- After some pushback from the military arm of the U.S. government, the Food and Drug Administration and the Department of Defense have hammered out an agreement to expedite approval of medical products for military use.
- Put in place through H.R. 4374, the initial part of the program will be handled by FDA’s Center for Biologics Evaluation and Research because current high-priority DoD needs include freeze-dried plasma, cold-stored platelets, and cryopreserved platelets.
- The FDA and the DoD’s Office of Health Affairs will host a workshop to better determine the needs of military personnel. That workshop will inform future guidance documents.
DoD previously tried to strip the FDA of its oversight power for medical products for military use. The latest pact maintains the FDA’s oversight of safety and efficacy, but will speed what the DoD sees as a frustratingly slow process.
"Expeditious access to life-saving medical products for U.S. troops on the battlefield is part and parcel to ensuring our shared priority of operational readiness. The Department of Defense looks forward to working with the FDA on this important program to ensure delivery of critical battlefield medicine to our service members downrange,” said Tom McCaffery, acting Assistant Secretary of Defense for Health Affairs, in a statement.
The first step of the program will have members of the FDA’s CBER working closely with Health Affairs to move urgently needed biologics products forward that are used in the field of battle.
The drug regulator is planning to provide guidance to help inform commercial manufacturers about what products are needed and “identify opportunities to fulfill unmet medical needs for battlefield settings.”
The FDA emphasized in its statement that the agreement is just the first step and that it expects the needs of the program to evolve to include preventative vaccines, as well as other therapeutics.