The U.S. Food and Drug Administration (FDA)
sent letters warning seven pharmacy operations that the claims they make about
the safety and effectiveness of their so-called "bio-identical hormone
replacement therapy," or "BHRT" products are unsupported by
medical evidence, and are considered false and misleading by the agency. 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 has not 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.
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, and
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.
"We want to assure that Americans
receive accurate information about the risks and benefits of drug
therapies," said 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. FDA regards this use of
"bio-identical" as a marketing term implying a benefit for the drug,
for which there is no medical or scientific basis.
The pharmacy operations also make unsupported
claims that their drugs are better than FDA-approved menopausal hormone therapy
drugs and can be used to prevent and treat serious diseases such as Alzheimer's
disease, stroke, and various forms of cancer.
The pharmacy operations compound hormone
therapy drugs that contain estriol as well as
progesterone and estrogen. No drug product containing estriol
has been approved by FDA and the safety and effectiveness of estriol is unknown.
Firms that do not properly address violations
identified in warning letters risk further enforcement, including injunctions
that prevent additional violations, and seizure of violative
drugs.
FDA's action today 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. FDA's current view on human drug compounding is addressed in its compounding
Compliance Policy Guide, available at http://www.fda.gov/cder/pharmcomp/default.htm.
FDA also responded to a citizen petition from
Wyeth,
All patients who use compounded hormone
therapy drugs should discuss menopausal hormone therapy options with their
health care provider to determine if compounded drugs are the best option for
their specific medical needs. If patients or practitioners encounter problems
with compounded hormone therapy drugs, they are encouraged to file a MedWatch report with the FDA at www.fda.gov/medwatch or by phone at
1-800-FDA-1088.
For more information, see a consumer article
called Bio-Identicals: Sorting Myths from Facts http://www.fda.gov/consumer/updates/bioidenticals010908.html.
Warning Letters and Q and A's are available
at http://www.fda.gov/cder/pharmcomp/default.htm.