In 2013, the U.S. Food and Drug Administration (FDA) began holding a series of meetings to hear directly from patients, caregivers, advocates, and other key community stakeholders about what it’s like to live with various medical conditions and how well available treatments are meeting patients’ needs. This meeting series, called the “Patient-Focused Drug Development” initiative or PFDD, was immensely beneficial to FDA teams and the agency as a whole. The meeting series was expanded to enable patient organizations to host externally-led PFDD meetings (EL-PFDD meetings) in collaboration with FDA. To date, there have been a total of more than 110 PFDD and EL-PFDD meetings combined; one of the first PFDD meetings was dedicated to narcolepsy.

The IH EL-PFDD meeting was conducted as a parallel effort to FDA’s PFDD initiative. The purpose of the Illuminate Hypersomnia EL-PFDD meeting, like all PFDD meetings, was for FDA staff and researchers and developers of therapies to understand more fully the burdens of living with a particular medical condition and community perspectives on available treatments. At these meetings, patients also describe what they most value in terms of treatment benefits, as well as the risks and side effects they may be willing to tolerate as a tradeoff for the benefits that matter most to them.

An example of how PFDD can benefit people living with IH is to deepen understanding about all the ways in which IH impacts people’s lives. The IH community helped tell the full story of how IH affects an individual’s physical, intellectual, emotional well-being and more. This will help researchers and drug developers target symptoms that pose the greatest burden and better understand what degree of improvement would make a meaningful difference in the lives of people with IH and those around them.