ASA Testifies Before FDA on Safe Use of Propofol

ASA Immediate Past President Eugene P. Sinclair, M.D. testified before the FDA Advisory Committee on Anesthetic and Life Support Drugs on November 10, 2005. At issue was the petition filed by the American College of Gastroenterology to remove from the propofol (Diprivan^®) labeling the following language:

“For general anesthesia or monitored anesthesia care (MAC) sedation, DIPRIVAN Injectable Emulsion 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 was followed at the podium by anesthesiologists Carol Rose, M.D., of the University of Pittsburgh Medical Center, and until recently a member of the Advisory Committee, and Marc Koch, M.D., M.B.A., President and Chief Executive Officer of Somnia, Inc., a New York based Anesthesia Management Company, which specializes in providing comprehensive anesthesia, pain management and accreditation consulting services to office-based surgical facilities and ambulatory surgery centers throughout the United States. These three anesthesiologists were the only witnesses and they each testified in favor of keeping the warning on the propofol labeling.

Download a copy of Dr. Sinclair’s testimony and ASA’s letter commenting on the ACG petition filed with the FDA on October 19.