Administrative Law Commons^™

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

Faculty Scholarship

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 …

A Congressional Review Act For The Major Questions Doctrine, Christopher J. Walker

Articles

Last Term, the Supreme Court recognized a new major questions doctrine, which requires Congress to provide clear statutory authorization for an agency to regulate on a question of great economic or political significance. This new substantive canon of statutory interpretation will be invoked in court challenges to federal agency actions across the country, and it will no doubt spark considerable scholarly attention. This Essay does not wade into those doctrinal or theoretical debates. Instead, it suggests one way Congress could respond: by enacting a Congressional Review Act for the major questions doctrine. In other words, Congress could establish a fast-track …

Promoting Regulatory Prediction, Jonathan S. Masur, Jonathan R. Nash

Faculty Articles

It is essential for environmental protection that private actors be able to anticipate government regulation. If, for instance, the Biden Administration is planning to tighten regulations of greenhouse gas emissions, it is imperative that private companies anticipate this regulatory change now, not a few years from now after they have constructed even more coal- and gas-fired power plants. Those additional power plants will mean more irreversible greenhouse gases, and these plants can be politically challenging to shutter once built. The point is general to private actors making decisions in the shadow of potential government regulation. Better information about future government …

Medicare "Bankruptcy", Matthew B. Lawrence

Faculty Articles

Medicare, the social insurance program for the elderly and disabled, is once again facing insolvency. Spending from the program’s hospital insurance trust fund is predicted to exceed the accumulated payroll taxes and other revenues that support the fund within the next five years, leaving Medicare unable to honor some of its obligations. Yet, what happens if and when Medicare becomes insolvent has not previously been explored in legal scholarship and is not addressed in statute or regulation. This Article confronts for the first time the major legal questions that Medicare insolvency would present. It explains what policymakers could do to …

Delegating Climate Authorities, Mark P. Nevitt

Faculty Articles

The science is clear: the United States and the world must take dramatic action to address climate change or face irreversible, catastrophic planetary harm. Within the U.S.—the world’s largest historic emitter of greenhouse gas emissions—this will require passing new legislation or turning to existing statutes and authorities to address the climate crisis. Doing so implicates existing and prospective delegations of legislative authority to a large swath of administrative agencies. Yet congressional climate decision-making delegations to any executive branch agency must not dismiss the newly resurgent nondelegation doctrine. Described by some scholars as the “most dangerous idea in American law,” the …

Pathways To Preferences For Collaborative Conflict Resolution: Disputants’ Process Goals Drive Preferences, Ashley Votruba, Jared Noetzel, Abigail L. Herzfeld

Department of Psychology: Faculty Publications

Understanding individuals’ preferences for how to resolve conflict—specifically legal disputes—has long interested researchers, particularly those considering procedural justice. This study considers the impact of relational factors that influence individuals’ preferences for dispute resolution processes for civil legal issues. Specifically, it examines the impact of self-construal and the relationship between the parties in conflict on preferences for specific features of dispute resolution processes and considers the role of underlying resolution goals as potential mediators in a parallel mediation model. Using a novel paradigm in which the outcome variables of interest focused on specific dispute resolution process features allowed the researchers to …

What Does Effective Government Have To Do With The Constitution?, Gillian E. Metzger

Faculty Scholarship

Nearly a million people dead and counting. More than 77 million infected, a little less than one-fifth of the total infections worldwide. The United States has had more deaths than any other country, and its COVID-19 death rate of 276 per 100,000 people is the highest among the world’s wealthiest nations. Blacks, Hispanics, and Native Americans are hospitalized and die at significantly higher rates than whites. Some bright lights exist too, one being the speedy development of vaccines and their deployment in 2021 – although there, too, both the national government and the states have sometimes stumbled. Another is legislative …

The Right To Effective Self-Government, Katharina Pistor

Faculty Scholarship

Protecting individual rights is a core feature of democratic constitutionalism. The centralization of the means of coercion gave rise to the Hobbesian dilemma, the fear that this enormous power might be abused unless it be effectively controlled. In addition to dividing power among different branches of government or sharing it between the federation and its units, constitutions have fortified individual rights with judicial review and enforcement mechanisms against the executive branch to rein in state power.

Proposing a collective right to effective self-government sits oddly with a vision that pitches free individuals against an all-powerful state. Such a right can, …

The Alchemy Of Effective Auditor Regulation, Sarah J. Williams

Lewis & Clark Law Review

The audit profession has repeatedly failed in its obligation to accurately opine on financial statements prepared by companies that trade in U.S. markets. The list of entities that have contributed to the quest for effective regulation of these auditors is long; it includes the American Institute of Certified Public Accountants (AICPA), the U.S. Securities and Exchange Commission (SEC), Congress, outside directors of public companies, and the Public Company Accounting Oversight Board (PCAOB), a recent congressional creation. Yet, despite 50 years of effort, the formula for efficacious oversight of the audit profession remains elusive.

