2005P-0411

Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

FDA Comment Number :

EC7320

Submitter :

Mrs. Ruth Mundall

Date & Time:

03/06/2006 02:03:53

Organization :

Mrs. Ruth Mundall

Category :

Individual Consumer

Issue Areas/Comments

GENERAL

My name is Ruth Mundall and I have been taking bio-identical hormones for 2 years. It has been a tremendous comfort to me as it alleviates my insomnia and other perimenopausal symptoms.

I consult with my physician, who prescribes bio-identical hormones specifically for me, and my pharmacist prepares them. Without this medication, I would have to suffer the uncomfortable symptoms for which I take this medication. Furthermore, if I were to use the conventional HRT available, I would subject myself to the risks associated with conventional HRT, including cancer and stroke. Studies have shown that use of bio-identical hormones are not associated with the same level of risk from harmful side effects or long term risks as conventional HRT. Furthermore, the proportions and dosages of my formula are specifically prescribed and formulated for my specific needs, not mass produced in pre-set dosages and proportions.

The benefit of BHRT is that it is designed for me and has less harmful side effects and long term risks. 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. I am sure you can discern the true motive behind the Wyeth petition. They would like to eliminate any competition for their products. Please do all in your power to prevent Wyeth?s petition form being granted, and to preserve freedom and options in health care and pharmaceuticals.

Sincerely,

Ruth Mundall, BSC, RN

Labor and Delivery RN for 20 years

Sumas, WA