Alopecia Areata Gets Its Meeting Date with the FDA!

May 22, 2017

 An advocacy achievement five years in the making ... Read more

On Friday, May 19, NAAF learned the Food and Drug Administration has officially announced the Public Meeting for Patient-Focused Drug Development (PFDD) on Alopecia Areata is scheduled for Monday, September 11, 2017, at their campus in Silver Spring, Maryland, just outside Washington, DC.  This PFDD meeting is the same week as NAAF’s Day on Capitol Hill. 


We also encourage you to familiarize yourself with the questions the meeting will address and patients will answer.  Please email Gary Sherwood who will be happy to provide them.  Reviewing these questions in advance will help you provide your most cogent and helpful answers.  

History and Importance:

This is important to our community because it provides a forum to weigh in benefit and risk assessments for potential treatments.  The FDA committed to the Patient-Focused Drug Development (PFDD) with the goal of obtaining the patient perspective on certain disease areas. This information is a critical aspect of the FDA’s decision-making as it establishes the context in which the regulatory decision is made, and provides a more systematic approach for obtaining the patients' perspective on disease severity and currently available treatments for a set of disease areas.      

This is the culmination of an effort NAAF and the Legislative Liaisons have been working on since 2012 when we first submitted both written and in-person testimony to the FDA making the case for alopecia areata’s selection for such a meeting.  Following NAAF’s extremely successful Day on Capitol Hill during 2012’s patient conference in Washington, DC, alopecia areata was recognized by the FDA as one of just 39 diseases out of 12,000 known conditions having an unmet need and no approved drug, and therefore deserving of PFDDI consideration.  However, only a fraction of these considered diseases are selected for each biannual meeting cycle.

In October 2014, NAAF learned alopecia areata was one of 16 diseases being considered for PFDDI’s next meeting cycle in 2016-2017.  If alopecia areata was not selected, it would be years before the opportunity would come again.  We drafted written comments explaining alopecia areata’s emotional toll, which were submitted to the FDA.  Additionally, we mobilized our Legislative Liaisons to contact their congressional representatives asking for their support in this effort.  Perhaps most impactful, we requested the entire alopecia areata community both through NAAF and other organizations to tell their stories via a special online link set up by the FDA. 

In July 2015, the FDA announced alopecia areata was one of eight diseases selected for a highly-coveted Patient-Focused Drug Development meeting during FY 2016- 2017.  As we said then, “The selection of alopecia areata for this sought-after meeting is a measure of how far our legislative efforts have come in just the past few years.”  There is little doubt this wholehearted drive demonstrated both this community’s passion for a cure and increasing legislative clout.  

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