GOP senators grill FDA devices chief Shuren | FDA Roundup (MassDevice)
Republican senators grill FDA medical device chief Dr. Jeffrey Shuren on review times during a Senate committee hearing, the FDA seeks comment on recall process and Edaptive wins $40M FDA contract.
FDA Center for Devices & Radiological Health chief Dr. Jeffrey Shuren got pummeled by Republican members of the Senate Health, Education, Labor & Pensions committee this week.
Shuren took tough questions from North Carolina's Sen. Richard Burr (R), who called the agency out on its failure to meet goals associated with medical device user fee negotiations during a congressional hearing on medical devices, protecting patients and promoting innovation.
"Negotiations suggest that the agency is seeking a more than 250 percent increase in user fees from current levels," Burr said. "Let me ask you – would you agree to pay somebody any money at all, much less a 250 percent increase over what they're currently paying, when the terms of what you're paying for aren't being met?"
Burr also accused the agency of "bashing" the industry for the increase in application review times, which Shuren insisted was...
