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首页> 外文期刊>The regulatory affairs journal: Pharma >Creating a workable generic drug user fee programme in the US
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Creating a workable generic drug user fee programme in the US

机译:在美国建立可行的仿制药使用者收费计划

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摘要

Generic medicines are a critical component of the US healthcare system. Access to low-cost generic prescription drugs allows millions of Americans to comply with their doctors' medication orders while saving billions of dollars in costs. But the growth of the generics industry, coupled with a chronic lack of resources for the Food and Drug Administration's Office of Generic Drugs, has created a situation that neither the industry nor the agency considers acceptable.Today, nearly 76% of all prescriptions dispensed in the US are filled using FDA-approved generic equivalents of the brand-name counterparts.That figure may be slightly misleading because it includes drugs that have not yet come off patent and are available as brand only. When looking just at those medicines for which there are generic alternatives, consumers choose the generic for 92% of their prescriptions. As a result, generic drug use generated an astounding dollar 138 billion in savings in 2009 alone, according to a July 2010 analysis by IMS Health.
机译:仿制药是美国医疗保健系统的重要组成部分。使用低成本的通用处方药可以使数以百万计的美国人遵守医生的用药要求,同时节省数十亿美元的成本。但是,仿制药行业的发展,再加上美国食品和药物管理局(FDA)的仿制药办公室长期缺乏资源,造成了制药行业或该机构都不认为可以接受的情况。如今,已分发的所有处方中将近76%美国市场上使用的是FDA批准的与品牌相对应的通用等效产品。该数字可能会引起误解,因为其中包括尚未获得专利保护且只能作为品牌使用的药物。当仅查看那些具有通用替代品的药物时,消费者会选择92%处方药的通用药品。因此,根据IMS Health在2010年7月的一项分析,仅2009年,仿制药的使用就节省了惊人的1,380亿美元。

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