Law Commons^™

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 …

The Law And Economics Of Behavioral Regulation, Avishalom Tor

Journal Articles

This article examines the law and economics of behavioral regulation (“nudging”), which governments and organizations increasingly use to substitute for and complement traditional instruments. To advance its welfare-based assessment, Section 1 examines alternative nudging definitions and Section 2 considers competing nudges taxonomies. Section 3 describes the benefits of nudges and their regulatory appeal, while Section 4 considers their myriad costs—most notably the private costs they generate for their targets and other market participants. Section 5 then illustrates the assessment of public and private welfare nudges using cost-benefit analysis, cost-effectiveness analysis, and rationality-effects analysis.

Dual Regulation Of Insurance, Christopher French

Journal Articles

Since this country was created, the insurance industry has been principally regulated by the states with infrequent Congressional interventions. As the insurance industry has evolved in recent decades, however, individual states have become unable to adequately regulate some insurers, such as multinational insurers and foreign insurers, because they lack jurisdiction over such entities. Simply having the federal government assume responsibility for regulating insurers will not solve the current regulatory problems, however, because Congress’ past forays into regulating certain areas of insurance generally have yielded poor results. Consequently, this Article makes the novel proposal and argument that, with the creation of …

Constraining Monitors, Veronica Root

Journal Articles

Monitors oversee remediation efforts at dozens, if not hundreds, of institutions that are guilty of misconduct. The remediation efforts that the monitors of today engage in are, in many instances, quite similar to activities that were once subject to formal court oversight. But as the importance and power of monitors has increased, the court’s oversight of monitors and the agreements that most often result in monitorships has, at best, been severely diminished and, at worst, vanished altogether.

The lack of regulation governing monitors is well documented; yet, the academic literature on monitorships to date has largely taken the state of …

Demand Response And Market Power, Bruce R. Huber

Journal Articles

In her article, Bypassing Federalism and the Administrative Law of Negawatts, Sharon Jacobs educates her readers about the concept of demand response, and then describes its propagation in recent years while making the broader argument that the Federal Energy Regulatory Commission (“FERC”) — the federal government’s principal energy regulator — has engaged in a strategy of “bypassing federalism” that may entail more costs than benefits. Professor Jacobs is right to call attention to demand response and to FERC’s approach to matters of jurisdictional doubt. While I share many of her concerns about boundary lines in a federal system, I argue …

Food Miles: Environmental Protection Or Veiled Protectionism?, Meredith Kolsky Lewis, Andrew D. Mitchell

Journal Articles

This article examines the international trade, environmental, and development implications of campaigns to convince consumers to make food purchases based on food miles. Buying food from nearby sources has become a popular objective. One of the unmistakable messages of the “locavore” movement is that importing food – particularly food that comes from far away – causes environmental harm. The theory is that transporting food long distances results in the release of high levels of greenhouse gases (GHGs) into the atmosphere and is thus a dangerous contributor to climate change. Proponents of this view therefore argue that “food miles” – the …

The Durability Of Private Claims To Public Property, Bruce R. Huber

Journal Articles

Property rights and resource use are closely related. Scholarly inquiry about their relation, however, tends to emphasize private property arrangements while ignoring public property — property formally owned by government. The well-known tragedies of the commons and anticommons, for example, are generally analyzed with reference to the optimal form and degree of private ownership. But what about property owned by the state? The federal government alone owns nearly one-third of the land area of the United States. One could well ask: is there a tragedy associated with public property, too? If there is, here is what it might look like: …

Jurisdictional Standards (And Rules), Adam I. Muchmore

Journal Articles

This Article uses the jurisprudential dichotomy between two opposing types of legal requirements — “rules” and “standards” — to examine extraterritorial regulation by the United States. It argues that there is natural push toward standards in extraterritorial regulation because numerous institutional actors either see standards as the best option in extraterritorial regulation or accept standards as a second-best option when their first choice (a rule favorable to their interests or their worldview) is not feasible.

