National Community Pharmacists Association Statement On "Sense Of Congress" Resolution Opposing FDA Restrictions On Estriol Usage

Main Category: Women's Health / Gynecology
Also Included In: Regulatory Affairs / Drug Approvals;  Endocrinology
Article Date: 08 May 2008 - 2:00 PDT

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Yesterday H. Con. Res. 342 was introduced by Rep. Mike Ross (D-Ark.) and Jo Ann Emerson (R-Mo.) opposing the Food and Drug Administration's (FDA) decision to restrict Estriol (a form of Estrogen), a compounded hormone preparation used by women to alleviate the symptoms of menopause. The action was taken after the FDA sent letters to seven pharmacies in January asking them to cease and desist with the use of estriol. At this time, there is insufficient evidence substantiating the need for restriction. In response Bruce Roberts, RPh, executive vice president and CEO of the National Community Pharmacists Association (NCPA), issued the following statement:

"Estriol helps women manage the menopause process and has been proven safe and effective. FDA's decision is not predicated on evidence, therefore questioning their interference in the states' jurisdiction over drug compounding. The National Community Pharmacists Association commends Representatives Mike Ross and Jo Ann Emerson for their 'Sense of Congress' resolution urging the FDA to reconsider their restrictions on the use of Estriol."

NOTE: Representatives Tammy Baldwin (D-Wis.), Michael Burgess (R-Texas), John Carter (R-Texas), Sam Farr (D-Calif.), and Gabrielle Giffords (D-Ariz.) were also instrumental in bringing this much needed language to the House floor.

The National Community Pharmacists Association, founded in 1898, represents the nation's community pharmacists, including the owners of more than 23,000 pharmacies. The nation's independent pharmacies, independent pharmacy franchises, and independent chains dispense nearly half of the nation's retail prescription medicines.

National Community Pharmacists Association