扩大美国食品和药物管理局的市场后管理机构
Holly Fernandez Lynch1,2,3, Rachel E Sachs4, Sejin Lee1
1Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
JAMA health forum
|June 9, 2023
概括
美国食品和药物管理局 (FDA) 可以加强后市场药物保障. 该机构应该利用现有的权力要求进行疗效研究,并加快撤销具有不确定的益处的药物.
科学领域:
- 药物监管事务 药物监管事务
- 制药政策 制药政策
- 临床试验的设计
背景情况:
- 美国食品和药物管理局 (FDA) 在药物批准方面利用了重要的监管灵活性,经常允许基于有限的益处证据进入市场.
- 这种灵活性并未始终与强有力的市场后保障措施相匹配,以确认药物的疗效或解决不确定性.
- 对于市场上市后监测的充分性和没有确定的益处的药物的及时撤销存在担忧.
研究的目的:
- 探索FDA加强其在要求市场后有效性研究方面的权威的机会.
- 评估使用在大量剩余不确定性下批准的药物的加速退出程序的可能性.
- 评估这些机会超出现有的加速审批途径.
主要方法:
- 对FDA目前对药物批准标准的监管方法的分析.
- 审查市场后的缺陷和现有法规,规范市场后研究要求.
- 审查最近的立法改革和与加速审批相关的机构行动.
主要成果:
- 根据"食品,药物和化品法案",FDA拥有法律权力,将市场后疗效研究要求和加速撤销程序扩展到已批准的药物,其残留不确定性很大.
- 这包括由单个关键试验支持的药物,与核心加速批准机构保持一致.
- 有效实施需要经过精心设计,及时进行市场推广后的研究,以及在没有证实好处的情况下采取果断的撤销行动.
结论:
- 目前的FDA药物批准做法可能会让患者,临床医生和支付人对药物的真正益处感到不确定.
- 优于证据确定性的早期市场准入的政策决策需要更强有力的市场后保障措施.
- 美国食品和药物管理局可以利用其现有的法律框架来实施更广泛的市场后安全性和有效性评估.
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