美国药物有效性评价简析

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Time of issue:2017-09-28 16:43
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(Summary description)去年上半年，我国开展的“药物一致性评价”无疑是中国制药工业的一次革命。回顾历史，药物一致性评价与发生于上世纪60年代后期的美国“药效评价”(DrugEfficacyStudyImplementation，DESI)有着很多相似之处。　　发生于1960s的Thalidomide事件催生了美国的Kefauver-Harris法案。该法案不仅开创了现代医药工业的理念革命，而且在过去的近60年一直是世界各

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美国药物有效性评价简析

Categories:最新消息
Author:
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Time of issue:2017-09-28 16:43
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　　去年上半年，我国开展的“药物一致性评价”无疑是中国制药工业的一次革命。回顾历史，药物一致性评价与发生于上世纪60年代后期的美国“药效评价”(Drug Efficacy Study Implementation，DESI)有着很多相似之处。

　　发生于1960s的Thalidomide事件催生了美国的Kefauver-Harris法案。该法案不仅开创了现代医药工业的理念革命，而且在过去的近60年一直是世界各国药物法规的基本构架，甚至为80%的国家直接模仿，该法案被誉为“现代医药的圣经”。强调药物安全和有效的统一是该法案的精髓所在。本着安全、有效的原则，Kefauver-Harris法案对新药研究、开发、上市多做出了严格、科学的规定以及制定了相应的审查和批准程序。

　　但是，如何处理1938年至1962年上市药物是个令人棘手的问题。根据1938年的法案，这些药都没有经过“有效性”审查。Kefauver法案只是概念性地提出必须解决这4000个药物有效性问题，并授权FDA实施。但是具体由谁负责，采取什么方式来解决这一问题，却是一直回避的。

　　为什么回避呢?

　　第一，开启有效性评价有可能引发大面积的药物下架，会造成治疗上的混乱和无序。

　　第二，当时FDA大量的人力资源在应付调查性新药和新药申请(IND，NDA)，抽不出人力来参与药物药效评价。此外，FDA雇员本身的知识、经验和能力也不足以评价如此之多的药物。

　　第三，按各州的法律，药物退市要经过听证。4000个药，4000个听证，那是不可能完成的任务。

　　1966年6月，James Goddard就任FDA局长(1966-1968)， Goddard决心要解决摆在FDA面前的最大难题：开启pre-1962的约4000个已上市药物的有效性评估，宣布开始DESI(Drug Efficacy Study Initiative)。Goddard首先和美国国家科学院(NAS)、国家学术理事会(NRC)签订了合同，由国家级科学家按照学科对pre-1962药物做出有效性报告。同时，要求制药商在1967年1月14日前提交药物有效性证据。来自科学院的180位科学家分成30个课题组开始工作。他们审查和评估的依据是：制药商提供的药物简报;制药商提供的补充性有效证据;FDA文档;已有相关文献。

　　FDA从1968年开始逐步在“联邦公告”(Federal Register)上公布评价结果。1969年到1970年大批药物的评价结果公布，DES转入了实施阶段(Drug Efficacy Study Implementation)。即随着Federal Register不断公布DES报告，无效药物开始退市。矛盾爆发了，制药商和美国医学会联手向FDA发难。1969年FDA拿Upjohn的Panalba(四环素和新霉素组合)开刀，拟将组合抗菌素类药物驱逐出市场。但是遇到了Upjohn的顽强抵抗。Upjohn认为FDA没有药物退市决定权，药物退市必须经过国会听证。美国医学会(AMA)站在Upjohn一边，说是“美国医生的自由用药权”不能侵犯。甚至当时FDA的顶头上司美国健康，教育和福利局长Finch要求FDA放水Panalba。FDA新任局长Jey不惜与自己的老板反目，也要将Panalba驱逐出美国市场。最后美国最高法院驳回了Upjohn 的申诉，并修改了CFR，给予了FDA药物退市权。以此，FDA彻底将临床使用了多年的组合抗菌素下架美国市场。此事过后不久，Jey还是被迫辞去FDA局长的职务。

　　截止到1984年《药物价格竞争和专利期补偿法案》颁布，美国FDA与美国国家科学院、美国学术理事会合作，通过文献评价，专家评议，临床试验相结合的方法，评价了3443个药物，其中：2252个有效，1015个无效，167个未定。

　　由于1984年的Hatch-Waxman法制定了仿制药的新规则，1966年开始的美国药效性评价很好的解决了“新法规”管理“老药物”的难题，并使之与1984年法规衔接。

　　借用法律诉讼得到药物退市权：打赢Panalba的官司，击败Upjohn，使法官，陪审员，相信FDA有能力独立判断药物退市，而不需要听证。它是改变美国法律历史的决定!因为这一案例，改变了美国药物退市需要法院听证的制度，将药物退市权交给FDA。

　　http://www.sohu.com/a/163824840_749427

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Electronic Arts pledges free use for five accessibility patents

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