Lawmakers Eye Linking Lab Test Oversight Bill to FDA Fee Plan

Lawmakers behind a bill to revamp diagnostics regulation are eyeing FDA user fee legislation as a vehicle for pushing their proposal across the finish line.

“The time for Congress to clarify the rules of the road for diagnostic testing is now,” Rep. Larry Bucshon (R-Ind.) said Tuesday during a Friends of Cancer Research event. He and Rep. Diana DeGette (D-Colo.) are working to advance their measure, nearly a decade in the making, “on its own or attached to must-pass bills like MDUFA,” the next iteration of the Medical Device User Fee Amendments that’s up for renewal this year.

Their ...