Dear Senator or Representative ________:
I appreciate your response; however I am very disappointed by your stance on this issue. My doctor has worked closely with me to prescribe a bioidentical hormone treatment that has alleviated my menopausal symptoms. I’d like to highlight a few additional points you may be unaware of and encourage you to reconsider your response.
The FDA’s action is a direct response to a citizen petition filed by the drug company Wyeth in October 2005. Wyeth requested that the FDA ban the use of estriol for “safety” reasons since it is not a component of any FDA approved drug. The Wyeth citizen petition generated over 70,000 comments from the public primarily women, doctors and pharmacists who opposed Wyeth’s request. This ban was requested despite the fact that estriol has a long-standing USP monograph and has been compounded safely in the U.S. for decades.
At a press conference announcing their decision, the FDA admitted there were no adverse events or safety issues supporting its decision. Ironically, Wyeth itself manufactures estrogen products in Germany containing estriol, and there are almost 40 estrogen products with estriol approved and used safely in Europe and other parts of the world.
Further, U.S. Pharmacopeia, state boards of pharmacy and the Pharmacy Compounding Accreditation Board allow pharmacists to compound with estriol because it has a USP monograph. Even Congress in 1997 indicated in the FDA Modernization Act that drugs with a USP monograph could be compounded.
The FDA also announced that it was taking action against unsubstantiated claims on pharmacy websites related to compounded bioidentical hormones. As a patient and consumer I do not dispute this as I, and the compounding pharmacy community, understand that unsubstantiated claims and false advertising are inappropriate.
I encourage you to reconsider your statement. If allowed to stand, the FDA’s action will result in an unnecessary disruption not just in my life, but in the lives of hundreds of thousands of women who will be forced to discontinue their treatments or alter their medications. Further, doctors who have successfully treated their patients with medications containing estriol will be denied this treatment option.
Thank you in advance for your consideration of my request.