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
SILVER SPRING, Md., July 10, 2018
SILVER SPRING, Md., July 10, 2018 /PRNewswire-USNewswire/ -- Today, the U.S Food and Drug Administration announced that an emergency use authorization (EUA) has been granted to the U.S. Department of Defense (DoD) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma manufactured by the Centre de Transfusion Sanguine des Armées (referred to in the EUA as French FDP).
"Earlier this year, we reaffirmed our commitment to the Department of Defense (DoD) and to the dedicated men and women protecting our country, by expediting 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 in a potential battlefield setting," said FDA Commissioner Scott Gottlieb, M.D. "Through our collaborative program with the DoD, they've made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma. Granting this authorization will support access to this important product in the event it's needed. 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."
Under this EUA, the use of French FDP is authorized for the treatment of hemorrhage or coagulopathy of U.S. Military personnel during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical. Hemorrhage, sometimes accompanied by coagulopathy (a condition that affects the blood's ability to clot), is the leading cause of preventable deaths among combat trauma casualties. Plasma contains proteins that help clot blood and can be used for the management of hemorrhage 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 thawing period. This French FDP is a powdered freeze-dried product that can be used following reconstitution in settings where refrigeration is not available, thus enabling the rapid availability of plasma for use at the point of injury.
The FDA issued this EUA in response to a request from DoD and after receiving the required determination by DoD and a declaration by the Secretary of the Department of Health and Human Services. This action is the result of the close collaboration between the FDA and the DoD to prioritize the efficient development of safe and effective medical products intended to help save the lives of American military personnel.
The FDA outlined its approach to advancing the development and availability of medical products to help save the lives of American military personnel in a work plan the agency developed in close collaboration with DoD earlier this year. The FDA remains committed to working to address the medical needs of military personnel. Among other steps, the FDA is providing its highest level of attention to helping expedite the development and review of medical products that are a priority for DoD, to aid in the rapid development and manufacturing of safe and effective medical products for use by the U.S. military.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration