Tuesday, April 11, 2006
Natural Solutions FoundationApril 10, 2006: " The FDA has extended the comment period on the Citizens Complaint filed by pharmaceutical giant Wyeth (Docket: 2005P-0411) against the sale of natural hormones ("bioidentical") by special pharmacists. Wyeth filed their complaint in October, 2006 claiming that both the bio identical hormones and the pharmacisits who filled the customized prescriptions posed a health hazard. After receiving 37,000 written responses, the FDA will accept comments until May 4, 2006.
The FDA announced that it would allow comments on the Citizens Complaint against bio identical hormones until May 4, 2006 although the original comment period expired on April 4, 2006. Wyeth filed their complaint (Docket: 2005P-0411) on October 6, 2006 asking the FDA to impose significant restrictions on consumer’s access to bio identical hormones. These natural molecules are prescribed by physicians in amounts and delivery systems which are customized to the need of each patient. The prescription is then filled by special pharmacists who are trained in the compounding of these individualized formulations.
Comments may be sent to the FDA HERE.
Consumers, compounding pharmacists, physicians practicing bio identical and health freedom advocates are up in arms over this action by Wyeth. States, not the federal government have jurisdiction over compounding pharmacies. Health freedom advocates characterize Wyeth's move as seeking an extension of federal power on its behalf and attempting to eliminate a competitor in a failing market.
Health freedom advocates also fear that this is merely another step in the restriction of the consumer's right to make their own health choices whether or not they add to the pharmaceutical or medical coffers. Physicians and patients who have experienced the benefit of bio identical hormones fear that they will loose a powerful, gentle and effective option to drugs when they need to replace and regulate their hormone levels. During the final days of the comment period, the traffic was so heavy that the FDA's electronic comment system was reportedly overwhelmed.
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