Tell It To The FDA

The much anticipated FDA meeting on drug development for ME/CFS on April 25-26th is fast approaching, and your participation is needed! There is a great deal of time set aside for patient input, but the process will work very differently from what we’re used to at CFS Advisory Committee meetings. In this post, I will pick apart the process so you can participate in the most effective way possible.

First, if you want to attend the meeting in person you must register by April 8th. Space is limited, so sign up soon. If you want to watch the meeting via webcast, you must register. The webcast is observation only, not participatory.

Second, there are several ways to offer comment at the meeting. This is not the CFSAC format of five minute slots, one patient after another, with no interaction. The session on April 25th from 1pm to 5pm will collect patient input on the impact of ME/CFS on patients’ lives and individual experience with current treatment regimens. You can participate in several ways:

1. Apply to be included on a patient panel addressing one or more of the questions FDA has identified in the meeting notice. My understanding is that each panel will feature approximately five patients, and each will have a minute or so to address the specific question.
2. Participate in the facilitated discussion after each panel. This part of the session will be opened to the floor, but it will be facilitated to stay focused on the specific question.
3. Offer comment during the open public comment session on topics not addressed by the panels. There will be time limits enforced in order to give everyone a chance to speak.
4. If you cannot attend the meeting in person, you can submit written or electronic comments. Comments will also be accepted after the meeting through August 2, 2013. Electronic comments can be submitted to regulations.gov using the docket number FDA–2012–N–0962.

What are the questions FDA wants to address? The Federal Register notice for the meeting (pdf link) lists the following questions that patients will be asked to address during the April 25th session:

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
1.  What are the most significant symptoms that you experience resulting from your condition? (Examples may include prolonged exhaustion, confusion, muscle pain, heat or cold intolerance.)
2.  What are the most negative impacts on your daily life that result from your condition and its symptoms? (Examples may include difficulty with specific activities, such as sleeping through the night.)
a) How does the condition affect your daily life on the best days and worst days?
b) What changes have you had to make in your life because of your condition?

Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME
1.  What treatments are you currently using to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-the- counter products, and other therapies, including non-drug therapies such as activity limitations.)
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) Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
b) How well have these treatments worked for you as your condition has changed over time?
c) What are the most significant downsides of these treatments (for example, specific side effects)?

It is very important that patients address these questions through their comments. The input collected during this afternoon session will be used during the scientific meeting on the second day to inform discussion about endpoints, outcome measures, and clinical trial design.

How do I get on a panel? You must register for the meeting and apply for the panel discussion by April 8th. Indicate which topic(s) you want to address and provide a brief summary of your answers to the questions. FDA will identify panel participants and confirm with those individuals in advance of the meeting. You must physically attend the meeting to participate on a panel.

How do I get a public comment slot? You must register for the meeting and apply for the public comment session by April 8th. You will be asked to provide a brief summary of your comments via email to ME-CFS-Meeting@fda.hhs.gov. FDA will notify those with public comment slots in advance of the meeting.

Where do I submit comments? You can submit comments electronically through regulations.gov using the docket number FDA–2012–N–0962. You can submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Again, use the docket number FDA–2012–N–0962.

REMEMBER: If you want to present comments in person at the meeting, you must register and provide your comments by April 8th. FDA will notify those selected for the panels and open public comment slots.