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GPhA Applauds FDA for Completing Generic Drug User Fee Act Recommendations

WASHINGTON, D.C. (JAN. 13, 2012) — The Generic Pharmaceutical Association (GPhA) today commended the Food and Drug Administration (FDA) for completing and submitting to Congress its recommendations for a proposed Generic Drug User Fee Act (GDUFA).

“This is an important landmark that could not have been achieved without the extraordinary efforts of the FDA, my colleagues in the generic industry and all other stakeholders,” said Ralph G. Neas, President and CEO of GPhA. “We now look forward to working with Members of Congress in the weeks and months ahead to ensure that the final program is one that expedites access to low-cost, high-quality generic drugs for Americans and further safeguards the quality and accessibility of our nation’s drug supply.”

GDUFA calls for the generic drug industry to pay $299 million annually in user fees for the next five years, beginning October 1, 2012. This funding is supplemental to what Congress appropriates to FDA each year and will enable the FDA’s Office of Generic Drugs to hire the scientific resources needed to provide timely approval of generic medicines. The new fees also will boost spending for generic manufacturer facility inspections, which are required before new generics can be approved. The GDUFA program will help assure that American consumers will continue to receive the significant cost savings from generics that within the last decade have provided more than $931 billion in savings to the nation’s health care system.

Additional information can be found online at www.gphaonline.org.

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 78 percent of the prescriptions dispensed in the U.S. but consume just 25 percent of the total drug spending. Additional information is available at gphaonline.org.

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