The FDA is conducting a public meeting on Patient-Focused Drug Development for fibromyalgia on March 26, 2014. The main information they are interested in obtaining is:
Patient input on the impact fibromyalgia has on daily life.
Patients’ views on currently available therapies to treat the condition.
This is a rescheduling of the original December 10, 2013 meeting, which I first reported to you last October.
Following is the basic information about the meeting:
Date: March 26, 20114 Time: 1:00 p.m. to 5:00 p.m. EDT Location: FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Room 1503 B and C (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA’s White Oak campus)
Registration: To register for this meeting, visit: https://marchfibromyalgia.eventbrite.com.
Registration will close on March 20, 2014.
If you're not able to attend in person, you can also register to view the meeting via Webcast. For registration and meeting details, visit https://marchfibromyalgia.eventbrite.com.
In addition to providing input at the public meeting, the FDA is inviting patients to share their perspectives on the discussion questions through the public docket. The questions below are those that will be asked of patients at the meeting. They are also the questions the FDA would like you to comment on through their website. To answer these questions, go to the Open Docket Folder and click on the blue “Comment Now!” button in the upper right corner.
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?
Once again, to answer these questions, go to the Open Docket Folder and click on the blue “Comment Now!” button in the upper right corner.
Or if you prefer, you can fax or mail your comments. Fax comments to the Division of Dockets Management at 301-827-6870, or mail comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should include the docket number FDA-2013-N-1041.
This is a great opportunity for all of us to impress upon the FDA just how much fibromyalgia impacts our lives. Let them know which symptoms you need the most help with and exactly what you expect from a medication intended to treat FM. We don't get that many chances to have our voices heard on a federal level by the agency that will ultimately have to approve any medications developed for FM. Don't let this opportunity pass by without speaking your mind.
Source: “Public Meeting on Fibromyalgia Patient-Focused Drug Development.” FDA Notice, January 23, 2014.
Published On: February 22, 2014