Senators call for congressional investigation into FDA’s handling of device recalls

Following the publication of a report suggesting that the FDA has a history of taking a lax approach to enforcing regulations around medical device recalls, a pair of senators have requested an investigation into the agency’s actions.

Dick Durbin of Illinois and Richard Blumenthal of Connecticut, both Democratic senators, sent a letter this week to Gene Dodaro, who heads up the U.S. Government Accountability Office (GAO), asking him to open a probe into the FDA so his office can update an existing report dating back to 2011 that called on the agency to “enhance its oversight of recalls.”

As they wrote in the letter (PDF), their request was spurred by a report from ProPublic and the Pittsburgh Post-Gazette last week. It argued not only that the FDA had overlooked a decade’s worth of warnings before Philips began its wide-ranging respiratory device recall in 2021 and failed to penalize Philips for its own alleged missteps in handling the recall—but also that those actions are part of a larger pattern for the FDA. According to the report, the agency has often failed to act swiftly on early information about other device malfunctions and stopped short of taking permitted legal actions against devicemakers.

The GAO’s 2011 report found several failures in the FDA’s oversight of medical device recalls, and its findings helped to inform certain provisions in the 2012 FDA Safety and Innovation Act. But, Durbin and Blumenthal wrote in their letter, “given recent reporting and the dramatic increase in recalls since then, it is clear that GAO and Congress must examine FDA’s oversight of medical device recalls once again.”

The senators cited data showing that there have been manifold increases in the number of recalls conducted and medical device reports submitted to the FDA since the last investigation took place. Recalls have gone up about 125%, from just under 400 events in 2012 to nearly 900 last year, while adverse event reports have risen more than 500% from almost 500,000 a decade ago to nearly 3 million in 2022.

They went on to offer up a list of 10 questions that the requested review should consider, including probes into how the FDA reacts to devicemakers who don’t begin their recalls within legally required timeframes; the extent to which the agency is using adverse event reports to improve how it handles recalls; and what types of funding or legislative support could boost the regulator’s oversight of both device reports and recalls.

The letter and request for a GAO investigation come shortly after Durbin and Rep. Jan Schakowsky, a fellow Illinois Democrat, introduced legislation in both houses of Congress aimed at improving the entire medical device recall process.

Their Medical Device Recall Improvement Act, proposed in September, would require the FDA to set up “an electronic format for medical device recall notifications” to simplify communications between the agency, devicemakers and users of affected devices, rather than relying on physical letters and emails.

In addition, the new legislation would mandate that devicemakers include in their recall notices specific information about the effects of using recalled devices, and it would also require that healthcare providers share that information directly with any patients using the devices.

In a statement at the time, Durbin called the act “an obvious solution to ensure that medical device manufacturers, FDA, and health providers can share up-to-date information as soon as possible.”