食品和药物管理局采取重大措施抗击冠状病毒，为在应对这次疫情的过程中实现2019新型冠状病毒诊断的第一个重大进展发布紧急使用授权
 
美国食品和药物管理局（U.S. Food & Drug Administration）
华盛顿哥伦比亚特区（Washington, D.C.）
2020年2月4日
 
今天，美国食品和药物管理局发布紧急使用授权(EUA)，疾病控制与预防中心（Centers for Disease Control and Prevention）可紧急使用2019-冠状病毒逆转录聚合酶链式反应即时诊断试剂（2019-nCoV Real-Time RT-PCR Diagnostic Panel）。目前这项检测方法仅限于在疾病控制与预防中心各实验室使用；今天的授权允许在国内各地符合疾病控制与预防中心要求的实验室使用。
 
食品和药物管理局局长，医学博士史蒂芬•哈恩（Stephen M. Hahn）说，“自疫情第一次爆发以来，我们始终与美国政府内和全球的伙伴密切合作，努力加速关键医疗产品的研制和供应，为尽可能快地结束疫情贡献力量。目前的局势仍在不断变化。向合格的实验室提供这种诊断试剂的能力是为保护公众健康迈出的重要一步。我们与疾病控制与预防中心的合作对于迅速研制这类诊断试剂并为人们获得试剂提供便利至关重要。食品和药物管理局仍积极要求通过我们的监管工具并利用我们的技术和科学专长，促进关键医疗产品的问世，尽可能以最迅捷、安全和有效的方式抗击疫情。”
 
2019年12月在中国武汉发现的2019-nCoV属于一种新型的冠状病毒，可导致人体出现严重呼吸系统疾病。大多数确诊感染2019-nCoV的患者出现发烧和/或急性呼吸系统疾病的症状（例如咳嗽、呼吸困难等）。但是对于与感染2019-nCoV有关的全部临床表征，目前获得的信息仍很有限。截至目前为止，在中国以外地区上报的2019-nCoV感染病例大多数都与在中国武汉居住或前往该地旅行有关。当前，联邦卫生官员仍然认为，美国公众受这种病毒威胁的程度相对不高。
 
根据这项紧急使用授权， 2019-nCoV逆转录聚合酶链式反应即时诊断试剂可以用于符合疾病控制与预防中心关于2019-nCoV检测条件的患者。检测限于疾病控制与预防中心指定的合格实验室，在美国指获得高复杂性检测认证的实验室。这项检测采用逆转录聚合酶链式反应诊断试剂，可通过棉签刮取鼻腔或口腔等呼吸道分泌物获得2019-nCoV的推定性检测结果。检测结果为阳性提示有可能感染2019-nCoV，受感染的患者应配合医疗护理人员对症状进行处理并决定如何对患者周围的人员提供最好的保护。检测结果为阴性并不排除感染2019-nCoV的可能，不可以此为治疗或对其他患者进行管理的唯一依据。检测为阴性的结果必须结合临床观察、病史和流行病学信息一并考虑。
 
一旦卫生与公众卫生服务部长（Secretary of Health and Human Services）认定已发生公共卫生紧急事件或存在发生公共卫生紧急事件的重大危险，从而可能严重影响国家安全或美国公民的健康和安全，并宣布根据现有情况有理由批准紧急使用该医疗产品，则食品和药物管理局可依据某些医疗产品可能有效诊断、治疗或防止有关疾病或病状的科学数据，发布紧急使用授权。
 
1月31日，卫生与公众服务部长亚历克斯·阿扎尔（Alex Azar）宣布发生公共卫生紧急事件，认定2019-nCoV具有潜在的威胁，并重申本届政府坚决采取一切可动用的资源协助预防、缓解和应对这个威胁。考虑到目前食品和药物管理局尚未确认或批准任何检测2019-nCoV的商用诊断试剂，谨此认定紧急使用授权对于保证人们及时获得诊断具有关键意义。为此今天卫生与公众服务部长有必要决定和宣布给予紧急使用授权，并由食品和药物管理局应疾病控制与预防中心的要求，发布紧急使用授权的公告。这项行动是食品和药物管理局、疾病控制与与预防中心及联邦医疗保险和医疗补助服务中心（Centers for Medicare and Medicaid Services）密切合作的结果。联邦医疗保险和医疗补助服务中心负责管理美国各实验室，为抗击新型冠状病毒等新出现的传染病疫情，重点安排关键医疗产品的有效研制和采行。
 
