“万络撤市事件”后美国FDA药品安全监管体系的变革和具体应对举措分析  

Analysis on the Reform and Countermeasures of the FDA's Drug Safety Regulatory System After“Vioxx Withdrawal Event”

作　　者：周天爱 马倩 杨劲 ZHOU Tian-ai;MA Qian;YANG Jin(School of International Pharmaceutical business,China Pharmaceutical University)

机构地区：[1]中国药科大学国际医药商学院

出　　处：《中国食品药品监管》2023年第4期62-73,共12页China Food & Drug Administration Magazine

摘　　要：本文梳理了美国FDA“万络撤市事件”的时间线,通过回顾万络不良反应证据在不同阶段的累积过程,并利用Meta数据挖掘手段在相应阶段进行动态分析,评估如何及发现万络存在严重心肌梗死风险,进一步剖析美国FDA在“万络撤市事件”中监管滞后的原因(包括信息采集来源单一、信号挖掘与分析能力不足、风险评估与决策过程中沟通不畅等)。本文通过总结“万络撤市事件”发生后美国FDA药品安全监管体系的变革和具体应对举措(包括颁布新的法案、重组机构、开展监管科学研究等),以期从法律体系、组织体系、技术体系等方面进一步为我国药品上市后安全性监测模式的完善提供参考和建议。This paper first reviewed the timeline of the“Vioxx Withdrawal Event”of the FDA.By reviewing the accumulation of adverse reaction evidence for Vioxx at different stages and using meta-data mining to conduct dynamic analysis at corresponding stages to find out when Vioxx can be found to have a serious risk of myocardial infarction,this paper then analyzed the reasons for the FDA's lag in the regulation of Vioxx,including:single source of information collection,lack of signal mining and analysis ability,poor communication mechanism in risk assessment and decision-making.Finally,this paper summarized the changes in the FDA's drug safety regulatory system and specific countermeasures after the“Vioxx withdrawal event”,including the promulgation of new legislation,reorganization of institutions,reconduction of regulatory scientific research,etc.,to provide references and suggestions for the improvement of post-market drug safety supervision in China from the legal system,organizational system and technical system perspectives.

关 键 词：万络 美国FDA 药品安全性监测 启示 

分 类 号：R95[医药卫生—药学]