Advocacy and FDA Meeting Update - cdn.myhealthteams.com
Transcript of Advocacy and FDA Meeting Update - cdn.myhealthteams.com
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Advocacy and FDA Meeting Update
Seemal Desai, MD & Richard H. Huggins, MD
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Virtual World Vitiligo Day
Advocacy Update WVD 2021
• Seemal R. Desai, MD, FAAD, Chair
• Innovative Dermatology• Clinical Assistant Professor • Department of Dermatology• The University of Texas Southwestern Medical Center• Dallas, Texas
• Twitter/Instagram: @SeemalRDesaiMD
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Virtual World Vitiligo Day
Advocacy Committee
• The goal of the VWG Advocacy Committee is to:
• -Help educate, advocate and promote education and awareness of vitiligo to local, state and federal government entities, insurance companies, third party payers, and special interest groups
• -Increase awareness of vitiligo as a disease, its treatment, and patient related issues to policymakers through efforts of advocacy and by combining the efforts of vitiligo clinicians, researchers, patients, support groups.
• -Have a continual and ultimate goal of finding a cure for this devastating disease.
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Virtual World Vitiligo Day
Advocacy Committee
• Advocacy Highlights thus far:
• US Healthcare policy discussion• Payer relations• Need for more NIH research funding• Access to generic medications, and cost of treatments
• 1st ever Vitiligo Advocacy Event on October 4, 2017 in Washington DC• Close to 30 patient attendees• Close to 20 unique congressional meetings
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Virtual World Vitiligo Day
Advocacy Committee
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Virtual World Vitiligo Day
Advocacy Committee
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Virtual World Vitiligo Day
Advocacy Committee
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Virtual World Vitiligo Day
Advocacy Committee
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Virtual World Vitiligo Day
Advocacy Committee
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Virtual World Vitiligo Day
Advocacy Committee
• CMS UPDATE
• Looking to work with our colleagues across ALL of Dermatology• US Policy work has to be done separately from other Vitiligo based events• Coalition of Skin Diseases• AADA Legislative Conference
• Call to action for specific legislation that can be sponsored
• FDA Update• PFDD meeting
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Virtual World Vitiligo Day
PFDD Update WVD 2021
• Richard H. Huggins, MD, FAAD
• Senior Staff Dermatologist, Division Head – Ford Road Satellite
• Henry Ford Hospital• Detroit, MI• Chair of the Global Vitiligo Foundation – Community
• E-mail: [email protected]
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Virtual World Vitiligo Day
Vitiligo PFDD Mtg - Prep
• Solicited input from organizations with prior experience
• Hired consultants with experience with PFDD meetings
• Organized virtual meetings for first the US-based vitiligo support groups and then the broader vitiligo community to help them learn more about the PFDD meeting and the various ways they could participate
• Orientation and training sessions for all of the invited PFDD speakers from the community
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Virtual World Vitiligo Day
Vitiligo PFDD Mtg - Prep
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Virtual World Vitiligo Day
Attendance
• >1000 pre-registrants• 700 individuals with vitiligo• >300 physicians and pharmaceutical
representatives• Potentially highest attendance of any
PFDD
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Virtual World Vitiligo Day
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Virtual World Vitiligo Day
Discussion Format
• Virtual Meeting on 3/8/21 from 10AM-2:30PM• Recording online: search “Vitiligo, PFDD, 2021” • FDA members provided background on the PFDD
meetings and the condition of vitiligo itself• > 16 community members with vitiligo and their loved
ones were invited to speak• Community members called in as well• Heard from a diverse group of individuals with vitiligo• Several polls completed by the individuals with vitiligo
who were logged on• FDA docket for community members to submit written
comments that will be a part of the final PFDD document – the GVF and the AAD also submitted comments
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Virtual World Vitiligo Day
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Virtual World Vitiligo Day
Discussion Recap
• Community members spoke about what is was like to live with vitiligo as well as their experiences and thoughts on vitiligo treatments
• Detailed the tremendous disruptive impact vitiligo can have on the lives on affected individuals
• Social isolation, loss of racial identity, employment difficulties and even suicidal ideation
• Many disappointing encounters with physicians• Not appreciating the potential psychological impact of the
condition• Not aware of the available treatments
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Virtual World Vitiligo Day
Discussion Recap
• Clarified the shortcomings and inconveniences of the current treatments
• Slow, ineffective, inconvenient, not durable• Detailed the properties of future treatments
that are most important to the individuals with the condition
• Indicated that even treatments that may have side effects should be considered for FDA approval
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Virtual World Vitiligo Day
Meeting Takeaways: What We’ve Seen Already
• Physician Takeaway points• Need to educate our colleagues• Deeper understanding of day-to-day impact of vitiligo and its
treatments on individuals with vitiligo and their loved ones
• Need for more numerous, more convenient, more effective and longer-lasting treatments (or a cure!)
• Value of support groups• Increased cohesiveness of the vitiligo community• Increased interest from pharmaceutical companies
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Virtual World Vitiligo Day
Meeting Takeaways: What We Hope To See As Outcomes
• Plan to use the PFDD meeting itself as well as the likely 100-page document that will summarize it to enhance our advocacy efforts and spread awareness
• Increased clinical trials for vitiligo treatments and cures resulting in increased treatments and cures being released onto the market
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Virtual World Vitiligo Day
THANK YOU!
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