FDA (Food and Drug Association) and Chronic Fatigue Syndrome (ME/CFS) Resource Center


Chronic Fatigue Syndrome (ME/CFS) is one of the only major disorders not to have an FDA approved drug. One drug, Ampligen, has been produced for ME/CFS in 25 years.

The Food and Drug Administration (FDA) approves drugs, medical devices, vaccines and regulates tobacco products, cosmetics, food products,etc., in the US.  It’s current budget is approximately 4 1/2 billion dollars a year.

Chronic fatigue syndrome may be the only major disorder in the United States without an FDA approved drug.

FDA Stakeholders Meeting

Thanks to the work of hundreds of ME/CFS patient advocates, in July 2012, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, committed to holding the first Stakeholders Meeting for a disorder since HIV/AIDS in the fall of 2012. This meeting  was later moved to the spring, 2013.

The need for a Stakeholders Meeting was prompted  by the recognition that the FDA had difficulty knowing how to move forward with ME/CFS drugs. Hemispherx, the only drug company to produce a drug for ME/CFS,  had  been moved to five different divisions as its drug, Ampligen, moved through the FDA pipeline.

The Stakeholders Meeting  is designed to refine guidelines and create clarity for drug companies that wish to move forward on drugs for Chronic Fatigue Syndrome.  The meeting is hopefully a sign that the FDA is willing to work with companies to bring drugs to a community with many un-meet treatment needs.

Ampligen and the FDA

Ampligen has been the only drug under review at the FDA to treat chronic  fatigue syndrome for over 15  years.

Patient Hunger Strike for Ampligen Approval

Stakeholders Meeting

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