Law Commons^™

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah

Faculty Scholarship

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute.

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 …

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 …

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 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 …

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 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. …