Johnson & Johnson’s (NYSE:JNJ) Ethicon Endo-Surgery division is giving up its appeal over the Sedasys automated anesthesia system, withdrawing its request for a review of the FDA’s decision not to approve the device as it gears up to file a new pre-market approval application.*
The federal watchdog agency cancelled a Dec. 14 meeting before its Medical Devices Dispute Resolution Panel, which was slated for a discussion of the pre-market approval application’s denial.
FDA commissioner Dr. Margaret Hamburg OK’d the review in March and the agency ordered the December meeting Nov. 21. A week later EES withdrew its request, according to the FDA.
"By letter dated November 28, 2011, EES notified OC that EES ‘withdraws its request for administrative review’ of that order," according to a notice in the Federal Register. "Because EES has withdrawn its petition for review of CDRH’s denial of approval of the Sedasys PMA, OC regards the matter it initiated closed and is, accordingly, canceling the previously mentioned meeting of the Medical Devices Dispute Resolution Panel scheduled for December 14, 2011."
The company filed its PMA application in March 2008. A little more than a year later, an FDA advisory panel voted 8-2 to recommend approval; although its panels’ votes are not binding, the agency often follows their lead. Still, in February 2010, the FDA denied the application, citing evidence that the Sedasys system "is associated with an increased incidence of deeper-than-intended sedation," according to the FDA.
"CDRH’s denial order maintained that the data provided demonstrates that ‘the Sedasys system is associated with an increased incidence of deeper-than-intended sedation, including episodes of general anesthesia, compared to the Current Standard of Care arm that was used as a control,’" according to the agency. "CDRH asserted in that order that it considered these observations to represent a ‘serious safety signal’ that would require restricting use of the device to persons trained in the administration of general anesthesia."
Ethicon E-S maintained that the five patients who experienced the episodes of general anesthesia are not a safety concern because "none experienced any apnea or oxygen desaturation," according to a federal meeting announcement. Moreover, the company says, Sedasys was designed with systems to avoid apnea and oxygen desaturation, features that helped it achieve "a significant reduction in the primary safety endpoint."
After the initial denial, EES asked the FDA to reconsider in light of the positive advisory panel vote in March 2010, but was shot down in October. In November the agency changed its mind, agreeing to allow the appeal to be heard.
The nine-member panel was to have reviewed submissions from both sides before sending a report to the FDA’s chief scientist, Dr. Jesse Goodman, recommending whether to let the denial stand.