Law Commons^™

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

High‐Frequency Trading And The New Stock Market: Sense And Nonsense, Merritt B. Fox, Lawrence R. Glosten, Gabriel V. Rauterberg

Articles

The stock market has been transformed during the last 25 years. Human suppliers of liquidity like the NASDAQ dealers and NYSE specialists have been replaced by algorithmic market making; stocks that once traded on a single venue now trade across twelve exchanges and a multitude of alternative trading systems. New venues like dark pools, and new participants like high‐frequency traders, have emerged to take on prominent roles. This new market has had more than its share of controversy and regulatory scrutiny, particularly in the wake of Michael Lewis’s bestseller Flash Boys. In this article, the authors analyze five of the …

Quacks Or Bootleggers: Who’S Really Regulating Hedge Funds?, Jeremy Kidd

Articles

Influential scholars of corporate law have questioned previous federal interventions into corporate governance, calling it quackery. Invoking images of medical malpractice, these critiques have argued persuasively that Congress, in responding to crises, makes policy that disrupts efficient private rules and established state laws. This Article applies the Bootleggers and Baptists theory to show that Dodd–Frank’s hedge fund rules are more than just negligent or reckless, but designed to benefit special interests that compete with the hedge fund model. Those rules offer no solutions to any real or perceived risks arising from hedge fund investing, but might offer an advantage to …

Indeconstructible: The Triumph Of The Environmental “Administrative State”, Stephen M. Johnson

Articles

Shortly after the 2017 Presidential inauguration, a senior advisor to the President proclaimed that a top priority of the Administration would be the “deconstruction of the administrative state.” A primary target of the Administration’s deconstruction efforts was the U.S. Environmental Protection Agency (“EPA”) and federal environmental regulations.

While the President can use a variety of tools, including the appointment power, budget power, treaty power, and executive orders, to influence the manner in which the EPA and other agencies interpret and enforce laws, the President has very little power to unilaterally “deconstruct the administrative state.” The “administrative state” is a creation …

The Brand-X Effect: Declining Chevron Deference In The 21st Century, Stephen Johnson

Articles

Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc. is the most frequently cited Supreme Court administrative law decision and has generated substantial scholarship over the past thirty-four ears. Almost three decades ago, Robert Glicksman and Christopher Schroeder examined the nature of judicial review of the actions of the Environmental Protection Agency ("EPA") by the federal courts during the agency's first twenty years of existence, focusing, in part, on the changing nature of that review in light of the Chevron decision. Glicksman and Schroeder concluded that the courts aggressively reviewed EPA's actions during the agency's early years, interpreting the …

Regulating By Example, Susan C. Morse, Leigh Osofsky

Articles

Agency regulations are full of examples. Regulated parties and their advisors parse the examples to develop an understanding of the applicable law and to determine how to conduct their affairs. However, the theoretical literature contains no study of regulatory examples or of how they might be interpreted. Courts differ about whether examples serve as an independent source of law. There is uncertainty about the proper role of this frequently used regulatory tool.

In this Article, we argue that regulatory examples make law. Our claim is that, as a default rule, the legal content offered by regulatory examples is coequal with, …

Pragmatism, Pragtivism, And Private Environmental Governance, Joshua Galperin

Articles

This essay is an edited version of a talk presented at the 2017 J.B. & Maurice C. Shapiro Environmental Law Symposium on Private Environmental Governance at the George Washington University. It is adapted from a longer article entitled Trust Me, I’m A Pragmatist: A Partially Pragmatic Critique of Pragmatic Activism, in 42 Colum. J. Envtl. L. 425 (2017).

Board Rooms And Jail Cells- Assessing Ngo Approaches To Private Environmental Governance, Joshua Galperin

Articles

Staff of the Nature Conservancy often find themselves in corporate board rooms. Staff of Greenpeace often find themselves in jail cells. The Nature Conservancy (TNC) prides itself on its non-confrontational, collaborative deal making, partnering closely with corporations like chemical giant Dow and agricultural lightning rod Monsanto. Both Dow and Monsanto, in fact, are members of TNC’s Business Council along with the likes of BP, Shell, and Cargill. Greenpeace, on the other hand, prides itself on direct action, civil disobedience, and non-violent confrontation. Greenpeace has launched combative operations against Dow, Monsanto, and other TNC collaborators. While business partners praise TNC’s cooperative …

Federalism, Convergence, And Divergence In Constitutional Property, Gerald S. Dickinson

Articles

Federal law exerts a gravitational force on state actors, resulting in widespread conformity to federal law and doctrine at the state level. This has been well recognized in the literature, but scholars have paid little attention to this phenomenon in the context of constitutional property. Traditionally, state takings jurisprudence—in both eminent domain and regulatory takings—has strongly gravitated towards the Supreme Court’s takings doctrine. This long history of federal-state convergence, however, was disrupted by the Court’s controversial public use decision in Kelo v. City of New London. In the wake of Kelo, states resisted the Court’s validation of the …

The Broken Medicare Appeals System: Failed Regulatory Solutions And The Promise Of Federal Litigation, Greer Donley

Articles

The Medicare Appeals System is broken. For years, the System has been unable to accommodate a growing number of appeals. The result is a backlog so large that even if no new appeals were filed, it would take the System a decade or more to empty. Healthcare providers wait many years for their appeals to be heard before an Administrative Law Judge (ALJ), and because the government recoups providers' Medicare payments while they wait, the delays cause them serious financial harm. Even worse, providers are more likely than not to prevail before the ALJ, proving that the payment should never …

Visual Rulemaking, Elizabeth G. Porter, Kathryn A. Watts

Articles

Visual politics are seeping into the technocracy. Rulemaking stakeholders—including agencies, the President, and members of the public—are deploying politically tinged visuals to push their agendas at every stage of high-stakes, often virulently controversial, rulemakings. These images, GIFs, and videos usually do not make it into the official rulemaking record, so this new “visual rulemaking” world has not been discussed much by scholars or others.

In this article, we explore the new visual rulemaking culture that emerged in Obama’s presidency, providing examples and discussing relevant policy implications. Although we recognize some risks, we argue that, on balance, visual rulemaking is a …