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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

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 …

Food And Drug Regulation: Statutory And Regulatory Supplement (2022 ), Adam I. Muchmore

Books

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 comprehensive.

Food And Drug Regulation: A Statutory Approach, Adam I. Muchmore

Books

This is the first chapter of a new casebook on food and drug regulation. This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act, and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role.

The book is designed to work with a Statutory and Regulatory Supplement provided as a PDF. The statutes and regulations in …

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

Books

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 comprehensive.

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 …

Proportionality Review In Administrative Law, Jud Mathews

Contributions to Books

At the most basic level, the principle of proportionality captures the common-sensical proposition that, when the government acts, the means it chooses should be well-adapted to achieve the ends it is pursuing. The proportionality principle is an admonition, as German administrative law scholar Fritz Fleiner famously wrote many decades ago, that “the police should not shoot at sparrows with cannons”. The use of proportionality review in constitutional and international law has received ample attention from scholars in recent years, but less has been said about proportionality’s role within administrative law. This piece suggest that we can understand the differences in …

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 …

Searching For Proportionality In U.S. Administrative Law, Jud Mathews

Contributions to Books

There is no such thing as “proportionality review” in American administrative law, but instead, a number of doctrines that courts deploy to evaluate agency exercises of discretion. In some respects, these frameworks for review resemble proportionality in operation, but there are also notable differences. This essay surveys the doctrines governing judicial review of administrative discretion in the United States, highlighting three distinguishing features of the American approach. First, American judicial review is characterized by a high degree of unpredictability, not only with respect to outcomes, but often with respect to what framework of review is applicable. Second, while classical proportionality …

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 …