The FDA Stakeholder Team began an effort in 2011 to accelerate drug development and discovery at the FDA for ME/CFS. With Chronic Fatigue Syndrome (ME/CFS) the only major disorder without have an FDA approved drug, our first goal was to get the FDA to create a “Stakeholders Meeting’ to clear up impediments to drug approval for this disorder. Patients, advocates and legislators provided support for this effort.
In July 2012, following a teleconference with members of the group, FDA announced it would host a “cross-agency coordinated multidisciplinary scientific workshop to address drug and biomarker development issues in ME/CFS”, making this the first Stakeholder’s Meeting at the FDA for a disease since the HIV/AIDS epidemic. On Sept 13, 2012 the FDA held an ME/CFS Advocacy Teleconference with patients and patient advocates.
Hundreds of patients and advocates have sent 1,000’s of testimonials to the FDA over the past couple of months and recently, Bob Miller’s hunger strike resulted in the inclusion of NIH personnel in the meeting.
Now the FDA has set the date (April 25th/26th, 2013) for a 1 1/2 day Stakeholders Meeting in Bethesda, Maryland. In response to requests from the FDA Stakeholder Team the FDA stated:
I am responding to your February 15 inquiry about the status of planning for the FDA ME/CFS Stakeholder meeting. The public workshop will be held on the afternoon of April 25 and all day, April 26, at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814, Phone 301-897-9400.
The public workshop will be held on the afternoon of April 25 and all day, April 26, at the Bethesda Marriott, 5151 Pooks Hill Road, Bethesda, MD 20814, Phone 301-897-9400.
Beginning at 1:00 pm on April 25, FDA will gather patients’ perspectives on CFS and ME through a facilitated group discussion focusing on two main topics: (1) disease symptoms and daily impacts that matter most to patients; and (2) patients’ perspectives on current approaches to treating CFS and ME.
The second day will include a scientific discussion with patients, clinicians, researchers and government experts focusing on how to identify quantitative outcome measures to determine if disease symptoms improve with specific drug interventions.
Additional information will be posted soon (see link below), including the Federal Register Notice that will describe the meeting format and provide details about how to register to attend the meeting.
Much remains to be done to determine the participants and agenda. Thanks for making this happen and thanks for your support.
We’ll be in touch.
The FDA Stakeholder Team