The breathing machine manufacturer has faced relentless criticism over its handling of the 2021 recall of millions of devices. Philips must meet the requirements outlined in an agreement with the Justice Department before it can resume sales.
Sens. Dick Durbin and Richard Blumenthal asked the Government Accountability Office to investigate the regulatory agency, citing ProPublica and Pittsburgh Post-Gazette reports on the 2021 recall of Philips breathing machines.
“Unacceptable”: Senators Call on GAO to Probe FDA’s Oversight of Medical Devices, Citing Series on Philips CPAP Recall
Sens. Dick Durbin and Richard Blumenthal sent a letter noting how the agency missed opportunities to protect the public from faulty medical devices, citing reporting by ProPublica and the Pittsburgh Post-Gazette.
Sen. Richard Blumenthal’s letter to two federal agencies comes after a ProPublica and Pittsburgh Post-Gazette investigation found Philips kept secret thousands of warnings about its tainted breathing machines.
The FDA also said it is “unsatisfied” with the company’s response to the crisis. Share prices dropped in early trading.