FDA Approves Freeze-Dried Plasma in Combat

The U.S. Food and Drug Administration (FDA) has approved the use of freeze-dried plasma for use by the U.S military. This emergency authorization, requested by the U.S. Department of Defense (DoD) and members of Congress, does not cover the use of freeze-dried plasma in other clinical situations, which has not been approved by the FDA.

Plasma transfusions are used to help patients forming clots and reduce bleeding, but the plasma itself typically needs to be refrigerated or frozen prior to its use. The freeze-drying process eliminates the need for refrigeration or thawing, allowing it to be deployed rapidly and remotely.

House of Representatives Armed Services Committee Chairman Mac Thornberry (R-TX) had attempted to pass a law allowing the DoD, rather than the FDA, to make the final decision on military access to freeze-dried plasma, but the agency’s decision renders that effort moot.

FDA Commissioner Scott Gottlieb, MD, emphasized the effect that the decision could have on the treatment of battlefield trauma. “Granting this authorization will support access to this important product in the event it’s needed,” he said in a statement. “The FDA remains deeply committed to implementing an enduring pathway to ensure that these potentially life-saving medical products are made available in the most expeditious, safe, and effective manner possible.”

Source: Politico, July 10, 2018; U.S. FDA news release, July 10, 2018.