Law Commons^™

Assessing Visions Of Democracy In Regulatory Policymaking, Shoba Sivaprasad Wadhia, Christopher J. Walker

Journal Articles

Motivated in part by Congress’s failure to legislate, presidents in recent years seem to have turned even more to the regulatory process to make major policy. It is perhaps no coincidence that the field of administrative law has similarly seen a resurgence of scholarship extolling the virtues of democratic accountability in the modern administrative state. Some scholars have even argued that bureaucracy is as much as if not more democratically legitimate than Congress, either in the aggregative or deliberative sense, or both.

In our contribution to this Ensuring Democratic Accountability in the Administrative State Symposium, we make a modest intervention …

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

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.

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: 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.

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 …

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 …

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 …

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.

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 …