Internal Deadlines, Drug Approvals, and Safety Problems
41 Pages Posted: 30 Jul 2019 Last revised: 20 Feb 2020
Date Written: July 26, 2019
Absent explicit quotas or incentives, drug approvals around the world surge in December, at month-end, and before holidays. In the United States, the number of December drug approvals is 80% larger than in any other month. Similar patterns hold in the EU and in Asia. Drugs approved in December, at month-ends, and pre-holiday are associated with significantly more adverse effects, including more life-threatening incidents and deaths. Our results suggest that regulators rush to meet internal production benchmarks associated with salient calendar periods: such "desk-clearing" behavior leads to lax review, resulting in both increased output and increased safety issues.
Keywords: Deadline, Adverse effect, FDA, Drug approval
JEL Classification: D91, G41, H75, I11, L65, K23, K32, I18, O32
Suggested Citation: Suggested Citation