Friday, August 9, 2013

It's Not Too Late to Make Your Voice Heard

The following is a special announcement from the Mass CFIDS Association. Please do take advantage of this unprecedented opportunity to make your voice heard.

The FDA will still accept comments from patients, even though the deadline has passed.
In the recent newsletter (July 27) we noted that Friday, August 2 was the deadline for submitting comments to the FDA’s Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop.

However on Friday the FDA’s server was unavailable for most of the day, and several of you notified us that you were unable to submit your comments.  Thanks to great research detective work by one of you, we have reached the person at FDA responsible for dockets, and he has agreed that they will continue to accept comments for the docket by mail or fax.  He assured me that all comments are read, so this is not a useless exercise!  If you have something to say, please say it.  Comments can be brief, and should address any of the points below.  Be sure to include the docket # with your comments.

The mailing address is:

Division of Dockets Management
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Docket #:  FDA-2012-N-0962-0004

Patients and advocates unfortunately have good reason to be disappointed in the lack of government action on this illness, but the FDA is an exception and is working actively to help.  Now we need to HELP THE FDA HELP US.

How you can help - tell the FDA your story 

The first day of the meeting "focused exclusively on gathering patients’ perspective. FDA heard directly from patients about their experiences with this debilitating condition. Discussion focused on two key topics: 1) disease symptoms and daily impacts that matter most to patients, and 2) the patient perspective on treatment of this condition." This portion of the meeting "provided a particularly valuable opportunity for FDA to hear in patients’ own words about how they experience their disease." Hearing the stories directly from patients was apparently eye-opening to the FDA.

Please add your voice - the FDA is listening!!  Even if you think your experience is common to many patients, and you are bored with re-telling it, it will be very valuable to share in this forum. Giving specific, seemingly mundane details is especially helpful to the FDA. Talk about the symptoms you experience and how they affect your life. Describe what helps you get from day to day, and how much (or little) it helps. What is your life like when you feel "better"?  How can you tell if a treatment is working?
Thank you for taking a few minutes to do this.  You will be helping all patients.
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