2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC20
Submitter : Mrs. Stacie Blewett Date & Time: 12/21/2005 05:12:04
Organization : Mrs. Stacie Blewett
Category : Health Professional
Issue Areas/Comments
Dear Sir or Madame:
I am very concerned over the recent petition filed by Wyeth Pharmaceuticals, Docket 2005P-0411. This petition has many flaws that must be examined before any fair decision is to be made. I have contact with several women and men who have suffered the discomfort of menopause and andropause. Many of these women had been on synthetic hormone replacement prior to the study released by the Womens' Health Initiative that showed the dangers of hormone replacment. Many of these patients were told to stop these medications by their PHYSICIANS. Bio-Identical Hormone Replacement Therapy (BHRT) was their only other choice. I have heard many success stories. Many of these patients tell us that their lives have been completely changed by BHRT and want to know why had they never been told of this option before now. These patients have told friends and family members about their success so that they too will know about these options. And it is not only menopause that BHRT helps to treat. Women with endometriosis, PMS, PMDD & infertility also benefit from BHRT. Pregnant patients who need progesterone compounded into a suppository to help maintain pregnancy also benefit. I was one of those pregnant patients four years ago. My physician prescribed the compounded progesterone because of several issuses: 1)direct delivery to where the hormone was needed, 2)it is not synthetic and 3)due to morning sickness, I was unble to take a capsule. I truly believe that had I not been able to receive this medication that my pregnancy would have ended in a mis-carriage: a mis-carriage that would have been caused by one reason only; the fact to my own body could not produce enough progesterone to sustain that pregnancy. My physician has told me that should I ever become pregnant again that I would probably still need to use the progesterone. Is it fair to take that away from me and others that find themselves in the same situation? NO! At our pharmacy the physician plays a significant role in the prescribing of natural hormones. In fact, we do not dispense the hormones without a prescription. We maintain constant contact with the physicians regarding their patients and their BHRT. We also help keep the physicians informed of any new information and research done in the field of BHRT. Many of these physicians are open to the BHRT option. They want to give their patients the best care and treatment possible. By giving their patients the OPTION of synthetic or natural they are giving their patients a voice in their own treatment. And if the patient finds that BHRT is not for them then they have the synthetic OPTION. We make every effort, at our pharmacy, to ensure the safety of all compounded medications - not just BHRT. Our customers are the driving force behind our success and we will take all steps necessary to ensure that they are getting exactly what they have been prescribed.

My point is that why should a pharmaceutical company try to take away treatment OPTIONS to any patient? Why should a pharmaceutical company tell me that I cannot suggest that a patient and their doctor look into all the OPTIONS of treatment? What is really scary about this docket is that if threatens pharmacy compounding in general. Case in point, we have patient who is now 6 months old that received a heart transplant not longer after birth. Many of the medications that this child must receive are not commercially available in a liquid form - the most important being his anti-rejection drug. If this child did not have access to compounded medications the end result would be death. A 6 month old cannot swallow a capsule. The only way for this child to receive life sustaining drugs is through compounding his medication into a liquid form. I am not saying that people would die without BHRT but the very nature of this petition threatens EVERYONE with a need for compounded medications. Please help keep all OPTIONS available to everyone