April 22, 2010
J&J Announces FDA Rejection of SEDASYS® Device
On Tuesday April 20, 2010 as reported by several media sources,1 2 Johnson & Johnson, parent company of Ethicon Endo Surgery, Inc., announced that the Food and Drug Administration (FDA) rejected its application for the SEDASYS® Computer-Assisted Personalized Sedation System. According to the reports, FDA sent the company a “not-approvable” letter after review of the application for, SEDASYS® which, through the use of a series of feedback and monitors, was designed to administer therapeutic levels of propofol to patients “undergoing colonoscopy and esophagoduodenoscopy procedures.”
The ASA had expressed concerns with the safety of the SEDASYS® system both in writing3 and during an FDA advisory panel hearing on the device back on May 28, 2009. However, following a presentation from the manufacturer and testimony from the public on the device, the advisory panel voted 8-2 that the device was “approvable with conditions.”4 Although reports indicate that the company will appeal the Agency’s decision, the final ruling contradicts the decision of the advisory panel and is a sound rejection of the application for the device.
In response to the news, ASA President, Dr. Alexander Hannenberg announced his strong support of the Agency’s decision and stated, “I am pleased that the FDA recognized the many unanswered questions and safety concerns about the device and the qualifications of those who sought to use it. ASA has a long history of advocating for patient safety and through its ruling on SEDASYS®, FDA has fulfilled its duty to protect patients; for that we are extremely grateful.”
- ASA comments to FDA
- FDA summary of the advisory committee meeting on May 28,2009