FDA Action Threatens to Cut Off Access to Needed Medications
August 28, 2008
Physicians who prescribe hormones containing estriol have grown concerned about the FDA’s so-called “abbreviated” Investigational New Drug (IND) application for estriol. The process will effectively ban most physicians from prescribing a medication they consider best for their patients.
The IND places a significant financial burden on physicians, most notably by requiring them to submit applications to an Institutional Review Boards (IRB). Submitting necessary documentation and contracting for a private IRB can easily cost between $10,000 and $25,000 and can take months.
The FDA’s new policy threatens the access of this important medication for patients who rely on hormones containing estriol to relieve the symptoms of menopause. It could force them off treatment their doctors have deemed necessary, and would either deny them treatment or subject them to the unnecessary expense and inconvenience of a new treatment regime.
Millions of women have been prescribed estriol and have used it safely for decades.