Clarity on Comment

As I said when the FDA formally announced the commenting process for the Drug Development Workshop, the process will be very different from what we’re used to from CFS Advisory Committee meetings. At the CFSAC, we sign up for a comment slot, submit our complete comments in advance, and then read those comments at the appointed time. There is no discussion, and time limits are strictly enforced.

The Drug Development Workshop will follow a very different format. Several advocates, including myself, have sought clarity from FDA on how it will work. We’ve received more details, and I’m trying to get the word out so people can choose how to participate.

You Must Register

You must register to attend the Workshop, regardless of whether you want to comment. The deadline to register is April 8th.

To Be On A Panel

On Day 1, discussion will start with two panels: “Disease Symptoms and Daily Impacts That Matter Most to Patients,” and “Patient Perspective on Treating CFS and ME.” If you would like to be on one or both of the panels, you must do the following:

  1. Indicate your interest in serving on a panel in your meeting registration.
  2. Send a brief summary of your responses to the panel topic(s) you are interested in to by April 8th. FDA has told us: “We do not need lengthy responses or verbatim testimony. We are just looking for enough detail to make sure that the patients identified to kick off the discussion can represent a range of experiences with CFS and ME.”
  3. If you are selected for the panel, you will be notified in advance and will receive more details about how the format will work.

To Participate in Discussion

After each panel on Day 1, the floor will be open for discussion. This is completely different from the CFSAC format. Remember, you need to register by April 8th to be at the Workshop. Here is how the FDA describes the way discussion will work:

We will then open the discussion to include other patients in the audience who are interested in adding to the discussion. There is no need to register for participation in these audience discussions, and we are not asking for prepared testimonies to be presented as part of the audience discussion. We plan for our facilitator to ask prompting questions and call on people who raise their hand. We will try to accommodate everyone who wants to contribute to the discussion, and we will need to work within the meeting time constraints.

Got it? So to make comments after each panel, you simply need to raise your hand and wait to be recognized by the facilitator. This is NOT the time to comment at length or talk about a different topic. This is a group discussion focused on the questions FDA has posed in the agenda (pdf link).

To Comment on Another Topic

Approximately 30 minutes has been set aside at the end of Day 1 for open public comment. This will follow the format we are more familiar with. If you want to comment during this time, you must do the following:

  1. Indicate your interest in offering comments in your meeting registration.
  2. Send a brief summary of your comments to by April 8th.
  3. FDA says: “To date, we have had a large set of people register to present in the open public comment period, and it will be a challenge to accommodate everyone within our time constraints. We encourage people to  use the open public comment period to address  topics that were not addressed by Topics 1 and 2 earlier in the day.

You Can Always Comment in Writing

You can provide written comments to FDA either before or after the meeting (until August 2). To submit comments, go to the docket and fill out the form.

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