News Release

For Immediate Release -- August 29, 2019

FDA Action Makes Blood Product More Accessible to Warfighters in Combat
New option can help save military lives

(Fort Detrick, Md.) – A recent action by the U.S. Food and Drug Administration (FDA) will help the military treat severely injured Warfighters suffering from traumatic bleeding on the battlefield. On August 15, 2019 the FDA granted a variance request submitted by the Army Blood Program for the use of cold stored platelets in theater for the Department of Defense. The issuance of this variance clears the way for platelets, a key blood component, to be refrigerated and stored for up to 14 days prior to treating bleeding patients when conventional platelet products are not available or their use is not practical.

The approval of the variance request is another important action under the collaboration between the FDA and the Department of Defense (DoD) to expedite the development and availability of safe and effective medical products that are essential to the health of U.S. military service members.

"The FDA granting of this platelet variance will directly increase survival of our service members on the battlefield," said Dr. Terry Rauch, Acting Deputy Assistant Secretary of Defense for Health Readiness Policy and Oversight, Office of the Assistant Secretary of Defense for Health Affairs. "The close working relationship between our DoD teams and the FDA was critical to providing this capability to the Department and we are grateful for the tremendous support we've received from the FDA."

The current DoD standard of care for treating a severely wounded patient requires room-temperature platelets, which carry a limited shelf life of five-to-seven days – a limitation that prevents their use in theater due to logistics requirements. The variance for cold stored platelets enables military blood banks to produce and test platelets for certain infectious diseases before shipping them to theater locations in support of combat operations when needed.

"Issuance of this variance is a critical first step to deliver platelets to combat zones," said Ms. Dawn Rosarius, Principal Assistant for Acquisition, U.S. Army Medical Research and Development Command, Army Futures Command. "Ultimately, wider availability of platelets will decrease the leading cause of preventable death on the battlefield--life-threatening bleeding due to trauma. In addition, during multi-domain operations of the future, cold-stored platelets could play a critical role in stabilizing casualties if evacuation is delayed. Our continuing work to develop a product for licensure is the crucial next step to achieve this goal."

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 and DoD outlined their approach in a plan developed last year, and both agencies remain committed to the medical needs of military personnel, including working together to facilitate development and review of DoD priority medical products for use by the U.S. military.

"Ensuring our Nation's warfighters have safe and effective medical products is a top priority for the agency," said Anna Abram, the FDA's Deputy Commissioner for Policy, Legislation, and International Affairs. "This decision will support access to platelet products in the battlefield where their use is most needed. The FDA remains deeply committed to helping ensure that these potentially life-saving medical products are made available in the most expeditious, safe and effective manner possible."

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