Under an emergency-use authorization, the FDA approved the use of freeze-dried plasma by the U.S. military. The authorization, requested by the U.S. Department of Defense and members of Congress, covers only the use of these plasma products for U.S. military service members during combat – not other clinical situations.
Plasma transfusions are used to treat hemorrhage and coagulopathy, which represent serious mortality threats in combative trauma situations. However, because the plasma itself typically needs to be refrigerated or frozen prior to its use, transfusions are often unavailable and impractical. The freeze-drying process eliminates the need for refrigeration or thawing, allowing plasma to be deployed rapidly and remotely.
In a press release announcing the decision, FDA Commissioner Scott Gottlieb, MD, said that the agency is committed to expediting both the production and availability of priority medical products for the care of the U.S. military. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting,” he noted. “Through our collaborative program with the Department of Defense, they’ve made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma.”
Sources: FDA news release, July 10, 2018; Medscape, July 10, 2018.