House Members Introduce Resolution Asking FDA To Stop Efforts To Ban Hormone Ingredient Estriol

Main Category: Menopause
Also Included In: Seniors / Aging;  Endocrinology;  Regulatory Affairs / Drug Approvals
Article Date: 29 May 2008 - 6:00 PDT

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Rep. Gabrielle Giffords (D-Ariz.) and eight other House members earlier this month introduced a "sense of Congress" resolution (H Con Res 342) that would ask FDA to stop its effort to ban custom-made hormones aimed at treating menopause-related symptoms that contain the ingredient estriol, the Arizona Daily Star reports. According to the Daily Star, FDA has said it "expects" pharmacies to stop using estriol -- which is contained in about 80% of custom-made female hormones -- but the agency has not issued a "cease-and-desist" order.

Some independent pharmacies are continuing to produce the products, but FDA's warning appears to have "discouraged" some patients from using the hormones, the Daily Star reports. Ten pharmacies have filed a lawsuit that challenges FDA's jurisdiction over the custom-made products (McClain, Arizona Daily Star, 5/24).

According to FDA, estriol is not a component of an FDA-approved drug and has not been proven safe and effective for any use (FDA release, 1/9). Giffords noted that estriol carries a USP monograph, a United States Pharmacopeia approval standard that is recognized by state pharmacy boards and endorsed by Congress. Giffords in a letter to her constituents said she knows of "no other precedent for FDA banning an ingredient with a USP monograph absent documented health and safety issues." She added that FDA's action "represents a denial of care to women" because some insurance companies have stopped covering compounded hormones containing estriol.

Giffords said she received letters from nearly 150 women in her district protesting FDA's efforts and asking her to intervene. "Doctors are in the best position to determine the best medications for their patients, and absent real safety issues, the FDA should not interject itself into the doctor-patient relationship," Giffords said. She added, "Eliminating (estriol's) availability would unnecessarily disrupt the lives of countless women" (Arizona Daily Star, 5/24).

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