Internal Deadlines, Drug Approvals, and Safety Problems
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.
We would like thank Daniel Carpenter, Sabrina Howell, Aaron Kesselheim, Christopher Malloy, and seminar participants at Harvard University and the 2020 American Economic Association meetings for helpful comments and suggestions. Copyright American Economic Association; reproduced with permission. The views expressed herein are those of the authors and do not necessarily reflect the views of the National Bureau of Economic Research.
- About 20 percent of drug approvals come in pre-holiday surges in December. They are associated with more adverse outcomes than drugs...
Lauren Cohen & Umit G. Gurun & Danielle Li, 2021. "Internal Deadlines, Drug Approvals, and Safety Problems," American Economic Review: Insights, vol 3(1), pages 67-82.