FDA: Freeze-Dried Plasma Product Approved for Medical Emergencies in Combat
Despite its useful medical properties, plasma use in combat settings can be challenging.
The US Food and Drug Administration (FDA) has granted emergency use authorization to the US Department of Defense (DoD), allowing for emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (French FDP) for treatment of hemorrhage or coagulopathy in military personnel during medical emergencies.
French FDP is manufactured by the Centre de Transfusion Sanguine des Armées. The emergency use authorization specifically applies to medical emergencies involving “agents of military combat,” defined as firearms, projectiles, or explosive devices, when plasma is either unavailable or not practical to use.
“Earlier this year, we reaffirmed our commitment to the Department of Defense…by expediting the development and availability of safe and effective priority medical products that are essential to the health of our medical service members,” said FDA Commissioner Scott Gottlieb, MD.
Despite its useful medical properties, plasma use in combat settings can be challenging, limited by the need for refrigeration or long thawing period. French FDP is a freeze-dried product that can be used “following reconstitution in settings where refrigeration is not available.”
The emergency use authorization was issued in response to a DoD request, and resulted from collaboration between the FDA and DoD to prioritize the development of medical products for military settings.
FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product [news release]. Silver Springs, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612893.htm. Published July 10, 2018. Accessed July 10, 2018.