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.
Authors
- Patricia J. Zettler (ORCID: https://orcid.org/0000-0001-9114-0735)
- Holly Fernandez Lynch (ORCID: https://orcid.org/0000-0001-7813-9879)
- Steven Joffe (ORCID: https://orcid.org/0000-0002-0667-7384)
- Rachel E. Sachs (ORCID: https://orcid.org/0000-0002-0172-3572)
Institutions
- Washington University in St. Louis (US)
- University of Pennsylvania (US)
Publication Details
- Journal
- JAMA
- Published
- 2025-03-06
- DOI
- https://doi.org/10.1001/jama.2025.2807
- Citations
- 1
- Primary Topic
- Pharmaceutical industry and healthcare
- Type
- article
- Field-Weighted Citation Impact
- 1.56