FDA 仿製葯辦公室主任：2016 是仿製葯創紀錄的一年

2017 年 2 月 24 日，FDA 仿製葯辦公室主任凱瑟琳·庫克·尤爾在 FDA Voice 發文稱，2016 年 FDA2016 年批准了有史以來最多的仿製葯申請，完全批准和預批准的數量達到 800 多件, 超過 2015 年的 726 件，凱瑟琳強調取得這一成效的主要原因在於 2012 年起始實施的《仿製葯使用者付費修正案》。此外，仿製葯審批數量的增加和首仿葯審批佔比的提高，一方面反映了 FDA 過去幾年改革的進步，另一方面也提示 FDA 仿製葯計劃的未來發展方向。

來自 FDA Voice, 原文標題「2016: A Record-setting Year for Generic Drugs」

寧大衛 編譯

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.

在過去 10 年，仿製葯為美國醫療保健系統節省了大約 1.68 萬億美元。我很高興的報告，2016 年是 FDA 仿製葯計劃創紀錄的一年，這將有助於：在保證仿製葯質量的同時，為美國消費者進一步節省醫療保健的費用。並且在民眾對於藥品價格上漲的關注問題中，這是再好不過的一個時機。

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 產生了 FDA 仿製葯計劃有史以來最多的批准數量，包括完全批准和預批准，合計有超過 800 件仿製葯獲得批准。數量超過了 2015 年 726 件的批准記錄，且這些批准中許多是「首仿葯」，這意味著之前沒有仿製葯的原研葯開始引入仿製產品。這是降低藥品價格代表性的第一步，因為原研葯的多種仿製葯將驅動價格競爭並帶來更加實惠的藥品。

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 創紀錄的業績有一個重要因素，是 2012 年的《仿製葯使用者付費修正案》（GDUFA）。GDUFA 是一個與仿製藥行業協商的具有里程碑意義的立法，在 FDA 徹底改造了仿製葯計劃。其中，GDUFA 授權 FDA 資金來招聘更多審評人員、使仿製葯審評現代化、擴大設施檢查能力、推進仿製葯申請審評的 IT 基礎建設、以及執行其它監管行動。這是美國國會首次授權「使用者付費計劃」給仿製葯。GDUFA 是一個為期五年的計劃，將於 2017 年 10 月 1 日更新。GDUFA 的第一個五年實行期已經挑戰 OGD，需要在保持和提高審評質量的同時達到各種目標。

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 其它辦公室的協助下，OGD 正在符合或已經符合我們 GDUFA 所有的承諾。在增加批准和預批准數量外，FDA 還改進與企業的溝通流程，來提醒企業他們申請中的缺陷，這減少了審評周期，使藥物更快獲得批准。

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.

我們也正在努力來激勵仿製葯的發展。例如，GDUFA 監管科學為仿製葯發展優先提供有價值的研究。我們致力於幫助仿製葯企業去開發經過驗證的科學方法，以用於證明仿製葯與原研葯的「生物等效」進而保證「治療等效」。我們通過為某些特定的產品提供規範的建議，將這些前人的科學成果應用到仿製葯的開發，這可以在產品開發中促進仿製葯發展。

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

這些只是 2016 年令人興奮進展中的一小部分，我們的年度報告講述了其餘的故事。

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.

儘管在 2016 年有這些進展，但在 GDUFA 計劃接近第一個五年結束時，我們仍有許多工作要做。我們期待與工業、研究團體、醫生、立法者和其他利益相關者一起，幫助美國的消費者和促進仿製葯在國家醫療保健體系中的使用。

Kathleen 「Cook」 Uhl, M.D.

FDA』s Director, OGD，CDER

相關名詞解釋：

CDER：Center for Drug Evaluation and Researchgenerated，FDA 藥品審評與研究中心。

OGD：Office of Generic Drugs ，FDA 仿製葯辦公室。

GDUFA：Generic DrugUser Fee Amendments《仿製葯使用者付費修正案》。

Tentative approvals：預批准，是指從科學角度做好批准準備的仿製葯申請，但由於原研葯的專利或專營期而無法完全批准。