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Dr. Andrew Von Eschenbach
Food and Drug Administration
Rockville , MD 20857

Dear Dr. Von Eschenbach,

I am very discouraged by the FDA's recent policy to eliminate the compounded bio-identical menopause treatment options that my patients rely on. The policy benefits Wyeth, while taking away vital treatment options for my patients. With this new policy, the FDA has unnecessarily inserted the federal government into the individual relationships I have with each of my patients.

As a physician, I try to find the best course of treatment for each of my patients' individual needs. Bio-identical hormone replacement therapy (BHRT), including compounded medications containing estriol, is a very important treatment option in helping my patients combat the symptoms of menopause.

Furthermore, FDA has admitted that there are no adverse events associated with estriol. Wyeth is also on record stating that there are no safety issues with estriol. With its new policy, FDA is taking away an important treatment option for women going through menopause.

The FDA has also asserted that if I want to prescribe my patients BHRT containing estriol, I must first file an investigational new drug application. This would cost my profession millions of dollars and would take several years to implement. The decision to prescribe my patients estriol should remain mine and the patients alone without undue interference from FDA.

FDA's new policy hurts patients, doctors and pharmacists, while only benefiting large pharmaceutical manufacturers like Wyeth. We need your help to call for FDA to reverse its policy on compounded bio-identical hormone replacement therapy immediately.

Sincerely,

Dr. Clark Hansen
8070 E Morgan Trl Ste 120
Scottsdale , AZ 85258-1228

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