PDUFA Clears Senate Committee; Amendments and House Differences Await

The Senate Health Committee approved its version of an omnibus FDA user fee bill Wednesday, sending it to the Senate floor for a vote as early as next month. While there is only one slight change between the committee-reported version and the manager’s amendment offered by Chair Tom Harkin (D-Iowa), differences are emerging between Senate and House versions. This could complicate agreement on a final bill reauthorizing the Prescription Drug User Fee Act (PDUFA) and enacting user fee programs for generic drugs and biosimilars.
Drug Industry Daily