Digital Commons Network^™

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

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In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Since the passage of DSHEA nearly thirty years ago, U.S. adults have steadily increased their annual consumption of dietary supplements. The once $4 billion industry comprising approximately 4,000 products has swelled to a $40 billion trade with anywhere from 50,000 to 80,000 dietary supplements available over-the-counter.

Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under …

Building Better Compliance, Cary Coglianese

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A response to Dorothy Lund & Natasha Sarin: "Corporate Crime and Punishment: An Empirical Study"

President Biden's Executive Order On Competition: An Antitrust Analysis, Herbert J. Hovenkamp

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In July, 2021, President Biden signed a far ranging Executive Order directed to promoting competition in the American economy. This paper analyzes issues covered by the Order that are most likely to affect the scope and enforcement of antitrust law. The only passage that the Executive Order quoted from a Supreme Court antitrust decision captures its antitrust ideology well – that the Sherman Act:

rests on the premise that the unrestrained interaction of competitive forces will yield the best allocation of our economic resources, the lowest prices, the highest quality and the greatest material progress, while at the same time …

Moving Toward Personalized Law, Cary Coglianese

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Rules operate as a tool of governance by making generalizations, thereby cutting down on government officials’ need to make individual determinations. But because they are generalizations, rules can result in inefficient or perverse outcomes due to their over- and under-inclusiveness. With the aid of advances in machine-learning algorithms, however, it is becoming increasingly possible to imagine governments shifting away from a predominant reliance on general rules and instead moving toward increased reliance on precise individual determinations—or on “personalized law,” to use the term Omri Ben-Shahar and Ariel Porat use in the title of their 2021 book. Among the various technological, …

Algorithm Vs. Algorithm, Cary Coglianese, Alicia Lai

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Critics raise alarm bells about governmental use of digital algorithms, charging that they are too complex, inscrutable, and prone to bias. A realistic assessment of digital algorithms, though, must acknowledge that government is already driven by algorithms of arguably greater complexity and potential for abuse: the algorithms implicit in human decision-making. The human brain operates algorithmically through complex neural networks. And when humans make collective decisions, they operate via algorithms too—those reflected in legislative, judicial, and administrative processes. Yet these human algorithms undeniably fail and are far from transparent. On an individual level, human decision-making suffers from memory limitations, fatigue, …

From Negative To Positive Algorithm Rights, Cary Coglianese, Kat Hefter

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Artificial intelligence, or “AI,” is raising alarm bells. Advocates and scholars propose policies to constrain or even prohibit certain AI uses by governmental entities. These efforts to establish a negative right to be free from AI stem from an understandable motivation to protect the public from arbitrary, biased, or unjust applications of algorithms. This movement to enshrine protective rights follows a familiar pattern of suspicion that has accompanied the introduction of other technologies into governmental processes. Sometimes this initial suspicion of a new technology later transforms into widespread acceptance and even a demand for its use. In this paper, we …

Due Process In Antitrust Enforcement: Normative And Comparative Perspectives, Christopher S. Yoo, Yong Huang, Thomas Fetzer, Shan Jiang

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Due process in antitrust enforcement has significant implications for better professional and accurate enforcement decisions. Not only can due process spur economic growth, raise government credibility, and limit the abuse of powers according to law, it also promotes competitive reforms in monopolized sectors and curbs corruption. Jurisdictions learn from the best practices in the investigation process, decisionmaking process, and the announcement and judicial review of antitrust enforcement decisions. By comparing the enforcement policies of China, the European Union, and the United States, this article calls for better disclosure of evidence, participation of legal counsel, and protection of the procedural and …

Administrative Law In The Automated State, Cary Coglianese

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In the future, administrative agencies will rely increasingly on digital automation powered by machine learning algorithms. Can U.S. administrative law accommodate such a future? Not only might a highly automated state readily meet longstanding administrative law principles, but the responsible use of machine learning algorithms might perform even better than the status quo in terms of fulfilling administrative law’s core values of expert decision-making and democratic accountability. Algorithmic governance clearly promises more accurate, data-driven decisions. Moreover, due to their mathematical properties, algorithms might well prove to be more faithful agents of democratic institutions. Yet even if an automated state were …

