Law Commons^™

Self-Regulation For Safety And Security: Final Minutes Or Finest Hour?, Douglas C. Michael

Law Faculty Scholarly Articles

The terrorist attacks of September 11, 2001, and the accounting and auditing crisis later caused by the Enron and Worldcom scandals of that same year, created a great sense of insecurity in many Americans. In this Article, I analyze the federal government's response to crisis. I first define what a crisis is: a sudden, existential threat to which the entity has insufficient resources to respond. I then explain how regulation for safety and security is unique in two aspects: perceptions matter, and the assistance of the regulated entities is essential. I proceed by describing and analyzing the regulatory history and …

Management-Based Strategies For Improving Private Sector Environmental Performance, Cary Coglianese, Jennifer Nash

All Faculty Scholarship

Improvements in environmental quality depend in large measure on changes in private sector management. In recognition of this fact, government and industry have begun in recent years to focus directly on shaping the internal management practices of private firms. New management-based strategies can take many forms, but unlike conventional regulatory approaches they are linked by their distinctive focus on management practices, rather than on environmental technologies or emissions targets. This article offers the first sustained analysis of both public and private sector initiatives designed specifically to improve firms' environmental management. Synthesizing the results of a conference of leading scholars and …

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

The Irrational Auditor And Irrational Liability, Adam C. Pritchard

Articles

This Article argues that less liability for auditors in certain areas might encourage more accurate and useful financial statements, or at least equally accurate statements at a lower cost. Audit quality is promoted by three incentives: reputation, regulation, and litigation. When we take reputation and regulation into account, exposing auditors to potentially massive liability may undermine the effectiveness of reputation and regulation, thereby diminishing integrity of audited financial statements. The relation of litigation to the other incentives that promote audit quality has become more important in light of the sea change that occurred in the regulation of the auditing profession …

Can Administrative Regulations Interpret Rights Enforceable Under Section 1983?: Why Chevron Deference Survives Sandoval And Gonzaga, Bradford Mank

Faculty Articles and Other Publications

There is a split in the circuits regarding whether and when agency regulations may establish rights enforceable through 42 U.S.C. Section 1983. In 1987, in Wright v. City of Roanoke, the Supreme Court held that a statute and regulations interpreting the statute could create enforceable rights under Section 1983, but left unclear to what extent it had relied on the regulations alone to reach this conclusion. The District of Columbia Circuit and Sixth Circuit have held that at least some valid federal regulations may create rights enforceable through Section 1983. Concluding that only Congress by enacting a statute may create …

Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg

Articles

Controversy over recent revelations concerning the adverse cardiovascular effects of selective cyclooxygenase- 2 (COX-2) inhibitors has generally been framed as a story of regulatory failure, in which the Food and Drug Administration (FDA) has failed in its mission to protect the public from unsafe products. But this simplistic understanding of the mission of the FDA seems to make failure all but inevitable, if the reliable observation of the risks and benefits of a drug requires rigorous long-term studies. Perhaps in an earlier era the goal of drug regulation was simply to protect the public from poisons. Today, drug regulation guides …

The Internet And Citizen Participation In Rulemaking, Cary Coglianese

All Faculty Scholarship

Each year, regulatory agencies promulgate thousands of important rules through a process largely insulated from ordinary citizens. Many observers believe the Internet could help revolutionize the rulemaking process, allowing citizens to play a central role in the development of new government regulations. This paper expresses a contrary view. In it, I argue that existing efforts to apply information technology to rulemaking will not noticeably affect citizen participation, as these current efforts do little more than digitize the existing process without addressing the underlying obstacles to greater citizen participation. Although more innovative technologies may eventually enable the ordinary citizen to play …

The Sec At 70: Time For Retirement?, Adam C. Pritchard

Articles

As one grows older, birthdays gradually shift from being celebratory events to more reflective occasions. One's 40th birthday is commemorated rather differently from one's 2lst, which is, in turn, celebrated quite differently from one's first. After a certain point, the individual birthdays become less important and it is the milestone years to whch we pay particular attention. Sadly for entities like the Securities and Exchange Commission, it is only the milestone years (the ones ending in five or zero, for some reason), that draw any attention at all. No one held a conference to celebrate the SEC's 67th anniversary. Clearly …

