Magazine article Drug Topics

AMA to FDA: Regulate Hormone Compounding

Magazine article Drug Topics

AMA to FDA: Regulate Hormone Compounding

Article excerpt

In a move that surprised both compounding proponents and advocates, the American Medical Association Board of Trustees adopted a resolution calling for Food & Drug Administration oversight of pharmacy-compounded bioidentical hormones. The resolution, which, according to sources at the AMA, passed with little opposition, also included an amendment that called on the FDA to regulate the use of the term bioidentical hormones.

The AMA resolution is broadreaching. In addition to calling for FDA oversight and limits on the use of the term bioidentical hormones, the group also called for the FDA to create a registry of adverse events and the development of uniform warning for bioidentical hormone products.

"There is no scientific basis for claims that compounded-hormone therapies have a different riskbenefit ratio than PDA-approved hormone replacement therapies," said AMA board member Ardis Hoven, M.D., in a written statement. "Confidence in the safety and effectiveness of the therapies patients take is absolutely essential for both patients and physicians," Hoven went on to explain. "New FDA policies that would require manufacturers and compounding pharmacies to provide adverse event information on compounded bioidentical hormones-and share the warnings and precautions with patients on the drug label-will help patients and doctors make better informed decisions on the course of treatment."

"We are very disappointed in the AMA resolution," responded L. D. King. He is executive director of the International Academy of Compounding Pharmacists (IACP). "It is a hasty, misguided approach. We hope to work with the AMA in the future to develop a better approach."

The resolution was originally proposed jointly by The Endocrine Society, the American Association of Clinical Endocrinologiste (AACE), and the American Society for Reproductive Medicine at the 2006 interim meeting of the AMA house of delegates, held last month in Las Vegas. "To us, it is very much about drug safety issues," explained Richard Hellman, M.D., presidentelect of AACE. Our concern is that the FDA seems at times not to be as focused on drug safety as they should be."

One of the underlying issues is the long-running controversy surrounding bioidentical hormone replacement therapy (BHRT) and the efforts of synthetic hormone manufacturer Wyeth Pharmaceuticals to get the FDA to regulate BHRT. …

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