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  • Article
  • American Economic Review: Insights

Internal Deadlines, Drug Approvals, and Safety Problems

By: Lauren Cohen, Umit Gurun and Danielle Li
  • Format:Print
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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

Health; Economics; Government and Politics; Innovation and Invention; Research; Science; Biotechnology Industry; Health Industry; Pharmaceutical Industry

Citation

Cohen, Lauren, Umit Gurun, and Danielle Li. "Internal Deadlines, Drug Approvals, and Safety Problems." American Economic Review: Insights 3, no. 1 (March 2021): 67–82.
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About The Author

Lauren H. Cohen

Finance
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More from the Authors
  • All Options on the Table: The Haber Family By: Lauren Cohen, Grace Headinger and Juan Ruiz
  • Baofeng's Philanthropic Efforts in China By: Lauren Cohen, Hao Gao, Bo Li and Zhaoheng Gong
  • Junson Capital (B): Digital Transparency In the Family Office By: Lauren Cohen, Hao Gao, Trang Duong, Grace Headinger and Keven Wang
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