The Article explores several reasons for this push toward standards, including: statutory text, statutory interpretation theories, the nonbinary nature of the domestic/foreign characterization, the tendency …

Animal Mobilegalities: The Regulation Of Animal Movement In The American City, Irus Braverman

Journal Articles

The initial focus of “animobility” scholarship has been on the dynamic physical geographies of animals. This article extends the meaning of animobility to explore the ways in which animals are affected — and, in fact, constituted — by law, as well as the ways in which they affect and constitute law, which I call “mobilegalities.” Specifically, I ask how animobility in contemporary American cities translates into the animals’ legal mobility, and how laws can adapt to animobility and the ensuing mobilegality by setting “traps” that then immobilize the animals. This article demonstrates, finally, that law is not a static narrative …

International Activity And Domestic Law, Adam I. Muchmore

Journal Articles

This invited essay explores the ways States use their domestic laws to regulate activities that cross national borders. Domestic-law enforcement decisions play an underappreciated role in the development of international regulatory policy, particularly in situations where the enforcing State's power to apply its law extraterritorially is not contested. Collective action problems suggest there will be an undersupply of enforcement decisions that promote global welfare and an oversupply of enforcement decisions that promote national welfare. These collective action problems may be mitigated in part by government networks and other forms of regulatory cooperation.

How The "Unintended Consequences" Story Promotes Unjust Intent And Impact., Martha T. Mccluskey

Journal Articles

In the guise of critical analysis of the limits of law reform, the familiar phrase “unintended consequences” serves to rationalize rising inequality and to undermine democratic accountability. This paper examines how the phrase promotes a story of disentitlement, using the recent financial crisis as an example. By naturalizing inequality as power beyond law’s reach, this phrase’s message that benign law is likely to bring unequal consequences dovetails with a seemingly contradictory message that benign intent, rather than harmful impact, is what primarily counts for evaluating inequality.

As part of a LatCrit XV symposium taking a “bottom-up” view of the recent …

Pornography As Pollution, John C. Nagle

Journal Articles

Pornography is often compared to pollution. But little effort has been made to consider what it means to describe pornography as a pollution problem, even as many legal scholars have concluded that the law has failed to control internet pornography. Opponents of pornography maintain passionate convictions about how sexually-explicit materials harm both those who are exposed to them and the broader cultural environment. Viewers of pornography may generally hold less fervent beliefs, but champions of free speech and of a free internet object to anti-pornography regulations with strong convictions of their own. The challenge is how to address the widespread …

Private Regulation And Foreign Conduct, Adam I. Muchmore

Journal Articles

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens of …

Lawyers Without Borders, Catherine A. Rogers

Journal Articles

Professional regulation of attorneys is still attempting to catch up with the burgeoning international legal profession, which until recently has been wholly unregulated. The primary effort has been through revisions to Model Rule 8.5 to extend the reach of the Rule to international cases and professional activities in foreign countries. Because Rule 8.5 was drafted for domestic multi-jurisdiction practice, however, it is based on assumptions about territoriality and the historical relationship between the jurisdiction of tribunals and the licensing of attorneys that are simply inapposite in international settings. As a result, applying Rule 8.5 to international tribunals and international advocacy …

Lawyers Without Borders, Catherine A. Rogers

Journal Articles

Professional regulation of attorneys is still attempting to catch up with the burgeoning international legal profession, which until recently has been wholly unregulated. The primary effort has been through revisions to Model Rule 8.5 to extend the reach of the Rule to international cases and professional activities in foreign countries. Because Rule 8.5 was drafted for domestic multi-jurisdiction practice, however, it is based on assumptions about territoriality and the historical relationship between the jurisdiction of tribunals and the licensing of attorneys that are simply inapposite in international settings. As a result, applying Rule 8.5 to international tribunals and international advocacy …

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

Journal Articles

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

Insurer Moral Hazard In The Workers' Compensation Crisis: Reforming Cost Inflation, Not Rate Suppression, Martha T. Mccluskey

Journal Articles

This article challenges the standard story of the insurance crisis that led to the near-collapse and major reform of a number of states’ workers’ compensation programs in the 1980s and 1990s.

In the prevailing account, insurance costs rose due to expanding costs of benefits for injured workers’, much of which was blamed on wasteful or abusive "moral hazard" by workers and their lawyers and doctors. Because state regulators had substantial power to control insurance rates, this account claims governments tried to suppress prices in the face of rising benefit costs in a misguided attempt to avoid political trade-offs between labor …

Federal Power Over Indians: Its Sources, Scope, And Limitations, Nell Jessup Newton

Journal Articles

Judicial deference to federal legislation affecting Indians is a theme that has persisted throughout the two-hundred-year history of American Indian law. The Supreme Court has sustained nearly every piece of federal legislation it has considered directly regulating Indian tribes, whether challenged as being beyond federal power or within that power but violating individual rights.' This judicial deference often has been justified by invoking federal plenary power to regulate Indian affairs and the political question doctrine's requirement of deference to the political branches. Indeed, not until 1977 did the Court explicitly repudiate use of the political question doctrine to bar equal …