Pentagon, FDA to speed up approval for battlefield medical products

The Defense Department and the Food and Drug Administration (FDA) announced on Tuesday new steps aimed at expediting the approval of medical devices and drugs for use on the battlefield.

The plan is being carried out in line with a law passed last year in the wake of a controversy over whether the Pentagon should be allowed to approve products for battlefield use.

“We recognize that there are essential and in some cases unmet health-care needs of those protecting our nation and that we at the FDA need to do our part to better protect them,” Anna Abram, the FDA’s deputy commissioner for policy, planning, legislation and analysis, said in a conference call with reporters. “Although we have had successful collaborations with [the Department of Defense] on some fronts, some pressing areas have clearly not received the attention from the FDA that they have needed.”

Right now, the Pentagon is focusing on getting approval for freeze-dried plasma, cold-stored platelets and cryopreserved platelets, which the military hopes will help save troops from bleeding out on the battlefield.

Because of the Pentagon’s initial priorities, the steps outlined Tuesday focus on collaboration between the Defense Department and the FDA’s Center for Biologics Evaluation and Research (CBER).

The steps announced Tuesday include quarterly meetings between Pentagon health leadership and CBER leadership to discuss Pentagon priorities; treating the Pentagon’s priority programs as if they’ve received “breakthrough therapy” designation, which is a program designed to expedite development and review of medical products for serious conditions; FDA-hosted workshops with the Pentagon to develop guidance on facilitating the development of products; and formal FDA-Pentagon meetings at least two times a year to review the Pentagon’s product development pipeline.

“The partnership we announced today reflects the invaluable collaboration between our organizations, it strengthens our ability to equip troops with the best possible medical support, and it helps us achieve our mission of providing battlefield care to support our entire military’s effort to achieve a safer, more secure world,” Tom McCaffery, acting assistant secretary of Defense for health affairs, said in the conference call. “FDA’s expertise and guidance will help us put the best, most effective products in the hands of battlefield medical personnel.”

The Pentagon and its advocates in Congress have been frustrated by what they describe as the FDA’s slow approval of certain treatments they say could save lives on the battlefield. In particular, there has been a decade-long impasse between the Pentagon and the FDA over freeze-dried plasma.

Because of that frustration, last year’s National Defense Authorization Act (NDAA) would have allowed the Pentagon to approve the use of freeze-dried plasma and other medical products.

But the FDA and it advocates in Congress pushed back at the provision, arguing the language in the NDAA could have opened troops up to more danger because the approval process was not as rigorous as the FDA’s and that language was broad enough to allow the Pentagon to approve a range of treatments not directly related to battle. 

Ultimately, a separate compromise bill was passed alongside the NDAA that sought to expedite the FDA’s approval process.