The Defense Department has partnered with the Food and Drug Administration to speed up the process of approving medical products that can help save lives on the battlefield.
The DoD’s Office of Health Affairs and the FDA announced on Tuesday the joint program that will prioritize the availability of these products, including freeze-dried plasma.
Freeze-dried plasma, which doesn’t need to be kept cold and is more stable than frozen plasma, helps stop bleeding with its clotting properties. Controlling blood loss is one of the most critical tasks facing medics on the battlefield.
Since the FDA hasn’t approved a U.S.-sourced product yet, the military is using French-manufactured freeze-dried plasma until a U.S. option is available.
Through this partnership, the FDA has committed to getting a freeze-dried plasma product licensed for use by the end of 2018, said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, during a conference call with reporters on Tuesday.
Right now, only special operations units are using the French-sourced product, but Marks said the hope is to have U.S.-sourced freeze-dried plasma available to a broader range of service members and units.
Language in the 2018 National Defense Authorization Act would have given the DoD — not the FDA — the power to approve medical products for emergency use. However, the FDA and its supporters in Congress pushed back on the language, saying a less-strict approval process could put troops in danger if the products weren’t deemed safe.
That language was removed from the NDAA, and a separate bill was passed as a compromise. This bill authorizes the DoD to request assistance to expedite the development and the FDA’s review of medical products.
“Although we have had successful collaborations with the Defense Department, some pressing areas have clearly not received attention from the FDA that they’ve needed,” FDA spokeswoman Tara Rabin said.
Rabin said the NDAA spurred meaningful dialogue, and the new bill will help the FDA better prioritize the DoD’s work while still ensuring the products are safe and effective.
Expediting the approval process doesn’t mean there will be relaxed standards, Marks said.
“We don’t intend to take a dramatically different approach to these products that we do to any other product,” he said, adding that more consideration will be given to what the DoD deems top priorities.
The DoD’s current high-priority product programs include freeze-dried plasma, cold-stored platelets and cryopreserved platelets — platelets are blood cells that help the body form clots to stop bleeding.
Tom McCaffery, the DoD’s acting assistant secretary of defense for health affairs, said the partnership will “equip troops with the best possible medical support.”
“The FDA’s expertise and guidance will help us put the best, most effective products in the hands of battlefield personnel,” McCaffery said.
Frozen plasma must be thawed and warmed before it can be injected into a patient, but the freeze-dried approach removes the water from the product, turning it into a powder.
This powder is reconstituted with sterile water and injected into the patient either intravenously or via intraosseous infusion — directly into the bone.
U.S. troops used this method in World War II, but they stopped after it was linked to hepatitis outbreaks. Since then, the safety testing improved and other militaries — including the French, Germans, Norwegians and Israelis — have used it.
Special operations units in the U.S. Army, Navy, Air Force and Marine Corps have received about 1,000 kits of the French product, according to the Associated Press.
The French freeze-dried plasma is contained in glass bottles, but the U.S. plans to hold its product in IV bags to make transporting them easier and safer.