2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
FDA Comment Number : EC24
Submitter : Mr. Dale Bartel Date & Time: 12/21/2005 05:12:54
Organization : Valley Pharmacy and Professional Compounding
Category : Health Professional
Issue Areas/Comments
How ironic it is that Wyeth is claiming that Bio-identical Hormones are a risk to women's health. Wyeth's hormone products have been shown to increase the risk of cancer, yet the suggested therapy is to give smaller doses if these dangerous substances. Bio-identical hormones have been used in Europe for years with great success, improving the quality of life for many. If bio-identical hormones were able to be patented, Wyeth would be making them. Bio-identical hormones are exactly the same as those in the human body. Therefore, it is hard to argue that these would be more logical to use as supplements than to use hormones derived from pregnant mares urine. There are countless studies availabe showing the benefits of bio-identicals. Should we ignore these studies and force women to use products already proven to be dangerous? Compounding has been a part of pharmacy since its inception. Compounding is not manufacturing. We make custom products for patients, not a "one size fits all" process. We, along with many other compounders have applied for credentialing. We follow professional standards as taught by the Professional Compounding Centers of America. Our products are professionally prepared, and have precise dosages. We voluntarily send samples to be tested every 6 months and tests have always shown us to be very, very accurate. I fail to see a danger to the public if compounders function with the kind of standards we do. Our products are exceeding the accuracy of many FDA approved generic products. Wyeth's actions are simply for its own selfish interests and have nothing to do with the safety for patients. I urge you to allow pharmacists to continue doing what we have done for decades. We want to continue to custom prepare medications for patients leading to a much better quality of life. Isn't that what medicine is supposed to do?