• Why is FDA hosting the narcolepsy meeting?

    The Food and Drug Administration is hosting the Narcolepsy Meeting on Sept 24, 2013 as part of FDA’s Patient Focused Drug Development Initiative (PFDDI). In April 2013, narcolepsy was selected as one of 20 conditions to be addressed in this five year initiative. FDA aims to gain patients' perspectives on the impact of narcolepsy on daily life as well as the adequacy of available therapies. To learn more about the PFDDI program, click here.

  • What is FDA interested in learning about?

    FDA would like to gain a better understanding of narcolepsy’s impact on patients' daily lives, the types of treatment benefits that matter most to patients, and patients' perspectives on how well available therapies work for them.

  • How will this initiative help patients

    The Food & Drug Administration (FDA) is the agency within the U.S. federal government that is responsible for regulating products that represent one-fourth of all consumer spending – products like human and veterinary drugs, medical devices (like pacemakers and knee implants), foods and cosmetics.  FDA has a very important role in helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. Participating in the FDA initiative will ensure that narcolepsy patients’ priorities and concerns are understood by FDA in its reviews of current and future treatments as they are studied and used by consumers.

  • What is the time frame?

    Prior to the meeting, patients are encouraged to take the survey and participate in the educational webinars being hosted by Unite Narcolepsy.  On Sept. 24, patients can participate in the live meeting via webcast or in-person. After the meeting, the comment docket will remain open until November 25, 2013.

    After the docket closes on Nov. 25, the FDA will produce a meeting report to be posted on FDA’s website and circulated within the agency. The patients’ perspective may also point to a need for new patient-focused outcome measures to be developed and qualified for use in drug development, to capture patient input more systematically, for example, in clinical trials.

  • Is this initiative only about treatment options? What about the narcolepsy research funding, awareness, insurance and disability issues?

    The narcolepsy community has many concerns beyond pharmaceutical treatments, including research funding, public awareness, insurance and disability issues. While this initiative cannot address all of these concerns, by coming together we are creating a strong coalition of narcolepsy advocates capable of collaborating with various stakeholders, organizations and government agencies in the future to pursue our other priorities and concerns.

  • Will the FDA be looking at vitamins and supplements in addition to pharmaceutical treatments?

    For this initiative, the FDA is interested in learning about what works for patients – including prescription medications, over-the-counter drugs, alternative treatments and lifestyle habits. Although FDA regulates these products differently than medicine, if vitamins and supplements are part of your treatment regimen, be sure to include this information in your survey responses and comments to FDA.

  • Can parents of children with narcolepsy participate?

    Yes, parents, spouses, and caregivers can get involved today through the survey, webinars and docket comments. On Sept. 24, 2013 you are encouraged to participate in the FDA meeting via webcast and in-person attendance. Your perspective on your loved one’s experience is invaluable to help FDA better understand narcolepsy.

  • Can people with narcolepsy outside of the United States participate?

    Yes, patients outside of the United States may participate in the survey, webinars, webcast and docket comments.

  • Will Idiopathic Hypersomnia be addressed?

    People with Idiopathic Hypersomnia (IH) are encouraged to participate in the survey and webinars with the understanding that the FDA workshop will focus on narcolepsy as it is currently defined in the medical and scientific literature.

  • I cannot attend in person. How can I participate?

    You can make a meaningful impact from home. Consider participating in the survey, educational webinars, comment docket and the live webcast on September 24th.

  • Any tips for speaking in public?

    Unite Narcolepsy will provide effective communication tips in an educational webinar on Sept. 11 at 2 p.m. EDT. All narcolepsy advocates are encouraged to participate! Register here.

  • Can I use a Mac or PC for webcast?

    The webcast program, Adobe Meeting Connect is compatible with both Mac and PC systems.

  • Are there scholarships available to attend the meeting?

    There are no scholarships opportunities to attend this meeting in person. However, you can make a meaningful impact from home. Please take the survey today, participate in the upcoming webinars, attend the meeting via webcast and submit docket comments.

  • Is there public transportation to the meeting?

    The meeting will be located at the FDA White Oak Campus

    10903  New Hampshire Ave.,
    Building 31 Conference Center,
    Section A of the Great Room (Rm. 1503)
    Silver Spring, MD 20993

    Silver Spring  Metro Station, on the Red Line, is the closest metro stop. The Silver Springs Metro Station is approximately 4 miles, a 20-minute cab ride, from the White Oak Campus. Ride-On Bus route 22 operates between the Silver Spring Metro Station and White Oak Campus. Additionally, C8 Metro Bus operates between College Park and White Flint and makes a stop at the FDA White Oak Campus.

    For more information and bus schedules, visit:




  • What happens after the meeting?

    After the Sept 24 meeting, FDA’s comment docket will remain open for two months, until Nov. 25 to continue collecting written comments from patients and patient stakeholders.  After Nov. 25, 2013, FDA will produce a meeting report, capturing the input obtained in response to their key questions. The reports will be posted on FDA’s website. The patients’ perspective may also point to a need for new patient-focused outcome measures to be developed and qualified for use in drug development, to capture patient input more systematically, for example, in clinical trials.