2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7751
Submitter : Ms. Jane Sturtevant Date & Time: 03/07/2006 02:03:54
Organization : Ms. Jane Sturtevant
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I have been using a natural estriol cream (referred to in this docket as a bio-identical hormone replacement therapy drug) prescribed by my GYN and approved by my primary care physician. I value my freedom to choose this form of therapy for two reasons: (1) I feel much safer with a bio- identical product, and (2) this generic cream, compounded by Women's International Pharmacy, actually costs less than my insurance co-pay. If you disallow pharmacy compounding of such products, it will unnecessarily and harmfully limit physicians' and women's choices and unfairly enrich drug companies. Estriol is not even produced by drug companies and is only available from compounders--not because it is unsafe, but because it is relatively unprofitable. Drug companies want nothing available but their own propriatory brands. Please do not allow them to prevail.