FDA Goes After 'Natural' HRT Claims

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 women.

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.

Court Battle

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 appropriate."