User fee re-authorization 
fuels generics’ outlook

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


The enactment in July of the Prescription Drug User Fee Act, or PDUFA, which by law must be re-authorized every five years, provides the Food and Drug Administration with much of the funding the agency needs to review and approve manufacturers’ new-drug applications.


This year, for the first time, the law included Generic Drug User Fee Amendments, thus creating a system of user fees for generic drug companies. The fees, which are projected to raise about $299 million per year over five years, will go toward hiring extra staff to help clear the agency’s estimated backlog of 2,500 generic drug approval applications awaiting review.


The new funding also will spur development of bioengineered and biosimilar medicines by providing the FDA “with the resources necessary to help build new scientific and regulatory capabilities … and promote ongoing biopharmaceutical innovation,” according to Castellani.