2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC15
Submitter : Dr. Stacey Burns Date & Time: 12/19/2005 12:12:53
Organization : Dr. Stacey Burns
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
As a compounding pharmacist, I am outraged by Wyeth's claims in their petition. I have several patients for whom I compound BHRT at their physician's request. Most of my BHRT patients were having menopause symptoms not relieved by premarin or other estrogen therapies currently manufactured. They have turned to BHRT as an alternative to relieving their symptoms. In these cases, BHRT has made a tremendously positive impact in the lives of each patient. In each case the physician has made the initial decision to place the patients on BHRT and the physician has ordered the hormone level testing and decided on the dosage which we have compounded for each patient based on their baseline lab results. We make every effort to ensure that we compound the ordered medication as safely as possible. Without BHRT, my patients would again be left with no other options for hormone replacement therapy as they have all tried and failed treatment on currently commercially available products such as Premarin, Estrace, Cenestin, Estratest, etc. Wyeths petition blurs the line between synthetic and bioidentical hormones, suggesting that both carry the same risks, which is not supported by scientific evidence. It mischaracterizes the safety of compounded medications. And it threatens the First Amendment rights of pharmacists to communicate with patients and physicians. Wyeth's petition proposes broad restrictions that would limit pharmacists' ability to prepare bio-identical hormones which might also impede the ability of pharmacists to compound in other ways as well.
For some women, BHRT is the only thing that eases symptoms. More women are turning to BHRT which is composed of a custom-compounded mixture of estrogens and progesterone that are identical to hormones produced by the human body. Pharmacy compounding is performed by responsible, trained professionals who have a strong relationship with thier patient and their patient's physician. The successful practice of compounding is based on open communication between the patient, physician and pharmacist. By attacking these communications and the ability to treat these patients with BHRT or other compounding, Wyeth's petition would do much more harm than good. As a result, I would like to request that the FDA deny Wyeth's petition.

Thank You,

Stacey Burns, Pharm.D.