Drug-Review Deadlines and Safety Problems

To the Editor: Carpenter et al. (March 27 issue)¹ report that new molecular entities (NMEs) approved in the 2 months before the first review deadlines established under the Prescription Drug User Fee Act (PDUFA) showed a higher rate of postmarketing safety problems — as measured by safety-based withdrawals, new black-box warnings, or dosage-form discontinuations — than drugs approved at any other time. They suggest that pressure to respond within the allotted time leads to poorer decision making. We consider the questions they raise to be important and have tried to replicate their analysis of safety-based withdrawals and new black-box warnings. . . .