DOD-FDA Enhanced Engagement to Accelerate the Development of Medical Products for Our Military Personnel

5 min

Since its enactment in 2017, Public Law No. 115-92 has significantly boosted the availability of medical products that protect and treat military personnel. Designed to overcome the unique challenges posed by military medical product development, the law enables the use of enhanced regulatory engagement, expedited reviews, and other flexibilities that can greatly accelerate the regulatory review process. As a result, several medical products have already received approval or authorization from the U.S. Food and Drug Administration (FDA), providing crucial benefits to military personnel and increasing military readiness. Companies that are developing products for potential military use should consider whether P.L. 115-92 can be leveraged to their advantage to expedite approval and commercialization.

What does the law do?

P.L. 115-92 (131 Stat. 2023-2025) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to increase collaboration and communication between the U.S. Department of Defense (DOD) and the FDA with a goal of more rapidly fielding DOD’s medical product priorities (MPPs) necessary to meet military emergencies. The full statutory text is available here. In summary, P.L. 115-92:

  • Expands FDA’s emergency use authorization (EUA) authority under §564 of the FD&C Act to allow FDA to issue EUAs for emergency use of unapproved medical products or unapproved uses of approved medical products to address additional types of threats (beyond chemical, biological, radiological, and nuclear (CBRN) agents) related to an attack with an “agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the United States military forces” (see §1(a), P.L. 115-92)
  • Allows the Secretary of Defense to request, and authorizes FDA to take, specific actions to expedite the development of medical products, and the review of investigational submissions, applications for approval/licensure, and submissions/notifications for clearance for such medical products reasonably likely to diagnose, prevent, treat, or mitigate a specific and life-threatening risk to the U.S. military (see §1(b), P.L. 115-92)
  • Requires semi-annual review between DOD and FDA of DOD’s MPP portfolio and requires quarterly DOD-CBER meetings for CBER-regulated MPPs (see §1(b)(3), P.L. 115-92)

How has P.L. 115-92 been implemented?

Since 2017, the DOD and FDA have worked collaboratively to implement P.L. 115-92. Shortly after enactment, the agencies executed a Memorandum of Understanding (MOU) to implement the new collaboration. The coordination begins with DOD, which has established the Medical Product Acceleration Committee (MPAC) to manage the creation and maintenance of the DoD Priority List of MPPs that will be communicated to FDA. As described by the U.S. Army Medical Research and Development Command—a key research and development command now under the Defense Health Agency—the MPAC is “intended to serve as the DOD enterprise-wide forum for discussions on which products are identified as DOD MPPs for the Priority List” and helps “achieve a DOD ‘one voice’ approach envisioned by the statute.” After receiving the list of MPPs, FDA stated that it “give[s] the highest level of attention to and expedite[s] its review of priority DOD medical products in a manner similar to products under the breakthrough therapy designation[.]” FDA also provides “ongoing technical advice to DOD” and proactively examines “products currently under development to determine opportunities to expedite their availability.”

It is important to note that, while PL 115-92 can expedite medical product development, it does not change FDA’s statutory standards for medical products to be proved safe and effective. Furthermore, not every DOD collaboration for product development will make it onto the DOD Priority List. Under the DOD-FDA MOU, DOD is obligated to prioritize and rank MPPs for the Priority List as follows:

DOD will evaluate and rank MPPs based on need (i.e., risk-to-mission of an unmet medical need and/or capability gap) and feasibility (i.e., is the product mature enough in the development pathway and capable of deployment to offer a significant improvement over current medical treatments), as well as describe whether the MPP will require emergency use, accelerated management, or whether there is a cross-cutting regulatory science issue or some combination thereof.

These measures help ensure that FDA can focus its resources on the medical products that are truly of the highest priority for the warfighter.

In practical terms, what effect has P.L. 115-92 had on DOD medical products?

While it is still relatively new, the law has largely achieved its aim of accelerating the fielding of desperately needed military medical products. These products include French Freeze Dried Plasma (authorized under an EUA), sufentanil for battlefield pain, tafenoquine and intravenous artesunate for the prevention of severe malaria, and an atropine autoinjector for the treatment of chemical nerve agent poisoning. Within the last year, FDA has also approved two new autoinjectors: (1) for the treatment of status epilepticus in adults, and (2) for the treatment of high-potency opioids when used as a chemical weapon. Even more recently, FDA cleared a commercially available laboratory traumatic brain injury (TBI) blood test, which will allow clinicians to quickly assess individuals with mild concussions in 18 minutes versus the previous standard of four hours. In each case, P.L. 115-92 brought efficiencies to the development and regulatory review process, which enabled soldiers to receive these products months or even years ahead of schedule.

What is the process to get a product added to the DOD Priority List?

The DOD relies significantly on private collaborators to develop products for military use. Interested medical product developers must engage with the DOD—a wide enterprise of multiple research and development organizations—to determine if their product meets a priority military need. If so, developers must then rely on a determination by the MPAC as to whether the product will benefit from P.L. 115-92 assistance and expedited development. Close coordination with legal counsel, DOD program management, contracting, and regulatory personnel is essential throughout the process.

How can Venable help?

Venable is uniquely able to help navigate medical product development and collaboration with DOD, as our team includes attorneys who helped draft, implement, and carry out P.L. 115-92 during previous government service as counsel to DOD. If you think your product may be of interest to the military, we can help you engage with the DOD to help explore partnership opportunities that could lead to inclusion on the DoD Priority List as an MPP. Once a product is added to the DOD Priority List, we can also ensure the product receives the maximum advantage of the flexibilities authorized under the law.

For more insights into P.L. 115-92, please contact our team members: Jeremiah Kelly, Justin Coen, and Richard A. Starr.