Following is a note circulated Sep 14 by ‘Rivka’ – a well-known patient activist and one of a group of ME/CFS patients and advocates who teleconferenced on Sep 13 with FDA officials, drug companies, and others. The large meeting was part of the FDA’s planned series of activities focused on drug development to treat the symptoms of ME/CFS.* Thank you Rivka and all!
FDA Meeting with ME/CFS Community
In an exciting turn of events, the FDA seems to be taking ME/CFS seriously.
We had a very successful 1.5 hr phone meeting yesterday with the FDA, led by Sandy Kweder (FDA/CDER’s Office of New Drugs, Deputy Director).
• Her superior, Dr. Janet Woodcock, joined for a short time.
• The meeting included 50 people: FDA officials, patients, advocates, drug companies and unidentified others. I expect the CDC had reps there, too.
• A transcript of the meeting and a participant list will be available shortly.
At yesterday's meeting, the FDA pronounced ME/CFS a "serious and life threatening disease with no meds currently available" (or some lingo like that), which opens the door for new drugs for our illness to be considered for "Accelerated Approval."
• Many meds were mentioned by patients (including Rapid Lab's mDAPTA, by me).
• The FDA also said there are currently 8 open INDs [investigational new drug applications] for ME/CFS.
More FDA meetings will follow, including an Ampligen meeting in December and a larger ME/CFS-FDA Stakeholder meeting this spring. Info will be posted on this website: http://www.fda.gov/Drugs/NewsEvents/ucm319188.htm
Yesterday's FDA meeting comes just weeks after Obama raised the priority of ME/CFS and assigned a key health care policy point person to watch over it and just days before
the Sept 18th NIH-funded Lipkin/XMRV study release and press conference in which ME/CFS will be taken very seriously by the scientific research community.
After decades in the dark, perhaps the tide is turning on the government's response to this illness.
* Drug Development for Myalgic Encephalomyelitis & Chronic Fatigue Syndrome (ME/CFS)
[This is the FDA.gov page on ME/CFS drug development activities. It lists the Sep 13 phone meeting, will post the meeting transcript, and will list further activities when they are announced. Please go to this link - www.fda.gov/Drugs/NewsEvents/ucm319188.htm - for links to the referenced PDFs and additional resources.]
FDA will be planning a series of activities focused on drug development to treat the symptoms of Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME/CFS) in order to explore:
• The burden of disease that impacts the quality of life for ME/CFS patients;
• The quantitative outcome measures or endpoints that determine if disease symptoms improve with intervention; and
• How drug efficacy should be clinically tested based on these endpoints or measurements.
Please send correspondence regarding ME and CFS to ME-CFS-Meeting@fda.hhs.gov.
Please Note: The list of activities will be updated as each activity is announced.
Teleconference between FDA and Patients/Patient Advocates – September 13, 2012 [completed]
• Background Information (PDF - 20KB)
• Docket for questions/comments that are not addressed on the teleconference (Docket Number: FDA-2012-N-0962)
• Response Letter to Questions and E-mails Regarding Teleconference Invitation (PDF - 22KB)
How FDA Evaluates Regulated Products: Drugs