Background - PDUFA II
As a result of this success, PDUFA was reauthorized and extended through September 30, 2002. This extension authorized FDA to collect and spend fee revenue to accomplish increasingly challenging goals over this five-year span. These new goals were set forth in letters from the Secretary of Health and Human Services to Congressional Committee Chairmen on November 12, 1997. PDUFA, amended and extended and with its new goals, was referred to as PDUFA II, and its predecessor as PDUFA I. By 2002, PDUFA fees permitted FDA to spend an additional $161.8 million a year for the drug evaluation process.
FDA continued to spend these new resources primarily to hire additional personnel to review human drug applications and to update the IT infrastructure supporting the human drug review process. FDA staff dedicated to these reviews in the CDER, CBER, ORA, and OC increased over 85 percent during the 10 years since PDUFA was enacted--from 1,277 staff years in 1992 before PDUFA was enacted to 2,365 staff years by 2002.