Health Law and Policy Commons^™

The Information Quality Act: The Little Statute That Could (Or Couldn't?) Applying The Safe Drinking Water Act Amendments Of 1996 To The Federal Communications Commission, Kellen Ressmeyer

Federal Communications Law Journal

In December 2000, Congress passed the Information Quality Act - a two sentence rider to a 712-page Appropriations Bill. The Information Quality Act, which seeks to ensure the quality of government-disseminated information, places the White House Office of Management and Budget in a supervisory role. The Office of Management and Budget subsequently finalized a set of mandatory Guidelines applicable to all federal agencies. Among other things, the Guidelines require adherence to the scientific standard articulated in the 1996 Amendments to the Safe Drinking Water Act where such agencies engage in risk analysis to human health, safety, and the environment. As …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

On March 31, 2006, the European Commission published Council Regulation (EC) No. 510/2006 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs. This new regulation repealed Council Regulation (EEC) No. 2081/92 On the Protection of Geographical Indications and Designations of Origin for Agricultural Products and Foodstuffs mainly to bring Community law into conformity with the World Trade Organization (WTO) agreements and the findings of a recent WTO panel. Under the new Regulation, persons in third countries (non-European Union members) are entitled to address applications for the protection of geographic names and statements of objection …

United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook

Journal of Food Law & Policy

This update summarizes some of the significant changes and developments in food law over the first half of 2006. Not every change in food law is included; instead, this update provides a starting point for scholars, practitioners, food industry members, and policymakers determined to understand the shaping of food law in modern society. Tracing the development of food law through these updates, which appear in each issue of the Journal of Food Law & Policy, also provides historical context for the development of significant food law issues over time. New developments in state law, while certainly important and deserving in …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner

West Virginia Law Review

No abstract provided.

Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp

ExpressO

This brief comment suggests where the anti-eminent domain movement might be heading next.

Zoning And Eminent Domain Under The New Minimum Scrutiny, John H. Ryskamp

ExpressO

Recently the Supreme Court has made it clearer that minimum scrutiny is a factual analysis. Whether in any government action there is a rational relation to a legitimate interest is a matter of determining whether there is a policy maintaining important facts. This has come about in the Court’s emerging emphasis on developing fact-based criteria for determining government purpose. Thus, those who want to affect zoning and eminent domain outcomes should look to what the Court sees as important facts, and whether government action is maintaining those facts with its proposed land use or eminent domain action.

Health Courts And Malpractice Claims Adjudication Through Medicare: Some Questions, Timothy Stoltzfus Jost

Scholarly Articles

No abstract provided.

"For It's One, Two, Three Strikes, You're Out . . .", 39 J. Marshall L. Rev. 493 (2006), Kaycee Hopwood

UIC Law Review

No abstract provided.

Shifting Science, Considered Costs, And Static Statutes: The Interpretation Of Expansive Environmental Legislation, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Congress often passes expansive legislation, frequently environmental and public health regulatory statutes, where both the definition of those items being regulated and the mandate have significant breadth. How should these provisions be construed? While it is difficult to establish a model which determines whether to broadly or narrowly construe an expansive statutory provision, factors that impact this choice include the existence of express limitations on the mandate, understandings of congressional intent, the need to avoid regulation that might do more harm than good, the nature of the regulated item, and intervening circumstances such as new understandings in law, policy, or …

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.

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. …

Taking The Stand: The Lessons Of The Three Men Who Took The Japanese American Internment To Court, Lorraine K. Bannai

Seattle Journal for Social Justice

No abstract provided.

Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor

ExpressO

No abstract provided.

Examining The Underlying Purposes Of Municipal And Statewide Smoking Bans, Mark J. Horvick

Indiana Law Journal

No abstract provided.

A Right To No Meaningful Review: The Aftermath Of Shalala V. Illinois Council On Long Term Care, Inc., Ruqaiijah Ayanna Yearby

ExpressO

A RIGHT TO NO MEANINGFUL REVIEW: THE AFTERMATH OF SHALALA v. ILLINOIS COUNCIL ON LONG TERM CARE, INC. Ruqaiijah A. Yearby

The Due Process Clause of the Fifth Amendment has been perverted in the federal administrative system. Federal agencies, such as the U.S. Department of Health and Human Services (HHS), regularly deprive individuals of liberty and property with little to no review. In its regulation of the health care industry through the Medicare program, HHS often turns a blind eye to procedural Due Process protections, such as providing individuals an opportunity to challenge the deprivation of property at a hearing, …

