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House lawmakers introduce bipartisan legislation creating user fees for generic drugs
House lawmakers have introduced legislation to reduce the backlog of 2,000 generic drug applications that have piled up at the Food and Drug Administration.
The Generic Drug and Biosimilars User Fee Act calls on generic drug makers to pay about $1.5 billion over the next five years to help fund the federal regulators who review and approve new drugs.
It would also enable the FDA to implement a pathway for approving generic versions of complex biologic drugs, which was made possible for the first time by the 2010 healthcare reform law.
The Generic Pharmaceutical Association, a trade group, called for Congress to rapidly adopt user fee legislation.
"The generic industry has stepped up to the plate to do our part to help ensure U.S. drug safety, establish a more level playing field among all participants in the U.S. pharmaceutical supply chain and significantly reduce the time needed to commercialize a generic drug," David Gaugh, vice president for Regulatory Sciences at GPhA, testified Thursday at a House Energy and Commerce Health subcommittee hearing on the generic user fees. "The [user fee] programs will help assure that American consumers continue to receive the significant cost savings from generics that, over the past dozen years, have provided more than $1 trillion in savings to the nation's healthcare system."
The bill was introduced by Reps. Tim Murphy (R-Pa.), Henry Waxman (D-Calif.), Frank Pallone Jr. (D-N.J.) and Joe Pitts (R-Pa.).
