A Disease that Hurts™! Alopecia Areata and the FDA’s Patient-Focused Drug Development Initiative

Jul 22, 2016

In 2015, thanks to the tireless efforts of NAAF’s Legislative Liaisons and our community at large, the Food and Drug Administration (FDA) selected alopecia areata for a Patient-Focused Drug Development Initiative (PFDDI) meeting during FY2016–2017 to enhance regulatory assessment and help innovative new drugs receive approval.

What this means: When the patient community informs regulatory decision-making, it usually creates a more preferential benefit-risk assessment. Regulators need to hear from you—your experience, your challenges and your pain. If you or a loved one has suffered with alopecia areata, your unique experience and understanding could help to influence the FDA’s decision-making at this critical time, which may lead to safe and effective treatments tailored to the specific needs of patients. We invite you to share your story with us through written and oral testimony.

Alopecia areata has been misperceived as a “cosmetic disease” because its primary burden is not physical pain or incapacity and it is not life-threatening. However, for many people with alopecia areata, there is suffering: emotional, social and economic. The stigma of living with visible difference negatively impacts the lives of many. Therefore, over the coming months, in preparation for this highly coveted meeting, we now need to articulate this burden in order to educate the FDA about the very real burdens of this disease.

Through NAAF’s SeeUs Campaign, we focused on our shared challenges and strengths in overcoming the painful realities of this disease. However, if we only share how overcoming the hardships has made us stronger, there will be less reason for the FDA to believe that alopecia areata hurts and that treatments are warranted.

SeeUs Phase II will focus its message on the flip side of empowerment: alopecia areata as A Disease that Hurts. We are looking for people brave enough to speak up about the most painful experiences and the most painful moments in your journey with alopecia areata. If you are one of those brave people, please join with us. We want to hear your story. There are several opportunities for involvement.

To ensure that our patient community is prepared to testify at the FDA hearings about their personal experiences we invite you to:

  • Attend a training to testify through written and oral testimony; learn to share your story!
  • Raise awareness and increase engagement during Alopecia Areata Awareness Month in September 2016 with the next phase of the SeeUs Campaign: Alopecia Areata, A Disease that Hurts™
  • Help us raise $100,000 to support this critical advocacy work!

Your continued and increased engagement at this time is crucial!

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—and we will need you to participate every step of the way!

Several other disease groups have already had their PFDDI meetings over the past two years, most recently psoriasis in March 2016. To better familiarize yourself with how the meetings are conducted, we encourage you to watch these recordings online:  http://tinyurl.com/NAAF-PFDDI1 and http://tinyurl.com/NAAF-PFDDI2.

We will share further information, including the date of the alopecia areata meeting, which is yet to be set, as we learn more in the coming weeks and months. 

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Legislative Liaisons Hold Important Meetings with Members of Congress