August 31, 2005

ASA Prepares Response to FDA Propofol Petition

The American College of Gastroenterology filed a petition with the FDA on June 28, 2005, asking the Agency to remove from the labeling for propofol (Diprivan®) the warning that propofol should be administered only by persons trained in the administration of general anesthesia and not involved in the conduct of the surgical/diagnostic procedure.

Dr. Sinclair immediately appointed three highly qualified ASA members, Drs. Lee Fleisher, Beverly Philip and Rebecca Twersky, to work with Vice-President for Scientific Affairs Dr. Charles Otto on a response. The Statement on Safe Use of Propofol approved by the House of Delegates in October 2004 and the Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists provide the basis for our response. Various anesthesiologists have supplied information for the effort. A thorough statistical analysis of the literature referenced in the petition has been performed. A formal letter is now under development, with the advice and assistance of the Washington Office and expert FDA counsel. A copy will be posted on the ASA website shortly after we file the original with the FDA.