Internal Deadlines, Drug Approvals, and Safety Problems

Abstract

Absent explicit quotas, incentives, reporting, or fiscal year-end motives, drug approvals around the world surge in December, at month-ends, and before respective major national holidays. Drugs approved before these informal deadlines are associated with significantly more adverse effects, including more hospitalizations, life-threatening incidents, and deaths – particularly, drugs most rushed through the approval process. These patterns are consistent with a model in which regulators rush to meet internal production benchmarks associated with salient calendar periods: this “desk-clearing” behavior results in more lax review, leading both to increased output and increased safety issues at particular—and predictable—periodicities over the year.

Keywords: Deadline, Adverse effect, FDA, Drug approval

JEL Classification: D91, G41, H75, I11, L65, K23, K32, I18, O32