LITIGATING AUTHORITY FOR THE FDA.

• Date: 01 September 2022
• Author: Daval, C. Joseph Ross

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 decision-making 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.

TABLE OF CONTENTS I. LITIGATION AUTHORITY AND ENFORCEMENT POLICY IN THE ADMINISTRATIVE STATE A. Defense and Criticism of DOJ Control of Litigation B. Interagency Enforcement C. Agencies with Independent Litigation Authority II. FDA ENFORCEMENT VIA LITIGATION A. The 1972 Bill to Grant FDA Litigation Authority B. Prohibited Acts and Remedies Under the FDCA C. FDA's Enforcement Process Through Litigation III. STUDY DESIGN AND FINDINGS 201 A. DOJ Control of Litigation Impedes FDA's Preferred Implementation of the FDCA B. FDA's Priority Is Public Health; DOJ's Is Preventing Fraud C. DOJ Can Be More Aggressive than FDA D. Understanding Divergent Enforcement Priorities: The Litigious Lawyer IV. LITIGATING AUTHORITY FOR THE FDA 211 A. Participants' Views for and Against Litigation Authority B. Proposal: Civil Litigation Authority C. A Defense Against Arguments for DOJ Control V. RESPECT FOR PRESIDENTIAL POLICYMAKING AND THE POLITICS OF ENFORCEMENT CONCLUSION APPENDIX INTRODUCTION

When the Food and Drug Administration (FDA) goes to court, it depends on the Department of Justice (DOJ), by law, to conduct all formal aspects of litigation. (1) To sue a drug manufacturer, FDA must convince a DOJ attorney to file the complaint. (2) When FDA gets sued over a regulation, a DOJ attorney stands up in court to defend it. (3) DOJ holds ultimate control over filings, arguments, and appeals. (4) Indeed, all FDA actions--rules, warning letters, or guidance--can be challenged in court or ignored. At that point, FDA's only option to seek compliance or defend its policies is litigation, where all decisions ultimately rest with DOJ. (5)

This arrangement, common to most federal regulatory agencies, is not preordained. Some agencies, most of them independent agencies, litigate their own cases how and when they choose, rather than relying on DOJ to litigate on their behalf. (6) Arguing for FDA independence in 2019, seven former FDA Commissioners urged Congress to grant the agency litigation authority, along with other reforms designed to insulate it from political pressure. (7) The report added to a growing discourse around FDA independence. (8) Litigation authority, the Commissioners thought, was "key" to making FDA an independent agency. (9) FDA's actions in response to the COVID-19 pandemic led to more public discussion of independence, spurred by criticism of the agency's apparent susceptibility to presidential control. (10)

FDA indeed presents a compelling case for controlling its own litigation. It is the paradigmatic scientific decisionmaker, leveraging its broad authority to regulate global industries on the basis of highly technical, time-sensitive assessments. (11) Its litigation decisions hinge on questions of science and public health policy. (12) FDA has a strong claim that, if any agency ought to have the power to make its own decisions in court, it should. It is, by many accounts, the preeminent public health agency in the world. (13) But it relies on DOJ to file basic enforcement actions against contaminated products.

Scholars have debated whether DOJ affects the policies of government agencies through its gatekeeping authority over litigation. Some question the basis for DOJ control of federal litigation, (14) and propose that it may affect agencies' substantive programs. (15) But there is no in-depth agency case study looking at how, or even if it actually docs. (16) Existing work focuses instead on litigation authority's role in discrete episodes of high-profile litigation, (17) including litigation between executive and independent agencies, (18) and how it may shift power within agencies themselves. (19)

This Article uses the case of FDA--an executive agency on the precipice of independence--to uncover how DOJ control of agency litigation, especially enforcement decisions, shapes agency policymaking. To do so, I draw on anonymous semi-structured interviews with twenty former government attorneys--ten each from DOJ and FDA--totaling over twenty-two hours of qualitatively-analyzed discussion, shedding light unavailable from any published sources. (20) Using their responses I sketch, for the first time in detail, the working relationship between the powerful agencies that must coordinate to enforce the federal food and drug laws of the United States, (21) and how that relationship shapes the implementation of the FDA's substantive statute.

I find that DOJ control of FDA litigation in fact shapes FDA policy, with the interview responses centering around three main themes. First, DOJ's final say-so limits FDA's preferred implementation of the Food, Drug, and Cosmetic Act (FDCA), the main statute FDA is tasked with administering. (22) Participants described how DOJ sometimes declined to pursue FDA cases, or delayed filing them. The agencies regularly disagree over what kinds of arguments to make, whether to appeal adverse judgments, and other litigation decisions. Furthermore, the expectation of DOJ review shapes FDA referrals to align more with DOJ priorities.

Second, the agencies have distinct enforcement priorities. Although there is overlap, FDA tends to prioritize health and safety violations, while DOJ tends to favor promotional cases, such as prosecutions for illegal marketing of drugs and devices for indications not approved by FDA ("off-label" promotion). (23) Some respondents predicted that an untethered FDA would likely bring more low-level seizure and injunction actions than it can today and might show far less interest in promotional violations than DOJ has. I argue that the agencies' divergent interpretations of the statute result from their underlying missions. (24) FDA, as a public health agency, views the statute as a tool to protect public health, while DOJ views it as an extension of its existing authority to prosecute fraud.

Third, and most surprisingly, DOJ control can at times lead to more enforcement. Because the enforcement priorities of the agencies differ, DOJ can be more zealous than FDA, pushing it to help pursue enforcement actions it otherwise would not. Sometimes, DOJ pursues cases without consulting FDA at all, or even over FDA's objection. These responses cast doubt on some scholars' claims that DOJ's client agencies "almost certainly will advance a pro-enforcement agenda." (25) Instead, I find DOJ can be a "litigious" lawyer, sometimes favoring more enforcement than its client.

The aim of this Article is to forge a link between the public enforcement literature and the body of work on interagency relationships. (26) Numerous articles address government enforcement policy in which authors tend to conceive of enforcement policy as the product of a single agency, an administration, or the government as a whole. (27) A separate body of work explores the myriad relationships between government agencies. (28) These scholars have shown how agencies exist in varying states of conflict, cooperation, dysfunction, duplication, and reinforcement, in what Jody Freeman and Jim Rossi describe as...