FDA Goes After 'Natural' HRT Claims
Compounding Pharmacies Told to Stop Marketing 'Bio-identical Hormone Replacement Therapy'
Jan. 9, 2008 -- Federal regulators warned several pharmacy companies
Wednesday to stop marketing so-called "natural" hormone replacement
therapy, calling their sales to women "false and misleading."
The FDA took aim at seven compounding pharmacy companies that it says use a
product called estriol in reformulated hormone replacement therapy for
The agency warned the pharmacies to cease marketing HRT containing estriol
and to stop making claims that their products are "natural" or
"bioequivalent" to standard HRT.
"Estriol has not been approved by the FDA in any dose for any use,"
says Debra Autor, director of the office of compliance in the FDA's Center for
Drug Evaluation and Research.
Autor says the agency has "no reliable scientific evidence" that
estriol is safe and effective and that claims made by the seven pharmacies,
mostly in Internet marketing, are "false and misleading."
Some doctors rely on a cottage industry of compounding pharmacies to
reformulate medications in concentrations, amounts, or preparations
that are not available on the regular U.S. market.
FDA officials say their move against the pharmacies was in response to
concerns raised by several health providers and consumer groups, as well as to
a petition filed by the Wyeth pharmaceutical company.
Wednesday's action also comes as the FDA continues a legal battle over
whether it has jurisdiction over compounding pharmacies. Oral arguments are
expected tomorrow in the U.S. 5th Circuit Court of Appeals in New Orleans. The
agency is appealing a lower court ruling concluding the agency does not have
jurisdiction over drug preparations produced by compounding pharmacies.
Agency officials said Wednesday's action was also intended to crack down on
pharmacies' false and misleading claims that "bio-identical hormone
replacement therapy," sometimes called BHRT, is a natural alternative to
standard HRT. The FDA considers the safety and effectiveness of BHRT products
to be unsupported by scientific evidence.
"BHRT is not a term that is recognized by FDA. It is essentially used as
a marketing term," says Kathleen Yule, the FDA's assistant commissioner for
women's health. "Women should be aware that these 'bioequivalent' products
are not safer just because they are natural."
The seven pharmacies targeted by the FDA include:
- Panorama Compounding Pharmacy
- Saint John's Medical Plaza Pharmacy
- Murray Avenue Apothecary
- Village Compounding Pharmacy
- Pharmacy Compounding Specialties
- Reed's Compounding Pharmacy
- Pacifica Pharma
Tom Murray, executive director of the Pharmacy Compounding Accreditation
Board, said only two of the seven companies targeted by the FDA have
accreditation from his organization.
Pharmacies should not make claims that aren't substantiated by scientific
facts, Murray says. "If you don't have the data to back it up, that's not