I just received this email from the FDA announcing the publication of "The Voice of the Patient" CFS and ME Meeting Report:
As part of our efforts in Patient-Focused Drug Development, we are pleased to announce the availability of “The Voice of the Patient: Chronic Fatigue Syndrome and Myalgic Encephalomyelitis,” a report that summarizes patient input from the April 25, 2013 FDA Patient-Focused Drug Development meeting and the online docket that closed on August 2, 2013. The report has been posted online and can be found at this website: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm.
FDA is grateful to patients, caretakers, and others who so thoughtfully and courageously shared their experiences and perspectives on CFS and ME through the Patient-Focused Drug Development initiative. It is clear that CFS and ME is a debilitating disease that can severely affect a patient’s day-to-day functioning and have a devastating impact on a patient’s life. The variability in the nature of symptoms and in the approaches to treatment is striking. Patients have tried a wide range of drug and non-drug therapies with varying effectiveness, and for some, none are effective.
The April 25, 2013 meeting was the first of the Patient-Focused Drug Development meetings. It allowed FDA to obtain patients’ points of view, in a systematic way, on the severity of CFS and ME, its impact on daily life, and available treatment options. FDA recognizes that patients have a very unique ability to contribute to our understanding of this broader context of the disease, which is important to our role, and that of others, in the drug development process. We share the patient community’s commitment to facilitate the development of safe and effective drug therapies for this disease.