Law Commons^™

Rise Of The Digital Regulator, Rory Van Loo

Faculty Scholarship

The administrative state is leveraging algorithms to influence individuals’ private decisions. Agencies have begun to write rules to shape for-profit websites such as Expedia and have launched their own online tools such as the Consumer Financial Protection Bureau’s mortgage calculator. These digital intermediaries aim to guide people toward better schools, healthier food, and more savings. But enthusiasm for this regulatory paradigm rests on two questionable assumptions. First, digital intermediaries effectively police consumer markets. Second, they require minimal government involvement. Instead, some for-profit online advisers such as travel websites have become what many mortgage brokers were before the 2008 financial crisis. …

Tip Of The Iceberg Ii: How The Intended-Uses Principle Produces Medical Knowledge And Protects Liberty, Christopher Robertson

Faculty Scholarship

In recent years, the Food and Drug Administration’s pre-market approval process has come under increasing scrutiny as an infringement on liberty and a regulation of speech. In the first part of this symposium contribution, we offer a case study of Seroquel XR, showing how the FDA’s premarket approval process – and the restrictions on “off-label” promotion in particular – caused the drug company to produce and disseminate knowledge about safety and efficacy for new uses. The law successfully resolved the collective action problem of producing knowledge, even while the law protected the liberty of individual doctors and patients to use …

Law And Economics Of Information, Tim Wu

Faculty Scholarship

Information is of enormous importance to contemporary economics, science, and technology. Since the 1970s, economists and legal scholars, relying on a simplified “public good” model of information, have constructed an impressively extensive body of scholarship devoted to the relationship between law and information. The public good model tends to justify law, such as the intellectual property laws or various forms of securities regulation that seek to incentivize the production of information or its broader dissemination. This chapter reviews the public choice model and identifies two recent trends. First, scholars have extended the public good model of information to an ever-increasing …

Debating Autonomous Weapon Systems, Their Ethics, And Their Regulation Under International Law, Kenneth Anderson, Matthew C. Waxman

Faculty Scholarship

An international public debate over the law and ethics of autonomous weapon systems (AWS) has been underway since 2012, with those urging legal regulation of AWS under existing principles and requirements of the international law of armed conflict, on the one side, in argument with opponents who favor, instead, a preemptive international treaty ban on all such weapons, on the other. This Chapter provides an introduction to this international debate, offering the main arguments on each side. These include disputes over defining an AWS, the morality and law of automated targeting and target selection by machine, and the interaction of …

Trade Agreements, Regulatory Sovereignty And Democratic Legitimacy, Bernard Hoekman, Charles F. Sabel

Faculty Scholarship

Governments increasingly are seeking to use bilateral and regional trade agreements to reduce the cost-increasing effects of differences in product market regulation. They also pursue regulatory cooperation independent of trade agreements. It is important to understand what is being done through bilateral or plurilateral mechanisms to address regulatory differences, and to identify what, if any, role trade agreements can play in supporting international regulatory cooperation. This paper reflects on experience to date in regulatory cooperation and the provisions of recent trade agreements involving advanced economies that have included regulatory cooperation. We argue for a re-thinking by trade officials of the …

Overreach And Innovation In Equality Regulation, Olatunde C.A. Johnson

Faculty Scholarship

At a time of heightened concern about agency overreach, this Article highlights a less appreciated development in agency equality regulation. Moving beyond traditional bureaucratic forms of regulation, civil rights agencies in recent years have experimented with new forms of regulation to advance inclusion. This new "inclusive regulation" can be described as more open ended, less coercive, and more reliant on rewards, collaboration, flexibility, and interactive assessment than traditional modes of civil rights regulation. This Article examines the power and limits of this new inclusive regulation and suggests a framework for increasing the efficacy of these new modes of regulation.

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …