Burr pushes stripped-down user fee bill
Move could speed reauthorization, but would frustrate patients, industry and FDA by abandoning reforms
Sen. Richard Burr has introduced a stripped-down medical products user fee reauthorization bill and urged his colleagues to pass it quickly. While supporters of more expansive legislation are scrambling to find a path to enactment, it isn’t clear that they will be able to find the 60 votes necessary, or that they could bring a bill to the Senate floor, get it passed and reconcile it with legislation passed by the House in time to avoid ruinous interruptions in medical product reviews.
The move by Burr (R-N.C.), the ranking Republican on the Senate committee responsible for FDA oversight, could speed reauthorization of prescription drug, generic drug, biosimilar, and medical device user fees, but it would also frustrate patients, regulated industries and FDA officials who have lobbied for years to get regulatory reforms attached to the legislation. ...