Draft agenda posted for the FDA Meeting April 25th and 26th, 2013

The FDA has updated its webpage (http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm) on Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) to include links to the draft agenda for the April meeting http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344665.pdf as well as to a statement about the purpose of the meeting http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344666.pdf

Registration (first come, first served) is required to attend and you can do that here http://mecfsmeeting.eventbrite.com/# and the meeting will be webcast for those who cannot attend in person. (Link to be provided http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm about one week before the meeting.)

Ms Spotila – author of the Occupy CFS blog – has another very good post http://www.occupycfs.com/2013/03/19/showcase/ about the importance of our voices and what we say at the meeting:

…What we say at the meeting will help us or hurt us. Showing drug developers and FDA that there is a market for new treatments, and telling them which symptoms to target and how to measure improvement, will help us. …

…This is our moment. FDA wants to hear what we have to say about our disease and the need for treatment. We have to get this right. Let’s use this opportunity to teach people about our disease. Let’s show the world what we need, and that we’re willing to participate constructively in the process to get it.  There’s no way to know when (or if) we’ll have this opportunity again. Let’s bring our A game to this showcase event.”

She is right.

Giving careful, measured consideration about the reality of living with ME(cfs) and the reality of the need for treatment will help us. This is not the time to talk about the wrongs that have been done to us…

The FDA has provided questions to help us develop our public comment (deadline 8 April 2013).

The discussion topics on Day I are geared to the patient experience of symptoms, daily impact and perspective on treatment.

Discussion 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, etc.)

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, sleeping through the night, etc.)

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?


Discussion topic 2: Patient perspective on treating CFS and ME

1. What treatments are you currently using to help treat your condition or its symptoms?

(Consider prescription medicines, over-the-counter products and 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. How well have these treatments improved your daily life (for example, improving your ability to do specific activities)?

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)?


When asked about the role of caregivers, FDA has responded that the discussion topics will allow for caregivers speaking on behalf of patients who cannot speak for themselves but that the time really is geared to patients. One could assume that FDA would allow a caregiver speaking on behalf of – for instance, a child who, because they got sick during formative years, and has forgotten or never experienced age appropriate normal.

Alternatively, people can register to speak during the open public comment period that follows the discussion topics.


Submit either electronic or written comments by April 8, 2013, to receive consideration.

Submit electronic comments to www.regulations.gov .

Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number FDA-2012-N-0962-0004. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http:// www.regulations.gov. Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop

Document ID: FDA-2012-N-0962-0004 Document Type: Notice
Docket ID: FDA-2012-N-0962  

Electronic or written comments will be accepted after the meeting until August 2, 2013. “



REMEMBER – if you want to be connected with a mentor to help you craft your public comment, contact us at SpeakUpAboutME -at- gmail -dot- com.


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