Last year, word circulated about a 3-hour meeting convened by the FDA in October 2012 where patients representing 39 different diseases spoke briefly about the daily impact of their conditions. One disease organization presented this meeting as the FDA’s “Meeting on Patient-Focused Drug Development” and even went so far as to say “Alopecia areata may soon be getting significantly greater research funding and study.”
The interested reader (especially one who has the disease) might erroneously conclude that the result of the meeting could be an increased allocation of research funds for development of AA treatments. For anyone or any organization to give the impression that the meeting had anything to do with increasing research funds for alopecia areata indicates that they have no idea what they are talking about. Yet, as incredible as it sounds, that is just what one well known USA-based foundation told its followers. They mislead them.
So we are here to educate you with the facts.
Let’s Clarify What Happened
According to an FDA official, no new drugs to treat alopecia areata are being reviewed for FDA approval at this time.
The complete name of the meeting was the “Prescription Drug User Fee Patient-Focused Drug Development”. The meeting was a requirement of the Prescription Drug User Fee Act (PDUFA V) the 1992 Act of Congress (renewed every 5 years) which requires drug manufacturers to pay fees. The collected fees help fund the work of the FDA in drug reviews and approvals.
The PDUFA V requires the FDA to hear from patients affected by each of 20 specific diseases to better inform FDA decision-makers as they review new drugs in various stages of development and approval. Patients’ perspectives will be sought on how the disease affects their daily lives, the types of treatment benefits that matter most to patients, and the adequacy of current treatments.
In compliance with PDUFA V, a separate public meeting will be conducted for each selected disease over the 5-year life of the law. The meeting in October 2012 was conducted to help the FDA decide which 20 diseases would be the subjects of this patient-focused initiative in 2013-17. In essence, it was a whittling down process. Alopecia Areata was one of 39 candidate diseases that were evaluated for this purpose. In April 2013, the FDA announced that they had selected an initial group of 16 diseases for 2013-15. AA was not included.
What’s Next for Alopecia Areata and the FDA?
In 2014, the FDA will continue to fulfill its commitment and determine the diseases for this initiative for 2016-2017. This blog will announce those diseases when available. While it is valuable for FDA reviewers to hear patient perspectives in their decision-making process, these PDUFA V disease specific meetings are not involved in the review of drugs let alone any drugs for alopecia areata.
You can read more in the Federal Register/Vol. 78, No. 70/Thursday, April 11, 2013/Notices and see the list of diseases to be addressed through 2015.