Internal Deadlines, Drug Approvals, and Safety Problems

43 Pages Posted: 30 Jul 2019 Last revised: 15 Sep 2020

See all articles by Lauren Cohen

Lauren Cohen

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

Umit Gurun

University of Texas at Dallas

Danielle Li

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

Date Written: July 26, 2019

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: Deadline, Adverse effect, FDA, Drug approval

JEL Classification: D91, G41, H75, I11, L65, K23, K32, I18, O32

Suggested Citation

Cohen, Lauren and Gurun, Umit and Li, Danielle, Internal Deadlines, Drug Approvals, and Safety Problems (July 26, 2019). Available at SSRN: https://ssrn.com/abstract=3427338 or http://dx.doi.org/10.2139/ssrn.3427338

Lauren Cohen

Harvard University - Business School (HBS) ( email )

Rock Center 321
Soldiers Field
Boston, MA 02163
United States

HOME PAGE: http://www.people.hbs.edu/lcohen

National Bureau of Economic Research (NBER) ( email )

1050 Massachusetts Avenue
Cambridge, MA 02138
United States

Umit Gurun (Contact Author)

University of Texas at Dallas ( email )

2601 North Floyd Road
Richardson, TX 75083
United States

HOME PAGE: http://www.umitgurun.com

Danielle Li

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

100 Main Street
E62-416
Cambridge, MA 02142
United States

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