FDA takes action to support U.S. military personnel in granting clearance for freeze-dried plasma product to allow wider access while agency works on product approval

For immediate release:

Today, the United States Food and Drug Administration announced that an Emergency Use Authorization (EUA) has been granted to the United States Department of Defense (DoD) to allow the emergency use of plasma. Lyophilized reduction of leukocytes and pathogens manufactured by the Center de Transfusion Sanguine des Armées (called French FDP in the EUA).

“Earlier this year, we reaffirmed our commitment to the Department of Defense (DoD) and the dedicated men and women who protect our country, by accelerating the development and availability of safe and effective priority medical products that are essential to the health of our military service members. This is especially true when it comes to products used to treat injuries on a potential battlefield, “said FDA Commissioner Scott Gottlieb, MD” Through our collaborative program with the DoD, they have clearly indicated the importance of access to lyophilized plasma. in initial efforts to control bleeding from battlefield trauma. Granting this permission will provide access to this important product when needed. The FDA remains deeply committed to implementing a sustainable path to ensure that these potentially life-saving medical products are made available in the fastest, safest, and most effective ways possible. “

Under this EUA, the use of French FDP is authorized for the treatment of hemorrhage or coagulopathy of United States military personnel during an emergency involving military combatants (e.g., firearms, weapons, projectiles and explosive devices) when plasma is not available for use or when the use of plasma is impractical. Bleeding, sometimes accompanied by coagulopathy (a condition that affects the ability of blood to clot), is the leading cause of preventable death among victims of combat trauma. Plasma contains proteins that help the blood to clot and can be used for the management of bleeding and coagulopathy. But its use in combat settings is severely limited by logistical and operational challenges such as the need for refrigeration and, in the case of frozen plasma, a long thaw period. This French FDP is a lyophilized powder product that can be used after reconstitution in environments where refrigeration is not available, thus allowing rapid availability of plasma for use at the point of injury.

The FDA issued this EUA in response to a request from the DoD and after receiving the determination required by the DoD and a statement from the Secretary of the Department of Health and Human Services. This action is the result of the FDA’s close collaboration with the DoD to prioritize the effective development of safe and effective medical products intended to help save the lives of US military personnel.

The FDA outlined its approach to advancing the development and availability of medical products to help save the lives of U.S. military personnel in a work plan the agency developed in close collaboration with the DoD earlier this year. The FDA remains committed to working to meet the medical needs of military personnel. Among other steps, the FDA is paying its highest level of attention to help accelerate the development and review of medical products that are a priority for the DoD, to aid in the rapid development and manufacture of safe and effective medical products. for use by the US military. .

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.

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