Philips has announced a deal with the FDA to cease the sale of new CPAP, BiPAP and certain other respiratory care devices in the U.S. following a recall episode that drew government watchdog attention.
"Patient safety and quality remain Philips’ highest priority across the company," said Philips CEO Roy Jakobs in comments posted alongside the company’s 2023 annual report. Jakobs acknowledged the distress caused by the recall and sought to affirm the company's dedication to resolving the issue in cooperation with the consent decree.
Under the terms of a newly established consent decree, which have to be finalized in federal court, Philips Respironics will have to meet certain milestones and deliverables to demonstrate compliance with regulatory requirements. They would not sell their sleep therapy or respiratory care devices in the U.S. until these requirements were met, though the company will continue to service existing devices and supply necessary accessories and parts.
Outside the U.S., Philips Respironics will continue to provide both new devices and related accessories.
Philips has also earmarked a provision of €363 million ($394 million) in Q4 2023 for remediation activities and related financial adjustments. The anticipated economic impact in 2024 includes approximately 100 basis points of costs related to these activities and disgorgement payments for U.S. sales.
This development follows a tumultuous period for Philips, initiated by a recall of millions of breathing devices and ventilators in 2021 over concerns about potentially toxic foam degradation. A wave of patient complaints ultimately led the Government Accountability Office to announce an investigation into the FDA’s handling of recalls.
Philips shares dipped on news of the agreement, which some analysts characterized as “very punitive,” according to a Reuters report. Jakobs indicated it will take between five and seven years to comply with the consent decree, which is the average generally for such industry agreements.
Evan joined TriMed in 2011, writing primarily for Health Imaging. Prior to diving into medical journalism, Evan worked for the Nine Network of Public Media in St. Louis. He also has worked in public relations and education. Evan studied journalism at the University of Missouri, with an emphasis on broadcast media.