2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC5
Submitter : Dr. Mark Burger Date & Time: 12/19/2005 12:12:53
Organization : Health First ! Pharmacy
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
I am asking the FDA to reject Wyeth's petition (Docket: 2005P-0411)on behalf of the physicians who write for and the patients who recieve the benefit of bio-identical hormone therapy. The pharmacies who fill these orders are not violating any law. Pharmacists have, and should continue to be able to, compound prescriptions upon a doctor's orders to fulfill the unique individual needs of the patient.

As Department of Health and Human Services (HHS) Secretary Michael O. Leavitt stated at the recent FDA Science Forum that the development of personalized drug therapies through pharmacogenomics will redefine: (1) the pharmaceutical industry, (2) the practice of medicine, and (3) the FDA, in much the same way that the Internet expanded but disrupted the telecommunications trade.

Felix Frueh, Associate Director of Genomics in FDA's Office of Clinical Pharmacology and Biopharmaceutics went further to state that the paradigm of a "one-size-fits-all" approach to prescribing a medication is "clearly outdated."

Concerned physicians and compounding pharmacists have been individualizing medications for many years. We should be allowed to do so in the future.

Lastly, consider the history of the Wyeth organization. It falsely maintained that competitor's generic version of Premarin were unsafe and it mislead physicians and women at the inception of Premarin's release decades hence.

Thank you in advance for sending Wyeth back to the "drawing board". If they had anything new in the "pipline", which should be their primary mission, they would not be attempting to deny women their rights to health and customized medications.

Mark T. Burger, Pharm.D.
Former Drug Information Specialist (1975)
Burea of Drugs
FDA