Physicians: Oppose Wyeth & FDA Actions to Limit Prescribing!

Source: Patients and Professionals for Customized Care

As you may be aware, FDA made a horrible decision on January 9, 2008—choosing Wyeth’s wealth over patient health. FDA agreed to support Wyeth in their campaign to end access to compounded hormone replacement therapies—specifically by starting a crackdown on the use of estriol, which FDA is claiming to be illegal.

FDA also stated that pharmacies must stop using the term bio-identical. IACP is unequivocally opposed to FDA’s efforts to restrict the use of estriol and believes the use of the term “bio-identical” is appropriate.

Be assured that you are on the right side of this issue:

• Hundreds of thousands of patients—perhaps millions—currently benefit from compounded hormone replacement therapy as prescribed by their physicians. For many of these patients, these medications have been their only source of relief and health from symptoms of menopause and perimenopause. We are not aware of any evidence, clinical or otherwise, to suggest that these women should have their therapies stripped from them.
  
  
• In a press conference, FDA admitted there was not a single instance of an adverse event related to estriol that has been reported to FDA.
  
  
• Estriol has a USP monograph. It is recognized by USP. For a pharmacy to compound estriol pursuant to a valid prescription is consistent with USP standards (chapters 795 and 1075), the Pharmacy Compounding Accreditation Board’s standards, and state pharmacy law. Congress specifically recognized and approved the use of active ingredients that have a USP monograph as appropriate for use in compounding.
  
  
• There is currently an estriol product in phase III clinical trials for the treatment of Multiple Sclerosis. The safety data thus far has allowed the trials to continue to proceed.
  
  
• Estriol has been used in Asia and Europe for years. Its use is well-supported in medical literature.
  
  
• The use of the term bio-identical is an accurate descriptor of what these estrogens are. FDA-registered manufacturers use the term on their websites to describe FDA-approved estrogen and progesterone products.

From both a clinical and legal point of view, the evidence supporting our position for compounded bio-identical hormone replacement therapy as a continued option in women's health is compelling. FDA is wrong. It is in the best interest of patients to continue to receive the medications they are prescribed.

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