2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7272
Submitter : Ms. Michelle Halloran Date & Time: 03/06/2006 02:03:45
Organization : Ms. Michelle Halloran
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
My name is Micki Halloran. I have been using bio-identical hormones for three years. They have been trememdously helpful to my good health. My physician prescribes my individual dosage and my pharmacist prepares it for me. Without this medication I experience irritability, hot flashing and general irregular mood. My relationship with my husband, children, friends and community is negatively impacted. My physician was able, just one year ago, to tweak the dosage of my hormone medication to accomodate changes my 61 year old body was naturally experiencing.
The benefit of BHRT's is that it is designed for me. 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 individual doses for me. The FDA should reject Wyeth's petition.
Sincerely,
Michelle (Micki Halloran)