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FDA Asserts New Policy to Restrict Women's Access to Bioidentical Hormones
Date:1/9/2008

Agency Warns Pharmacies Not to Compound Commonly Prescribed Hormone Treatments, Use the Term "Bio-identical"

MISSOURI CITY, Texas, Jan. 9 /PRNewswire-USNewswire/ -- In a series of warning letters to compounding pharmacies across the country, the Food and Drug Administration (FDA) has asserted a policy that would deny hundreds of thousands of women access to many compounded bioidentical hormones commonly, substituting its judgment for that of doctors. Wyeth Pharmaceuticals, the number one manufacturer of synthetic hormone products, petitioned the FDA to do so in October 2005. More than 66,000 doctors, patients, and pharmacists filed comments with the FDA opposing Wyeth's petition.

"Under this policy, patients will suffer while Wyeth profits," said L.D. King, executive director of the International Academy of Compounding Pharmacists (IACP). "Thousands of doctors are making patient-by-patient decisions that compounded hormones are medically appropriate, sometimes because Wyeth's products are found to be ineffective or produce side effects. This is a decision that should be left to doctors."

In the letters, the FDA states that it will "halt" compounding of medications containing estriol, an estrogen produced by the human body. Estriol is one of the most widely prescribed hormones and is regularly compounded with other bio-identical hormones pursuant to doctors' prescriptions for women suffering from symptoms of menopause. Like many commonly prescribed drugs (e.g, Phenobarbital, quinine, tinidazole), estriol has a monograph from the U.S. Pharmacopeia (USP), but is not a component of an FDA-approved drug. When it passed the FDA Modernization Act in 1997, Congress clearly indicated that drugs with a USP monograph could be compounded.

The FDA also stated in its letters that pharmacies may not use the term "bio-identical" to characterize compounded hormone therapies, even though the chemicals used in such compounds are chemically id
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SOURCE International Academy of Compounding Pharmacists
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