Food and Drug Law Commons^™

Patents: Help Or Hindrance To Technology Transfer?, Rebecca S. Eisenberg

Book Chapters

Intellectual property is a broad heading used to refer to a wide variety of rights associated with inventions, discoveries, writings, artistic works, product designs, and designations of the source of goods and services. Patents and trade secrets are the most important of these sorts of intellectual properties in the field of biotechnology. One aspect of intellectual property that distinguishes it sharply from other forms of property-and for some people makes it harder to justify-is that intellectual properties may be possessed and used by many people simultaneously. This is not so for tangible property. If someone borrows my car, I cannot …

What's In A Name - Nothing Good If It's Friday: The Seventh Circuit Invalidates Good Friday Public School Holiday, 29 J. Marshall L. Rev. 1031 (1996), Joanne Yasus

UIC Law Review

No abstract provided.

To Patent Or Not To Patent: Gene Therapy In The European Union And The United States, Nada Jain

Cardozo Journal of International and Comparative Law

The note examines the role of patent systems in the biotechnology industry, particularly in gene therapy, comparing the approaches of the EU and the U.S. It highlights how differences in patentability standards, such as the exclusion of treatment methods in the EU versus broader protections in the U.S., impact innovation and investment. The analysis emphasizes the need for balanced patent policies that foster innovation while addressing ethical concerns.

Meeting The Objectives Of The Mda: Implied Preemption Of State Tort Claims By The Medical Device Amendments, Theresa J. Pulley Radwan

Journal of Law and Health

This article attempts to reconcile the competing purposes of the MDA, and to offer one alternative to effectuate Congress' purposes without preempting some claims and permitting others. First, this article will describe the arrangement of the MDA, including the classification provisions for medical devices and the preemption provision of the MDA. Next, this article will interpret the caselaw regarding preemption in general, and specifically preemption of state tort claims by the MDA. Finally, this article seeks to reconcile two competing purposes of Congress in enacting the MDA through implied preemption of state tort claims, with exceptions for devices which have …

Is Law The Prescription That Can Cure Medicine?, Samuel Gorovitz

Journal of Law and Health

Now medical care has been transformed. We recognize that the human organism is a complex interaction of many different systems-respiratory, circulatory, neurological, digestive, and so on. Some of them can fail and create both problems and opportunities we did not formerly have. One of the opportunities we now have is that we can keep people alive who in an earlier era would not have survived. And one of the problems we now have is also that we can keep people alive who in an earlier era would not have survived. Some of them are kept alive with such diminished capacity …

A False Start?: The Impact Of Federal Policy On The Genotechnology Industry, Michael J. Malinowski, Maureen A. O'Rourke

Faculty Scholarship

Important scientific discoveries in the field of human genetics have been reported in the nation's major newspapers since the beginning of the decade, and these discoveries have given rise to a multi-billion dollar industry. Mr. Malinowski and Professor O'Rourke explore the impact of federal policy on the field and the resulting industry. They argue that federal policy in support of genetics research and development has not been followed by the introduction of regulatory and health policy necessary for the efficient and responsible commercialization of the industiy's products. As a consequence, Mr. Malinowski and Professor O'Rourke suggest, federal policy may have …

Crime And Punishment: Benign Neglect Of Racism In The Criminal Justice System, Angela J. Davis

Scholarly Articles in Law Reviews & Journals

This article is a literary review and analysis of Malign Neglect: Race, Crime, and Punishment in America by Michael Tonry (1995). Part I of this review describes Tonry's analysis of the crime policies of the Reagan and Bush administrations. Part II discusses Tonry's indictment of the War on Drugs and criticizes his failure to acknowledge the effects of discriminatory prosecutorial practices and sentencing laws. Part III critiques Tonry's trivialization of the significance of race discrimination in the criminal justice system more generally. Part IV summarizes Tonry's proposals for change and stresses the importance of documenting, examining, and eliminating racial bias …

Assembling A Theory Of Infringement: Third Party Liability Based On In Vivo Production Of Patented Pharmaceuticals, Eitan Alexander Ogen