This Article is the first in a …

Don’T “Estop” Me Now: Estoppel, Government Contract Law, And Sovereign Immunity If Congress Retroactively Repeals Public Service Loan Forgiveness, Michael J. Cole

Lewis & Clark Law Review

This Article discusses whether Direct Loan borrowers can obtain recourse against the federal government using either promissory or equitable estoppel theories if Congress retroactively repeals the Public Service Loan Forgiveness (“PSLF”) program. The Article addresses various hurdles, including sovereign immunity and the Sovereign Acts Doctrine, which the borrowers would encounter at litigation. It concludes that, despite likely overcoming these hurdles, in many cases, the plaintiff-borrowers’ government contract law claims would likely still fail to win on their merits. The Article also contends that most, if not all, equitable estoppel claims would likely fail before a court. The Article then offers …

“I’D Never Let My Sister Do It”: Exploitation Within The U.S. Au Pair Program, Victoria Bejarano Hurst Muirhead

Lewis & Clark Law Review

The U.S. Au Pair Program, administered by the U.S. Department of State, is many things all at once: a cultural exchange program, a guest worker program, and an affordable childcare program. The hybrid nature of the program makes it attractive to foreign young people and U.S. host families alike. However, the hybrid nature of the program also renders au pairs susceptible to exploitation, particularly where labor rights are concerned. This Comment argues that in order to effectively mitigate the exploitation of au pairs, the Department of State must strengthen protections for au pairs and improve its oversight of the program, …

New Democracy: Finding Hope In The Past And Heavy Lifting For The Future, Kate Andrias

Faculty Scholarship

Bill Novak has written a remarkable book that debunks the myth that the American state was weak and unconcerned with providing for social welfare until it was transformed by the extraordinary leadership of President Franklin Delano Roosevelt. He shows with compelling detail that the New Deal was not a magical or anomalous moment, but rather came about because of legal, institutional, socioeconomic, and democratic “heavy lifting” that occurred over the course of the preceding seventy years.

A Scholarly Error And A Larger Truth, Philip A. Hamburger

Faculty Scholarship

Can Congress delegate its legislative power? The question has stimulated much recent scholarship, including Professor Nicholas Parrillo’s detailed study of the 1798 federal tax act. According to his article, the statute delegated binding rulemaking power. My recent SSRN draft Nondelegation Blues questions Parrillo’s conclusion. But now in this blog, he suggests that my article misreads his argument.

Of Presidents, Democracy, And Congress, Gillian E. Metzger

Faculty Scholarship

Put one good thing down for the Trump presidency: It inspired Peter Shane to take up the pen to detail the fallacies of unitary executive theory and other forms of aggressive presidentialism. In Democracy’s Chief Executive, Shane provides a clear and powerful account for why unitary executive theory — the claim that the president can control the entire federal bureaucracy, which Shane notes usually includes the propositions that the president can fire any subordinate executive branch officer at will and determine how any discretion delegated to the executive branch is exercised — fails. As he explains, such propositions are …

What Is The Law's Role In A Recession?, Gabriel Rauterberg, Joshua Younger

Faculty Scholarship

In March 2020, the world faced not only a public health emergency but also one of the most profound shocks to the global economy in the modern era — a shock deeper and broader than any other in eighty years. Never before had virtually all of the world’s economies suffered a contraction at the same time (Tooze, p. 5). Global output decreased by nearly 3.4% in 2020, the largest contraction since the Second World War. The United States saw the largest recorded demand shock in its history (-32.9%), and the unemployment rate peaked around 15% during 2020, higher than at …

Presidential Signing Statements In The Federal Bureaucracy, Joshua M. Feinzig

Faculty Scholarship

This Note examines the relationship between presidential signing statements and administrative decision-making over the Obama and Trump presidencies and from a variety of institutional angles, updating previous studies rooted in a narrow set of observations from the mid-2000s. It identifies occasions where presidents, agencies, and other Executive Branch actors have referenced statements in the course of justifying inactions, rules and regulations, and legal characterizations of executive entities. In moving the focus beyond a strict causation approach to measuring influence, which suffers from proof limitations and indeterminacy, the Note offers a more modest formulation of statements’ contextual and atmospheric role in …

The Multi-Level Marketing Pandemic, Christopher G. Bradley, Hannah E. Oates

Law Faculty Scholarly Articles

Among the societal effects of the COVID-19 pandemic has been a sharp rise in the activities of multi-level marketing companies (MLMs). MLMs are business enterprises in which participants seek not only to sell products to friends, family, and social media contacts, but also to recruit them as MLM participants, with the promise of "building their own business from home."

False promises often pervade MLM sales pitches. Evidence shows that few participants see even a dollar of profit from their MLM work; the vast majority of recruits quickly abandon their MLM dreams and lose their investments. Yet the pitch has become …

Interring The Unitary Executive, Christine Chabot

Faculty Publications & Other Works

The President's power to remove and control subordinate executive officers has sparked a constitutional debate that began in 1789 and rages on today. Leading originalists claim that the Constitution created a “unitary executive” President whose plenary removal power affords her “exclusive control” over subordinates' exercise of executive power. Text assigning the President a removal power and exclusive control appears nowhere in the Constitution, however, and unitary scholars have instead relied on select historical understandings and negative inferences drawn from a supposed lack of independent regulatory structures at the Founding. The comprehensive historical record introduced by this Article lays this debate …

Good Intentions: Administrative Fiat And The General Welfare Exclusion, Samuel D. Brunson, Christian A. Johnson

Faculty Publications & Other Works

Since its introduction in 1913, the federal income tax has viewed income expansively, subjecting virtually all types of enrichment as gross income unless Congress explicitly exempted the income from taxation. But in the income tax’s second decade, the Bureau of Internal Revenue created an exception to the broad reach, an exception not grounded in any type of Congressional enactment. The Bureau’s practice of excluding certain benefits began innocuously in the late 1930s by excluding certain social security benefits from gross income. Over the decades, the IRS has used what it now refers to as the “general welfare exclusion” to exclude …

The Lawyer's Role In Improving "Humane" Meat Labeling, Ryne P. Smith

Mitchell Hamline Law Review

No abstract provided.