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International Regulatory Harmonization: A New Era In Prescription Drug Approval, David W. Jordan

Vanderbilt Journal of Transnational Law

Critics of the Food and Drug Administration (FDA) have asserted that the agency's process of reviewing new drugs has long been laden with inefficiency and waste and, as a result, new drugs are not made available to consumers on a timely basis. This Note considers the veracity of this claim by examining the history of prescription drug regulation in the United States and the current procedure by which new drugs are reviewed. This Note also addresses the limited extent to which the FDA has interacted with its foreign counterparts in assessing the safety and efficacy of new drugs and the …

Department Of Food And Agriculture, P. Penn, B. Reznik

California Regulatory Law Reporter

No abstract provided.

Voluntary Intoxication: A Defense To Intentional Injury Exclusion Clauses In Homeowner's Policies?, Tracy E. Silverman

Michigan Law Review

This Note argues that the current voluntary intoxication defense to the intentional injury exclusion clause should be modified to allow insurers subrogation rights against insureds who commit intentional acts while voluntarily intoxicated, subject to an exception for alcoholic insureds who successfully complete alcohol treatment programs. Part I discusses the public policy concerns of victim compensation and deterrence and how they influence courts deciding between the three traditional approaches to "intent." Part II analyzes the impact of these intent standards on courts' decisions to allow a voluntary intoxication defense and concludes that the defense as currently formulated promotes victim compensation at …

Umbilical Cords: The New Drug Connection, Margaret Phillips

Buffalo Law Review

No abstract provided.

Random Drug-Testing Of Public School Student Athletes: A Permissible Search Under The Fourth Amendment, Paul K. Madsen

Brigham Young University Education and Law Journal

No abstract provided.

Exporting United States Drug Law: An Example Of The International Legal Ramifications Of The "War On Drugs", D. Brian Boggess

BYU Law Review

No abstract provided.

Risk And Value Judgments: A Case Study Of The Poison Prevention Packaging Act, William E. Hilton

RISK: Health, Safety & Environment (1990-2002)

Mr. Hilton attempts to show why important choices presented in current proposals to amend child-resistant packaging regulations are fundamentally normative. He then argues that these choices should not be obscured by the technical issues.

Department Of Food And Agriculture, P. Penn, B. Reznik

California Regulatory Law Reporter

No abstract provided.

The Right To Refuse Antipsychotic Drug Treatment And The Supreme Court: Washington V. Harper, Jeannette Brian

Buffalo Law Review

No abstract provided.

International Regulation And Control Of The Production And Use Of Chemicals And Pesticides: Perspectives For A Convention, Hans-Wolfgang Micklitz

Michigan Journal of International Law

A wide variety of instruments and mechanisms for the regulation and control of chemicals and pesticides is already available internationally. What is missing is an analysis that attempts to systematize the different approaches, to create transparency, to define where they overlap, and to discover prospective deficiencies and shortcomings. In order to accomplish this task, this article covers legally binding rules as well as recommendations and codes - the international soft law. The overall purpose is to outline a framework for future international regulation of chemicals and pesticides and to propose an international convention as a possible solution.

The Changing Landscape Of Human Experimentation: Nuremberg, Helsinki, And Beyond, George J. Annas

Faculty Scholarship

Since World War II there have been persistent efforts at both the national and international level to develop rules to protect the rights and welfare of subjects of human experimentation.' These efforts have focused primarily on codifying the rights of subjects, and protecting their welfare by prior peer review of research protocols. In recent years research regulations have been under attack by politicians, drug companies, researchers, and advocacy groups. In less than half a century, human experimentation has been transformed from a suspect activity into a presumptively beneficial activity. With this transformation, traditional distinctions between experimentation and therapy, subject and …

The Patentability And Patent Term Extension Of Lifesaving Drugs: A Deadly Mistake, Jonathan L. Mezrich

Journal of Law and Health

The pharmaceutical business is dominated largely by two types of entities: large, research-intensive corporations, and the smaller "generic" drug "knock-off" artists. because the former organizations have to put so much of their budget into research and development (R&D), a form of investment which is often akin to pouring money into a hole, the 17-year exclusive monopoly of a patient is often the only way such a company can remain profitable. However, because of a concern for public safety, all substances prepared for human consumption must be put through extensive testing by the FDA. This testing could take a long period …

Book Review: The Aspirin Wars: Money, Medicine, And 100 Years Of Rampant Competition, Joseph A. Page

Georgetown Law Faculty Publications and Other Works

The recent identification of a possible link between the long-term use of aspirin and a reduced incidence of colon and rectal cancer has directed renewed attention to a familiar household medication whose origins reach back to antiquity.

Competition from other painkillers had begun to cut deeply into the market once dominated by aspirin-based products when studies indicated the possibilities, first that the regular consumption of aspirin might prevent second heart attacks, and later that it might lower the risk of heart attacks in healthy individuals. If these two discoveries, as well as the new finding about colon and rectal cancers, …