Following a series of reports on the FDA’s alleged history of mishandling medical device recalls, which in turn sparked a request for a government probe of the regulator, the U.S. Government Accountability Office has agreed to take on the job.
The GAO—the independent watchdog arm of the U.S. Congress—has accepted the investigation request and is aiming to launch the probe soon, an agency representative confirmed to Fierce Medtech.
ProPublica was first to report the news Wednesday; the outlet, together with the Pittsburgh Post-Gazette, is responsible for the series of reports that inspired the request for a congressional investigation.
That request came from Democratic Sens. Dick Durbin of Illinois and Richard Blumenthal of Connecticut, who penned a mid-December letter to Gene Dodaro, head of the GAO, asking him to dig into the FDA’s processes for handling recalls—and, ultimately, to update a 2011 GAO report that requested the FDA “enhance its oversight of recalls.”
The senators argued that it’s high time for a new accounting since the numbers of medtech recalls and medical device reports (MDRs) submitted to the FDA have significantly increased in the years since the GAO’s last probe.
They mapped out a series of 10 questions that a new investigation would answer, tasking the GAO with examining, for example, how the FDA enforces legal requirements around recalls—if at all—and how it’s using MDRs to inform its handling of recalls. The senators also suggested that the investigators determine how certain legislative funding and other support could improve the FDA’s performance.
Durbin and Blumenthal specifically credited ProPublica and the Post-Gazette’s reporting on the matter for spurring them to send the letter. Just a week before the senators issued their request, the outlets had published a report detailing what they described as a longstanding pattern of “regulatory failure” at the FDA.
Their analysis found that the FDA has often allowed devicemakers to pass along MDRs later than the 30-day deadline—and to backdate them as necessary—without facing any major consequences, though the FDA could be pursuing criminal charges for those violations.
That allegedly lax attitude extends to Philips’ ongoing recall of several million respiratory devices. Though previous reporting from ProPublica and the Post-Gazette suggested that Philips had failed to pass along thousands of complaints about the devices in the decade before the recall began in 2021, their FDA-focused report noted that the agency, for its part, had largely failed to act on the MDRs that it did receive from Philips during that period—and then allowed Philips to submit thousands of complaints late with no penalty, keeping their original dates “concealed … from the public,” per the report.