The Government Accountability Office is launching a probe into the FDA's oversight of medical device recalls, ProPublica reported Jan. 18.
In a statement to the news outlet, the GAO confirmed it will conduct an inquiry in response to requests from Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D.-Conn. The two wrote a letter to the GAO in December, raising concerns about a lack of oversight that cited reports from ProPublica and the Pittsburgh Post-Gazette about Philips' 2021 recall of breathing machines.
Earlier investigative reports from the news outlets indicated the FDA did not alert patients or physicians about issues with the breathing machines, despite having received hundreds of complaints in the years leading up to Philips' massive 2021 recall. The recall was related to an issue with foam fitted inside the machines that could break down and potentially release "toxic and carcinogenic" material.
The senators requested the GAO look into how the FDA ensures companies initiate medical device recalls, how it ensures companies submit adverse event reports, and what authority or action the agency has taken in situations where device manufacturers did not initiate recalls in a timely manner.
The FDA told ProPublica it "welcomes the opportunity for GAO review" of its oversight on medical device recalls.
Mr. Durbin has also proposed legislation that would require the FDA to create a communication system to ensure patients and providers are alerted about recalls.