House Republicans will have to wait another day for their chance to grill CDRH chief Dr. Jeffrey Shuren about the FDA’s “inconsistent application of reasonable standards for safety” in clearing medical devices for market.
The House Oversight & Government Reform Subcommittee on Health Care was slated to hold its “Pathway to FDA Medical Device Approval: Is there a Better Way?” hearing today to “study the FDA’s inconsistent application of reasonable standards for safety and effectiveness in approving medical devices, and the impact it has on American job creators.”
Bu the hearing was abruptly canceled shortly before it was due to start, because of time constraints, one of the committee’s aides told MassDevice. The hearing has not been re-scheduled.
The GOP-led committee was set to call Rep. Erik Paulsen (R-Minn.), Shuren, Jack Lasersohn, a general partner at venture capital firm The Vertical Group, and David Gollaher, president and CEO of the California Healthcare Institute. The committee is chaired by Rep. Trey Gowdy (R-S.C.).
Yesterday, the Senate Special Committee on Aging held its own hearing on the safety of medical devices FDA and its role in “protecting patient safety as part of the medical device approval process.”
The 21-member committee heard testimony from patient-safety advocates, industry representatives and academics during the two-hour hearing. Most of the dialogue centered around increasing measures to prevent recalls and to improve post-market recognition of products that need to be recalled.
“The FDA has had over 20 years to solve these problems,” chairman Sen. Herb Kohl (D-Wisc.) told the panel. “I believe the FDA needs to develop a more robust post-market surveillance program.”
Kohl said he’s “encouraged” by the FDA’s renewed emphasis on patient safety, but added, “I’m concerned that the agency’s oversight of medical products still remains on the GAO’s ‘high risk’ list. That is unacceptable.”
The hearings are part of a broader effort on Capitol Hill, from both sides of the aisle and from the medical device industry itself, to frame the discussion over the way medical devices are cleared for market.