The U.S. FDA and the Department of Defense’s (DoD) Office of Health Affairs have signed a Memorandum of Understanding (MOU) regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.
“It’s our honor and duty to support our military personnel by ensuring they have access to safe and effective medical products – especially products that meet the unique needs and settings in which soldiers may require medical treatment,” says FDA Commissioner Scott Gottlieb, M.D.
The MOU formally establishes the framework under which the DoD and the FDA will implement the law passed by Congress in 2017 for enhanced engagements between the DoD and the FDA. Under the terms of this MOU, the FDA will work closely with the DoD to evaluate how best to foster access to safe and effective medical products that serve the military’s medical needs; give the highest level of attention to and expedite review of priority DoD medical products; provide ongoing technical advice to aid in the rapid development and manufacturing of medical products for use by the military; and examine products currently under development to determine opportunities to streamline review and expedite their availability.
The 2017 law also expanded the FDA’s authority to authorize emergency uses of medical products to reduce deaths and severity of injuries caused by chemical, biological, radiological or nuclear (CBRN) agents or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to the U.S. military forces and for other purposes.
“This MOU furthers the existing partnership between the Department of Defense and the FDA to equip our military with the best and most innovative military medical support possible,” says Terry M. Rauch, PhD, MPH, MBA, Acting Deputy Assistant Secretary of Defense, health readiness policy and oversight, DOD.
The MOU signed builds upon the approach that the FDA outlined in 2018 to advance the development and availability of medical products to help save the lives of American military personnel in a work plan developed in close collaboration with the DoD. The MOU reflects the agency’s commitment to working to address the medical needs of military personnel, especially by helping to expedite the development and review of medical products that are a priority for the DoD and to aid in the rapid development and manufacturing of safe and effective medical products for use by the U.S. military.
Specifically, the MOU sets forth a framework to implement the 2017 law, which included provisions to allow the Secretary of Defense to request, and the 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 to diagnose, prevent, treat or mitigate a specific and life-threatening risk to the United States.