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 it 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 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. In order to help 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.

Please personalize the alert below – for instance, in the first line, name the state(s) where you are licensed.  If you have experience with INDs or IRBs, please describe.  We provide talking points (written by Dr. Jonathan Wright) in order to help you craft your letter. 

The alert below is for doctors only, if you are a consumer/patient, please click here to make your voice heard on the estriol issue.