2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7022
Submitter : Ms. Georgia Pate Date & Time: 03/06/2006 09:03:24
Organization : Ms. Georgia Pate
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear Sir Or Madam,
My name is Georgia Pate and I have been taking bio-identical hormones for 4 years. It has been a tremendous comfort to me as it alleviates all of the symptoms commonly associated with menopause, ie: hot flashes, night sweats, emotional swings, sleep disruptions,depression, mental fogginess, vaginal dryness and decreased libido. I consult with my physician, who prescribes bio-identical hormones specifically for me and my pharmacist prepares them. Without this medication I would once again have to deal with all of the above mentioned problems. Having lived with those symptoms for several years before discovering Bio-identical hormone replacement, I can not tell you how much I would suffer with them again should I be denied the opportunity to use these wonderful products. The benefit of BHRT (Bio-identical hormone replacement thereapy) is that it is identical to the hormones my body would procuce, and is designed specifically for me. And I am very concerned that Wyeth's petition (Docket #2005P-0411) would limit the ability of my physician and pharmacist to keep prescirbing and preparing these individualized doses for me. The FDA should REJECT Wyth's petition.
Sincerely,
Georgia B. Pate
Madison WI