Monday, April 7, 2014


On March 26, 20I4, I had the opportunity to actively participate in a webinar/meeting with the FDA.  The subject of the meeting was " Fibromyalgia Public Meeting on Patient Focused Drug Development" The purpose of this meeting was to discover, from the patient's point of view, what the FDA/researchers/drug companies can most do for patients to help alleviate symptoms.   The information from this meeting will be publicly shared with not only drug companies but also researchers.  It is our chance to be heard.  

I am going to post the link that the FDA provided as they are encouraging patients, caregivers, and other stakeholders to comment upon the meeting and the questions that were posted that were the basic guideline for the meeting. In OTHER words, they want to hear from you too.   

I feel strongly that as a patient, of a disease that there is no cure for and they aren't even sure of exactly why we have this disease, that we have a responsibility to ourselves to try to help researchers & doctors to find the answers we need so that maybe we can play even a small part in finding a cure for our disease and gaining back some semblance of our former selves. 

When commenting, as a patient, we can answer the questions listed and provide any other information that we feel is pertinant and helpful. They welcome comments though from anyone who is effected in any way by this disease so please share this link with your loved ones so they may comment also.   Here is what the FDA had to say after the meeting: 

"We know that not everyone who wanted to come to this meeting was able to attend. For anyone who missed the meeting or is interested in what was discussed, we have posted a full recording of the meeting on our website: 

In addition to the input we gathered at the March 26 meeting, we encourage fibromyalgia patients, caregivers, and other stakeholders to submit written comments to the online public docket. 

The comment period closes on May 26, 2014. 

Submit your comments through this website:

FDA is particularly interested in hearing patients’ perspectives on the questions outlined in the Federal Register Notice that announced this meeting. These questions are pasted below for your reference, and the Federal Register Notice can be found here: 

The focus was truly on the following questions (as provided by the FDA): 

Discussion Questions
Topic 1: Disease symptoms and daily impacts that matter most to
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
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.)
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?

My hope is that this post has been helpful and informative.  Additionally, I hope for relief of our symptoms to be in our near future!   (((((((((Gentle hugs))))))))) 

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