Ending FDA Restrictions on Estriol

The Challenge

On January 9, 2008, the FDA sent numerous pharmacies, large and small, an order to stop using estriol, and the term “bio-identical” in their hormone replacement formulas. This was an unprecedented attack on compounders, patients and physicians because until then not a single compounded drug component with a USP monograph had been withdrawn from circulation unless there had been evidence of harm to patients. Yet that is what the FDA did. Furthermore, the FDA admitted in their press conference that there is no evidence of harm to any patient from the use of estriol in compounds. If they can do it to estriol, they can do it to anything they wish to! In response, Congress introduced House Concurrent Resolution 342 and Senate Concurrent Resolution 88. These resolutions call on the FDA to stop their new policy of restricting women’s access to prescriptions containing estriol. This is one of our best courses of action to restore estriol’s availability to the market. The resolution also calls on the need of FDA to respect the physician-patient relationship and recognizes that doctors, not the FDA, are in the best position to determine which medications are appropriate for their patients. It also points out the FDA has acknowledged that it is unaware of any adverse events associated with the use of estriol over the past three decades. AAHF was proud to sponsor 2 full-page ads in Roll Call to support these resolutions (Ad 1, Ad 2). Additionally, we organized a coordinated effort of groups to write a letter to support (click here for the list) and hand-delivered the letters to every member of Congress. The Action Our challenge to you is this: can you help us get 100 sponsors in 100 days? We currently have 45 sponsors on House Con. Res. 342 and only 3 sponsors for S. Con. Res. 88 (introduced last month) but in order to be successful, we must have more Congressional support. And you can help us get that. To get involved, please visit: http://ga4.org/campaign/Estriol_Resolution

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One Response to “Ending FDA Restrictions on Estriol”

1. Steven Says:
   March 31st, 2009 at 12:37 pm

   Do you guys have a recommendation section, i’d like to suggest some stuff

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