Cardozo Law Review

This Note addresses the novel and still unresolved issues raised by the facts underlying Zenith. Part I describes the patent law system and its importance to the pharmaceutical industry. Part II discusses statutory interpretation issues raised by Zenith, relating to direct infringement and associated third party liability, as they pertain to the metabolic processes of living beings. Part III analyzes these issues in light of the existing case law. Part IV integrates the discussion by proposing a set of factors to be weighed in analyzing infringement actions against third parties that is consistent with the prevailing jurisprudence, the …

Reforming Cocaine Sentencing: The New Commission Speaks, David Yellen

Articles

No abstract provided.

A Definite And Permanent Idea - Invention In The Pharmaceutical And Chemical Sciences And The Determination Of Conception In Patent Law, 28 J. Marshall L. Rev. 687 (1995), Jackie Hutter

UIC Law Review

No abstract provided.

Hiv-Aids In The 1990s Aids Law Symposium: Legal, Ethical, And Policy Issues: Introduction, 27 J. Marshall L. Rev. 239 (1994), Michael L. Closen

UIC Law Review

No abstract provided.

Rare Diseases, Drug Development And Aids: The Impact Of The Orphan Drug Act, Michael Henry Davis, Peter S. Arno, Karen Bonuck

Law Faculty Articles and Essays

In this article, we examine the Orphan Drug Act with an eye toward its contribution to the public interest, using AIDS drugs to illustrate many of the central points. The major policy question is, How, if at all, can the act be used to meet the legislative goal of stimulating drug development for small patient populations without resulting in prices that make drugs inaccessible?

Drug Addiction During Pregnancy: A Call For Increased Social Responsibility, Page Mcguire Linden

American University Journal of Gender, Social Policy & the Law

No abstract provided.

Ua12/2/1 Phase - Drugs On Campus, Wku Student Affairs

WKU Administration Documents

Special magazine edition of the College Heights Herald:

• Grundy, Julie. Reality Check: We’re a Town That Has Drugs – Rebecca Maldonado, Student Health Services
• Bernardy, Patrick. Local Drug Use: A Slow But Steady Rise – WKU Police, Audrey Spies
• Quarles, Mitchell. Know the Downers: Jail, Fines, Probation
• Hutchins, Chris. I Did It Because It Was Fun . . . I Did Them to Escape – Drug Abuse
• Bernardy, Patrick. Marijuana No Worse than Alcohol
• Hieb, Dan. Drugs Steal Freedom; Don’t Create It

Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale For The Fda Regulatory Compliance Defense, W. Kip Viscusi, Steven R. Rowland, Howard L. Dorfman, Charles J. Walsh

Vanderbilt Law School Faculty Publications

This Article examines the interaction between direct regulation of pharmaceuticals under the Federal Food Drug and Cosmetic Act (FDCA) and the indirect regulation of pharmaceuticals provided by common law tort incentives. The Article concludes that tort liability is generally inappropriate in cases where manufacturers have complied with the FDCA. The Article begins with a description of the FDCA's operation, and provides an overview of the Food and Drug Administration's (FDA) role in the drug approval process and drug labeling. This overview will demonstrate the need for centralized control over drug labeling. Moreover, we will provide an explanation of the costs …

The Unconstitutional Conditions Doctrine And Mandating Norplant For Women On Welfare Discourse, Laurence C. Nolan

American University Journal of Gender, Social Policy & the Law

No abstract provided.

Book Review: Aids In The World, 16 Hous. J. Int'l L. 709 (1994), Mark E. Wojcik

UIC Law Open Access Faculty Scholarship

No abstract provided.

