美國(guó)**“停擺”對(duì)FDA的影響

時(shí)間：2021-08-25作者：深圳市華商技術(shù)有限公司瀏覽：14

**還在"停擺"，Gottlieb澄清了FDA的活動(dòng)
隨著美國(guó)**部分關(guān)閉一直持續(xù)到*13天，美國(guó)食品和藥物管理局（FDA）正在澄清它的資金已經(jīng)失效時(shí)可以開(kāi)展哪些業(yè)務(wù)。

部分關(guān)閉始于2018年12月22日，因?yàn)樘萍{德**拒絕簽署一項(xiàng)權(quán)宜之計(jì)的法案，以便在整個(gè)假期期間保持**開(kāi)放，并在2019年初為南部邊境的邊界墻提供資金。

從那以后，雙方都沒(méi)有接近達(dá)成妥協(xié)以終止關(guān)閉并為**提供資金，大約四分之一的**受到影響，大約80萬(wàn)聯(lián)邦工作人員要么被解雇，要么無(wú)償工作。

在周三的新聞發(fā)布會(huì)上，*繼續(xù)要求為邊境安全提供56億美元的資金，作為簽署資金法案的一個(gè)條件，并稱關(guān)閉可能持續(xù)“很長(zhǎng)時(shí)間”。

星期四，南希佩洛西（D-CA）接任眾議院議長(zhǎng)，并表示眾議院民主黨人將*通過(guò)立法終止關(guān)閉，盡管參議院準(zhǔn)備拒絕任何沒(méi)有*支持的立法。

對(duì)FDA的影響

由于資金失效，F(xiàn)DA表示它仍然可以維持基本的公共衛(wèi)生相關(guān)業(yè)務(wù)，并繼續(xù)為處方藥和仿制藥，生物仿制藥，醫(yī)療器械，動(dòng)物藥和**產(chǎn)品開(kāi)展用戶費(fèi)用資助活動(dòng)。

“在失效期間，該機(jī)構(gòu)將在法律允許的范圍內(nèi)繼續(xù)開(kāi)展至關(guān)重要的活動(dòng)，這對(duì)于確保美國(guó)的公共健康和安全至關(guān)重要，”FDA說(shuō)。

但是，F(xiàn)DA只能使用結(jié)轉(zhuǎn)用戶費(fèi)余額執(zhí)行用戶費(fèi)用資助的活動(dòng)，并且無(wú)法接受在當(dāng)前財(cái)政年度評(píng)估的新用戶費(fèi)用，直到新的撥款或持續(xù)決議通過(guò)為止。

“許多人質(zhì)疑FDA是否可以在關(guān)機(jī)期間接受新的醫(yī)療產(chǎn)品申請(qǐng)。在關(guān)閉期間，F(xiàn)DA無(wú)法收取2019財(cái)年的用戶費(fèi)用，這意味著我們無(wú)法接受用戶費(fèi)用計(jì)劃下的產(chǎn)品新申請(qǐng)，”FDA專員Scott Gottlieb周五發(fā)推文。

“對(duì)于原計(jì)劃在年初提交申請(qǐng)的藥品和設(shè)備制造商而言，關(guān)閉可能會(huì)導(dǎo)致FDA決策延遲?！?br>
星期三晚上，Gottlieb再次訪問(wèn)Twitter，進(jìn)一步澄清該機(jī)構(gòu)在關(guān)機(jī)期間能夠開(kāi)展的活動(dòng)。

Gottlieb周三補(bǔ)充說(shuō)，F(xiàn)DA仍然可以使用結(jié)轉(zhuǎn)資金與贊助商進(jìn)行預(yù)先批準(zhǔn)討論并接受不需要費(fèi)用的提交，例如研究性新藥（IND）申請(qǐng)和新藥申請(qǐng)（NDAs）和生物制劑許可申請(qǐng)的補(bǔ)充（BLA）有資格獲得免費(fèi)費(fèi)用。

此外，Gottlieb表示，在關(guān)閉期間提交的任何非緊急IND的30天審查時(shí)間將不會(huì)開(kāi)始，直到資金措施頒布。

Gottlieb表示，該機(jī)構(gòu)將繼續(xù)推進(jìn)某些領(lǐng)域的政策工作，例如制定指導(dǎo)，但他指出，資金流失將阻止該機(jī)構(gòu)開(kāi)展其他指導(dǎo)工作。

Gottlieb澄清說(shuō)，F(xiàn)DA將能夠使用結(jié)轉(zhuǎn)使用費(fèi)處理某些仿制藥的提交，例如變更生效（CBE）和事先批準(zhǔn)補(bǔ)充，修訂，年度和正電子**斷層掃描（PET）藥物的申請(qǐng)。他還表示，該機(jī)構(gòu)可以接受藥物主文件（DMFs）在仿制藥申請(qǐng)中被引用，但如果用戶費(fèi)用，該機(jī)構(gòu)將無(wú)法對(duì)II型活性藥物成分（API）DMF進(jìn)行初步完整性評(píng)估尚未支付。

藥物評(píng)估和研究中心（CDER）和生物制品評(píng)估與研究中心（CBER）也將在停工期間停止執(zhí)行某些非用戶費(fèi)用資助的活動(dòng)。這些活動(dòng)包括非處方（OTC）專題活動(dòng)和全血的非緊急工作，輸血的血液成分，過(guò)敏原提取物和人體細(xì)胞，組織以及單獨(dú)監(jiān)管的細(xì)胞和組織產(chǎn)品（HCT / Ps）根據(jù)“公共衛(wèi)生服務(wù)法”*361條。

FDA還將能夠繼續(xù)開(kāi)展其他法規(guī)結(jié)轉(zhuǎn)余額的活動(dòng)，例如2016年的“21世紀(jì)緩解法”和較近頒布的“患者和社區(qū)支持法案”。

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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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