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Declaration of Public Health Emergency Clears Path for FDA Emergency Use Authorization for Rapid Diagnostic

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On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization declared the outbreak a public health emergency of international concern (PHEIC). On January 31, 2020, Health and Human Services Secretary Alex M. Azar II declared a public health emergency (PHE) for the United States to aid the nation’s healthcare community in responding to 2019-nCoV. Also on January 31, the President of the United States signed a presidential Proclamation on Suspension of Entry as Immigrants and Nonimmigrants of Persons who Pose a Risk of Transmitting 2019 Novel Coronavirus. These measures were announced at a press briefing by members of the President’s Coronavirus Task Force.

Currently, confirmation of 2019-nCoV infection is performed at CDC using the CDC real-time RT-PCR assay for 2019-nCoV on respiratory specimens (which can include nasopharyngeal or oropharyngeal aspirates or washes, nasopharyngeal or oropharyngeal swabs, broncheoalveolar lavage, tracheal aspirates, or sputum) and serum. Information on specimen collection, handling, and storage is available at: Real-Time RT-PCR Panel for Detection 2019-Novel Coronavirus. After initial confirmation of 2019-nCoV infection, additional testing of clinical specimens can help inform clinical management, including discharge planning.

The PHE may enable the CDC Director to access the Infectious Diseases Rapid Response Reserve Fund (when funds are so appropriated) or apply for an Emergency Use Authorization for medical countermeasures needed for the public health response, for example, a new test kit to detect a novel virus.

“Today’s announcement is an important step and makes available critical resources to enhance our public health response. It allows the U.S. Food and Drug Administration to provide an Emergency Use Authorization (EUA) to the Centers for Disease Control and Prevention so that test kits can be produced and rapidly distributed to public health laboratories,” notes Scott Becker, Executive Director of the Association of Public Health Laboratories.

FDA may issue an EUA for an unapproved drug, biological product, or device; or for an unapproved use of a drug, biological product or device following a Declaration by the Secretary of Health and Human Services that the circumstances justify such authorization based on one of the following:

  • A determination by the Secretary of Homeland Security that there is an actual or significant potential for a domestic emergency involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent(s);
  • A determination by the Secretary of Homeland Security of a material threat of a chemical, biological, radiological or nuclear agent sufficient to affect national security or the health and security of United States citizens living abroad;
  •  A determination by the Secretary  of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States  military forces, including personnel operating under the authority of title 10 or title 50, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States  military forces; or
  • A determination by the Health and Human Services Secretary that there is a public health emergency or a significant potential for a public health emergency that affects, or has significant potential to affect, national security or the health and security of U.S. citizens living abroad and involves a biological, chemical, radiological, or nuclear agent(s) or disease or condition that may be attributable to such agent(s).

Public health laboratories across the country are increasing their readiness by reviewing pandemic preparedness plans, ensuring that necessary equipment and supplies are on hand; scheduling staff to ensure that there is adequate coverage for not only 2019-nCoV but also influenza; coordinating with epidemiologists and clinical labs on rule out testing, specimen referral and results reporting; and in other important ways, noted Becker.

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