Data and Code for: Internal Deadlines, Drug Approvals, and Safety Problems

Resource Type
  • Cohen, Lauren (Harvard University)
  • Gurun, Umit (University of Texas at Dallas)
  • Li, Danielle (MIT)
Publication Date
Free Keywords
Deadline; Adverse effect; FDA; Drug approval
  • 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.
Temporal Coverage
  • 1980-01-01 / 2016-12-31
    Time Period: Tue Jan 01 00:00:00 EST 1980--Sat Dec 31 00:00:00 EST 2016
Geographic Coverage
  • US, Europe, Japan, China, South Korea
This study is freely available to the general public via web download.
  • Is version of
    DOI: 10.3886/E120110

Update Metadata: 2021-02-18 | Issue Number: 1 | Registration Date: 2021-02-18