Generic Drug User Fee Act passes in Senate

WASHINGTON — The generic drug industry has applauded the passage of legislation that will expedite the Food and Drug Administration's review of generic drugs and biosimilars, as well as enhance the agency's ability to inspect foreign manufacturing sites.

The Generic Drug User Fee Act, which passed in the Senate on Thursday, is designed to provide the FDA with additional resources and ensure all participants in the U.S. generic drug system — whether U.S.-based or foreign — comply with strict quality standards to ensure all Americans receive timely access to safe, effective and affordable generic drugs. The GDUFA calls for the generic drug industry to pay $299 million annually in user fees for the next five years, beginning Oct. 1.

The Generic Pharmaceutical Association, which applauded the legislation, said the user fee programs are part of GPhA's multipronged effort to ensure patients have access to lifesaving generic medicines.

"The Senate's vote [today] is another critical step in ensuring patients will have access to the lifesaving generic medications they require for years to come," GPhA president and CEO Ralph Neas said. "The Generic Drug User Fee Act will expedite the availability of low-cost, high-quality generic drugs to Americans and further safeguard the quality and accessibility of our nation's drug supply. We urge the House to continue the remarkable bipartisan cooperation shown throughout this process and approve the legislation in a timely manner so that patients, the FDA, and generic manufacturers can begin to see its many benefits."

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