The Sec At 70: Time For Retirement?, Adam C. Pritchard

Articles

The Article proceeds as follows. Part I explains the pathologies of the SEC and explores the relation between those pathologies and the SEC's status as an independent agency. Part II then outlines an alternative regulatory structure primarily situated within the executive branch. I also argue that such a relocation of authority would enhance regulatory effectiveness while simultaneously reducing the cost of excessive regulation. The Article concludes with some thoughts about the viability of my proposal.

The Problem Of New Uses, Rebecca S. Eisenberg

Articles

Discovering new uses for drugs that are already on the market seems like it ought to be the low-lying fruit of biopharmaceutical research and development (R&D). Firms have already made significant investments in developing these drugs and bringing them to market, including testing them in clinical trials, shepherding them through the FDA regulatory approval process, building production facilities, and training sales staff to market them to physicians. By this point, the drugs have begun to enjoy goodwill among patients and physicians and casual observations in the course of clinical experience may point to potential new uses. One might expect that …

E-Rulemaking: Information Technology And The Regulatory Process, Cary Coglianese

All Faculty Scholarship

In order to channel interest in e-rulemaking toward effective and meaningful innovations in regulatory practice, the Kennedy School of Government's Regulatory Policy Program convened two major workshops, bringing together academic experts from computer sciences, law, and public management along with key public officials involved in managing federal regulation. This paper summarizes the discussions that took place at these workshops and develops an agenda for future research on information technology and the rulemaking process. It highlights the institutional challenges associated with using information technology in the federal regulatory process and suggests that in some cases existing rulemaking practices may need to …

Chevron And Preemption, Nina A. Mendelson

Articles

This Article takes a more functional approach to reconciling preemption doctrine with Chevron when Congress has not expressly delegated preemptive authority to an agency, an approach that considers a variety of concerns, including political accountability, institutional competence, and related concerns. The Article assumes that federalism values, such as ensuring core state regulatory authority and autonomy, are important and can be protected through political processes." It argues that although Congress's "regional structure" might hint at great sensitivity to state concerns, it actually may lead Congress to undervalue some federalism benefits that are more national in nature. Meanwhile, executive agencies generally have …

Regulatory Frameworks In International Law, Hilary Charlesworth, Christine M. Chinkin

Book Chapters

Regulatory theory is concerned with how various forms of regulation, including law, govern social interaction. Much of the theoretical work on legal regulation has been developed in the context of domestic law. This chapter examines international law in the particular setting of regulation of outsider entities, such as failed and nascent states, that is where international regulation fills the vacuum caused by the collapse of domestic institutions and the rule of law. Through a brief examination of international regulation in Bosnia–Hercegovina and East Timor, this chapter asks what light a regulatory lens sheds on international law. Drawing on Hugh Collins's …

The Epa's Risky Reasoning, Cary Coglianese, Gary E. Marchant

All Faculty Scholarship

Regulators must rely on science to understand problems and predict the consequences of regulatory actions, but science by itself cannot justify public policy decisions. We review the Environmental Protection Agency's efforts to justify recent changes to its National Ambient Air Quality Standards (NAAQS) for ozone and particulate matter, showing how the agency was able to cloak its policy judgments under the guise of scientific objectivity. By doing so, the EPA evaded accountability for a shifting and incoherent set of policy positions that will have major implications for public health and the economy. For example, even though EPA claimed to base …

Seeking Truth For Power: Informational Strategy And Regulatory Policymaking, Cary Coglianese, Richard Zeckhauser, Edward A. Parson

Articles

Information is the lifeblood of regulatory policy. The effective use of governmental power depends on information about conditions in the world, strategies for improving those conditions, and the consequences associated with deploying different strategies. Indeed, this need for information has led legislatures to create specialized committee structures, delegate policy authority to expert agencies, and develop administrative procedures that encourage analysis. Although legal scholars have extensively debated procedures and reforms designed to improve the analytic and scientific basis of regulatory policymaking, they have paid relatively little attention to how regulators gain the information they need for making and implementing regulatory policy. …

