BioCentury
ARTICLE | Regulation

PDUFA: Time stands still

December 8, 2003 8:00 AM UTC

Despite the promise of the Prescription Drug User Fee Act to speed drug reviews, wide discrepancies among FDA biopharmaceutical review bodies has resulted in less than half of all drugs being approved by the end of the first review cycle in the past two years.

An analysis of FDA biopharmaceutical review timelines reveals that entire categories of drugs are far more likely to experience multi-cycle reviews. Indeed, in fiscal 2001 and 2002, the last years for which complete data are available, some divisions of the Centers for Drug Evaluation and Research routinely approved or denied an NDA by the end of the user-fee deadline, while others almost always kept products in a state of regulatory suspended animation by issuing an "approvable" letter, which can allow FDA to extend review times without exceeding deadlines established by PDUFA...