Debating the next PDUFA

WASHINGTON - FDA Commissioner Jane Henney last week used a public forum on the Prescription Drug User Fee Act (PDUFA) to campaign for increased federal funding for the agency. Congress has flat-lined FDA's budget for several years while forcing it to absorb mandatory salary increases, an expanding workload and new missions. Henney said the situation reminds her of a song title, "Trying to Get a Dollar Song for a Nickel."

Henney and other senior agency officials acknowledged that user fees have significantly improved FDA's ability to review drug and biologic applications, but argued that the paucity of federal budget dollars has limited its ability to conduct pre-market and post-market activities. Public health could be jeopardized if, because of PDUFA, more drugs are put on the market at a time when FDA doesn't have resources for post-market surveillance and monitoring, Henney said. ...