High-Priority Drugs Gain Speedier FDA Reviews

Compiled By Deborah Austin The Prescription Drug User Fee Act (PDFUA) -- passed by Congress in 1992 to enable faster, more predictable U.S. Food and Drug Administration (FDA) drug-application reviews -- is succeeding, suggests analysis from the Tufts Center for the Study of Drug Development, Boston, a drug industry information source affiliated with Tufts University. Funded by special fees from drug developers, PDUFA's intent is to provide the FDA with more reviewers and support staff, as well as information-technology upgrades, to speed up the review process without sacrificing quality. It was renewed in 1997 and again this summer. Between fiscal 1994-1997 and fiscal 1998-2000, average FDA approval times for "priority reviewed" new drugs, those offering significant improvement potential in treating serious and life-threatening conditions, decreased by 40% for new chemical entities (NCEs) and 37% for new biopharmaceuticals. For "standard reviewed" NCEs, approval times shrank 9% but rose 33% for biopharmaceuticals. By the late 1990s, approval time for "priority" NCEs averaged seven months, versus 28 months in the late 1980s; for "standard" NCEs, 17 months versus 35 to 37 months.

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