Drug-Review Deadlines and Safety Problems

This article considers the effects of the deadlines imposed on the Food and Drug Administration (FDA) by the Prescription Drug User Fee Act (PDUFA 1992). The Act was intended to expedite the review process, but according to these findings may have compromised safety.

The PDUFA enabled drug manufacturers to pay a user fee to the FDA for each drug review to help cover the costs of staff required to perform that work, and by so doing to expedite the review process. The agreement required the FDA to make a decision about a new drug within a specified deadline. This study examines whether the deadlines enforced by this legislation have changed the pattern of FDA decision-making, and with what consequences. The researchers studied drugs approved by the FDA from January 1950 to December 2004, focusing on drugs submitted after the deadlines were first imposed in 1993.

The study found that the implementation of the PDUFA requirements increased the number of approval decisions made in the weeks immediately preceding the deadlines. As compared with drugs approved at other times, drugs approved in the two months before PDUFA deadlines were more likely to be withdrawn for safety reasons; more likely to carry a subsequent black-box warning; and more likely to have one or more dosage forms voluntarily discontinued by the manufacturer.

If a drug problem is not detected during the period prior to approval, then the issue with that drug may not be fully defined or included as a warning for years afterward. These findings suggest potential adverse effects of the imposition of deadlines governing FDA drug review.