Internal Deadlines, Drug Approvals, and Safety Problems / Lauren Cohen, Umit Gurun, Danielle Li.

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Cohen, Lauren

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Material type: Text

TextSeries: Working Paper Series (National Bureau of Economic Research) ; no. w28071.Publication details: Cambridge, Mass. National Bureau of Economic Research 2020.Description: 1 online resource: illustrations (black and white)Subject(s):

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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.

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Item type	Home library	Collection	Call number	Status	Date due	Barcode	Item holds
Working Paper	Biblioteca Digital	Colección NBER	nber w28071 (Browse shelf(Opens below))	Not For Loan

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Previous	nber w28069 Corporate Governance, Business Group Governance and Economic Development Traps /	nber w2807 The Excess Smoothness of Consumption: Identification and Interpretation /	nber w28070 Quality-adjusted Population Density /	nber w28071 Internal Deadlines, Drug Approvals, and Safety Problems /	nber w28072 Pandemics, Global Supply Chains, and Local Labor Demand: Evidence from 100 Million Posted Jobs in China /	nber w28073 Did U.S. Politicians Expect the China Shock? /	nber w28074 Long-term Effects of the Targeting the Ultra Poor Program /	Next

November 2020.

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.