Washington, DC, July 22, 2013 -- The Generic Pharmaceutical Association (GPhA) applauds the bipartisan introduction of the FDA Safety Over Sequestration (SOS) Act (H.R. 2725) in the House of Representatives. This legislation would exempt FDA user fees, including those provided by generic manufacturers, from sequestration, the automatic federal budget cuts that went into effect in March 2013.
“One year ago, President Obama signed into law the Generic Drug User Fee Act (GDUFA),” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. “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. All of these outcomes are at risk if user fees are subject to sequestration.
We commend the sponsors of the FDA SOS Act, Rep. Leonard Lance (R-NJ), Rep. Anna Eshoo (D-CA), Rep. Doris Matsui (D-CA), and Rep. Mike Rogers (R-MI),” continued Neas, “for recognizing that privately-funded user fees should be exempt from sequestration, and instead used to eliminate avoidable financial strain on the FDA. This vital measure would help the agency effectively carry out its mission.” GPhA joins AdvaMed, PhRMA and other industry trade groups in supporting the bill, which will improve timely access to safe and effective medicines and medical devices for all Americans.