FDA Moving Forward on ME/CFS


Founder of Health Rising and Phoenix Rising
Staff member
It's great to see an agency moving forward vigorously on ME/CFS. The FDA convened a Working Group to produce clinical outcome measures (COA's) drug companies can use in ME/CFS drug trials. This is a critical area.

From Jennie's blog

After the April 2013 FDA meeting on Patient Focused Drug Development in ME/CFS, FDA took steps to address the need for a qualified COA in ME/CFS. FDA convened an ME/CFS Outcomes Measures Working Group comprised of representatives from FDA, NIH, CDC, and academia. Last year, I joined this group in the capacity of patient representative. While FDA is not developing the COA itself, the Working Group is collaborating on a proposal for funding to conduct the necessary research.

While I can’t share specifics about the proposal at this point in time, I can share my impressions from working with the group. First of all, I think it is fair to say that FDA is highly motivated to make progress on ME/CFS. The agency is not developing the COA tool itself, but they really want to help make it happen. Second, I have been able to participate as an equal member in the Working Group and in sidebar conversations. I have been treated as an equal, and my perspective as a patient has been sought out by the proposal team. Even better, my experiences as a patient have had an impact on the group’s work. This is a group that is open to data and information, and opinions shift as a result.

For more check out her blog: http://www.occupycfs.com/2015/03/31/assessing-outcomes/

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