Dive Brief:
- FDA and the Department of Defense on Friday signed a memorandum of understanding intended to speed availability of life-saving medical products for soldiers, especially those in need of treatment in battlefield settings, the FDA said.
- FDA cited the example of French-made freeze-dried plasma, for which an emergency use authorization was issued earlier this year.
- The memorandum creates the framework for implementing congressional legislation passed in 2017 that gave the DoD authority to ask FDA to expedite development and review of products to diagnose, treat or prevent conditions facing American military personnel.
Dive Insight:
The memorandum of understanding formalizes a program announced in January to speed review of high-priority Department of Defense medical products, including freeze-dried plasma, and cold-stored and cryo-preserved platelets.
The Pentagon had sought the ability to authorize emergency use of unapproved drugs and medical devices, but the 2017 legislation left the power of approvals with FDA.
Freeze-dried plasma, a dehydrated form of plasma, is a priority for the military because it offers an alternative to traditional plasma products that must stay frozen until thawed. The freeze-dried variety can be reconstituted and administered quickly, making it useful in remote areas without freezers.
Last month, FDA published draft guidance for industry for the development of dried plasma products. In July, FDA granted an emergency use authorization to the Defense Department for freeze-dried plasma made by France’s Centre de Transfusion Sanguine des Armées.
The 2017 law also expanded FDA’s authority to grant emergency use of medical products to reduce death and injury from chemical, biological radiological or nuclear agents. In July, the FDA approved the atropine auto-injector device as a medical countermeasure for chemical nerve agent exposure. In August, following a priority review, FDA approved the first prophylactic drug for malaria in over 18 years, tafenoquine (Arakoda).
