FDA sends warning letters to compounding pharmacies over hormone therapy drugs

WASHINGTON The Food and Drug Administration announced that it has sent warning letters to seven pharmacy operations, stating claims they make about the safety and effectiveness of their so-called “bio-identical hormone replacement therapy” products are unsupported by medical evidence, and are considered false and misleading by the agency, according to published reports and the agency’s own Web site.

The pharmacy operations improperly claim that their compounded drugs, which contain hormones such as estrogen, progesterone and estriol—which has not been proven safe and effective for any use by the FDA—are superior to FDA-approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer’s disease, stroke and various forms of cancer.

“We want to assure that Americans receive accurate information about the risks and benefits of drug therapies,” said Janet Woodcock, chief medical officer and acting director of the FDA Center for Drug Evaluation and Research. “In addition to today’s regulatory action, the FDA is publishing an informational article for women on its consumer health information web page that provides the facts to make informed decisions about these unapproved therapies. Women taking these drugs should discuss with their health care providers the drugs’ risks and whether they’re getting effective treatment.” 

FDA is concerned that the claims for safety, effectiveness and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professionals. Compounded drugs are not reviewed by the FDA for safety and effectiveness. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.

“We certainly hope other pharmacies will take heed,” Deborah Autor, director of the FDA drug center’s Office of Compliance, told the Wall Street Journal. The FDA noted that its action does not target pharmacists who practice traditional pharmacy compounding and who do not make false or misleading claims about compounded products.

Traditional pharmacy compounding typically involves preparation of a drug for an individual patient by a pharmacist in response to a valid prescription from a licensed practitioner. This compounding follows a practitioner’s decision that his or her patient has a special medical need that cannot be met by FDA-approved drugs. The FDA has posted its current view on human drug compounding online at www.fda.gov/cder/pharmcomp/default.htm.

Phillip Pylant, owner of one of the seven pharmacies, Village Compounding Pharmacy in Houston, told the Journal his pharmacy goes by “the highest standards” and follows “all the rules we’re supposed to follow.” Elaine Blieden, a pharmacist at Panorama Compounding Pharmacy in Lake Balboa, Calif., said the pharmacy was taking the FDA’s letter “very seriously.”

FDA also responded Thursday to a citizen petition from Wyeth—which reported $791 million in revenue from its hormone products for the first nine months of 2007—asking the agency to take regulatory action against compounding pharmacy operations that produce compounded BHRT drugs. Other stakeholders, including health care providers and consumer groups, have also raised concerns about BHRT drugs.

Wyeth spokesman Doug Petkus said the company supports the FDA’s action against the pharmacies. He added that Wyeth was “pleased” with the FDA’s formal response to its petition, the Journal reported.