FDA CFS and ME Teleconference - October 16, 2013

[Denise]

1. In case you have not seen it, FDA has produced a report based on the April 25th meeting. You can download it or read it here http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM368806.pdf. Based on the input received at the meeting and from material submitted to the docket, their characterization of ME is quite good.
2. As a followup to the April FDA meeting, FDA is hosting a teleconference on Wednesday Oct 16th fro 1:30-3pm (eastern time). Details below.

On October 16 from 1:30 PM – 3:00 PM EST, FDA will hold a teleconference that is open to the public. FDA will provide introductory and background remarks then the teleconference will be open for public comment on the following three topics:
1. Feedback from the CFS and ME public workshop.
2. Current projects related to drug development in CFS and ME.
3. Potential methods to catalyze CFS and ME drug development.

Registration (Closes October 11, 2013): https://cfsmeteleconference2013.eventbrite.com/

FDA CFS and ME Activities Website: http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm

Please contact Randi Clark (Randi.Clark@fda.hhs.gov) or Mary Gross (Mary.Gross@fda.hhs.gov) if you have any questions.

 

[Nielk]

Reminder to register for this call. Today is the last day.

 

[Simon]

Registered - and can record if I can access by Skype, but don't have time to write. Anyone know how 'phoning in' works, or is it actually online?

 

[WillowJ]

I have an e-ticket with a barcode--instructions say to print it (as, on paper) and bring it with me to the door--which I'm sure will be very useful over the telephone and internet

 

[WillowJ]

Registered - and can record if I can access by Skype, but don't have time to write. Anyone know how 'phoning in' works, or is it actually online?

Details for dialing in to the teleconference will be sent to all attendees at a later date.

https://cfsmeteleconference2013.eventbrite.com/

 

[August59]

Most of the FDA is shutdown due to budget.

 

[WillowJ]

Most of the FDA is shutdown due to budget.

so do we think it will not be held on schedule? I did not find any further instructions, in my inbox.

 

[beaker]

I just saw this and therefore missed the sign up. Will someone be taking notes and /or recording ? Would be much appreciated. Thanks.

 

[Seven7]

I registered succesfully just now.

 

[beaker]

I registered succesfully just now.

I tried it and it worked for me too. Thanks for letting me know they are still taking registrations !

 

[Nielk]

PANDORA just posted on Facebook that the teleconference will go on as scheduled.

 

[Nielk]

Agenda

Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME) Teleconference
October 16, 2013
1:30 PM – 3:00 PM EST

Dial‐In: 1‐888‐324‐9559
Password: CFS

1:30 PM Introductions and Opening Remarks
RADM Sandra Kweder, MD
Deputy Director, Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

1:50 PM Topic 1: CFS and ME Public Workshop Feedback
Dial *1 to be placed in the queue for comment.

2:10 PM Topics 2 and 3: Current Projects Related to Drug Development in CFS and ME and
Potential Methods to Catalyze CFS and ME Drug Development
Dial *1 to be placed in the queue for comment.

2:50 PM Closing Comments RADM Sandra Kweder, MD

 

[Seven7]

bump

 

[Firestormm]

I look forward to hearing from you guys the salient details tomorrow

 

[beaker]

I slept through it.
I look forward to anything anyone can share from it.

Thank you .

 

[snowathlete]

I only just twigged that this call even existed so hope someone else can report on it.

 

[Nielk]

I listened in but, I had a huge headache and could not concentrate.

They had a few FDA members there as a panel.

They had a short re-cap of the 2 day April meeting. They kept saying how successful it was and how they were happy with the positive feedback from patients.

They introduced the new CGSAC FDA ex-officio. her name is Janet Maner (sic?)

They said that ME/CFS is a serious disease with no approved therapies. It represents a public health concern.
They are working on a "guidance document" which will help pharmaceutical companies who want to work on finding treatments. It will help catalyze drug development.

A lot of time was allotted to question/comments from the listeners.

Questions from doctors, care takers, patients, one pharmaceutical representative (Eli Lilly), advocates.

Enlander asked about how to get approval for clinicians to use Rituximab. I'm not sure what the answer was but I think they said that sometimes this can best achieved through the maker of the drug.

I remember a question about how the IOM contract for definition will effect them. They said that it's great to have such a respectable institute work on a clear definition. This will help the pharmaceutical companies to know what is needed.

My brain is freezing now...maybe someone else can continue?

 

[Nielk]

I remember an important question/comment about the fact that the FDA panel for ME/CFS drugs would be knowledgeable about the disease. It was asked because at the Ampligen debate, the panel was pretty much ignorant to the disease.

The reply was that the problem is that panel members cannot have a bias. For example anyone who had or was involved in any study of the disease has to be ruled out!

Think about what this application means for the IOM fiasco.

 

[Firestormm]

I remember an important question/comment about the fact that the FDA panel for ME/CFS drugs would be knowledgeable about the disease. It was asked because at the Ampligen debate, the panel was pretty much ignorant to the disease.

The reply was that the problem is that panel members cannot have a bias. For example anyone who had or was involved in any study of the disease has to be ruled out!

Think about what this application means for the IOM fiasco.

I have access to a recording, if I get time and it's worth doing, I'll transcribe.

 

[Bob]

The reply was that the problem is that panel members cannot have a bias. For example anyone who had or was involved in any study of the disease has to be ruled out!

Think about what this application means for the IOM fiasco.

Yes, this is a very worrying aspect of the IOM contract.
If none of the panel members have any in-depth or first-hand knowledge of ME, then I can only anticipate that the whole process will be an unmitigated disaster.