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Quality Digest

FDA Compliance

Compounded Hormone Therapy Drug-makers Warned

Published: Tuesday, January 22, 2008 - 23:00

(FDA: Rockville, Maryland) -- The U.S. Food and Drug Administration has sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of so-called bio-identical hormone replacement therapy (BHRT) products are unsupported by medical evidence, and are considered false and misleading by the agency. The FDA is concerned that unfounded claims like these mislead women and health care professionals.

The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen, progesterone, and estriol (which is not a component of an FDA-approved drug and hasn’t been proven safe and effective for any use) 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.

Compounded drugs aren’t reviewed by the FDA for safety and effectiveness, and the FDA encourages patients to use FDA-approved drugs whenever possible. The warning letters state that the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs. 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.

“We want to ensure that Americans receive accurate information about the risks and benefits of drug therapies,” says Dr. Janet Woodcock, FDA’s chief medical officer and acting director of the agency’s Center for Drug Evaluation and Research. “In addition to today’s regulatory action, 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.”

The pharmacy operations receiving warning letters use the terms “bio-identical hormone replacement therapy” and BHRT to imply that their drugs are natural or identical to the hormones made by the body. The FDA regards this use of “bio-identical” as a marketing term implying a benefit for the drug, for which there’s no medical or scientific basis. 

Firms that don’t properly address violations identified in warning letters risk further enforcement, including injunctions that prevent additional violations, and seizure of violative drugs.

The FDA’s action today doesn’t target pharmacists who practice traditional pharmacy compounding and who don’t 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. FDA’s current view on human drug compounding is addressed in its compounding Compliance Policy Guide.

The FDA also recently responded to a citizen petition from Wyeth asking it 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.

For more information, visit www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html


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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.