1月27日，食品和药物管理局介绍了为抗击这次疫情采取一切适当的监管授权并努力加速预防、诊断和治疗2019-nCoV的关键医疗产品的研制和上市采取的策略。该机构一贯坚持与研制人员、国际伙伴和美国政府共同支持目前为公共卫生采取的对应措施。食品和药物管理局坚持与其他2019-nCoV诊断试剂的研制人员共同加快研制项目的进度和紧急使用授权的申请程序。实际上已有几个项目为抗击这次疫情申请并获得紧急使用授权的模板。食品和药物管理局正在采取的各项措施之一是，对于有助于加快为诊断、治疗和预防疫情扩散正在研制的各类医疗产品的研制和审查给予最高程度的重视。
 
食品和药物管理局作为美国卫生与公众服务部下属机构，负保护公众健康，保障用于人体和动物的药物、疫苗和其他用于人体的生物产品及医疗设备的可靠性、有效性和安全性。该机构还负责保障我国食品供应、化妆品、营养补充剂、电子辐射产品的可靠性和安全性，并对烟草产品实施监管。

FDA Takes Significant Step in COVID-19 Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel COVID-19 Diagnostic
Critical Milestone Reached in Response to this Outbreak
For Immediate Release: February 04, 2020
Today, the U.S Food and Drug Administration issued an emergency use authorization (EUA) to enable emergency use of the Centers for Disease Control and Prevention’s (CDC) COVID-19 Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.
“Since this outbreak first emerged, we’ve been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible. This continues to be an evolving situation and the ability to distribute this diagnostic test to qualified labs is a critical step forward in protecting the public health,” said FDA Commissioner Stephen M. Hahn, M.D. “Our collaboration with the CDC has been vital to rapidly developing and facilitating access to this diagnostic test. The FDA remains deeply committed to utilizing our regulatory tools and leveraging our technical and scientific expertise to advance the availability of critical medical products to respond to this outbreak in the most expeditious, safe and effective manner possible.”
The COVID-19, identified in Wuhan, China in December 2019, is a new type of coronavirus that can cause severe respiratory illness in humans. Most patients with confirmed COVID-19 infection have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). However, limited information is currently available to characterize the full spectrum of clinical illness associated with COVID-19 infection. To date most reported cases of COVID-19 infection outside of China have been linked to residence in or travel to Wuhan, China. At this time, federal health officials continue to believe that the threat to the general American population from this virus is relatively low.
Under this EUA, the use of COVID-19 Real-Time RT-PCR Diagnostic Panel is authorized for patients who meet the CDC criteria for COVID-19 testing. Testing is limited to qualified laboratories designated by the CDC and, in the U.S., those certified to perform high complexity tests. The diagnostic is a reverse transcriptase polymerase chain reaction (PCR) test that provides presumptive detection of COVID-19 from respiratory secretions, such as nasal or oral swabs. A positive test result indicates likely infection with COVID-19 and infected patients should work with their health care provider to manage their symptoms and determine how to best protect the people around them. Negative results do not preclude COVID-19 infection and should not be used as the sole basis for treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history and epidemiological information.
The FDA can issue an EUA to permit the use, based on scientific data, of certain medical products that may be effective in diagnosing, treating or preventing such disease or condition when there is a determination, by the Secretary of Health and Human Services (HHS), that there is a public health emergency or a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens, and a declaration that circumstances exist justifying the medical products’ emergency use.
On Jan. 31, HHS Secretary Alex Azar declared a public health emergency recognizing the potential threat that COVID-19 poses and reiterating the government’s dedication to leveraging all available resources to help prevent, mitigate and respond to this threat. As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of COVID-19 it was determined that an EUA is crucial to ensure timely access to diagnostics. The HHS Secretary accordingly today made the necessary EUA determination and declaration and the FDA issued this EUA in response to a request from the CDC. This action is the result of the close collaboration between the FDA, the CDC and the Centers for Medicare and Medicaid Services, which provides oversight for U.S. laboratories, to prioritize the efficient development and implementation of critical medical products in response to emerging infectious disease outbreaks, such as COVID-19.
The FDA outlined its approach to expediting the development and availability of critical medical products to prevent, diagnose and treat COVID-19 using all applicable regulatory authorities to respond to this outbreak on Jan. 27. The agency remains committed to working with developers, international partners and the U.S. government to help support this public health response. The FDA is dedicated to actively working with other COVID-19 diagnostic developers to help accelerate development programs and requests for EUAs, in fact several have already requested and received the EUA template for this outbreak. The FDA, among other steps, is providing its highest level of attention to helping expedite the development and review of a variety of medical products being developed to diagnose, treat and prevent the spread of this outbreak.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.