Enhanced Engagement: The Evolving Relationship between FDA and DoD Regulatory Authorities
Jeremiah J. Kelly
The U.S. Department of Defense (DoD) and U.S. Food and Drug Administration (FDA) relationship has, by necessity, evolved throughout the modern era as new national security and public health threats have shaped the authority, organization, and execution of each agency’s unique mission. This continual evolution requires balancing FDA’s interest in protecting the public health from unsafe and ineffective medical products with DoD’s role in fighting and winning the nation’s wars. There will always be a natural tension between the risk–benefit calculus of FDA decisionmaking for public health purposes and the risk–benefit calculus of DoD’s warfighting mission in austere environments. The unique DoD–FDA relationship was enhanced by Congress’ enactment of Public Law 115-92. But the DoD–FDA “enhanced engagement” relationship created by this statute must develop further. This Article will explore: 1) the history of DoD–FDA relations; 2) the dependency of DoD medical product authorities on FDA’s legal framework; 3) the impact of P.L. 115-92 and the progress of the two organizations under this landmark statute; 4) opportunities for additional, mutually beneficial regulatory coordination; and 5) recommended solutions to systemic challenges to spur development of FDA-approved, licensed, or cleared medical products for the unique medical needs of the warfighter.