Military Personnel Authorized to Receive Freeze-Dried Blood

The US Food and Drug Administration (FDA) has granted the US Department of Defense (DoD) an emergency use authorization (EUA) of freeze-dried plasma product (FDP) that is made in France.

Known as French FDP, or Pathogen-Reduced Leukocyte Freeze-Dried Plasma, the product is manufactured by the Centre de Transfusion Sanguine des Armees, and has eliminated a typically long thawing period and made plasma rapidly available for use at the point of injury.

Plasma is typically frozen within 24 hours following donation, to preserve clotting factors. When the frozen plasma is needed, it must be placed in a water bath at 30 to 37 C in an FDA-cleared device. The long thawing period is impractical when treating hemorrhage or coagulopathy in US military personnel during an emergency involving agents of military combat.

The FDA has partnered with the DoD and the Center for Biologics Evaluation and Research (CBER) to see the delivery of safe and effective products to those protecting the nation. An initial work plan was created to address DoD’s medical needs. In this new plan, the FDA will facilitate the development and availability of specific products regulated by the CBER, determined to be important to the health of military service members by the DoD.

In a statement, FDA Commissioner, Scott Gottlieb, MD, explained. “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.”

A Pennsylvania-based company is also developing a freeze-dried plasma product.

Reference

FDA takes action to support American Military personnel by granting an authorization for freeze-drived plasma product to enable broader access while the agency works toward approval of the product [news release]. FDA’s website.https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm612893.htm. Accessed July 12, 2018.

American Red Cross. Blood Components: How can one donation help multiple people? American Red Cross Website.https://www.redcrossblood.org/donate-blood/how-to-donate/types-of-blood-donations/blood-components.html. Accessed July 12, 2018.