Internal Deadlines, Drug Approvals, and Safety Problems
AbstractAbsent 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.
CitationCohen, Lauren, Umit G. Gurun, and Danielle Li. 2021. "Internal Deadlines, Drug Approvals, and Safety Problems." American Economic Review: Insights, 3 (1): 67-82. DOI: 10.1257/aeri.20200086
- D83 Search; Learning; Information and Knowledge; Communication; Belief; Unawareness
- I11 Analysis of Health Care Markets
- L51 Economics of Regulation
- L65 Chemicals; Plastics; Rubber; Drugs; Biotechnology