Updated November 26, 2013: More space is available for in-person registration. The deadline for registration is now December 2, 2013. Registration to attend via webcast is also open until December 2. On-site registration on the day of the meeting is available, but will be based on space availability. Overflow rooms will be available for on-site registrants if the main meeting room is full.

Date:                December 10, 2013

Time:               1:00 p.m. to 5:00 p.m.

Location:          FDA White Oak Campus

                        10903 New Hampshire Ave.

                         Building 31, Room 1503A (Great Room)

 Silver Spring, MD 20993

Description

On December 10, 2013, FDA is conducting a public meeting on Fibromyalgia Patient-Focused Drug Development. FDA is interested in obtaining patient input on 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 are located at the bottom of this page.

For each of these topics, a panel of patients and patient representatives/advocates will present comments to begin the dialogue and will be followed by a facilitated discussion inviting comments from other patients and patient representatives.

If you are interested in providing comments as part of the initial panel discussion, indicate so during the registration process. Participants for the panel discussions will be confirmed prior to the meeting.

There will also be an opportunity for patients, patient representatives and others to provide comments on issues other than topics 1 and 2 during an Open Public Comment session. Sign up for Open Public Comment will take place the day of the meeting.

For more information, refer to the FDA meeting website at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm363203.htm.

Questions for Discussion

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 therapies 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?