacists who make custom-made hormones use estriol (CongressDaily, 1/29).

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