2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
FDA Comment Number : | EC7196 | |||||||||||||||||||||||
Submitter : | Ms. Gwyn Blanton | Date & Time: | 03/06/2006 11:03:05 | |||||||||||||||||||||
Organization : | Ms. Gwyn Blanton | |||||||||||||||||||||||
Category : | Individual Consumer | |||||||||||||||||||||||
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Division of Dockets Management
Food and Drug Administration 5630 Fishers Lane, Room 1061 (HFA-305) Rockville, MD, 20852 RE: Docket 2005P-0411 Dear Sir or Madam: My name is Gwyn Blanton and I have been taking bio-identical hormones for two years. It has been a tremendous comfort to me as it alleviates hot flashes, bloating, and moodiness. I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist who prepares them. Without this medication, I weighed 10 pounds more, had no libido and was listless and depressed. I had tried prescription birth control pills and HRT patches for the same symptoms and had no success. The benefit of BHRT is that it is designed for me and I am concerned that Wyeth?s petition (Docket # 2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized doses for me. The FDA should reject Wyeth?s petition. PLEASE!!!! Sincerely, Gwyn Blanton Wilton, CT | ||||||||||||||||||||||||