The FDA has issued a communication stating its desire for more testing in the massive respiratory device recall at Philips
(NYSE: PHG)
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The morning after the FDA’s evening announcement, PHG shares were down more than 7% on the NYSE to $18.31 apiece. PHIA shares in Amsterdam closed the day down more than 8%. (MassDevice’s MedTech 100 Index was up slightly.)
Philips has been handling a Class I recall of certain respiratory devices since mid-2021. Respironics recalled millions of ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines. Here’s a timeline of the events of the ongoing saga.
FDA’s statement follows a scathing investigational report from ProPublica and the Pittsburgh Post-Gazette. The report outlined the alleged withholding of information around the issues with the devices even as they became more alarming.
“The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices,” the agency wrote.
Why the FDA wants more testing from Philips
Late last year, Philips released testing results showing that, among other things, exposure to certain emissions from the recalled devices is “unlikely to result in appreciable harm to health in patients.” Further test results released in July of this year came to the same conclusion.
However, the FDA remains unconvinced by the data provided by Philips.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices. Although Philips concluded that the exposure to foam particles and VOCs from these devices is ‘unlikely to result in an appreciable harm to health in patients,’ the FDA believes additional testing is necessary,” the agency said.
Philips agreed to conduct the additional testing requested by the FDA. The agency maintains its recommendations regarding the health risks associated with the PE-PUR foam breakdown at the center of the recall.
The company said in a statement: “The FDA stated that the testing is extensive and conducted with independent parties and expressed no concerns with the validity or objectivity of the testing. Philips Respironics is still in discussions with the FDA on the details of further testing.”
As part of its effort to keep consumers informed, the FDA published a new resource section on FDA.gov. It includes a comprehensive timeline of FDA activities related to the June 2021 recall.
This story originally ran on Oct. 5, 2023. Updated Oct. 6 with Philips statement and next-day stock price.