The Changing Game: The United States Evolving Supply-Side Approach To Narcotics Trafficking, Gregory Wilson

Vanderbilt Journal of Transnational Law

Despite over two decades of focused government efforts, drug use and related problems persist in the United States. Moreover, combatting narcotics trafficking now may be more difficult than ever as the sophisticated Cali Cartel has replaced the Medellin Cartel as the world's preeminent supplier of cocaine. Cali's advanced methods of operation have rendered traditional approaches to battling drugs even less effective than they were previously. Clearly, the United States must establish a new direction in drug law enforcement. This Note traces the development of Colombia's drug cartels from the rise of the Medellin Cartel to the emergence of Cali as …

Anatomy Of A Regulatory Program: Comment On 'Strategic Regulators And The Choice Of Rulemaking Procedures', Jeffrey Lubbers

Scholarly Articles in Law Reviews & Journals

Besides being a very interesting, cogent, and even a tidy study, "Strategic Regulators" sheds some bright light on agency behavior and on the important issue of whether agency rulemaking may be "ossifying."

The study design employed by Hamilton and Schroeder is attractively simple. They started with all of the Environmental Protection Agency's ("EPA's") hazardous waste regulations under the Resource Conservation and Recovery Act ("RCRA") appearing in the Code of Federal Regulations ("CFR"), counting each decimal point CFR number as a separate rule. This yielded 697 rules. They then examined all EPA/RCRA guidance documents issued since the inception of the program …

Daubert's Significance, Thomas G. Field Jr., Colleen M. Keegan

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

The authors review and note the limited reach of Daubert v. Merrell Dow Pharmaceuticals. They also address its implications for concerned non-lawyers.

Losing Sticks From The Bundle: Incompatibility Of Tenancy By The Entireties And Drug Forgeiture Laws, Barbara W. Sharp

Brigham Young University Journal of Public Law

No abstract provided.

Ru-486; Safe? Effective? Banned! Why Would The Food And Drug Administration Ban A Drug With Such Potential?, Mark A. Hernandez

Penn State International Law Review (1982 - 2011)

No abstract provided.

The Tension Between Policy Objectives And Individual Rights: Rethinking Extradition And Extraterritorial Abduction Jurisprudence, Darin A. Bifani

Buffalo Law Review

No abstract provided.

The Hunger Trap: Women, Food, And Self-Determination, Christine Chinkin, Shelley Wright

Michigan Journal of International Law

The authors examine the relationship of international law and food to women by first presenting seven stories of women from different situations, geographical locations, and conditions of affluence or poverty. These individual stories illustrate in a concrete way the circumstances of individual women's lives and their relationship to food and hunger. They are, to some extent, representative of women generally. We then examine the international legal framework and the provisions of international law that might be relevant to relieving the reality of hunger and women's vulnerability to food deprivation.

Prostitution: A Narrative By A Former "Call Girl", Anonymous

Michigan Journal of Gender & Law

Why do women get involved in prostitution? I believe there are two primary causes: money and drugs.

Approval Of Ru-486 As A Postcoital Contraceptive, Kari Hanson

Seattle University Law Review

This Comment argues that if RU-486 were approved as a postcoital contraceptive rather than as an abortifacient, the drug would be of greater overall benefit to women seeking to control their fertility. To support the argument that RU-486 should be approved as a postcoital contraceptive, Part II of this Comment examines the background and development of the drug, the controversy it has engendered, and the drug's recently discovered contraceptive potential. Part III provides a short look at the process by which the FDA approves new drugs and discusses how RU-486 would likely progress through this process. Part IV begins by …

The Impact Of The Cipollone Case On Federal Preemption Law, Richard C. Ausness

Law Faculty Scholarly Articles

The United States Supreme Court handed down an opinion in the Cipollone case on June 24, 1992. Justice Stevens, writing for the majority, concluded that the Federal Cigarette Labeling and Advertising Act preempted all tort claims against cigarette manufacturers based on failure to provide adequate warnings about the health risks of smoking. However, the Court also held that claims based on breach of express warranty, misrepresentation, and conspiracy were not preempted by the Act. Thus, although Cipollone represents a clear victory for tobacco companies, it also leaves the door open for future litigation. The first part of this Article will …

Assisted Conception And Surrogacy - Unfinished Business, 26 J. Marshall L. Rev. 775 (1993), Keith J. Hey

UIC Law Review

No abstract provided.

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.