Internal Deadlines, Drug Approvals, and Safety Problems

44 Pages Posted: 16 Nov 2020 Last revised: 15 Mar 2025

See all articles by Lauren Cohen

Lauren Cohen

Harvard University - Business School (HBS); National Bureau of Economic Research (NBER)

Umit G. Gurun

University of Texas at Dallas

Danielle Li

Massachusetts Institute of Technology (MIT) - Sloan School of Management

Multiple version iconThere are 2 versions of this paper

Date Written: November 2020

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.

Suggested Citation

Cohen, Lauren and Gurun, Umit G. and Li, Danielle, Internal Deadlines, Drug Approvals, and Safety Problems (November 2020). NBER Working Paper No. w28071, Available at SSRN: https://ssrn.com/abstract=3731240

Lauren Cohen (Contact Author)

Harvard University - Business School (HBS) ( email )

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Umit G. Gurun

University of Texas at Dallas ( email )

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Danielle Li

Massachusetts Institute of Technology (MIT) - Sloan School of Management ( email )

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