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Full-Text Articles in Law
The California Greenhouse Gas Waiver Decision And Agency Interpretation: A Response To Galle And Seidenfeld, Nina A. Mendelson
The California Greenhouse Gas Waiver Decision And Agency Interpretation: A Response To Galle And Seidenfeld, Nina A. Mendelson
Articles
Professors Brian Galle and Mark Seidenfeld add some important strands to the debate on agency preemption, particularly in their detailed documentation of the potential advantages agencies may possess in deliberating on preemption compared with Congress and the courts. As they note, the quality of agency deliberation matters to two different debates. First, should an agency interpretation of statutory language to preempt state law receive Chevron deference in the courts, as other agency interpretations may, or should some lesser form of deference be given? Second, should a general statutory authorization to an agency to administer a program and to issue rules …
Nsf Fees, James J. White
Nsf Fees, James J. White
Articles
Overdraft fees now make up more than half of banks' earnings on consumer checking accounts. In the past century, overdrafts have gone from the banker's scourge to the banker's profit center as bankers have learned that there is much to be made on these short term loans at breathtaking interest rates. I note that the federal agencies have been complicit in the growth of this form of lending. I propose that the banks and the agencies recognize the reality and attempt to mitigate these rates by encouraging the development of a competitive market.
Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson
Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson
Articles
Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to-consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise …
The Irrational Auditor And Irrational Liability, Adam C. Pritchard
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 …
Guidance Documents And Regulatory Beneficiaries, Nina A. Mendelson
Guidance Documents And Regulatory Beneficiaries, Nina A. Mendelson
Articles
Federal agencies rely heavily on guidance documents, and their volume is massive. The Environmental Protection Agency and the Occupational Safety and Health Administration recently catalogued over 2000 and 1600 such documents, respectively, issued between 1996 and 1999. These documents can range from routine matters, such as how employees should maintain correspondence files, to broad policies on program standards, implementation, and enforcement. Documents in the latter category include Education Department policies on Title IX implementation, Environmental Protection Agency policies on hazardous waste cleanup, the Food and Drug Administration's policies on food safety and broadcast advertising of pharmaceuticals, and many more.Although these …
Global Administrative Law: The View From Basel, Michael S. Barr, Geoffrey P. Miller
Global Administrative Law: The View From Basel, Michael S. Barr, Geoffrey P. Miller
Articles
International law-making by sub-national actors and regulatory networks of bureaucrats has come under attack as lacking in accountability and legitimacy. Global administrative law is emerging as an approach to understanding what international organizations and national governments do, or ought to do, to respond to the perceived democracy deficit in international law-making. This article examines the Basel Committee on Banking Supervision, a club of central bankers who meet to develop international banking capital standards and to develop supervisory guidance. The Basel Committee embodies many of the attributes that critics of international law-making lament. A closer examination, however, reveals a structure of …
The Problem Of New Uses, Rebecca S. Eisenberg
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 …
The Sec At 70: Time For Retirement?, Adam C. Pritchard
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
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.
Learning The Value Of Drugs - Is Rofecoxib A Regulatory Success Story?, Rebecca S. Eisenberg
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 …
Regulatory Frameworks In International Law, Hilary Charlesworth, Christine M. Chinkin
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 …
Seeking Truth For Power: Informational Strategy And Regulatory Policymaking, Cary Coglianese, Richard Zeckhauser, Edward A. Parson
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. …
Chevron And Preemption, Nina A. Mendelson
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 …
Self-Regulation And Securities Markets, Adam C. Pritchard
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.
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
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
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 Topology Of Uniform Environmental Standards In A Federal System And Why It Matters (Symposium: Environmental Federalism), James E. Krier
On The Topology Of Uniform Environmental Standards In A Federal System And Why It Matters (Symposium: Environmental Federalism), James E. Krier
Articles
Uniform standards are much favored among the makers of federal environmental policy in the United States, which is to say, among the members of Congress. By and large-judging at least from the legislation it has enacted-Congress expects the air and water eventually to meet the same minimum levels of quality in every state in the country, and expects each pollution source in any industrial category or subcategory to be controlled just as much as every other such source, notwithstanding the source's location or other peculiar characteristics. There are exceptions to these generalizations, but they are exceptions and not the rule.1 …
Authority And Responsibility: The Jurisprudence Of Deference, Joseph Vining
Authority And Responsibility: The Jurisprudence Of Deference, Joseph Vining
Articles
he connection between authority and responsibility is such that the one cannot be thought of without the other. In legal method, close reading and rereading of a text marks it as an authoritative text; the presupposition of mind which is necessary to close reading is presupposition of a responsible mind. In the working of institutions that embody authority, the disposition to follow the decisions and statements of a person responsible for a matter inevitably rests upon a presupposition that the decisions and statements followed are those of the responsible person. As that presupposition fades with bureaucratization of decision and writing, …
Direct Judicial Review And The Doctrine Of Ripeness In Administrative Law, Joseph Vining
Direct Judicial Review And The Doctrine Of Ripeness In Administrative Law, Joseph Vining
Articles
There has been recent interest in rationalizing and codifying the opportunities for judicial review of federal administrative determinations outside an enforcement context or special proceedings designated by statute. Abbott Laboratories v. Gardner culminated the development of a strong judicial presumption in favor of such review, founded in general considerations and justified by the broad language of the Administrative Procedure Act (AP A or Act). Since the petitioners in Abbott had theoretical rights to later review of the agency position in enforcement proceedings, the Court called the procedure "pre-enforcement" review. But similar opportunities for immediate and direct review of agency positions …