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Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the Reintroduction of the FDA SOS Act

Contact: Steve Arnoff 202.249.7113 

WASHINGTON, DC (February 26, 2015) -

“GPhA applauds Reps. Leonard Lance (R-N.J.) and Rep. Anna G. Eshoo (D-Calif.) for the bipartisan reintroduction of the Food and Drug Administration Safety Over Sequestration (FDA SOS) Act, which exempts user fees for generic drug reviews paid to FDA by manufacturers from sequestration.

User fees for generic drugs are 100 percent industry-supported and applied to the shared priorities established by the historic Generic Drug User Fee Act (GDUFA). These efforts include reducing the backlog of generic drug applications at FDA, enhancing safety, expediting access, and promoting transparency for high-quality and affordable generic drugs.

Subjecting more than $300 million in annual generic drug industry user fees to sequestration puts these efforts at risk — the financial strain this would place on FDA is avoidable. GPhA is pleased to support this bill which will ensure that the FDA can continue to enable safe and timely access to drugs and medical devices for millions of Americans.”

About GPhA
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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha