FDA Issues Emergency Use Authorization for Military Use of Freeze-Dried Plasma
The use of French FDP will be authorized for the treatment of hemorrhage or coagulopathy experienced by US military personally during combat caused by firearms, projectiles, and explosive devices, when plasma is not available for use or when its use is not practical. The majority of preventable combat trauma casualty deaths are caused by these conditions, according to the agency.
Normally, plasma’s use in combat settings it restricted by the logistical and operational challenges, mainly 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,” according to the FDA.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “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.”
The issuance was in response to a request by the DoD, and after the FDA received a declaration from Alex Azar, JD, the secretary of the Department of Health and Human Services (HHS). Gottlieb announced the decision via a series of tweets.
THREAD 1/6 At the request of @DeptofDefense, FDA issued an Emergency Use Authorization (EUA) for a freeze dried plasma product (referred to as French FDP). https://t.co/Gii2ik3Up4 pic.twitter.com/0nzMlWja9O— Scott Gottlieb, M.D. (@SGottliebFDA) July 10, 2018
2/6 French FDP is a powdered freeze dried plasma product that can be used following reconstitution in settings where refrigeration is not available, enabling the rapid availability of plasma for use at the point of injury.— Scott Gottlieb, M.D. (@SGottliebFDA) July 10, 2018
3/6 French FDP is authorized to treat U.S. military personnel with severe or life-threatening hemorrhage due to traumatic injuries sustained in the conduct of military operations in situations when plasma is not available, or when its use is not practical.— Scott Gottlieb, M.D. (@SGottliebFDA) July 10, 2018
4/6 Earlier this year, we reaffirmed our commitment to DoD and the dedicated men and women protecting our country by expediting development and availability of safe, effective, priority medical products essential to health of our military service members. https://t.co/3dNqzvkbAF— Scott Gottlieb, M.D. (@SGottliebFDA) July 10, 2018
5/6 Emergency Use Authorization allows FDA to help strengthen the Nation’s public health protections by facilitating availability and use of medical countermeasures needed during public health and military emergencies https://t.co/ulBRXpI8FN (EUA process graphic attached) pic.twitter.com/rivEi3mHan— Scott Gottlieb, M.D. (@SGottliebFDA) July 10, 2018
6/6 This EUA action is the result of close collaboration between the FDA and the @DeptofDefense to prioritize the efficient development of safe and effective medical products intended to help save the lives of American military personnel. https://t.co/4LeyPxra3x— Scott Gottlieb, M.D. (@SGottliebFDA) July 10, 2018