Litigating Authority for the FDA

52 Pages Posted: 25 Apr 2022

See all articles by C. Joseph Ross Daval

C. Joseph Ross Daval

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School

Date Written: March 1, 2022

Abstract

The Food and Drug Administration (FDA), like most federal agencies, is a captive client. Its “lawyer,” the Department of Justice (DOJ), ultimately decides whether and when to sue. When FDA goes to court, a DOJ lawyer decides what arguments to make, and whether to appeal if they lose. But Congress could, and perhaps should, change this arrangement. In this Article, I discuss the prospect of independent litigation authority—the authority to conduct litigation without DOJ—for the FDA.

Because FDA and DOJ must cooperate to litigate cases, their working relationship profoundly influences federal policy, especially enforcement decisions. Drawing on twenty semi-structured interviews with former DOJ and FDA attorneys, I provide the first qualitative empirical account of the interaction between these powerful agencies. I find that three key tensions between the agencies shape enforcement policy: (1) DOJ makes use of its authority to decline and delay FDA referrals and to direct key decisionmaking in litigation, limiting FDA’s preferred implementation of the Food, Drug, and Cosmetic Act; (2) the agencies have distinct, yet overlapping, enforcement priorities; and (3) DOJ control can result in more enforcement, with DOJ pursuing cases without consulting FDA, or over FDA’s objection, and pushing FDA to take on others. Drawing upon these findings, I propose and defend a reallocation of litigation authority in which Congress would grant FDA independent authority over civil—but not criminal—litigation.

This Article uses litigation authority to link theories of public enforcement with scholarship on interagency relationships. The example of FDA and DOJ illustrates how relationships between agencies can shape federal enforcement policy. Enforcement policy is determined not simply by monolithic agencies or administrations, but also by interactions among individual agencies with different missions, authority, and expertise, overruling and deferring to each other’s preferences on a case-by-case basis. Understanding interagency relationships likewise requires interrogating enforcement policy as a site of interagency contestation, with the decisions of DOJ and FDA lawyers embodying divergent policy preferences stemming from their agencies’ institutional identities. By uncovering how FDA enforcement policy results from many individual discretionary decisions, each subject to negotiation, this Article seeks to better understand both interagency relationships and the process of public enforcement.

The question of who controls agency litigation also implicates foundational issues of regulatory power. This Article anchors those debates in the experiences of the public servants who have spent their careers navigating the pathways of authority Congress created. Their novel insights allow for a more nuanced discussion of agency independence, litigation authority, and the legitimacy of regulatory power.

Suggested Citation

Ross Daval, Charles Joseph, Litigating Authority for the FDA (March 1, 2022). Washington University Law Review, Forthcoming, Available at SSRN: https://ssrn.com/abstract=4046934

Charles Joseph Ross Daval (Contact Author)

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School ( email )

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Boston, MA 02120
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