2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC6980
Submitter : Ms. NYLA JACOBS Date & Time: 03/06/2006 09:03:23
Organization : Ms. NYLA JACOBS
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
Dear Sir or Madam:

My name is Nyla Jacobs and I have been taking bio-identical hormones for 1 year. It has been a tremendous comfort to me as it alleviates my premenstrual symptoms.

I consult with my physician, who prescrives bio-identical hormones specifically for me and my pharmacist prepares them. Without this medication,I would continue to suffer from severe mood swings prior to my menstrual period resulting in time lost from work.
The benefit of BHRT is that it is designed for me and I am conerned that Wyeth's petition (Docket # 2005P-0411) would limit the ability of my physician and pharmacist to keep prescribing and preparing these individualized does for me. The FDA should reject Wyeth's petitions.

Sincerely,


Nyla Jacobs
Houston, TX