Webinar Recording: How FDA Ad Comms Work & What Role You Can Play

Ad Comms – What’s the buzz all about? If you’ve been anywhere near social media lately, you’ve likely seen the term ‘Ad Comm’ referenced. Speculation about dates, implications for approvals and access to therapies we all care about, questions about who should participate and how, and more. So, to ensure that ALL members of our Duchenne community have access to all information possible, PPMD asked the FDA to participate in a public webinar and go through the Advisory Committee process from A to Z. What is it? Who’s on it? How do decisions get made? What happens during the AdComm? What’s the role of the sponsor? What’s the role of the public? How can members of the Duchenne community participate? And more. We were thrilled that the FDA accepted our invitation — and they were delighted to talk with us as this was a ‘first ever’ webinar for them too.

So on September 2nd, PPMD convened a public webinar for the Duchenne community focused on FDA Advisory Committee Meetings. The webinar lasted for a bit over an hour, was one of our best attended webinars ever, and was recorded. We encourage you to watch the recording at your convenience.

What's next?
This is a historic moment in our community and PPMD is in the process of working with members of the Duchenne community who are interested in participating in the upcoming Ad Comms in any way — either through the submission of written testimony, by presenting oral testimony, or by helping us to fill the room on the day of the meeting.

Our primary focus at PPMD is that all eligible members of our Duchenne community be able to access safe and effective therapies as soon as possible. Our goal as we lead in to these FDA Advisory Committee meetings is seeing safe & effective therapies approved — and then working to ensure that therapies that are approved are accessible to our Duchenne community. Our community has a critical role to play in both the upcoming Ad Comm meetings and the efforts to ensure that approved therapies are available to you through your public and private insurers — and our PPMD team has been working hard on both of these issues.

We need YOU!
We are asking all members of our Duchenne community to notify us of your interest in participating in engagement around approvals and access over the coming months. PPMD’s army is ratcheting up to the next level, and we need YOU. Please email Ryan Fischer to indicate your interest at ryan@parentprojectmd.org.

Please take some time to watch the recorded webinar and then reach out. We hope you’ll join forces with us; this is a critical moment for our community.

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