The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for fibromyalgia. Patient-Focused Drug Development is part of FDA's performance commitments in the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow the FDA to obtain patients' perspectives on the impact of fibromyalgia on daily life as well as the available therapies for fibromyalgia.
The public meeting will be held on December 10, 2013, from 1 p.m. to 5 p.m. In Silver Spring, Maryland. Registration to attend the meeting must be received by November 27, 2013. Seating will be limited, so early registration is recommended. Registration is free and will be on a first-come, first-served basis.
If you are not able to attend the meeting in person, you can also register to view the meeting via webcast. For more information about location and to register to attend either in person or by webcast, go to https://patientfocusedfibromyalgia.eventbrite.com/
Request for Patient Input
As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on symptoms of fibromyalgia that matter most to patients and on current approaches to treating fibromyalgia. Fibromyalgia is a chronic disorder characterized by widespread musculoskeletal pain and tenderness in multiple tender points and may be accompanied by fatigue, sleep disturbances, irritable bowel syndrome, headache, and mood disorders. While there is currently no definitive cure, treatments for fibromyalgia include medications and lifestyle changes with emphasis on minimizing symptoms and improving general health and daily function. FDA is interested in obtaining a better understanding of fibromyalgia patients' perspectives on the severity of the disease and the available therapies used to treat fibromyalgia and its symptoms.
The questions that will be asked of patients and patient stakeholders at the meeting are listed below, organized by topic. For each topic, a brief patient panel discussion will begin the dialogue, followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments that patients can submit electronically or by mail. Comments must be submitted by February 10, 2014. Information on how to submit comments will follow the topics.
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
(1) Of all the symptoms that you experience because of your condition, which 1-3 symptoms have the most significant impact on your life? (Examples may include chronic pain, fatigue, difficulty concentrating, sleep disorders, etc.)
(2) Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your condition? (Examples of activities may include sleeping through the night, daily hygiene, driving, household chores, etc.)
(a) How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
(3) How have your condition and its symptoms changed over time?
(a) Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?
(4) What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treating Fibromyalgia
(1) What are you currently doing to help treat your condition or its symptoms? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies such as exercise or acupuncture)
(a) What specific symptoms do your treatments address?
(b) How has your treatment regimen changed over time, and why?
(2) How well does your current treatment regimen treat the most significant symptoms of your disease?
(a) How well do these treatments improve your ability to do specific activities that are important to you in your daily life?
(b) How well have these treatments worked for you as your condition has changed over time?
(3) What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital for treatment, restrictions on driving, etc.)
(4) What specific things would you look for in an ideal treatment for your condition?
To submit comments electronically: Go to http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4219 and click the “Comment Now” button in the top right corner.
Or mail comments to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA_FRDOC_0001-4219
For additional information, visit http://www.regulations.gov/#!documentDetail;D=FDA_FRDOC_0001-4219