Working Paper: NBER ID: w28071
Authors: Lauren Cohen; Umit Gurun; Danielle Li
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: drug approvals; safety; regulatory behavior
JEL Codes: I18; K32; O38; P16
Edges that are evidenced by causal inference methods are in orange, and the rest are in light blue.
| Cause | Effect |
|---|---|
| Internal deadlines (C41) | rushed drug approvals (I19) |
| rushed drug approvals (I19) | increased adverse effects (I12) |
| Internal deadlines (C41) | increased adverse effects (I12) |
| Timing of drug approvals (L65) | number of adverse effects (I12) |