The Dangers of Decoupling Safety and Effectiveness in Drug Approval

This Viewpoint argues safety and effectiveness are inseparable in US drug approval, that postmarket approaches to assess safety and effectiveness are insufficient, and that reducing the emphasis on effectiveness undermines autonomy.

May 27, 2025 - 17:05
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This Viewpoint argues safety and effectiveness are inseparable in US drug approval, that postmarket approaches to assess safety and effectiveness are insufficient, and that reducing the emphasis on effectiveness undermines autonomy.