Reconciled PDUFA bill omits REMS provision

Congress released late Monday a reconciled PDUFA reauthorization bill that excludes a pay-for provision in the Senate version of the bill that would have reduced marketing barriers for generics and biosimilars. The provision, opposed by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Industry Organization (BIO), would have prevented branded manufacturers from using a product's REMS as justification for refusing to sell to manufacturers that want to use the branded product in the development of a generic or biosimilar. The reconciled bill does include the House version's pay-for provision that would shorten the deadline for FDA to respond to Citizen's Petitions from branded drug manufacturers challenging a generic drug application to 150 days from 180 days. The different mechanisms to pay for PDUFA reauthorization emerged last week as sticking points in the negotiations to reconcile the two bills (see BioCentury Extra, June 14).

The reconciled bill contains a provision requiring FDA to notify Congress 60 days prior to issuing guidance on the regulation of laboratory-developed tests, a provision that was not in the version of PDUFA passed by the Senate. Additionally, the reconciled PDUFA bill contains provisions from the Generating Antibiotic Incentives Now (GAIN) Act, and gives FDA 60 days to respond to requests from sponsors for a product to be qualified for incentives. ...