advocacy and fda meeting update - cdn.myhealthteams.com

Advocacy and FDA Meeting Update

Seemal Desai, MD & Richard H. Huggins, MD

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


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.


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


Advocacy Committee


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


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]


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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Vitiligo PFDD Mtg - Prep


Attendance

• >1000 pre-registrants• 700 individuals with vitiligo• >300 physicians and pharmaceutical

representatives• Potentially highest attendance of any

PFDD

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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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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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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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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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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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THANK YOU!

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