FDA Posts Background Info for Ampligen Review

FDA-advisory-committee-meetingThe Food and Drug Administration’s Arthritis Advisory Committee will review data on Ampligen submitted by manufacturer Hemipsherx Biopharma and an internal FDA team. The December 20, 2012 meeting is the first-ever FDA advisory committee meeting to review a drug for possible approval to treat CFS. Extensive background materials were posted to the FDA’s website on Dec. 18, 2012, the customary time period for public review of data analyses and other documents, committee rosters and questions that will be posed to the advisory committee.

The documents are linked here: http://1.usa.gov/UIfDae

The December 20, 2012 meeting will be webcast live. It begins at 8:00 a.m. (Eastern standard time) Instructions about how to access the meeting are provided here: http://1.usa.gov/T5XQuS Based on materials available from past advisory committee meetings, it appears that the webcast will be archived for viewing later.

FDA advisory committee meetings are conducted in a manner similar to a courtroom trial, featuring evidence provided by presenters for the manufacturer and the FDA. It is customary for the dialogue to become adversarial and observers are cautioned to prepare for tough questioning by members of the advisory panel. The advisory committee membership composed for this session includes some CFS experts, including Dr. Anthony Komaroff of Harvard Medical School, Dr. Gailen Marshall of University of Mississippi Medical Center and Dr. Elizabeth Unger of the U.S. Centers for Disease Control & Prevention. The patient representative appointed as a voting member is Alaine Perry, MPH, of Washington, D.C.

FDA-hallThere will be a 90-minute session following the lunch break devoted to public testimony. At the end of the public session the committee will vote on five questions. Although FDA usually follows the guidance of its advisory committees when making final decisions for drug approvals, it is not required to do so. A final decision is expected from the agency by February 2, 2013.

The release of these documents has prompted some media coverage, particularly in the financial press. The stock price for Hemispherx fell 45 percent upon release of the documentation from Hemispherx and FDA. Here are some of the links to news stories:

For other information about the FDA review of Ampligen, please see our post, “FDA Set to Review Ampligen Application.”

December 18, 2012