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1 [1] (August 13, 2018)

handle is hein.crs/crsmthzzbcl0001 and id is 1 raw text is: Congesoa ReerhNevc 0 August 13, 2018 Emergency Use Authorization and FDA's Related Authorities Under most circumstances, drugs, medical devices, and biologics may only be introduced into interstate commerce if they have been approved, cleared, or licensed by the Food and Drug Administration (FDA). Under certain circumstances, however, FDA may permit a medical product to be provided to patients outside the standard regulatory framework. One of these circumstances is if the Secretary of Health and Human Services (HHS) declares, pursuant to §564 of the Federal Food, Drug, and Cosmetic Act (FFDCA), that an emergency or threat exists due to a chemical, biological, radiologic, or nuclear (CBRN) agent, in which case the HHS Secretary may temporarily authorize the emergency use of an unapproved product or the unapproved use of an approved product. P.L. 115-92, signed into law on December 12, 2017, amended this authority to allow for emergency uses of medical products for threats in addition to CBRN agents, to include agents that may cause or are associated with an imminently life- threatening and specific risk to the United States military. The four-step process required to authorize the emergency use of a medical product-referred to as Emergency Use Authorization (EUA)-is shown in Figure 1 and described in the following sections. Figure I. Steps in Emergency Use Authorization 12 37 Source: Developed by CRS based on FFDCA §564. Secretar al Determinadion and Declaration FFDCA §564, established by the Project BioShield Act of 2004 (P.L. 108-276) and amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA, P.L. 113-5) and P.L. 115-92, allows the HHS Secretary to declare that the circumstances exist justifying the emergency use of certain medical products upon one of the following determinations: * A determination by the Secretary of the Department of Homeland Security (DHS) that there is an actual or significant potential for a domestic emergency involving a heightened risk of attack with one or more CBRN agents; * A determination by the Secretary of the Department of Defense (DOD) that there is an actual or significant potential for a military emergency involving a heightened risk of attack with either with one or more CBRN agents, or with one or more agents that may cause or are associated with an imminently life- threatening and specific risk to United States military forces; * A determination by the HHS Secretary that there is an actual or significant potential for a public health emergency that affects or has significant potential to affect national security or the health and security of United States citizens living abroad, and that involves one or more CBRN agents; or * The identification by the DHS Secretary of a material threat pursuant to Public Health Service Act §319F-2. The HHS Secretary may fulfill both the determination and declaration functions. Each of the secretarial determination mechanisms have been used as the basis for an EUA, and EUAs have been issued for a variety of uses and products. The emergency declaration must terminate on the earlier of (1) a determination by the HHS Secretary that the emergency no longer exists or (2) a change in the approval status of the product such that the EUA would not be necessary. Issuance of an EUA Following the HHS Secretary's declaration, the FDA Commissioner, in consultation with the Assistant Secretary for Preparedness and Response (ASPR) and the Directors of the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC), may authorize the emergency use of a specific drug, device, or biologic, by issuing an EUA, provided that certain criteria are met: * the CBRN agent that is the subject of the EUA can cause a serious of life-threatening disease or condition; * the product may be effective in diagnosing, treating, or preventing such disease or condition, based on the totality of the available scientific evidence; www.crs.gov 7-5700

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