Law Commons^™

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. …

Approaches To Regulatory Reform In The United States: A Response To The Remarks Of Professors Levin And Freeman, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Of Gift Horses And Great Expectations: Remands Without Vacatur In Administrative Law, Daniel B. Rodriguez

University of San Diego Public Law and Legal Theory Research Paper Series

Administrative law has been shaped over the years by fundamentally practical considerations. Displacement of agency decisions by courts was rare; yet, the omnipresent threat of substantial judicial intrusion surely affected agency decisions. While the Administrative Procedure Act, adopted nearly 60 years ago, provides a comprehensive template for federal agency decisionmaking, what is striking about the APA is how much is left out and how much is left to the discretion of both agencies in implementing regulatory decisions and to the courts in superintending agency action. Given this history, it is hardly surprising that many doctrinal techniques represent the pragmatic effort …

A Reexamination Of Federal Agency Use Of Declaratory Orders, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Cutting Science, Ecology, And Transparency Out Of National Forest Management: How The Bush Administration Uses The Judicial System To Weaken Environmental Laws, William Snape Iii

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Spurious Interpretation Redux: Mead And The Shrinking Domain Of Statutory Ambiguity, Michael P. Healy

Law Faculty Scholarly Articles

In skewering the Supreme Court's recent decision in United States v. Mead Corp., Justice Scalia's rhetoric is exceptional. He derides the decision as "one of the most significant opinions ever rendered by the Court dealing with the judicial review of administrative action. Its consequences will be enormous, and almost uniformly bad." Although Justice Scalia objects to Mead's new and uncertain limits on the applicability of the Chevron doctrine, this Article will focus instead on how Mead employs a method of interpretation imputing a clear intent to Congress, and authorizes courts to discern statutory meaning without strong deference to …

3rd Annual Open Government Summit: Access To Public Records Act & Open Meetings Act, 2001, Department Of The Attorney General, State Of Rhode Island

School of Law Conferences, Lectures & Events

No abstract provided.

Respecting Deference: Conceptualizing Skidmore Within The Architecture Of Chevron, Jim Rossi

Vanderbilt Law School Faculty Publications

This Article addresses critically the implications of the U.S. Supreme Court's recent decision in Christensen v. Harris County, 120 S.Ct. 1655 (2000), for standards of judicial review of agency interpretations of law. Christensen is a notable case in the administrative law area because it purports to clarify application of the deference doctrine first articulated in Skidmore v. Swift & Co., 323 U.S. 134 (1944). By reviving this doctrine, the case narrows application of the predominant approach to deference articulated in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), thus reducing the level of deference in …

Alj Final Orders On Appeal: Balancing Independence With Accountability, Jim Rossi

Vanderbilt Law School Faculty Publications

This essay addresses how ALJ final order authority in many state systems of administrative governance (among them Florida, Louisiana, Missouri, and South Carolina) poses a tension between independence and accountability. It is argued that political accountability is sacrificed where reviewing courts defer to ALJ final orders on issues of law and policy. Standards of review provide state courts with a way of restoring the balance between independence and accountability, but reviewing courts should heighten the deference they give to the agency's legal and policy positions -- giving little or no deference to the ALJ on these issues -- even where …

The Administrative Law Agenda For The Next Decade, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Reconceptualizing Chevron And Discretion: A Comment On Levin And Rubin, Gary S. Lawson

Faculty Scholarship

Professors Ronald Levin and Edward Rubin want to change the way we think about important administrative law concepts. Ronald Levin's paper, The Anatomy of Chevron: Step Two Reconsidered,1 argues that Chevron's currently ill-defined second step ought to be reconceptualized as an application of arbitrary or capricious review. Edward Rubin's paper, Discretion and Its Discontents,3 is part of his ongoing project to reconceptualize the way we think-and, more importantly, the way we talk-about the modern administrative state. Professor Rubin suggests that the oft-used word "discretion" does not usefully describe the bureaucratic operation of the modern managerial state and that it profitably …

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 …

The Apa Procedural Rule Exemption: Looking For A Way To Clear The Air, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Management Of Federal Agency Adjudication, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Deference To Agency Interpretations Of Regulations: A Post-Chevron Assessment, Thomas A. Schweitzer, Russell L. Weaver

Scholarly Works

No abstract provided.

Legislative Oversight Of Administrative Agencies In Minnesota, J. David Prince

Faculty Scholarship

Due to the expanding role of agencies within the Executive branch at both the state and federal level, legislatures are struggling to fulfill their obligation to hold agencies accountable and to modify legislative mandates when necessary. In order for the legislature to fulfill this obligation, it must have the capability to exercise policy formation and oversight goals. This Article will first examine the need for legislative oversight and the legislative oversight mechanism in Minnesota. Next, the Article discusses the legislative controls currently being used at the federal and state level. Executive control mechanisms and their possible use by a legislature …

Regulating The Regulators In New York State: Part I, Harold I. Abramson

Scholarly Works

No abstract provided.

Regulating The Regulators In New York State, Part Ii: The Office Of Business Permits And Regulatory Assistance, Harold I. Abramson

Scholarly Works

No abstract provided.

Federal Agency Adjudications: Trying To See The Forest And The Trees, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

A Fresh Look At Agency "Discretion", John M. Rogers

Law Faculty Scholarly Articles

Lawyers who represent or litigate against government agencies must wrestle so frequently with the concept of agency "discretion" that they may be forgiven for believing that the term is devoid of intrinsic meaning—a chameleon deriving substance only from its particular context. For instance, mandamus will lie only for ministerial acts, as opposed to "discretionary" ones. Agency acts that are "by law committed to agency discretion" are not reviewable in court under the federal Administrative Procedure Act (APA). However, agency actions are reviewed for "abuse of discretion." On the other hand, tort suits against the government will not be allowed for …

Federal Administrative Law Judges: A Focus On Our Invisible Juridicary, Jeffrey Lubbers

Articles in Law Reviews & Other Academic Journals

No abstract provided.

Kentucky Law Survey: Administrative Law, John M. Rogers, Michael H. Sims

Law Faculty Scholarly Articles

This article provides a survey of administrative law in the Commonwealth of Kentucky, including discussions of de novo review and the delegation doctrine.

Report Of The Committee On Agency Rule Making, Ralph F. Fuchs

Articles by Maurer Faculty

No abstract provided.

Conclusion (Symposium On Administrative Law And Procedure), Ralph F. Fuchs

Articles by Maurer Faculty

No abstract provided.

Introduction By Chairman (Symposium On Administrative Law And Procedure), Ralph F. Fuchs

Articles by Maurer Faculty

No abstract provided.