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The FDA stated on January 9, 2008 that pharmacies cannot use the term"bio-identical" to describe the hormones they are compounding. "Even thoughthe hormones they are using are actually chemically identical to what isproduced by the human body," says Dr. Hart.
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"I am astounded that the FDA does not recognize that estradiol,progesterone, testosterone, and DHEA are chemically identical to hormonesfound in our bodies, and are therefore bio-identical. I don't know what'substantial evidence' they are waiting for to figure that one out."
According to their news release, the FDA does not approve of the use ofthe estrogen estriol in any compounded formula. They consider this themanufacture of an unapproved drug. "This is certainly news to me, sinceestriol is one of the types of hormones naturally found in a woman's body. Forthe FDA to say that menopausal women cannot benefit from the use of Estriol inHRT amazes me. I would certainly like the FDA to reconsider the publishedevidence on this estrogen and change their ruling," comments Dr. Hart.
Because of the misleading title of the FDA News release, Dr. Hart wants toreassure her patients that while it sounds like FDA is banning compoundedbio-identical hormones, it is not banning the compounded hormones.
"It is really up to the compounding pharmacies and their organizations,PCCA and IACP to get this straightened out with the FDA. Since the FDA's newposition is that compounds containing estriol represent a 'new drug' it wouldbe improper for me or any other medical practitioner to continue to prescribeEstriol compounds at this time," says Cheryle Hart, M.D.
SOURCE Cheryle R. Hart, M.D.