Ai In Adjudication And Administration, Cary Coglianese, Lavi M. Ben Dor

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The use of artificial intelligence has expanded rapidly in recent years across many aspects of the economy. For federal, state, and local governments in the United States, interest in artificial intelligence has manifested in the use of a series of digital tools, including the occasional deployment of machine learning, to aid in the performance of a variety of governmental functions. In this paper, we canvas the current uses of such digital tools and machine-learning technologies by the judiciary and administrative agencies in the United States. Although we have yet to see fully automated decision-making find its way into either adjudication …

Relentless Pursuits: Reflections Of An Immigration And Human Rights Clinician On The Past Four Years, Sarah Paoletti

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No abstract provided.

Deploying Machine Learning For A Sustainable Future, Cary Coglianese

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To meet the environmental challenges of a warming planet and an increasingly complex, high tech economy, government must become smarter about how it makes policies and deploys its limited resources. It specifically needs to build a robust capacity to analyze large volumes of environmental and economic data by using machine-learning algorithms to improve regulatory oversight, monitoring, and decision-making. Three challenges can be expected to drive the need for algorithmic environmental governance: more problems, less funding, and growing public demands. This paper explains why algorithmic governance will prove pivotal in meeting these challenges, but it also presents four likely obstacles that …

Private Company Lies, Elizabeth Pollman

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Rule 10b-5’s antifraud catch-all is one of the most consequential pieces of American administrative law and most highly developed areas of judicially-created federal law. Although the rule broadly prohibits securities fraud in both public and private company stock, the vast majority of jurisprudence, and the voluminous academic literature that accompanies it, has developed through a public company lens.

This Article illuminates how the explosive growth of private markets has left huge portions of U.S. capital markets with relatively light securities fraud scrutiny and enforcement. Some of the largest private companies by valuation grow in an environment of extreme information asymmetry …

Regulation Of Algorithmic Tools In The United States, Christopher S. Yoo, Alicia Lai

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Policymakers in the United States have just begun to address regulation of artificial intelligence technologies in recent years, gaining momentum through calls for additional research funding, piece-meal guidance, proposals, and legislation at all levels of government. This Article provides an overview of high-level federal initiatives for general artificial intelligence (AI) applications set forth by the U.S. president and responding agencies, early indications from the incoming Biden Administration, targeted federal initiatives for sector-specific AI applications, pending federal legislative proposals, and state and local initiatives. The regulation of the algorithmic ecosystem will continue to evolve as the United States continues to search …

Dimensions Of Delegation, Cary Coglianese

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How can the nondelegation doctrine still exist when the Supreme Court over decades has approved so many pieces of legislation that contain unintelligible principles? The answer to this puzzle emerges from recognition that the intelligibility of any principle dictating the basis for lawmaking is but one characteristic defining that authority. The Court has acknowledged five other characteristics that, taken together with the principle articulating the basis for executive decision-making, constitute the full dimensionality of any grant of lawmaking authority and hold the key to a more coherent rendering of the Court’s application of the nondelegation doctrine. When understood in dimensional …

Our Administered Constitution: Administrative Constitutionalism From The Founding To The Present, Sophia Z. Lee

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This article argues that administrative agencies have been primary interpreters and implementers of the federal Constitution throughout the history of the United States, although the scale and scope of this "administrative constitutionalism" has changed significantly over time as the balance of opportunities and constraints has shifted. Courts have nonetheless cast an increasingly long shadow over the administered Constitution. In part, this is because of the well-known expansion of judicial review in the 20th century. But the shift has as much to do with changes in the legal profession, legal theory, and lawyers’ roles in agency administration. The result is that …

Occupational Licensing And The Limits Of Public Choice Theory, Gabriel Scheffler, Ryan Nunn

