The U.S. Food and Drug Administration said Tuesday it has granted the Pentagon an emergency authorization to use freeze-dried plasma to save U.S. troops wounded in combat.
The decision gives the military a potentially life-saving treatment when troops are in danger of bleeding out from bullet or blast wounds, and comes after a political dustup on Capitol Hill last year that threatened to hold up a must-pass defense authorization bill.
The Pentagon has been lobbying for years for permission to use the freeze-dried blood component, which was developed by the French military. But it has not cleared the lengthy U.S. regulatory process for such products.
“Through our collaborative program with the [Defense Department], they’ve made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma,” FDA Commissioner Scott Gottlieb said in a statement. “Granting this authorization will support access to this important product in the event it’s needed.”
The FDA and Pentagon began a joint program in January to fast-track the use of unapproved products that could save the lives of troops after a decadelong impasse.
Frustrated leaders on the House Armed Services Committee included language in the National Defense Authorization Act last fall that would have allowed Defense Secretary Jim Mattis to sidestep federal restrictions on the plasma, which does not require refrigeration and is manufactured by the French FDP.
Gottlieb opposed the move at the time and the dispute briefly held up the NDAA bill, but forced the Pentagon and FDA to come to an agreement.
