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Internal Deadlines, Drug Approvals, and Safety Problems

Author

Listed:
  • Lauren Cohen
  • Umit Gurun
  • Danielle Li
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

  • Lauren Cohen & Umit Gurun & Danielle Li, 2020. "Internal Deadlines, Drug Approvals, and Safety Problems," NBER Working Papers 28071, National Bureau of Economic Research, Inc.
    • Handle: RePEc:nbr:nberwo:28071
    Note: AP EH POL PR
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    File URL: http://www.nber.org/papers/w28071.pdf
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    More about this item

    JEL classification:

    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • K32 - Law and Economics - - Other Substantive Areas of Law - - - Energy, Environmental, Health, and Safety Law
    • O38 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights - - - Government Policy
    • P16 - Political Economy and Comparative Economic Systems - - Capitalist Economies - - - Capitalist Institutions; Welfare State

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