Litigating Authority for the FDA

Drawing on 20 semi-structured interviews with former DOJ and FDA attorneys, the author provides a qualitative empirical account of how the interagency relationship between FDA and DOJ shapes federal enforcement policy, identifying three key tensions: DOJ’s authority to decline or delay FDA referrals, the agencies’ distinct but overlapping enforcement priorities, and instances in which DOJ pursues cases without or over FDA’s objection. The author proposes that Congress grant FDA independent authority over civil (but not criminal) litigation, arguing that this reallocation would better align enforcement with FDA’s institutional expertise and mission.