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News of the Day ... In Perspective


Wyeth petitions FDA to regulate compounding pharmacies; 40,000 respond

Wyeth, manufacturer of the hormones Prempro and Premarin, is petitioning the FDA to take action against compounding pharmacies that supply “bioidentical” hormones on a physician’s prescription, saying that the products are inadequately regulated.

Since 2002, when health risks were reported, sales of commercial hormones have fallen by half, to about $2 billion annually. It is not known how many women are substituting compounded products, but the flood of responses, most protesting Wyeth’s petition, suggest that the number is substantial. The final number may exceed 50,000.

Compounding pharmacies are regulated by state pharmacy boards. Manufacturers are regulated by the FDA. Wyeth is suggesting that compounding pharmacies are acting more like manufacturers than corner drugstores and should thus be under the jurisdiction of the FDA.

The testing and follow-up doctor’s visits for obtaining individualized prescriptions may cost more than $1,000 over the course of a year, and the compounded hormones cost $30 to $100 monthly. Unlike with commercial hormones, many of the costs are typically not covered by insurance.

The North American Menopause Society, the American College of Obstetricians and Gynecologists, and the American Medical Women’s Association are siding with Wyeth, saying there’s no evidence that compounded drugs are safer. They are also skeptical about the purity of the products (Tara Parker-Pope, Wall St J 5/2/06).

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