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.

• ME/CFS expert asserts FDA should approve Ampligen (Jan 2013)
• FDA Advisory Committee Meeting for Ampligen Pt 1: Dueling Presentation Set Stage for Critical Vote (Jan 2013)
• FDA Advisory Meeting for Ampligen Pt II: The Vote and Aftermath (Jan 2013)
• Harsh FDA Report…Good Committee…Which Way Ampligen (Dec 20th 2012)
• Ampligen ME/CFS Resource Center

Patient Hunger Strike for Ampligen Approval

• Ampligen Recipient Begins Hunger Strike For Ampligen Approval 
• Hunger Strike For FDA Ampligen Approval Gets More Support/Hits News Media
• TV interview with Ampligen Hunger Striker

Stakeholders Meeting

• FDA Stakeholders Meeting Date Set
• Objectives for the Stakeholder Meeting (Aug 7, 2012)
• Stakeholder Effort: An Update (July 24th, 2012)
• FDA Letter to Advocates Agreeing to Stakeholders Meeting (July 10th, 2012)
• Success! FDA Commits to Stakeholder Meeting (July 2nd, 2012)
• Bringing the FDA Stakeholder Meeting Home: One More Push (June 07, 2012) 
• Fighting For a Stake! FDA Cold Shoulder = More Action On Treatments For ME/CFS (May 19, 2012)
•  Accelerating Treatments For ME/CFS: A Call to Action for the FDA (April 23rd, 2012)