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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
  • 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.

Update Metadata: 2020-06-28 | Issue Number: 1 | Registration Date: 2020-06-28

Cohen, Lauren; Gurun, Umit; Li, Danielle (2020): Data and Code for: Internal Deadlines, Drug Approvals, and Safety Problems. Version: V0. ICPSR - Interuniversity Consortium for Political and Social Research. Dataset.