It's Time To Make The Administrative Procedure Act Administrative, Edward L. Rubin

Vanderbilt Law School Faculty Publications

The Administrative Procedure Act (APA) has been out of date from the day it was written because it fails to address the administrative character of the modern state. The APA imposes procedural requirements on agency rulemaking and adjudication, two activities that are singled out because they resemble legislation and judicial decision making in the premodern state. The requirements for adjudication are based on the procedural rules that govern courts; the requirements for rulemaking would be based on the procedural rules that govern legislatures, but because very few such rules exist, they are also based on the rules that govern courts. …

Building Sector-Based Consensus: A Review Of The Epa's Common Sense Initiative, Cary Coglianese, Laurie K. Allen

All Faculty Scholarship

In the late 1990s, the U.S. Environmental Protection Agency (EPA) conducted what the agency considered to be a "bold experiment" in regulatory reinvention, bringing representatives from six industrial sectors together with government officials and NGO representatives to forge a consensus on innovations in public policy and business practices. This paper assesses the impact of the agency's "experiment" - called the Common Sense Initiative (CSI) - in terms of the agency's goals of improving regulatory performance and technological innovation. Based on a review of CSI projects across all six sectors, the paper shows how EPA achieved, at best, quite modest accomplishments. …

Mozart And The Red Queen: The Problem Of Regulatory Accretion In The Administrative State, J.B. Ruhl, James Salzman

Vanderbilt Law School Faculty Publications

Part I of this Article describes the phenomenon of regulatory accretion from several perspectives. We start by using the hypothetical professor-turned- monarch to isolate regulatory accretion as an independent variable in the operation of regulatory systems, separate from the three conventional topics of administrative law scholarship--efficiency, clarity, and institutional accountability. To describe regulatory accretion, we then define a range of metrics, showing that over the last fifty years, regulatory growth has been the rule rather than the exception using virtually any measure. We also show why regulatory law theory suggests that we should expect accretion to be the dominant dynamic …

Self-Regulation And Securities Markets, Adam C. Pritchard

Articles

Enron, Arthur Andersen, Tyco, ImClone, WorldCom, Adelphia - as American investors reel from accounting scandals and self-dealing by corporate insiders, the question of trust in the securities markets has taken on a new urgency. Securities markets cannot operate without trust. Markets known for fraud, insider trading, and manipulation risk a downward spiral as investors depart in search of safer investments. Today, many investors are rethinking the wisdom of entrusting their financial futures to the stock market. Absent trust in the integrity of the securities markets, individuals will hoard their money under the proverbial mattress.

Performance-Based Regulation: Prospects And Limitations In Health, Safety And Environmental Protection, Cary Coglianese, Jennifer Nash

All Faculty Scholarship

Regulation aims to improve the performance of individual and organizational behavior in ways that reduce social harms, whether by improving industry's environmental performance, increasing the safety of transportation systems, or reducing workplace risk. With this in mind, the phrase "performance-based regulation" might seem a bit redundant, since all regulation should aim to improve performance in ways that advance social goals. Yet regulators can direct those they govern to improve their performance in at least two basic ways. They can prescribe exactly what actions regulated entities must take to improve their performance. Or they can incorporate the regulation's goal into the …

Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg

Other Publications

It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …

Agency Burrowing: Entrenching Policies And Personnel Before A New President Arrives, Nina A. Mendelson

Articles

This Article examines executive branch agency actions concluded just before a new President takes office, such as "midnight" rulemaking and late-term hiring and promotion, which Professor Mendelson collectively refers to as "agency burrowing." Congress, the media, and some commentators have portrayed such activities as unsavory power grabs that undermine the President-elect's ability to direct the functions of administrative agencies. Rather than dismissing agency burrowing out of hand, however, Professor Mendelson argues for a more nuanced approach. In some cases, burrowing can make positive contributions to the democratic responsiveness of agencies, agency accountability, and the "rule of law." A fuller analysis …

