NFMCPA Taking FDA Public Comments (3)

FDA Seeking Comments from People with Fibromyalgia  at December 10, 2013 Meeting

Thank you for taking time to let the FDA know about your experiences with FM--good/bad experiences with medications/treatments and your recommendations to them on how to help us.  What medications do you take to treat fibromyalgia? Do they work? How does fibromyalgia affect your daily life? Do your symptoms come and go?  What are your most serious symptoms?  What treatments work for you?  What medications do you take to treat fibromyalgia? Do they work? How does fibromyalgia affect your daily life? Do your symptoms come and go? 

Click here to sign up to view the webcast.   
 
Click here to register to attend the meeting. 

Click here to check the availability of the FDA website to submit comments.

THE FOLLOWING QUESTIONS ARE FROM THE FDA WEBSITE.  PLEASE USE THEM TO GUIDE YOUR COMMENTS.  THANK YOU.

FDA Topic 1 questions: - 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 issues, crawly skin etc.)

1. 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.)
   1. How do your symptoms and their negative affects impact your daily life on the best days?
   2. On the worst days?

1. How have your condition and its symptoms changed over time?
   1. Do your symptoms come and go? If so, do you know of anything that makes your symptoms better? Worse?

1. What worries you most about your condition?

FDA Topic 2 questions: - 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.)
   1. What specific symptoms do your treatments address?
   2. How has your treatment regimen changed over time, and why?

1. How well does your current treatment regimen treat the most significant symptoms of your disease?

1. How well do these treatments improve your ability to do specific activities that are important to you in your daily life?
2. 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.)

1. What specific things would you look for in an ideal treatment for your condition?