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Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Journal Articles

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Power Corrupts, Emily Bremer

Journal Articles

Administrative law today neglects administration, focusing instead on power and the institutions that wield it, particularly the Supreme Court, the president, and Congress. Tracing the field’s reorientation—from the New Deal–era cases that revealed the thin political will behind the Administrative Procedure Act to the emergence of the Chevron doctrine—this paper argues that administrative law’s obsession with power corrupts the field.

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Journal Articles

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Introduction To The Bremer-Kovacs Collection: Historic Documents Related To The Administrative Procedure Act Of 1946 (Heinonline 2021), Emily S. Bremer, Kathryn E. Kovacs

Journal Articles

Few statutes have a legislative history as rich, varied, and sprawling as the Administrative Procedure Act of 1946 (APA). In recent years, courts and scholars have shown increased interest in understanding this history. This is no mean feat. The APA’s history spans nearly two decades, and it includes numerous failed bills, a presidential veto, and a full panoply of congressional documents. In addition, much of the most crucial documentation underlying the APA was produced outside of Congress—by the executive branch—and even outside of government—by the American Bar Association. Identifying and locating all the relevant documents is difficult. Understanding each piece …

The Undemocratic Roots Of Agency Rulemaking, Emily S. Bremer

Journal Articles

Americans often credit—or blame—Congress for the laws and policies that govern their lives. But Congress enacts broad statutes that give federal administrative agencies the primary responsibility for making and enforcing the regulations that control American society. These administrative agencies lack the political accountability of those in public office. To address this democratic deficit, an agency seeking to adopt a new regulation must publish a notice of proposed rulemaking and provide an opportunity for the public to comment on the proposal. Heralded as “one of the greatest inventions of modern government,” the Administrative Procedure Act’s (APA) notice-and-comment rulemaking procedure is understood …

Retheorizing Precedent, Randy J. Kozel

Journal Articles

Does the doctrine of stare decisis support judicial attempts to retheorize dubious precedents by putting them on firmer footing? If it does, can retheorization provide a means for Chevron to endure as a staple of administrative law notwithstanding serious challenges to its established rationale?

The Case Against Chevron Deference In Immigration Adjudication, Shoba Wadhia, Christopher Walker

Journal Articles

The Duke Law Journal’s fifty-first annual administrative law symposium examines the future of Chevron deference—the command that a reviewing court defer to an agency’s reasonable interpretation of an ambiguous statute the agency administers. In the lead article, Professors Kristin Hickman and Aaron Nielson argue that the Supreme Court should narrow Chevron’s domain to exclude interpretations made via administrative adjudication. Building on their framing, this Article presents an in-depth case study of immigration adjudication and argues that this case against Chevron has perhaps its greatest force when it comes to immigration. That is because much of Chevron’s theory for congressional delegation …

Neoclassical Administrative Law, Jeffrey Pojanowski

Journal Articles

This Article introduces an approach to administrative law that reconciles a more formalist, classical understanding of law and its supremacy with the contemporary administrative state. Courts adopting this approach, which I call “neoclassical administrative law,” are skeptical of judicial deference on questions of law, tend to give more leeway to agencies on questions of policy, and attend more closely to statutes governing administrative procedure than contemporary doctrine does. As a result, neoclassical administrative law finds a place for both legislative supremacy and the rule of law within the administrative state, without subordinating either of those central values to the other. …

Statutory Interpretation, Administrative Deference, And The Law Of Stare Decisis, Randy J. Kozel

Journal Articles

This Article examines three facets of the relationship between statutory interpretation and the law of stare decisis: judicial interpretation, administrative interpretation, and interpretive methodology. In analyzing these issues, I emphasize the role of stare decisis in pursuing balance between past and present. That role admits of no distinction between statutory and constitutional decisions, calling into question the practice of giving superstrong deference to judicial interpretations of statutes. The pursuit of balance also suggests that one Supreme Court cannot bind future Justices to a wide-ranging interpretive methodology. As for rules requiring deference to administrative interpretations of statutes and regulations, they are …

Designing The Decider, Emily S. Bremer

Journal Articles

The Administrative Procedure Act (APA) contains several provisions designed to ensure that presiding officials in so-called formal adjudications are able to make fair, well-informed, independent decisions. But these provisions do not apply to the vast majority of federal adjudicatory hearings. In this world of adjudication outside the APA, agencies enjoy broad procedural discretion, including substantial freedom to “design the decider.” This Article defines the scope of this discretion and explores how various agencies have exercised it. The discussion is enriched by examples drawn from an expansive new database of federal adjudicatory procedures. The Article argues that, although agency discretion to …

Municipal Responses To Vacant Properties In The United States, James J. Kelly Jr.

