C. Joseph Ross Daval, JD

From 2000-2022, the Federal Trade Commission (FTC) pursued 22 enforcement actions against pharmaceutical firms for alleged anticompetitive practices and challenged 62 mergers, of which 61 were allowed to continue, 58 after divesting drugs to third-party competitors. Congressional action may be necessary to strengthen the FTC’s authority and enforcement capacity related to pharmaceuticals.

A review of legal precedents and coverage determinations reveals how CMS exercises its legal discretion to shape Medicare coverage of FDA-regulated drugs and devices. As products come to market with limited clinical evidence and narrow risk-benefit profiles, CMS should leverage conditional or limited coverage mechanisms to account for these evidence gaps.

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.