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Public choice theory has long been the dominant lens through which economists and other scholars have viewed occupational licensing. According to the public choice account, practitioners favor licensing because they want to reduce competition and drive up their own wages. This essay argues that the public choice account has been overstated, and that it ironically has served to distract from some of the most important harms of licensing, as well as from potential solutions. We emphasize three specific drawbacks of this account. First, it is more dismissive of legitimate threats to public health and safety than the research warrants. Second, …

Procedural Fairness In Antitrust Enforcement: The U.S. Perspective, Christopher S. Yoo, Hendrik M. Wendland

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Due process and fairness in enforcement procedures represent a critical aspect of the rule of law. Allowing greater participation by the parties and making enforcement procedures more transparent serve several functions, including better decisionmaking, greater respect for government, stronger economic growth, promotion of investment, limits corruption and politically motivated actions, regulation of bureaucratic ambition, and greater control of agency staff whose vision do not align with agency leadership or who are using an enforcement matter to advance their careers. That is why such distinguished actors as the International Competition Network (ICN), the Organization for Economic Cooperation and Development (OECD), the …

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

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Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons.

Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing …

Chapter: “Health Law And Ethics”, Allison K. Hoffman, I. Glenn Cohen, William M. Sage

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Law and ethics are both essential attributes of a high-functioning health care system and powerful explainers of why the existing system is so difficult to improve. U.S. health law is not seamless; rather, it derives from multiple sources and is based on various theories that may be in tension with one another. There are state laws and federal laws, laws setting standards and laws providing funding, laws reinforcing professional prerogatives, laws furthering social goals, and laws promoting market competition. Complying with law is important, but health professionals also should understand that the legal and ethical constraints under which health systems …

The Operational And Administrative Militaries, Mark P. Nevitt

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This Article offers a new way of thinking about the military. The U.S. military’s existing legal architecture arose from tragedy: in response to operational military failures in Vietnam, the 1980 failed Iranian hostage rescue attempt and other military misadventures, Congress revamped the Department of Defense (DoD)’s organization. The resulting law, the Goldwater-Nichols Act, formed two militaries within the DoD that endure to this day. These two militaries – the operational military and the administrative military – were once opaque to the outside observer but have emerged from the shadows in light of recent conflicts. The operational military remains the focus …

Rethinking Judicial Review Of High Volume Agency Adjudication, Jonah B. Gelbach, David Marcus

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Article III courts annually review thousands of decisions rendered by Social Security Administrative Law Judges, Immigration Judges, and other agency adjudicators who decide large numbers of cases in short periods of time. Federal judges can provide a claim for disability benefits or for immigration relief the sort of consideration that an agency buckling under the strain of enormous caseloads cannot. Judicial review thus seems to help legitimize systems of high volume agency adjudication. Even so, influential studies rooted in the gritty realities of this decision-making have concluded that the costs of judicial review outweigh whatever benefits the process creates.

We …

The Ecology Of Transparency Reloaded, Seth F. Kreimer

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As Justice Stewart famously observed, "[t]he Constitution itself is neither a Freedom of Information Act nor an Official Secrets Act." What the Constitution's text omits, the last two generations have embedded in "small c" constitutional law and practice in the form of the Freedom of Information Act and a series of overlapping governance reforms including Inspectors General, disclosure of political contributions, the State Department’s “Dissent Channel,” the National Archives Information Security Oversight Office, and the publication rights guaranteed by New York Times v. United States. These institutions constitute an ecology of transparency.

