The FDA Heard Us Loud and Clear!

The FDA Heard Us Loud and Clear!

The agency hosted a patient-focused meeting to learn more about what it's like to live with alopecia areata. We gave them an earful, and now they want to know more.

On September 11, the U.S. Food and Drug Administration (FDA) held a half-day patient-focused drug development (PFDD) meeting focused exclusively on alopecia areata. The goal was to collect patient perspectives on current and potential treatment options and learn about the ways alopecia areata impacts our everyday lives.

Everyone living with alopecia areata has their own opinion on the effectiveness, accessibility and potential side effects of current treatment options. So if you could be in a room with the FDA – the decision-makers behind which medications are made available to patients – what would you say?

Katie Krueger recently had that chance. She described her experience with various treatments including topical, steroid injections and oral prednisone. She told them, “All these treatments and the side effects were simply not worth the slim possibility that one day I might retain some hair growth…An ideal treatment for my life will consist of something you can do at home, preferably a pill with limited doctor visits. My hope is that one day they will be an easily accessible treatment that will result in a well-managed condition.”

“Alopecia is a serious condition with physical, emotional and social impacts and we recognize that there is an unmet need for the patients,” said Tatiana Oussova, MD of the agency’s Division of Dermatology and Dental Products (DDDP) at the Center for Drug Evaluation and Research.

The FDA wants to know from patients how to develop better endpoints for clinical trials to measure aspects of alopecia areata that are important to patients, how to best facilitate drug development and to understand how patients view benefits and risks of treatment.

“It is then FDA's responsibility to ensure that the benefit of the drug outweighs its risks,” said Tatiana Oussova, MD of the DDDP. “We look forward to incorporating all what we learn today into the agencies thinking and understanding of how patients view benefits and risks of alopecia areata treatments.”

FDA recognizes patient needs

Alopecia areata is one of only 24 diseases selected to be topics of these patient-focused meetings, which started in 2013 and will conclude after this year. HIV, breast cancer, Parkinson’s disease, psoriasis and fibromyalgia are among the other PFDD meetings hosted by the agency.

We’ve been busy laying the groundwork for this unprecedented meeting since fall 2014, when, thanks to the tireless efforts of NAAF’s Legislative Liaisons and our community at large, the FDA agreed on the need for a PFDD meeting on alopecia areata to enhance regulatory assessment and help innovative new drugs receive approval.

The overwhelming response from patients across the country cemented that need. At final count, more than 170 people attended the meeting in person and more than 200 people opted to participate online through a live webcast. The FDA said it was the largest response it’s received from a disease community thus far.

We made a lasting impression 

The PFDD meeting was divided into two topics: 

  1. Health effects and daily impacts that matter most to patients
  2. Patient perspectives on treatment approaches

For each topic, the FDA hosted a panel of patients who offered their personal stories and opinions. This was followed by a commentary period from patient members and caregivers in the audience, as well as individuals phoning in. 

What resulted was a candid conversation about the psychosocial impacts of living with this disease that meeting attendees were brave enough to discuss – from coping with depression and anxiety to dealing with bullying and thoughts of suicide. 

The courage it took for panel participants and audience members to share such personal accounts not only unified the room, but at times, visibly moved members of the FDA, who passed around tissues to one another throughout the meeting. 

A resounding theme was the need for effective therapeutic options for all age groups with the disease. “Over the course of my youth I have been to multiple dermatologist and doctors and others I can't even remember. All of them had different methods of treatment are frankly it seems like the method was to throw any idea they had at the wall and see what would stick,” Andrea Alberti said, adding, “Any hair that may have grown would eventually fall out again after a couple of months.”

You can watch the full meeting recording online here

By the numbers

Throughout the meeting, members of the audience and people participating online were polled by the FDA, and the results were reported in real-time. Here are some interesting takeaways:

  • Have you ever been diagnosed with alopecia areata? 65% said yes

  • Where is your alopecia areata located? 55% said scalp, 8% said beard, side burns or moustache, 46% said eyebrows, 34% eyelashes, 63% said all areas, and 31% said other areas not mentioned (such as nails)

  • What aspects of your alopecia areata are most bothersome to you? 56% said widespread hair loss and 56% said skin sensitivity (such as to sun, temperature, or sweat)

  • What do you find to be the most bothersome impacts of alopecia areata on your daily life? 83% said emotional or psychological impacts (such as anxiety, fear, depression, etc.) and 67% said self-consciousness or embarrassment

  • Have you ever used any of the following drug therapies or medical devices to treat your alopecia areata? 77% said topical corticosteroids, 77% said injectable corticosteroids, and 69% said other topical treatments (such as minoxidil, anthralin, immunotherapy)

  • Besides the therapies mentioned previously, what else are you doing to manage any symptoms or manifestations you experience because of your alopecia areata? 71% said temporary cosmetic measures (e.g., wig, hat, hair weave, makeup, etc)

  • For the therapies you use, what do you consider to be the most burdensome downsides? 64% said difficulty in accessing treatment (for example, insurance) and 52% the treatment only provides minimal benefit