House resolution calls on FDA to reverse its policy on estriol for menopause

May 9, 2008

A large group of physicians, pharmacists, and patients have pressed Congress to urge FDA to rescind its policy that bars the use of compounded estriol to treat menopause.

It was understandable for the Food & Drug Administration to take action against compounding pharmacies that claim that their bioidentical hormone products are superior to traditional hormone replacement therapy. But banning the use of estriol to treat women with menopause is unwarranted. That’s the position of a large body of physicians, pharmacists, and patients who have pressed several members of the House of Representatives to introduce a resolution calling on FDA to reverse its policy related to estriol.. H. Con. Res. 342, introduced by Rep. Mike Ross (D, Ark.) and Jo Ann Emerson (R, Mo.), maintains that physicians are in the best position to determine which medications are appropriate for their patients and FDA should not limit access to this substance, which has proven safe and effective over many years of use. The resolution follows a letter Sen. Tom Coburn (R, Okla.) wrote to the agency, criticizing its estriol policy. Both the National Community Pharmacists Association and the International Academy of Compounding Pharmacists applauded the resolution. IACP pointed out that FDA took its action thanks to a petition from Wyeth, which argued that compounded bio-identical hormone replacement therapy containing estriol posed a serious threat to public health. Yet, Wyeth itself was marketing drugs containing estriol as an “ideal therapy” across Europe, IACP said. The compounding association added that FDA’s stance that estriol can be prescribed if an investigational new drug application is completed is unworkable.

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