Internal Deadlines, Drug Approvals, and Safety Problems

Lauren Cohen, Umit Gurun and Danielle Li

No 28071, NBER Working Papers from National Bureau of Economic Research, Inc

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.

JEL-codes: I18 K32 O38 P16 (search for similar items in EconPapers)
Date: 2020-11
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Published as 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.

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