Have your patients ever said that they wished more people knew what it was like to have vitiligo?
Would they like to give the U.S. Food and Drug Administration (FDA) a piece of their minds about the challenges they face in finding the right treatment?
Thanks to an ongoing FDA commitment to place the patient at the core of the drug development process, people living with vitiligo will soon have the opportunity to tell the FDA face-to-face what it is like to live with this disease.
On March 8 the FDA will hold a daylong public meeting, Patient-Focused Drug Development for vitiligo, focused exclusively on vitiligo. This meeting is part of the agency’s commitments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V), and is intended to spotlight the patient experience.
Patients who attend will be able to share their perspectives on the impact of vitiligo on their everyday lives, treatment approaches, and how and why they make decisions about their treatment. The FDA is particularly interested in patients’ perspectives regarding the types of vitiligo with primarily skin symptoms (such as loss of pigment, itchy skin, etc.).
Here’s how the meeting works
For each topic, including disease symptoms/daily impacts and perspectives on treatment, the FDA will select a panel of patients and/or patient representatives (such as a parent or caregiver) who will present comments to begin the dialogue. This will be followed by a facilitated discussion inviting comments from all patients and patient representatives in the audience.
When patients register for the event here they are invited to indicate whether they wish to serve on one of the two panels. Panel participation is not required and patients may simply choose to participate as members of the audience.
How can health care professionals get involved?
Health care professionals have a crucial role to play in this event. Given this unique opportunity to inform the FDA about the perspectives of patients, we ask for your assistance in making the meeting a success!
- Encourage your patients to attend.
We need your help to make sure that the FDA can hear firsthand what it is like to live with vitiligo. Since late fall, we’ve been sharing information about the meeting with our patient community to build awareness and interest in participation. Please encourage your patients—particularly if you practice on the East Coast—to participate in the meeting. You are invited to share this flyer about the meeting and reception with your patients and encourage them to participate—particularly those who may bring a unique perspective on these issues. Help us to fill the “room” with the varied perspectives of the vitiligo patient community!
The GVF has also planned an informational meeting for Thursday, February 25 from 7 – 8 p.m. EST for a GVF webinar to inform the community about how the meeting works and to answer questions about the meeting. Click here to register for the webinar.
While patient participation is our most critical need, healthcare providers may support the meeting in other ways.
- Join the Open Public Comment session.
Limited public comment opportunity will exist near the conclusion of the meeting for physicians interested in speaking.
- Send in your comments—and encourage patients to do the same—after the meeting.
Comments may also be submitted up to two months after the meeting via the public docket. These comments will be reviewed and incorporated into a Voice of the Patient Report on the proceedings, anticipated to be issued in Summer 2021. Because these reports may be referenced in FDA reviews of new therapy applications, the meeting and comment period could have a direct impact on agency actions.
GVF helps put vitiligo disease in the national spotlight
The Global Vitiligo Foundation (GVF) is pleased to be able to support a productive meeting with the FDA as a part of our ongoing plan to engage patients in research and improve health outcomes for our community. GVF has been busy laying the groundwork for this unprecedented meeting since the fall of 2019.
Opportunities like these are rare for patients. Through this new FDA program, over 20 disease communities have been invited over the last few years to participate in these conversations. Along with the vitiligo community, other communities will participate in these meetings over the next couple of years. Being selected for such a meeting is quite a recognition. This first-of-its-kind opportunity is not likely to come around again anytime soon, so thank you in advance for helping ensure it is truly reflective of the perspectives and needs of the vitiligo community. For more information about the meeting and ways to support patient engagement, please visit the GVF website page dedicated to the FDA-PFDD meeting.
Editorial support provided by the National Psoriasis Foundation.