Wall Street Journal Examines Wyeth's Petition To FDA To Regulate Plant-Based Hormones; Response From Women

Main Category: Complementary Medicine / Alternative Medicine
Also Included In: Endocrinology
Article Date: 04 May 2006 - 3:00 PDT

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The Wall Street Journal on Tuesday examined pharmaceutical company Wyeth's petition for FDA to investigate the sale and marketing of plant-based "compounded" hormones and the more than 40,000 e-mails and letters the agency in the last six months has received in reaction to the petition (Parker-Pope, Wall Street Journal, 5/2). Compounded -- also known as so-called "bio-identical" -- hormones are mixtures of estrogens and progesterone that are extracted from plants and usually customized for women by pharmacies based on the results of hormone tests. Up to two million women in the U.S. use compounded hormones, according to the Web site of the Midlothian, Va.-based South River Compounding Pharmacy. Companies making the hormones and their advocates say the compounds are safer and work better than prescription hormones sold by drug companies. Wyeth in October 2005 asked FDA to investigate the issue, saying many compounding pharmacies are making unsubstantiated marketing claims that are confusing women about the risks and benefits of the hormones. Pharmaceutical companies say compounding pharmacies are acting as drug manufacturers by mass producing bio-identical hormones, and some doctors say a lack of federal oversight of the industry puts consumers at risk. A group of compounding pharmacies last year filed a lawsuit seeking protection from FDA regulations because pharmacies are regulated by state laws (Kaiser Daily Women's Health Policy Report, 10/25/05). Wyeth renewed the request to FDA last week (Kaiser Daily Women's Health Policy Report, 4/27). FDA has said it needs more time to review Wyeth's request. Meanwhile, an "overwhelming majority" of the comments the agency received regarding the petition were in opposition to Wyeth's position as a result of a "grassroots effort in pharmacies and on Web sites to urge women and doctors to write" to FDA, the Journal reports (Wall Street Journal, 5/2).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

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