House, Senate pass Prescription Drug User Fee Act
Margaret Hamburg, the commissioner of the Food and Drug Administration, said that she was pleased with the House passage of the law. The Senate passed its own version of the bill, the FDA Innovation and Safety Act (S. 3187), last week.
The House bill now awaits reconciliation with the Senate bill. Eric Cantor (R-Va.), the House majority leader, said on Friday that he hopes a Senate agreement can be reached by July 4 to send a final bill to President Obama.
The current PDUFA, which provides funding for the FDA via user fees from brand name pharmaceutical companies, medical devices and generic manufacturers, expires on September 30. The latest version of PDUFA covers incentives for pediatric research, increasing the FDA's transparency and accountability, increasing the FDA's authority over the supply chain and adding mechanisms to prevent drug shortages, Securing Pharma reports.
The version of the bill in the House is closely aligned with the Senate bill with a few minor differences. One provision in the House bill would require that the FDA notify Congress 60 days before issuing guidance on the regulation of tests developed in the laboratory. Both versions of the bill contain provisions from the Generating Antibiotic Incentives Now Act, though they contain slightly different timelines for sponsor incentive requests and for the FDA to respond to requests.