US FDA told to back down over estriol action

A bill has been introduced in the US House of Representatives by Mike Ross (Democrat, Arkansas) and Jo Ann Emerson (Republican, Missouri) to oppose the decision by the Food and Drug Administration to restrict estriol, a compounded estrogen preparation for the alleviation of 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."

Supporters of the drug's use argue that there is insufficient evidence substantiating the need for restriction. Bruce Roberts, executive vice president of the National Community Pharmacists Association, backed the legislators, stating that "estriol helps women manage the menopause process and has been proven safe and effective. [The] FDA's decision is not predicated on evidence, therefore questioning their interference in the states' jurisdiction over drug compounding."

He added: "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." The NCPA represents the owners of more than 23,000 US pharmacies.