Wednesday, January 15, 2014
WASHINGTON DC, (January 15, 2014)
— Today, the U.S. House of Representatives voted to restore $85 million in Food and Drug Administration (FDA) sequestered user fees, reflecting bipartisan recognition of the critical need to ensure the agency has the resources required to carry out its mission, including the review and approval of affordable generic medicines.
“User fee programs are instrumental in the shared effort by FDA and the generic industry to help patients gain timely access to more affordable generic medicines and biosimilars,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA).
GPhA commends House Agriculture and FDA Appropriations Chairman Rep. Rob Aderholt, Ranking Member Rep. Sam Farr, and Reps. Leonard Lance and Anna Eshoo, as well as the leadership of Senate Agriculture and FDA Appropriations Subcommittee Chair Sen. Mark Pryor, and Ranking Member Sen. Roy Blunt, for recognizing the importance of restoring user fees. GPhA looks forward to prompt Senate approval in the coming days.
“Restoration of previously sequestered user fees, particularly those designated in accordance with the Generic Drug User Fee Act (GDUFA), and the Biosimilar User Fee Act (BsUFA), is a necessary and commendable step. Now, Agency experts can get back to business, expediting site inspections and enhancing the generic drug application and review process to ensure that savings from generic medicines are realized by patients, government, businesses and others,” Neas said.
Indeed, generics saved the nation’s health system $217 billion in 2012 and $1.2 trillion over the most recent decade, according to the 2013 Generic Drug Savings in the U.S. report
User fees expected from biosimilar product applications, paid for by manufacturers under the Biosimilar User Fee Act (BsUFA), will give FDA the needed resources for timely review and feedback for companies developing biosimilar products, helping to speed biosimilars to market and give consumers a more affordable alternative to brand biologic medicines.
“GPhA, its members and partners throughout the supply chain look forward to continued collaboration with the FDA. GPhA remains in full support of the application of industry-supplied user fees for safe and timely access to generics and biosimilars,” said Neas.