Organizational Misconduct: Beyond The Principal-Agent Model, Kimberly D. Krawiec

ExpressO

This article demonstrates that, at least since the adoption of the Organizational Sentencing Guidelines in 1991, the United States legal regime has been moving away from a system of strict vicarious liability toward a system of duty-based organizational liability. Under this system, organizational liability for agent misconduct is dependant on whether or not the organization has exercised due care to avoid the harm in question, rather than under traditional agency principles of respondeat superior. Courts and agencies typically evaluate the level of care exercised by the organization by inquiring whether the organization had in place internal compliance structures ostensibly designed …

Against “Individual Risk”: A Sympathetic Critique Of Risk Assessment, Matthew D. Adler

Faculty Scholarship

No abstract provided.

Weight-Loss Advertising Too Good To Be True: Are Manufacturers Or The Media To Blame?, Jodie Sopher

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Preemption And Regulatory Failure, David C. Vladeck

Georgetown Law Faculty Publications and Other Works

This symposium was convened to address the growing and seemingly conflicting jurisprudence governing federal preemption of state damage actions. One way to evaluate the evolution of preemption law is to examine it through the lens of litigation under the preemption provision of the 1976 Medical Device Amendments ("MDA") to the federal Food, Drug, and Cosmetic Act - a provision that in many respects is typical of express preemption provisions in regulatory statutes and has spawned a high volume of litigation. The question raised in cases under the MDA is whether the Act's preemption provision nullifies state damage actions based on …

Health Law And Administrative Law: A Marriage Most Convenient, Timothy Stoltzfus Jost

Scholarly Articles

This symposium explores the complex relationship between health law and administrative law. It is based on the observation that these two fields of law are peculiarly intertwined. It attempts to understand why this is so, as well as whether it is necessary and whether it is desirable. Would we as a society, that is, be better off if health law were less permeated by administrative law? Even if we would be better off, is it indeed possible to extricate health law from administrative law? This essay begins by defining health law and administrative law. It then proceeds to describe the …

Managed Care’S Crimea: Medical Necessity, Therapeutic Benefit, And The Goals Of Administrative Process In Health Insurance, William M. Sage

Faculty Scholarship

This Essay explores the concept of medical necessity as it has evolved in the judicial and administrative oversight of managed care. The goals of the Essay are to illustrate the range of plausible rationales for establishing administrative procedures to govern medical necessity disputes, and to demonstrate the difficulty of incorporating into those procedures the most important professional and social responsibilities of managed care in today’s health care system. Part I of the Essay explains the ideological and practical significance of medical necessity as managed care has evolved. Part II examines medical necessity as a legal problem, and questions whether current …

Medicare Coverage Decision-Making And Appeal Procedures: Can Process Meet The Challenge Of New Medical Technology?, Eleanor D. Kinney

Washington and Lee Law Review

No abstract provided.

The Administration Of Medicare: A Neglected Issue, Thomas H. Stanton

Washington and Lee Law Review

No abstract provided.

Academics And Bioterrorists: New Thinking About The New Terror, Richard Danzig

Cardozo Law Review

No abstract provided.

Drug Regulations And The Constitution After Western States, Margaret Gilhooley

University of Richmond Law Review

No abstract provided.

The Next Wave: Federal Regulatory, Intellectual Property, And Tort Liability Considerations For Medical Device Software, 2 J. Marshall Rev. Intell. Prop. L. 259 (2003), Paul A. Mathew

UIC Review of Intellectual Property Law

Counsel for the medical software technologist faces an unusually complex, ongoing, high-stakes challenge. Counsel operates in a special field of commercial, legal and regulatory forces: (1) intellectual property laws which govern the expression and protection of commercial rights derived from advances in medical science and technology; (2) existing and proposed contracts/warranty laws that govern technological commercial relationships; (3) negligence, professional liability, and product liability laws that govern the marketing of medical technologies; and, (4) a new body of regulation derived from the power of the federal government to indirectly provide for the safety, effectiveness, privacy, and security of medical technologies …

Developing A Full And Fair Evidentiary Record In A Nonadversary Setting: Two Proposals For Improving Social Security Disability Adjudications, Jeffrey Lubbers, Frank S. Bloch, Paul R. Verkuil

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Department Of Managed Health Care, Amy Kay Boatright, Kelly Ann Debie, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.