On The Hijacking Of Airplanes (And Agencies): The Faa, "Agency Capture," And Airline Security, Mark C. Niles

Faculty Publications

(Excerpt)

On September 11, 2001, millions of Americans watched in awe and horror as over a period of less than two hours, a succession of commercial airliners crashed first into the two World Trade Center towers in New York City, and then into the Pentagon in suburban Virginia. As government officials and news organizations scrambled in the first hours after the events to gather information, possible explanations for the crashes were offered. One theory was the obvious assumption that the planes had all been hijacked by "terrorists" using some kind of weapons (guns, bombs) that had presumably been smuggled onto …

Responsible Regulation: A Sensible Cost-Benefit, Risk Versus Risk Approach To Federal Health And Safety Regulation, Steve Calandrillo

Articles

Federal health and safety regulations have saved or improved the lives of thousands of Americans, but protecting our citizens from risk entails significant costs. In a world of limited resources, we must spend our regulatory dollars responsibly in order to do the most we can with the money we have. Given the infeasibility of creating a risk-free society, this paper argues that a sensible cost-benefit, risk versus risk approach be taken in the design of U.S. regulatory oversight policy. The goal should always be to further the best interests of the nation, rather than to satisfy the narrow agenda of …

The Challenge Of Administration By Regulation: Preliminary Findings Regarding The U.S. Government's Venture Capital Funds, Jonathan G.S. Koppell

Publications from President Jonathan G.S. Koppell

This article assesses the ability of elected officials to control public policy as implemented by public/private hybrid organizations, specifically, government venture capital funds. The study reveals greater control over OPIC investment funds than Enterprise Funds despite the existence of more traditional administrative tools of control for Enterprise Funds. This finding suggests that the regulatory infrastructure for hybrid organizations is more determinative of control than the existence (or lack) of traditional administrative control tools. Thus the challenge of hybrid government centers on the development of regulation as a substitute for administration.

Collaborative Approaches To Conservation: A Critical Look, Larry Macdonnell

Strategies in Western Water Law and Policy: Courts, Coercion and Collaboration (Summer Conference, June 8-11)

7 pages.

Differentiating Regulation Of Public And Private Institutions: A Preliminary Inquiry, Jonathan G.S. Koppell

Publications from President Jonathan G.S. Koppell

Twenty years ago, James Q. Wilson and Patricia Rachal argued that government cannot regulate itself. In an era of revived federalism, increased reliance on contractors, and proliferation of quasi-public organizations, the importance of government self-regulation is greater than ever. This paper tests an underlying assumption of Wilson and Rachal's claim: that regulation of public and private organizations can be differentiated. Employing a meta-research design, this pilot study uses existing regulatory case studies to create "regulatory relationship profiles" for public and private organizations. These profiles include information on the structure of the regulator, the intent of the regulation, the enforcement tools …

Electricity Restructuring: A Case Study In Government Regulation, Joseph P. Tomain

Faculty Articles and Other Publications

Understanding the electric power industry can at times be overwhelming given the amount of information, technical jargon, economic forecasts, and detail involved with such a complex field. For the sanguine (or the cynical), the more regulatory or deregulatory initiatives the better because the industry needs the regulatory services of lawyers and other consultants. For the less sanguine (or the less cynical), there is a desire for some stillness in this ongoing change in the regulation of the electric power industry. It is the intent of this article to provide some relief through a brief regulatory history of the electric industry. …

Administrative Law In The 21st Century, Andrew Popper

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Cooperative Implementation Of Federal Regulations, Douglas C. Michael

Law Faculty Scholarly Articles

Professor Michael examines regulatory programs in which the federal government leaves many compliance decisions up to the regulated entities themselves. Drawing on prior research and theory in the area, he concludes that such "cooperative implementation" is feasible if three principles are observed: (1) regulatory standards are written to leave discretion in methods of compliance and that discretion is within the competence of the regulated entities; (2) there are economic incentives to offset the additional costs to these entities; and (3) the entities self-report their own compliance, the agency closely monitors the program, and the agency maintains a residual program of …