FDA Selects Alopecia Areata for Important Meeting
On Thursday, July 2, the Food and Drug Administration (FDA) announced alopecia areata was one of eight diseases selected for a highly-coveted Patient-Focused Drug Development Initiative (PFDDI) meeting during FY 2016- 2017. The FDA committed to PFDDI 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.
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. There is little doubt this wholehearted drive demonstrated both this community’s passion for a cure and increasing legislative clout.
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. It also signals a major opportunity on the horizon as we'll need community members to participate in this landmark meeting.
Further info, including the date of the alopecia areata meeting, to come as we learn more in the coming weeks and months.