FDA Simplifies A Process – Or Is Trying To Kill It

August 12, 2008
Category: Uncategorized

AAHF is committed to helping to save estriol for patients.  While the FDA is careful to say that it is not “banning” estriol, they are making the process of prescribing estriol extremely difficult.  Furthermore, they have been attacking compounding pharmacists and have given an order to stop using estriol, and the term “bio-identical” in their hormone replacement formulas.
We have done extensive lobbying on this issue, meeting with many members of Congress as well as placing full page ads in Roll Call , bringing attention to H.Con.Res.342 and S.Con.Res.88.  AAHF has reached out to numerous groups to include them in the effort and most have responded, taking up the battle cry as well.
Recently the FDA released information on how to obtain an Investigational New Drug Application (IND) for estriol. The agency claimed that it had “simplified” the process.
Actually the only thing “simplified” is the FDA form. No changes were made in the requirement for lining up an IRB (investigative review board). The IRB process calls for extensive documentation that has to be submitted to the organization sponsoring it. It usually requires about six months to set up and is expensive. One estimate is that the process involves about 50 hours of work. As an indication of its complexity, one of the manuals for setting up an IRB is 100 pages long. In addition, the record keeping and monitoring requirements are extremely onerous.
As part of our continuing campaign to keep bio-identical hormones and estriol available for millions of women, AAHF wants to ensure that the FDA hears directly from doctors. It is the doctors prescribing estriol who have first-hand knowledge of dosage and benefits, and who want to be able to provide estriol as a safe alternative to pharmaceuticals.
The FDA has made it more and more difficult for American citizens to communicate with the agency. As of last year, it is no longer possible to e-mail the FDA. In order to help (truly) simplify the process, AAHF has created an alert that will be faxed directly to the FDA Commissioner and also be emailed to your Congressional representatives (talking points provided by Dr. Jonathan Wright).
Click here to contact your representatives.

One response to “FDA Simplifies A Process – Or Is Trying To Kill It”

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