Obama signs PDUFA reauthorization

Generic drug industry calls law 'historic'

WASHINGTON — President Barack Obama signed into law Monday what some called a "historic" reauthorization of the Prescription Drug User Fee Act.

Senate bill 3187, the Food and Drug Administration Safety and Innovation Act, passed in a 92-4 vote on June 26. Under the law, starting Oct. 1, the generic drug industry will pay $299 million a year in user fees over the next five years, which will help pay for more FDA staff and help clear a backlog of some 2,500 generic drug applications and more inspections of manufacturers' production plants. The law also creates a user fee program for companies that make biosimilar drugs.

The new law, which is the fifth reauthorization of PDUFA since 1992, drew applause from a trade group representing generic drug manufacturers.

"Today's enactment of the Food and Drug Administration Safety and Innovation Act is a remarkable achievement for patients, industry and the FDA," Generic Pharmaceutical Association president and CEO Ralph Neas said. "The historic user fee legislation — the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act — will provide FDA with additional resources and ensure all participants in the U.S. generic drug system, whether U.S.-based or foreign, comply with our country's strict quality standards. Very importantly, the programs will make certain that all Americans receive timely access to safe, effective and affordable generic drugs."



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