US House and Senate reconcile PDUFA reauthorization legislation

The US Congress has released a reconciled Prescription Drug User Fee Act (PDUFA) reauthorization bill that is effectively a comprise on two sets of legislation that were passed by the Senate (the Food and Drug Administration Safety and Innovation Act; FDASIA) and House of Representatives (PPDUFA), respectively, last month (The Pharma Letters May 28 and June 1).

The reconciled bill does include the House version's pay-for provision that would shorten the deadline for Food and Drug Administration to respond to Citizen's Petitions from branded drug manufacturers challenging a generic drug application to 150 days from 180 days.

The reconciled bill, which reauthorizes the PDUFA and MDUFA [medical device] programs and creates new user fee programs for biosimilars and generics, will need to be presented again to both the House and Senate before going for signature to President Barack Obama.