FDA To Re-Open J&J’s Rejected Sedasys PMA Without Dispute Panel Input

Article preview from "The Gray Sheet"- December 5, 2011

J&J/Ethicon Endo-Surgery and FDA say they have come to an understanding over the firm’s Sedasys computer-assisted personalized sedation system. As a result, the company has withdrawn a formal appeal of FDA’s prior denial of the Sedasys PMA and FDA has agreed to re-review the pre-market submission.

FDA To Re-Open J&J’s Rejected Sedasys PMA Without Dispute Panel Input

Article preview from "The Gray Sheet"- December 5, 2011

FDA has agreed to take a second look at a previously rejected PMA application for Ethicon Endo-Surgery’s Sedasys computer-assisted personalized sedation system following discussions with the company, pre-empting the need to go forward with a rare appeals proceeding scheduled for Dec. 14.

While the Johnson & Johnson subsidiary has submitted no additional data, both sides now suggest that FDA’s original concerns with the device may be resolved.

“CDRH and the company found a pathway to move the application forward that should address the agency’s safety concerns,” FDA spokeswoman Karen Riley affirmed in an emailed statement.

This marks a change in tune from the agency’s 2010 “not-approvable” letter to Ethicon Endo-Surgery. FDA has expressed concerns that Sedasys could increase the incidence of deeper-than-intended sedation and that the firm’s pivotal trial was not sufficient to support the proposed indication: to aid clinicians in the delivery of the sedative hypnotic drug propofol to patients undergoing a colonoscopy or similar procedure, despite not having received training in the administration of general anesthesia.

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