Down to the Wire

Tomorrow is the big deadline to register for the FDA meeting on Drug Development for ME/CFS. I’m recapping the deadlines and also providing a little more information on how participation will work:

If you want to attend the meeting in person, you MUST REGISTER by 5pm Eastern on Monday, April 8th. This deadline applies even if you do not wish to provide public comment.

If you want to participate in one of the panels on Day One of the meeting, you must indicate your interest when you register. You must ALSO send a brief summary of your answers to the Federal Register questions (pdf link) by 5pm Eastern on Monday April 8th in order to be considered for one of the panels. Your summary should be emailed to

If you want to offer comment on a topic not covered by the Day One panels, you must indicate your interest when you register. You must ALSO send a brief summary of your comments to by 5pm Eastern on Monday April 8th in order to be considered for the open comment period.

If you want to watch the webcast of the meeting, FDA is asking people to REGISTER by 5pm Eastern on Monday, April 8th. However, FDA has told advocates that anyone who has the sign in access to the webcast will be able to see it, and the webcast access information will be posted on the FDA website about a week before the meeting.

If you want to submit written comments, you have until August 2nd to post comments through the meeting docket. The docket page currently says it will close on April 8th, but FDA has said in the Federal Register and in communication to advocates that the docket will be open until August 2nd.

How will these panels and public comment work? I’m seeing a lot of confusion among advocates about how this comment process will work. We are all accustomed to the CFSAC comment process, but this is very different. Based on FDA’s descriptions of the day in the Federal Register notice, the meeting FAQs (pdf link), and follow up emails to advocates, here is my understanding of how this will work:

  • Most of the Day One meeting will be devoted to discussion of the questions posed in the Federal Register notice. FDA will select panelists for each topic from those who indicated interest in their meeting registrations. Those panelists will be selected and notified some time after registration closes on April 8th.
  • For each panel topic on Day One, a brief panel discussion will start the dialogue. Two FDA moderators will then facilitate discussion by inviting comments from other patients. If you are at the meeting and want to comment, the moderators will recognize people from the floor and you do not have to register in advance for that. This is something we have NEVER had – a chance for interactive discussion at a public meeting.
  • The configuration of the panels, time allocation and other aspects of the discussion will not be finalized until after the registration deadline. So we don’t know who will be on the panels, how much time will be spent on each topic, and so on. These details will come out about a week before the meeting.
  • There is approximately 30 minutes allocated for public comment on other topics at the end of Day One. This time may change based on the final panel and discussion configuration. FDA has said that there have been significant numbers of requests to comment, and so it will be a challenge to give everyone a chance to speak. Comment by proxy will not be permitted, and the time allotted to each commenter has not been determined yet. In any case, this section of the day will be more similar to what we do at CFSAC meetings in terms of time-limited statements with no discussion or interaction.

This is an important opportunity for all of us in the ME/CFS community. Make sure you can participate by registering on time and providing comment in whatever way is possible for you.


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7 Responses to Down to the Wire

  1. Cindy Dutton says:

    As a sufferer of sever CFS, I am hopeful for any kind of help that can be done to find the cause and treatment of this extremely debilitating illness. I went from an active RN to a home bound invalid overnight in 2005 and now can do very little. I suffer daily. I am 58 and feel 78. I can not remake energy that I use so I am in a recliner or bed most of the time. I can no longer drive, work, or even read a page out loud to my grandchild.
    This disease is so misunderstood that every tired person I know thinks they have it. This is not so. They are tired, I am extremely sick.
    This disease needs answers!

    • Jennie Spotila says:

      Cindy, if you have the energy I hope you will post to the meeting docket about your symptoms and treatment experiences! FDA needs to hear our voices!

  2. Holly says:

    I have submitted a comment and registered to attend through webcast. I have had CFS for 16 years. If there is another way I can contribute I am interested although I cannot attend in person. Thank you for the information.

    • Jennie Spotila says:

      Those are both great ways to participate. I’m not sure if it’s possible to submit two written comments through the docket, but you may want to try again after the meeting if any new issues arise that you think need addressing. Thanks for participating!

  3. Kristina Henson says:

    Thanks for reminding us how to participate in this very organized article. I’m not feeling well today and was able to find the website to submit comments very quickly and get something in to the FDA. Looking forward to the meeting.

  4. Kathy says:

    Thank you so much for this post. You have put so much effort into this that I felt I must register and submit a comment! You made it so easy. I did my little part in this hugely important meeting!

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