House resolution calls for FDA reversal on estriol use

MISSOURI CITY, Texas, and ALEXANDRIA, Va. H. Con. Res. 342 was introduced in the House of Representatives yesterday by Reps. Mike Ross, D-Ark., and Jo Ann Emerson, R-Mo. The legislation states that, “the Food and Drug Administration’s new policy restricting women’s access to medications containing estriol does not serve the public interest.” It also calls for the FDA to “reverse its policy.”

In January, due to a petition from Wyeth, the FDA removed the drug, which is used to treat both multiple sclerosis and symptoms of menopause from the market. In response to the petition, 70,000 people, mostly women and doctors, wrote to the agency to ask them to oppose the petition. The drug is used in compounds to help relieve the symptoms.

Since the FDA announced its estriol policy in January, the agency has since attempted to allay the concerns of thousands of women by stating that doctors may prescribe compounded hormones containing estriol if they complete an Investigational New Drug Application.

The International Academy of Compounding Pharmacists has joined with the thousands of women and doctors who oppose the FDA’s policy.

In response to the legislation, National Community Pharmacists Association executive vice president and chief executive officer Bruce Roberts said, “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 NCPA 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.”