【奥译言】美国政府“停摆”对FDA的影响

2019-03-21 11:59 阅读数：4124 标签：

下载 (1).jpg

随着美国政府部分停摆状态进入第13天，美国食品药品监督管理局（FDA）开始对外澄清其资金中断期间可以开展哪些业务活动。

美国政府部分停摆始于2018年12月22日。此前，美国总统唐纳德•特朗普拒绝签署一项可以保证政府在假期和2019年初期间继续开放的临时拨款法案，而特朗普拒绝签署这一法案是为了给美国南部边境的边界墙提供资金。

自此，双方并没有就结束停摆和为政府提供资金达成一致，大约四分之一的政府运营受到影响，约80万联邦政府雇员要么被迫停薪放假，要么继续无偿工作。

在周三（2019年1月2日）举行的新闻发布会上，作为签署拨款法案的一项条件，特朗普敦促国会为边境安全提供56亿美元的经费，并表示停摆可能会持续“很长一段时间”。

1月3日，南希•佩洛西（D-CA）接任众议院议长，她表示众议院民主党将迅速通过立法终止政府停摆，然而参议院已经准备对未获得特朗普支持的任何立法予以否决。

▍对FDA的影响

随着资金的中断，FDA表示，其机构仍然可以维持基本的公共卫生相关业务，并继续开展处方药和仿制药、生物仿制药、医疗器械、动物用药和烟草产品方面的用户付费活动。

“在资金中断这段时间内，FDA将继续在法律允许范围内开展重要活动，这些活动对于确保美国公共卫生和安全至关重要，”FDA表示。

然而，FDA只能使用结转的用户费用余额来执行用户付费活动，并且在新的拨款行为或持续决议获得通过之前，不会收取经本财年评估的新用户费用。

FDA局长Scott Gottlieb上周五在推特上发文说：“许多人询问FDA是否在停摆期间受理新的医疗产品申请。停摆期间，FDA不得收取2019财年的用户费用，这意味着我们无法受理用户费用计划下的新产品申请。”

“对于计划在年初提交申请的药品和器械制造商来说，政府停摆可能导致FDA延迟作出决定。”

周三晚上，Gottlieb在推特上再次发文，进一步澄清了停摆期间FDA能够开展哪些活动。

Gottlieb周三补充道，FDA仍然能够利用结转资金与申请人进行批准前讨论，并受理无需付费的递交申请，如新药研究、新药申请发补及生物制品许可申请，这些申请符合费用豁免的条件。

此外，Gottlieb还表示，对于停摆期间提交的任何非紧急用新药研究，在拨款法案颁布之前，将不会开始为期30天的审查。

Gottlieb表示，FDA将继续推进某些领域的政策工作（如制定指南），但他指出，资金中断将导致FDA无法开展其他指导工作。

Gottlieb澄清说，FDA将能够利用结转的用户费用处理某些非专利药物的申请，例如“已生效变更（CBE）”和批准前补充、修正、年度报告以及正电子发射断层造影（PET）药物的申请。他还表示，FDA可以受理仿制药申请中引用的药物主文件，但如果用户费用尚未支付，FDA将无法对II类药物活性成分（API）的药物主文件进行首次完整性评估。

停摆期间，FDA药品评估与研究中心（CDER）和生物制品评估与研究中心（CBER）也将停止执行某些非用户付费的活动，包括非处方专论活动，以及涉及仅受《公共卫生服务法》第361条监管的全血、输血用血液成分、变态反应原浸出物和人体细胞、组织以及基于细胞和组织的产品（HCT/P）的非紧急工作。

此外，FDA还会继续开展由结转其他立法费用余额资助的活动，如2016年通过的《21世纪治愈法案》和最近颁布的《支持患者和社区法案》。

编者注：本文已更新，交代了美国政府停摆期间FDA活动的其他详细信息。

英文原文

Government Shutdown Continues as Gottlieb Clarifies FDA's Activities

As the partial US government shutdown continues into its thirteenth day, the US Food and Drug Administration (FDA) is clarifying what operations it can carry out while its funding has lapsed.

The partial shutdown began on 22 December 2018 after President Donald Trump refused to sign a stopgap funding bill to keep the government open through the holidays and into early 2019 over funding for a border wall along the southern border.

Since then, neither side has come close to a compromise to end the shutdown and fund the government, leaving roughly a quarter of the government impacted and some 800,000 federal workers either furloughed or working without pay.

During a press conference on Wednesday Trump continued to press for $5.6 billion in funding for border security as a condition for signing a funding bill and said that the shutdown could last "a long time."

On Thursday, Nancy Pelosi (D-CA) took over as Speaker of the House and has said that House Democrats will quickly pass legislation to end the shutdown, though the Senate is poised to reject any legislation that does not have Trump's support.

▍Impact on FDA

With its funding lapsed, FDA says it can still maintain essential public health-related operations as well as continue to perform user fee funded activities for prescription and generic drugs, biosimilars, medical devices, animal drugs and tobacco products.

"During the lapse period, the agency will be continuing vital activities, to the extent permitted by law, that are crucial to ensuring public health and safety in the United States," FDA says.

However, FDA is only able to perform user fee-funded activities using carry over user fee balances and is unable to accept new user fees assessed in the current fiscal year until new appropriations or a Continuing Resolution is passed.

"Many asked if FDA can accept new medical product applications during the shutdown. The FDA can't collect FY2019 user fee payments during the shutdown, which means we can't accept new applications for products under user fee programs," FDA Commissioner Scott Gottlieb tweeted on Friday.

"For drug and device makers that had planned to submit applications at the start of the year, the shutdown could lead to delays in FDA decision-making."

On Wednesday evening, Gottlieb took to Twitter again to further clarify what activities the agency is able to carry out during the shutdown.

Gottlieb added Wednesday that FDA is still able use carry over funding to hold preapproval discussions with sponsors and accept submissions for which no fee is required such as investigational new drug (IND) applications and supplements to new drug applications (NDAs) and biologics license applications (BLAs) that qualify for fee exemptions.

Additionally, Gottlieb said that 30-day review clock for any non-emergency IND submitted during the shutdown will not begin until a funding measure is enacted.

Gottlieb said that the agency will continue advancing policy work in certain areas, such as developing guidance, though he noted that the funding lapse will prevent the agency from working on other guidances.

Gottlieb clarified that FDA will be able to process certain submissions for generic drugs using carry over user fees, such as changes being effected (CBE) and prior approval supplements, amendments, annual reports and applications for positron emission tomography (PET) drugs. He also said that the agency can accept drug master files (DMFs) to be referenced in generic drug applications, but that the agency won't be able to conduct initial completeness assessments on Type II active pharmaceutical ingredient (API) DMFs if the user fee has not been paid.

Both the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) will also stop performing certain non-user fee funded activities during the shutdown. These include work on over-the-counter (OTC) monograph activities and non-emergency work on whole blood, blood components for transfusion, allergenic extracts and human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated solely under Section 361 of the Public Health Service Act.

FDA will also be able to continue activities with carry over balances from other legislation, such as the 21st Century Cures Act of 2016 and the recently enacted Support for Patients and Communities Act.

Editor's note: This article has been updated to reflect additional details on FDA activities during the shutdown.

内容来自：RAPS

整理翻译：奥咨达

奥咨达翻译服务

奥咨达翻译团队根植于中国，面向全球，专注为医疗器械领域的企业提供专业、高效的翻译解决方案。翻译领域包括医疗器械的研发、注册、临床、上市后监督、营销、管理、培训等，译稿已涵盖医疗器械领域的所有类型。

奥咨达翻译组联系方式：

邮箱：trans@osmundacn.com