2005P-0411 | Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs | |||||||||||||||||||||||
FDA Comment Number : | EC7255 | |||||||||||||||||||||||
Submitter : | Mrs. Linda Pasquali | Date & Time: | 03/06/2006 02:03:15 | |||||||||||||||||||||
Organization : | Mrs. Linda Pasquali | |||||||||||||||||||||||
Category : | Individual Consumer | |||||||||||||||||||||||
Issue Areas/Comments | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
GENERAL | ||||||||||||||||||||||||
My name is Linda Pasquali and I have been taking bio-identical hormones for a
year. It has been a tremendous comfort to me as it alleviates all the unwanted symptoms associated with Menopause. I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, I?m afraid I would go back to feeling all the discomforts that go along with the change of life. 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. | ||||||||||||||||||||||||