Authorization of Emergency Use of a Freeze Dried Plasma Treatment for Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) for a freeze dried plasma treatment for hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical. FDA issued this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by the U.S. Department of Defense (DoD). The Authorization contains, among other things, conditions on the emergency use of the authorized treatment. The Authorization follows the June 7, 2018, determination by the Deputy Secretary of Defense that there is a military emergency or significant potential for a military emergency, involving a heightened risk to U.S. military forces of an attack with an agent or agents that may cause, or are otherwise associated with an imminently life-threatening and specific risk to those forces. The Deputy Secretary of Defense further stated that, more specifically, U.S. forces are now deployed in multiple locations where they serve at heightened risk of an enemy attack with agents of military combat, including firearms, projectiles, and explosive devices, that may cause major and imminently life-threatening combat casualties involving uncontrolled hemorrhage. On the basis of such determination, the Department of Health and Human Services (HHS) Secretary declared on July 9, 2018, that circumstances exist justifying the authorization of emergency use of freeze dried plasma for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical, subject to the terms of any authorization issued under the FD&C Act. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.