2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC2644
Submitter : Ms. Janet Juntunen Date & Time: 02/16/2006 12:02:14
Organization : Ms. Janet Juntunen
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am writing to support the compounding pharmacies. I believe that consumers have the right to use natural bio-identical hormones prepared for the individual. These hormones can be customized for the dosage and route of administration that works best for the individual. I do not believe that we should be forced to use hormones that are foreign molecules to the human body. The materials that the compounding pharmacies use are bio-identical to the hormones found in the body naturally. It also allows absorbtion of the hormones without being modified by going through the GI system, thus it allows for better absorption. Please do not take this therapy away. It helps a lot of patients.
Please look at the motivation that this topic has come up. Wyeth has lost a significant portion of their profits. This should not mean that bio- identical hormones should be outlawed. Synthetic hormones have been linked to adverse side effects, but bio-identical hormones have not. Please be fair in looking at the whole picture.
Janet Juntunen