The National Fibromyalgia & Chronic Pain Association is offering three free webinars to help people prepare their comments. This is a unique opportunity to create a change in how ﬁbromyalgia is understood and viewed by the FDA. Through webinars the NFMCPA will help to empower and enhance your understanding of the many aspects of this important event, whether you attend the meeting and speak as an audience member or a panel member, or submit written comments.
Attend the public meeting
On December 10, the FDA is holding a public meeting on Fibromyalgia Patient-Focused Drug Development. There will be two topics of discussion: the impact of fibromyalgia on daily life (topic 1) and currently available therapies to treat the condition (topic 2). The questions for discussion on these topics can be found below and on the FDA’s meeting registration page.
For each topic, a preselected panel of patients/advocates with fibromyalgia or patient representatives will present comments to begin the dialogue followed by an Open Public Comment Discussion facilitating comments from people attending the meeting in person. Sign up for Open Public Comment online at the FDA's meeting registration page.
Space at the meeting is limited, and registration will close on November 27.
Additional Meeting Information
Date: December 10, 2013
Time: 1 p.m. to 5 p.m.
Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503A
Silver Spring, MD 20993 (Information about arrival to FDA’s White Oak campus)
For those who are not able to travel to Washington, DC, attendance via webcast is available. See the FDA’s meeting registration page to register for the webcast. Webcast capacity is limited, and registration will close on November 27.
at this link.
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 can be submitted to the public docket. Comments can be submitted until February 10, 2013.
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.)
3. How do your symptoms and their negative impacts affect your daily life on the best days? On the worst days?
4. How have your condition and its symptoms changed over time? Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?
5. 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?