Legislation would exempt GDUFA payments from sequester

WASHINGTON — A new bill would exempt user fees paid by drug companies to the Food and Drug Administration — including those of generic drug makers — from the automatic federal budget cuts that went into effect in March, commonly known as the sequester.

The bill, the FDA Safety Over Sequestration Act, received sponsorship from Reps. Leonard Lance, R-N.J.; Anna Eshoo, D-Calif.; Doris Matsui, D-Calif.; and Mike Rogers, R-Mich. Generic drug industry trade group the Generic Pharmaceutical Association heralded the bill.

"One year ago, president Obama signed into law the Generic Drug User Fee Act," GPhA president and CEO Ralph Neas said. "A landmark achievement for the generic industry, GDUFA authorizes the FDA to use private industry-funded payments to reduce the backlog of generic drug applications, enhance safety, expedite access and promote transparency for high-quality and affordable generic drugs."

The Pharmaceutical Research and Manufacturers of America, a branded drug industry trade group, is also supporting the bill.