Journal Articles

The administrative law specialized magazine No. 24 which explores the foundation of administrative law theory. This issue contains 5 articles that focus on the vacant house issue.

Vacant house measures in American municipalities

Administrative Lawmaking In The Twenty-First Century, Jeffrey Pojanowski

Journal Articles

It is always hard to map a river while sailing midstream, but the current state of administrative law is particularly resistant to neat tracing. Until the past few years, administrative law and scholarship was marked by pragmatic compromise: judicial deference on questions of law (but not too much and not all the time) and freedom for agencies on questions of politics and policy (but not to an unseemly degree). There was disagreement around the edges-and some voices in the wilderness calling for radical change-but they operated within a shared framework of admittedly unstated, and perhaps conflicting, assumptions about the administrative …

Minimally Democratic Administrative Law, Jud Mathews

Journal Articles

A persistent challenge for the American administrative state is reconciling the vast powers of unelected agencies with our commitment to government by the people. Many features of contemporary administrative law — from the right to participate in agency processes, to the reason-giving requirements on agencies, to the presidential review of rulemaking — have been justified, at least in part, as means to square the realities of agency power with our democratic commitments. At the root of any such effort there lies a theory of democracy, whether fully articulated or only implicit: some conception of what democracy is about, and what …

Who’S Exercising What Power: Toward A Judicially-Manageable Nondelegation Doctrine, Martin Edwards

Journal Articles

This Article argues that the traditional, "intelligible principle" nondelegation analysis is incomplete and that an examination of the delegate, rather than just the delegation, more effectively animates the doctrine. This is true not only as a practical matter; early Supreme Court cases, as well as later ones, have taken a keen interest in the recipient of the alleged delegation. In other words, a realistic and judicially enforceable nondelegation doctrine must include more than a mere tip of the juridical cap.

Strategic Delegation, Discretion, And Deference: Explaining The Comparative Law Of Administrative Review, Jud Mathews, Nuno M. Garoupa

Journal Articles

This paper offers a theory to explain cross-national variation in administrative law doctrines and practices. Administrative law regimes vary along three primary dimensions: the scope of delegation to agencies, agencies’ exercise of discretion, and judicial practices of deference to agencies. Working with a principal-agent framework, we show how cross-national differences in institutions’ capacities and the environments they face encourage the adoption of divergent strategies that lead to a variety of distinct, stable, equilibrium outcomes. We apply our model to explain patterns of administrative law in the United States, Germany, France, and Commonwealth jurisdictions.

Deference Lotteries, Jud Mathews

Journal Articles

When should courts defer to agency interpretations of statutes, and what measure of deference should agencies receive? Administrative law recognizes two main deference doctrines — the generous Chevron standard and the stingier Skidmore standard — but Supreme Court case law has not offered a bright-line rule for when each standard applies.

Many observers have concluded that courts’ deference practice is an unpredictable muddle. This Article argues that it is really a lottery, in the sense the term is used in expected utility theory. Agencies cannot predict which deference standard a court will apply or with what effect, but they have …

Maximum Feasible Participation Of The Poor: New Governance, New Accountability, And A 21st Century War On The Sources Of Poverty, Tara J. Melish

Journal Articles

In 1964, President Lyndon B. Johnson called for a Nationwide War on the Sources of Poverty to “strike away the barriers to full participation” in our society. Central to that war was an understanding that given poverty’s complex and multi-layered causes, identifying, implementing, and monitoring solutions to it would require the “maximum feasible participation” of affected communities. Equally central, however, was an understanding that such decentralized problem-solving could not be fully effective without national-level orchestration and support. As such, an Office of Economic Opportunity was established – situated in the Executive Office of the President itself – to support, through …

A Comparison Of The Administrative Law Of The Catholic Church And The United States, John J. Coughlin

Journal Articles

Some years ago, an international symposium of jurists described administrative law as encompassing "the entire range of action by government with respect to the citizen or by the citizen with respect to the government, except for those matters dealt with by the criminal law, and those left to private civil litigation where the government's only participation is in furnishing an impartial tribunal with the power of enforcement."

The broad parameters of the concept of administrative law attest to its importance in any legal system. Indeed, for at least the past fifty years, comparative legal scholars have focused on diverse national …