Patricia J. Zettler, Rachel E. Sachs, Steven Joffe, Holly Fernandez Lynch
{"title":"The Dangers of Decoupling Safety and Effectiveness in Drug Approval","authors":"Patricia J. Zettler, Rachel E. Sachs, Steven Joffe, Holly Fernandez Lynch","doi":"10.1001/jama.2025.2807","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":518009,"journal":{"name":"JAMA","volume":"131 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1001/jama.2025.2807","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
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.