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.