The late Justice Scalia argued that the …

Regulating By Robot: Administrative Decision Making In The Machine-Learning Era, Cary Coglianese, David Lehr

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Machine-learning algorithms are transforming large segments of the economy, underlying everything from product marketing by online retailers to personalized search engines, and from advanced medical imaging to the software in self-driving cars. As machine learning’s use has expanded across all facets of society, anxiety has emerged about the intrusion of algorithmic machines into facets of life previously dependent on human judgment. Alarm bells sounding over the diffusion of artificial intelligence throughout the private sector only portend greater anxiety about digital robots replacing humans in the governmental sphere. A few administrative agencies have already begun to adopt this technology, while others …

An Administrative Right To Be Free From Sexual Violence? Title Ix Enforcement In Historical And Institutional Perspective, Karen M. Tani

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One of the most controversial administrative actions in recent years is the U.S. Department of Education’s campaign against sexual assault on college campuses. Using its authority under Title IX of the Education Amendments of 1972 (mandating nondiscrimination on the basis of sex in all educational programs and activities receiving federal funds), the Department’s Office for Civil Rights (OCR) has launched an enforcement effort that critics denounce as aggressive, manipulative, and corrosive of individual liberties. Missing from the commentary is a historically informed understanding of why this administrative campaign unfolded as it did. This Essay offers crucial context by reminding readers …

Making Treaty Implementation More Like Statutory Implementation, Jean Galbraith

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Both statutes and treaties are the “supreme law of the land,” and yet quite different practices have developed with respect to their implementation. For statutes, all three branches have embraced the development of administrative law, which allows the executive branch to translate broad statutory directives into enforceable obligations. But for treaties, there is a far more cumbersome process. Unless a treaty provision contains language that courts interpret to be directly enforceable, they will deem it to require implementing legislation from Congress. This Article explores and challenges the perplexing disparity between the administration of statutes and treaties. It shows that the …

The Bounds Of Executive Discretion In The Regulatory State, Cary Coglianese, Christopher S. Yoo

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What are the proper bounds of executive discretion in the regulatory state, especially over administrative decisions not to take enforcement actions? This question, which, just by asking it, would seem to cast into some doubt the seemingly absolute discretion the executive branch has until now been thought to possess, has become the focal point of the latest debate to emerge over the U.S. Constitution’s separation of powers. That ever‐growing, heated debate is what motivated more than two dozen distinguished scholars to gather for a two‐day conference held late last year at the University of Pennsylvania Law School, a conference organized …

Public Laws And Private Lawmakers, Kimberly L. Wehle

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The Obama Administration's "Clean Power Plan" for addressing industrial carbon emissions is controversial as a matter of environmental policy. It also has important constitutional implications. The rule was initially crafted not by officers or employees of the Environmental Protection Agency, but by two private lawyers and a scientist with industry ties. Private parties operate extra-constitutionally, and no existing legal doctrine tethers constitutional scrutiny to the nature of the power delegated to them. The nondelegation doctrine applies to delegations by Congress-not to agencies' subdelegations of legislative power to private parties. The other doctrinal lens for reviewing rulemaking by entities other than …

Something Old, Something New: Reflections On The Sex Bureaucracy, Melissa Murray, Karen M. Tani

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This essay responds to “The Sex Bureaucracy,” in which Jacob Gersen and Jeannie Suk identify a “bureaucratic turn in sex regulation” — one that has expanded the reach of sexual regulation to include “nonviolent, non-harassing, voluntary sexual conduct” (or in their words, “ordinary sex”). In their view, the Department of Education’s campaign against sexual assault on college campuses epitomizes this bureaucratic shift. While applauding the authors’ attention to the intersection of sexuality and governance, we challenge their account of the “bureaucratic turn” as an unprecedented event. Drawing on examples from across U.S. history, we show how administrative agencies and unelected …

Separation Of Powers Legitimacy: An Empirical Inquiry Into Norms About Executive Power, Cary Coglianese, Kristin Firth

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The continuing debate over the President’s directive authority is but one of the many separation-of-powers issues that have confronted courts, scholars, government officials, and the public in recent years. The Supreme Court, for instance, has considered whether the President possesses the power to make appointments of agency heads without Senate confirmation during certain congressional recesses. The Court has passed judgment recently, but has yet to resolve fully, questions about Congress’s authority to constrain the President’s power to remove the heads of administrative agencies. And the Court has considered the limits on Congress’s ability to delegate legislative authority to other rulemaking …

Outsourcing, Data Insourcing, And The Irrelevant Constitution, Kimberly L. Wehle

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No abstract provided.