FDA Hears Narcolepsy Realities from Patients and Caregivers

By K. Kimberly McCleary


The skies above the U.S. Food & Drug Administration’s Silver Spring, Maryland, campus were clear and bright blue, a welcoming sign to nearly 150 narcolepsy patients, family members, and other stakeholders who gathered in the agency’s public facility on September 24, 2013. Many arrived well ahead of the 1 PM starting time, making the lobby a hub for greetings between people who’d previously met only online, were renewing long-distance friendships made over the years or were meeting for the first time.

There were nerves to calm and public testimony slots to claim. By the time FDA organizers got the session under way, there were also a few hundred participants logged into the live webcast. The FDA’s fourth Patient Focused Drug Development Initiative meeting and its first on a rare disease broke previous participation records, giving narcolepsy a major spotlight before a large audience that included FDA reviewers, pharmaceutical company representatives, reporters, researchers, advocacy organization leaders, and other government representatives.