2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7315
Submitter : Mrs. Nancy Tuttle Date & Time: 03/06/2006 02:03:29
Organization : Mrs. Nancy Tuttle
Category : Drug Association
Issue Areas/Comments
GENERAL
GENERAL
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061 (HFA-305)
Rockville, MD, 20852

RE: Docket 2005P-0411

Dear Sir or Madam:

My name is Nancy Tuttle and I have been taking bio-identical hormones for 6 months. It has been a tremendous comfort to me as it alleviates a hormonal issue I had for over 2 years where other medications that had been prescribed by another physician, did not help.

I consulted my physician, who prescribes bio-identical hormones specifically
for me, and my pharmacist prepares them. Without this medication, I would have to continue to endure the pain that this medication eliminates.


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.

Sincerely,
Nancy Tuttle
Lansdowne,PA