The FDA has been holding public meetings on 20 different disease areas, one disease per area over the last year or so to continue through 2017. Alopecia Areata is on a preliminary list to be chosen as a disease to be discussed in the 2016-2017 patient-focused meetings and the FDA is currently inviting commentary on this preliminary list.
Bald Girls Do Lunch is giving our network a quick way to give feedback. You may enter your name as anonymous. Your emal will not be disclosed. We will compile responses from our network and submit them to the FDA. The FDA staff wants your input to better understand patients' opinions about which diseases patients consider to be a high priority. Act now! Submit your feedback using our form by December 5, 2014.
What type of feedback is being requested?
Does this patient feedback improve current funding for drug research?
No. The FDA does not conduct nor fund research.
Why does the FDA seek patient input?
FDA believes that the various drug regulatory activites it carries out will be improved by patient input. Specifically, FDA states that "Patients who live with a disease have a direct stake in the outcome of the [drug] review process and are in a unique position to contribute to weighing benefit-risk considerations that can occur through the medical product development process."
Do my comments make it more likely that the FDA will conduct alopecia “studies”?
No. The FDA does not conduct research on any diseases. This current requirement is for public comments.**
We hope this clarifies any prompts you may have seen from other organizations that included “…nominating alopecia areata for study….” which could erroneously lead you to conclude that the disease itself or treatments for it are being researched.
**As stated in the Federal Register/Vol 79, No 195, October 8, 2014: “This law reauthorizes the
Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary user fee resources
to maintain an efficient review process for human drug and biologic products.”
One part of the reauthorization includes a requirement for patient input.
The FDA is the United States Food and Drug Administration agency of the United States Department
of Health and Human Services.
1. Click here to enter your comments yourself on the FDA website.
2. Submit written comments to:
The Division of Dockets Management (HFA-305),
Food and Drug Administration,
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All written comments should be identified with docket number FDA-2012-N-0967