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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

Decoding Nondelegation After Gundy: What The Experience In State Courts Tells Us About What To Expect When We're Expecting, Daniel Walters

Journal Articles

The nondelegation doctrine theoretically limits Congress’s ability to delegate legislative powers to the executive agencies that make up the modern administrative state. Yet, in practice, the U.S. Supreme Court has, since the New Deal, shied away from enforcing any limits on congressional delegation. That may change in the near future. In Gundy v. United States, the Court narrowly upheld a delegation, and a dissent signaled deep doubts about the Court’s longstanding “intelligible principle” standard and offered a new framework to replace it. Subsequent events strongly suggest that the Court is poised to move in the direction contemplated by the …

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 …

Sustainable Ecolabelled Seafood From The East China Sea: Regional And General Regulatory Regimes, Platinasoka Lin

SJD Dissertations

The aim of this work is to conduct a systematical review of fisheries management and to be an easy-understood guidebook for building an ecolabelling scheme of fisheries in the East China Sea, and also for Asian countries having plights of lacking good marine scientific research, advanced fisheries management, and public marine conservation awareness.

For this purpose, details of ecolabelling mechanism and the definitions of sustainable seafood are explored and a scoring checklist for ecolabelled seafood is created as a check tool, together with a certification standard named "ProFish." This work examines multiple types of legal documents, among them international conventions …

The Yates Memo: Looking For "Individual Accountability" In All The Wrong Places, Katrice Bridges Copeland

Journal Articles

The Department of Justice has received a great deal of criticism for its failure to prosecute both corporations and individuals involved in corporate fraud. In an effort to quiet some of that criticism, on September 9, 2015, then Deputy Attorney General Sally Q. Yates issued a policy entitled, "Individual Accountability for Corporate Wrongdoing," or the "Yates Memo," as it has been called. The main thrust of the Yates Memo is that in order for a corporation to receive any credit for cooperating with the government and obtain leniency in the form of a deferred prosecution agreement, the corporation must not …

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 …

Uncertainty, Complexity, And Regulatory Design, Adam I. Muchmore

Journal Articles

This Article develops an analytic framework for understanding the role of uncertainty in regulatory design. It begins by differentiating between three types of uncertainty: legal uncertainty, factual uncertainty, and uncertainty about the application of law to fact. This framework highlights the pervasiveness of factual uncertainty and law-fact uncertainty in daily affairs. Viewed through this framework, legal uncertainty is less problematic than it is typically thought to be.

The Article then focuses on legal uncertainty, examining it from two perspectives: the relationship between rules and standards, and the relationship between simplicity and complexity. It suggests that there are fundamental limits on …

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.

Effectuating Change In The Regulation Of Hiv Vaccines, Scott M. Engstrom

Scott M Engstrom

HIV has been at the forefront in politics, medicine, and law since its discovery in 1981. Over thirty years have passed since the virus began a wave of fear made worse by a sensationalist media. Though much of the uproar has dulled, the lasting effects on the American Psyche have remained as the AIDS death toll has risen. Although the medical community has made significant progress in managing the infection through complex drug cocktails, prevention remains the most effective tool in the fight against AIDS. However, the old aphorism “an ounce of prevention is worth a pound of cure” has …

Foia Request To Uscis On Deferred Action Records, Shoba Wadhia

Shoba Sivaprasad Wadhia

No abstract provided.

The Immigration Prosecutor And The Judge: Examining The Role Of The Judiciary In Prosecutorial Discretion Decisions, Shoba S. Wadhia

Shoba Sivaprasad Wadhia

Legal scholars and judges have long examined the role of judicial review in immigration matters, and also criticized the impacts of the “plenary power” doctrine and statutory deletions of judicial review for certain immigration cases. Absent from this scholarship is a serious examination of the judiciary’s role in immigration decisions involving prosecutorial discretion. I attribute this absence to both a silent concession that prosecutorial discretion decisions are automatically barred from judicial review because of the plain language of the Immigration and Nationality Act (INA); the judicial review “exceptions” in the Administrative Procedures Act (APA), and the cases that analyze these …

The Immigration Prosecutor And The Judge: Examining The Role Of The Judiciary In Prosecutorial Discretion Decisions, Shoba S. Wadhia

Journal Articles

Legal scholars and judges have long examined the role of judicial review in immigration matters, and also criticized the impacts of the “plenary power” doctrine and statutory deletions of judicial review for certain immigration cases. Absent from this scholarship is a serious examination of the judiciary’s role in immigration decisions involving prosecutorial discretion. I attribute this absence to both a silent concession that prosecutorial discretion decisions are automatically barred from judicial review because of the plain language of the Immigration and Nationality Act (INA); the judicial review “exceptions” in the Administrative Procedures Act (APA), and the cases that analyze these …

My Great Foia Adventure And Discoveries Of Deferred Action Cases At Ice, Shoba S. Wadhia

Journal Articles

This Article describes my adventures in FOIA litigation and analyzes deferred action data collected informally by 24 ICE field offices between October 1, 2011, and June 30, 2012. This Article also offers recommendations for the agency on data collection, recordkeeping, and transparency in deferred action cases. Deferred action is a form of prosecutorial discretion that can be granted at any stage of the immigration enforcement process and historically has been applied both to people who meet group characteristics and on an individual basis in compelling humanitarian circumstances. The theory behind deferred action and prosecutorial discretion more generally is to enable …

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 …

Embracing The Queen Of Hearts: Deference To Retroactive Tax Rules, James M. Puckett

Journal Articles

The Supreme Court’s decision in Mayo Foundation for Medical Education and Research v. United States underscored the importance of a uniform approach to judicial review of administrative action; accordingly, the Court clarified that tax administration is generally subject to the same review as other kinds of administrative action by other federal agencies. Tax guidance from the IRS and Treasury Department serves an important role in clarifying the tax law so that taxpayers may report their tax liability accurately and plan their affairs. Meanwhile, aggressive attempts by a relatively small number of taxpayers to avoid tax liability by exploiting arguable ambiguities …

Response From Uscis On My Foia Re: Deferred Action, Shoba Wadhia

Shoba Sivaprasad Wadhia

No abstract provided.

Do Chemicals Found In Plastic Toys Pose A Threat To The Children Who Play With Them? The European Community's Attempt To Regulate The Use Of Chemical Plasticizers, Patrick J. Jennings

Penn State International Law Review

No abstract provided.

German Occupational Safety And Health Regulation From An American Perspective, Kenneth S. Kilimnik

Penn State International Law Review

This article presents an inquiry into German occupational safety and health standards as compared to their United States counterpart, the Occupational Safety and Health Act. After an examination of the regulatory framework, standard-setting procedures~ and enforcement procedures of both countries, the author offers realistic recommendations, based on the best of both countries' safety and health provisions.