2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC7422
Submitter : Mrs. Jean Galyon Date & Time: 03/06/2006 03:03:44
Organization : Mrs. Jean Galyon
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
I am strongly in favor of protecting physicians' ability to prescribe and pharmacists' ability to compound medications to treat women's individual health needs. There had never been the exact dosage of biologically-identical hormone available to me until I found a pharmacy that could meet my physician prescribed specific dosage amount and form. I have been utilizing this pharmacy for at least 10 years and have had hormone levels monitored throughout by my doctor. Through all these years I have been comfortable that my pharmacy maintains good quality control and responds to my needs as expressed through my doctor's prescriptions. I do not want to lose the patient/physcian relationship tailored specifically to my needs. I am also not willing to take some the HRTs available by the pharmaceutical companies because of the ingredients they use. I wonder why the FDA is not reviewing the longtime use of some of those ingredients rather than the ones under attack. Please do not allow the pressure of large pharmaceutical companies to deny me this right. It is hardly a radical stand when my physician favors this approach! I have grave concerns about the motivation behind this petition by the large pharmaceuticals.