2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7104
Submitter : Mrs. Carolyn Ronca Date & Time: 03/06/2006 10:03:17
Organization : Mrs. Carolyn Ronca
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear Sir-
My name is Carolyn Ronca and I have been taking bioidentical hormones for one year. It has changed my life! It has given my energy, taken away hot flashes and helped me with depression, and brought back my sex life!
I consult with my physician, who prescibes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication I will be prone to osteoporosos(As i take Fosamx)and my quality of life will certainly diminish.
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!