2017 年 2 月 24 日，FDA 仿制药办公室主任凯瑟琳·库克·尤尔在 FDA Voice 发文称，2016 年 FDA2016 年批准了有史以来最多的仿制药申请，完全批准和预批准的数量达到 800 多件, 超过 2015 年的 726 件，凯瑟琳强调取得这一成效的主要原因在于 2012 年起始实施的《仿制药使用者付费修正案》。此外，仿制药审批数量的增加和首仿药审批占比的提高，一方面反映了 FDA 过去几年改革的进步，另一方面也提示 FDA 仿制药计划的未来发展方向。

来自 FDA Voice, 原文标题“2016: A Record-setting Year for Generic Drugs”

宁大卫 编译

Over the last 10 years, generic drugs have saved the U.S. healthcare system about $1.68 trillion. I’m pleased to report that 2016 was a record-setting year for FDA’s generic drug program, a result that will help generate further cost savings for American consumers, while assuring thequality of these generic products.And the timing couldn’t be better amid concerns about rising drug prices.

在过去 10 年，仿制药为美国医疗保健系统节省了大约 1.68 万亿美元。我很高兴的报告，2016 年是 FDA 仿制药计划创纪录的一年，这将有助于：在保证仿制药质量的同时，为美国消费者进一步节省医疗保健的费用。并且在民众对于药品价格上涨的关注问题中，这是再好不过的一个时机。

Last year, FDA’s Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research generated the highest number of approvals in the history of FDA’s generic drugprogram – more than 800 generic drug approvals, including both full approvals and tentative approvals. Last year’s performances urpassed 2015’s previous record of 726. Many of these approvals were for“first-time generic drugs,” meaning the introduction of a generic counterpartfor a brand-name product for which there was previously no generic. That’stypically the first step towards lower drug prices because multiple generic versions of brand-name drugs drive price competition, leading to more affordable drugs.

去年，OGD 产生了 FDA 仿制药计划有史以来最多的批准数量，包括完全批准和预批准，合计有超过 800 件仿制药获得批准。数量超过了 2015 年 726 件的批准记录，且这些批准中许多是“首仿药”，这意味着之前没有仿制药的原研药开始引入仿制产品。这是降低药品价格代表性的第一步，因为原研药的多种仿制药将驱动价格竞争并带来更加实惠的药品。

An important factor in OGD’s record-setting performance has been the Generic Drug User Fee Amendments (GDUFA) of 2012, a landmark legislation negotiated with the generic drug industry, which completely reshaped the generic drug program at FDA. Among other things, it authorized funds for FDA tohire additional reviewers, modernize the review of generic drug applications,expand facility inspection capabilities, advance IT infrastructure for generic application review, and perform other regulatory actions. This is the first time Congress has authorized a user fee program specifically for generic drugs.It’s a five-year program, up for renewal October 1, 2017. GDUFA I has challenged OGD to reach a variety of goals while maintaining or improving thequality of the review process.

OGD 创纪录的业绩有一个重要因素，是 2012 年的《仿制药使用者付费修正案》（GDUFA）。GDUFA 是一个与仿制药行业协商的具有里程碑意义的立法，在 FDA 彻底改造了仿制药计划。其中，GDUFA 授权 FDA 资金来招聘更多审评人员、使仿制药审评现代化、扩大设施检查能力、推进仿制药申请审评的 IT 基础建设、以及执行其它监管行动。这是美国国会首次授权“使用者付费计划”给仿制药。GDUFA 是一个为期五年的计划，将于 2017 年 10 月 1 日更新。GDUFA 的第一个五年实行期已经挑战 OGD，需要在保持和提高审评质量的同时达到各种目标。

With the assistance of many other offices throughout FDA, OGD is on track to meet,or has already met, all of our GDUFA commitments. In addition to increased approvals and tentative approvals, FDA improved communications processes toalert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals.

在 FDA 其它办公室的协助下，OGD 正在符合或已经符合我们 GDUFA 所有的承诺。在增加批准和预批准数量外，FDA 还改进与企业的沟通流程，来提醒企业他们申请中的缺陷，这减少了审评周期，使药物更快获得批准。

We also are making a significant effort to spur generic drug development. For example, GDUFA Regulatory Science priorities contribute valuable research to generic drug development. Our efforts are geared to helping the generic drugindustry develop validated scientific methods for demonstrating bioequivalenceand assuring therapeutic equivalence to the brand-name counterpart. We are translating the results of these scientific efforts into generic drug product development via recommendations for specific drug products,which assist the generic drug industry during product development.

我们也正在努力来激励仿制药的发展。例如，GDUFA 监管科学为仿制药发展优先提供有价值的研究。我们致力于帮助仿制药企业去开发经过验证的科学方法，以用于证明仿制药与原研药的“生物等效”进而保证“治疗等效”。我们通过为某些特定的产品提供规范的建议，将这些前人的科学成果应用到仿制药的开发，这可以在产品开发中促进仿制药发展。

These are just a few of the exciting developments for 2016. Our annual report tellsthe rest of the story.

这些只是 2016 年令人兴奋进展中的一小部分，我们的年度报告讲述了其余的故事。

Despite these developments in 2016, a lot remains to be done as we approach the end of our first-ever five-year GDUFA program. We look forward to working with industry, the research community, physicians, lawmakers, andother stakeholders to help American consumers and advance use of generic drugsin our nation’s health care system.

尽管在 2016 年有这些进展，但在 GDUFA 计划接近第一个五年结束时，我们仍有许多工作要做。我们期待与工业、研究团体、医生、立法者和其他利益相关者一起，帮助美国的消费者和促进仿制药在国家医疗保健体系中的使用。

Kathleen “Cook” Uhl, M.D.

FDA’s Director, OGD，CDER

相关名词解释：

CDER：Center for Drug Evaluation and Researchgenerated，FDA 药品审评与研究中心。

OGD：Office of Generic Drugs ，FDA 仿制药办公室。

GDUFA：Generic DrugUser Fee Amendments《仿制药使用者付费修正案》。

Tentative approvals：预批准，是指从科学角度做好批准准备的仿制药申请，但由于原研药的专利或专营期而无法完全批准。