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).
FDA may then issue an EUA for a product if FDA finds that:
- the agent specified in the declaration of emergency can cause a serious or life-threatening disease or condition;
- based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the serious or life-threatening disease or condition, or a serious or life-threatening disease or condition caused by a product authorized approved, cleared, or licensed by FDA for diagnosing, treating, or preventing the disease or condition;
- the known and potential benefits of the product outweigh the known and potential risks of the product when used to diagnose, prevent, or treat the serious or life-threatening disease or condition, taking into consideration the material threat posed by the agent or agents identified in a declaration by the DHS Secretary, if applicable;
- there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such serious or life-threatening disease or condition; and
- in the case of a determination by the Secretary of Defense regarding risk to U.S. military forces from agents other than chemical, biological, radiological and nuclear agents, that the request for emergency use is made by the Secretary of Defense.
FDA will, in issuing the EUA, impose conditions on the emergency use that is authorized. For more information on the emergency use authority, please see Emergency Preparedness and Response: Emergency Use Authorization.
