Food and Drug Administration (FDA) ME/CFS Resource Center
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 a single FDA approved drug. An FDA official is a member of the federal advisory committee on CFS (CFSAC).
FDA Stakeholders Meeting
In 2011 a group of advocates began the groundwork to request that the FDA hold a ‘Stakeholder’s Meeting’ to accelerate the drug approval process for chronic fatigue syndrome (ME/CFS). Thanks to the work of hundreds of ME/CFS patient advocates, in July, Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, committed to holding a Stakeholders Meeting for ME/CFS in the fall of 2012.
- 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)
Ampligen and the FDA
Ampligen has been the only drug under review at the FDA to treat chronic fatigue syndrome for over 15 years. It has been moved to five different sections in the FDA during that time.4 comments