|2005P-0411|| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs|
|FDA Comment Number :||EC17|
|Submitter :||Mrs. Cynthia Wilfong||Date & Time:||12/19/2005 12:12:40|
|Organization :||Mrs. Cynthia Wilfong|
|Category :||Drug Industry|
| To whom it may concern:
My name is Cynthia Wilfong, and I run a weight managment program. Over the last two years, since I have known about bio-identical hromone therapy, I have personally witnessed many of my clients getting much needed relief (with no adverse side effects) of pre-menopausal, and menopausal symptoms using BHRT compounded to personally suit their needs by a compounding pharmacist. These clients of mine have all consulted with their physicians, and been tested, prior to the pharmacist preparing their presciption. Without these much needed personalized medications, (that can be adjusted by the physician and the compounding pharmacist accordingly to each women's needs) , we are subjecting women to a "one size fits all" medication that would be a big step backwards in treatment of symptoms. I am concerned that Wyeth's petition (Docket#2005P-0411) would limit the ability of physicians and pharmacists to keep prescribing and preparing these individualized doses for my clients. I feel very strongly that the FDA should reject Wyeth's petitions.