FDA requesting additional testing in the Philips recall case
The FDA has released a communication expressing its need for additional testing in the extensive recall of respiratory devices by Philips.
Following the FDA’s announcement in the evening, shares of PHG on the NYSE experienced a decline of over 7%, reaching $18.31 per share. Similarly, PHIA shares in Amsterdam concluded the day with a drop of more than 8%.
Since mid-2021, Philips has been managing a Class I recall of specific respiratory devices, including ventilators, bi-level positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP) machines under the Respironics brand.
The FDA’s statement comes in the wake of a critical investigative report by ProPublica and the Pittsburgh Post-Gazette. The report highlighted allegations of withholding information concerning the issues with these devices, despite the growing concerns.
“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.
Towards the end of the previous year, Philips released test results indicating that exposure to certain emissions from the recalled devices was “unlikely to result in appreciable harm to health in patients.” Similar test results were published in July of this year, reaffirming this conclusion.
Nonetheless, 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 has agreed to conduct the additional testing requested by the FDA, and the agency continues to uphold its recommendations regarding the health risks linked to the breakdown of PE-PUR foam at the core 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 commitment to keeping consumers informed, the FDA has introduced a new resource section on its website. This section includes a comprehensive timeline of FDA actions related to the recall initiated in June 2021.