美国**“停摆”对FDA的影响

时间：2021-08-25

**还在"停摆"，Gottlieb澄清了FDA的活动
随着美国**部分关闭一直持续到*13天，美国食品和药物管理局（FDA）正在澄清它的资金已经失效时可以开展哪些业务。

部分关闭始于2018年12月22日，因为唐纳德**拒绝签署一项权宜之计的法案，以便在整个假期期间保持**开放，并在2019年初为南部边境的边界墙提供资金。

从那以后，双方都没有接近达成妥协以终止关闭并为**提供资金，大约四分之一的**受到影响，大约80万联邦工作人员要么被解雇，要么无偿工作。

在周三的新闻发布会上，*继续要求为边境安全提供56亿美元的资金，作为签署资金法案的一个条件，并称关闭可能持续“很长时间”。

星期四，南希佩洛西（D-CA）接任众议院议长，并表示众议院民主党人将*通过立法终止关闭，尽管参议院准备拒绝任何没有*支持的立法。

对FDA的影响

由于资金失效，FDA表示它仍然可以维持基本的公共卫生相关业务，并继续为处方药和仿制药，生物仿制药，医疗器械，动物药和**产品开展用户费用资助活动。

“在失效期间，该机构将在法律允许的范围内继续开展至关重要的活动，这对于确保美国的公共健康和安全至关重要，”FDA说。

但是，FDA只能使用结转用户费余额执行用户费用资助的活动，并且无法接受在当前财政年度评估的新用户费用，直到新的拨款或持续决议通过为止。

“许多人质疑FDA是否可以在关机期间接受新的医疗产品申请。在关闭期间，FDA无法收取2019财年的用户费用，这意味着我们无法接受用户费用计划下的产品新申请，”FDA专员Scott Gottlieb周五发推文。

“对于原计划在年初提交申请的药品和设备制造商而言，关闭可能会导致FDA决策延迟。”

星期三晚上，Gottlieb再次访问Twitter，进一步澄清该机构在关机期间能够开展的活动。

Gottlieb周三补充说，FDA仍然可以使用结转资金与赞助商进行预先批准讨论并接受不需要费用的提交，例如研究性新药（IND）申请和新药申请（NDAs）和生物制剂许可申请的补充（BLA）有资格获得免费费用。

此外，Gottlieb表示，在关闭期间提交的任何非紧急IND的30天审查时间将不会开始，直到资金措施颁布。

Gottlieb表示，该机构将继续推进某些领域的政策工作，例如制定指导，但他指出，资金流失将阻止该机构开展其他指导工作。

Gottlieb澄清说，FDA将能够使用结转使用费处理某些仿制药的提交，例如变更生效（CBE）和事先批准补充，修订，年度和正电子发射断层扫描（PET）药物的申请。他还表示，该机构可以接受药物主文件（DMFs）在仿制药申请中被引用，但如果用户费用，该机构将无法对II型活性药物成分（API）DMF进行初步完整性评估尚未支付。

药物评估和研究中心（CDER）和生物制品评估与研究中心（CBER）也将在停工期间停止执行某些非用户费用资助的活动。这些活动包括非处方（OTC）专题活动和全血的非紧急工作，输血的血液成分，过敏原提取物和人体细胞，组织以及单独监管的细胞和组织产品（HCT / Ps）根据“公共卫生服务法”*361条。

FDA还将能够继续开展其他法规结转余额的活动，例如2016年的“21世纪缓解法”和较近颁布的“患者和社区支持法案”。

Government Shutdown Continues as Gottlieb Clarifies FDA's ActivitiesAs 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," FDAsays.

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.

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