Food and Drug Law Commons^™

Thalidomide And The Titanic: Reconstructing The Technology Tragedies Of The Twentieth Century, George J. Annas

Faculty Scholarship

The Titanic has become a metaphor for the disastrous consequences of an unqualified belief in the safety and invincibility of new technology. Similarly, the thalidomide tragedy stands for all of the "monsters" that can be inadvertently or negligently created by modern medicine. Thalidomide, once banned, has returned to the center of controversy with the Food and Drug Administration's (FDA's) announcement that thalidomide will be placed on the market for the treatment of erythema nodosum leprosum, a severe dermatological complication of Hansen's disease. Although this indication is very restricted, thalidomide will be available for off-label uses once it is on the …

Teen Smoking Behavior And The Regulatory Environment, Joni Hersch

Vanderbilt Law School Faculty Publications

Professor Hersch argues that most state regulations aimed at fighting teen smoking have had little or no effect. She provides evidence that despite widespread age restrictions on purchasing tobacco, most teens do not consider it difficult for minors to purchase tobacco products within their community. She also presents evidence demonstrating a strong correlation between smoking rates and perceptions about the addictive nature of smoking. These findings suggest that facilitating greater awareness of the addictive power of cigarettes could be effective in curbing teen smoking. She explores the potential for parental restrictions on limiting teen smoking, but provides indications that parents …

Dollywood Is Not Just A Theme Park In Tennessee Anymore: Unwarranted Prohibitory Human Cloning Legislation And Policy Guidelines For A Regulatory Approach To Cloning, 31 J. Marshall L. Rev. 1385 (1998), Paul Tully

UIC Law Review

No abstract provided.

Race For Perfection: Children's Rights And Enhancement Drugs, Therese Powers

Journal of Law and Health

This Note will address the question of what are a child's rights when the child's views differ from his or her parents regarding the child's use or refusal of enhancement drugs such as Ritalin and Human Growth Hormone. This Note will begin with a description of Ritalin and Human Growth Hormone along with the uses and abuses of each drug. It will then discuss the evolution of children's rights dealing with situations such as civil commitment, abortion, and medical treatment over religious objection. Furthermore, it will draw comparisons from the case law in these situations to a child's right to …

Ru 486 Examined: Impact Of A New Technology On An 0 Id Controversy, Gwendolyn Prothro

University of Michigan Journal of Law Reform

Abortion is an extremely divisive issue in American politics and culture. Prothro begins this Article by analyzing the current legal standards governing reproduction, which draw a sharp distinction between abortion and contraception. Prothro then examines the function of RU 486, demonstrating that it acts both as a contraceptive and as an abortifacient. Because of this dual capacity, RU 486 does not fit neatly into the current legal framework. Prothro concludes this Article by arguing that RU 486 should force the Supreme Court to create a new framework for the "procreative right." Prothro argues that this new framework should treat the …

The Food Quality Protection Act Of 1996: Does The Delaney Clause Effectively Protect Against Cancer Or Is It Outdated Legislation, 30 J. Marshall L. Rev. 1127 (1997), Erin E. Moran

UIC Law Review

No abstract provided.

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 …

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.

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.

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.

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 …

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

UIC Law Review

No abstract provided.

Umbilical Cords: The New Drug Connection, Margaret Phillips

Buffalo Law Review

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.

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 …

Neonatal Hiv Testing: Governmental Inspection Of The Baby Factory, 24 J. Marshall L. Rev. 571 (1991), Scott H. Isaacman

UIC Law Review

No abstract provided.

Presumed Innocent: Illinois' Rejection Of Market Share Liability In Smith V. Eli Lilly & (And) Company Is Cause In Fact To Celebrate, 24 J. Marshall L. Rev. 869 (1991), Steven Bonanno

UIC Law Review

No abstract provided.

The Regulation Of Medical Devices: A Comparative Study Of American And Eec Law, Martine Carliese Pijnappels

LLM Theses and Essays

Part I of this thesis will describe the regulation of medical devices in the EEC. Before coming to the actual medical device legislation, a description of the legislative system in Europe will be given, to the extent that it is relevant for the Directives on medical devices. After dealing with the history of Directives and their current contents, the status of the Directives and their future prospects will be discussed. Part II will deal with the regulation of medical devices in the United States under the Food Drug & Cosmetic Act as amended by Medical Device Amendments of 1976. First, …

Elimination Of Process: Will The Biotechnology Patent Protection Act Revive Process Patents, 24 J. Marshall L. Rev. 263 (1990), Kerin Kelly

UIC Law Review

No abstract provided.

Cocaine, Demand, And Addiction: A Study Of The Possible Convergence Of Rational Theory And National Policy, A. Morgan Cloud, Iii

Vanderbilt Law Review

As the "war against drugs" meanders through the century,' policy-makers continue to search for effective strategies for combating the illegal drug industry. For seventy-five years the dominant federal strategy has been to curtail supplies of prohibited substances.' In its many permutations, this supply-side approach has included attempts to eradicate crops, to intercept drugs at the Nation's borders, and to arrest, prosecute, and punish commercial participants at every level of the production and distribution system.

By any rational measure, the supply-side "war against drugs" has failed. Only ten to fifteen percent of the illicit drugs entering the country are intercepted and …

Federal Preemption Of Prescrption Drug Labeling: Antidote For Pharmaceutical Industry Overdosing On State Court Jury Decisions In Products Liability Cases, 22 J. Marshall L. Rev. 629 (1989), John F. Del Giorno

UIC Law Review

No abstract provided.

Dralle V. Ruder: Did The Decision Close The Book On Recovery For Society And Companionship In Illinois Or Just Turn The Page, 22 J. Marshall L. Rev. 721 (1989), Frank I. Powers

UIC Law Review

No abstract provided.

Drug Product Liability And Health Care Delivery Systems, William M. Sage

Faculty Scholarship

This note will use the principles of law and economics to examine the interaction of market structures and product liability rules in a world of imperfect information. The goals of the analysis are to create incentives for optimal care by producers and consumers, induce the socially appropriate amount of consumption of each product (often referred to as the "activity level"), and minimize the costs of bearing the risk of injury. The note will conclude that the existence of health maintenance organizations ("HMOs") and similar prepaid providers with superior information capacity and total patient care responsibility may create a context in …

Commission V. Germany And Article 36 Protection Of Human Life And Health, Mimi Y. Lee

Northwestern Journal of International Law & Business

Free movement of goods is a fundamental principle of the European Community. Article 36 of the EEC Treaty, however, provides important exceptions to the principle of free movement of goods as embodied in Article 30. Recently, the Court of Justice of the European Community ("Court of Justice" or "Court") has begun to develop a significant body of case law on the protection of human health exception of Article 36. This development coincides with the increasing public interest in consumer protection law, particularly with regard to the production of food-stuffs. Commission of the European Communities v. Federal Republic of Germany presents …

The Intentional Creation Of Fetal Tissue For Transplants: The Womb As A Fetus Farm, 21 J. Marshall L. Rev. 853 (1988), James David Roberts

UIC Law Review

No abstract provided.

Reducing Diet-Induced Cancer Through Federal Regulation: Opportunities And Obstacles, Richard A. Merrill

Vanderbilt Law Review

For more than a decade, federal health regulatory agencies have devoted major attention to controlling human exposure to substances believed capable of causing cancer. These efforts have evoked a broad spectrum of criticism; government has been accused of both indolence in the face of an incipient epidemic' and reckless distortion of science to support restrictions on substances that present only trivial risks. A central object of regulatory concern has been the safety of the food supply. At least since the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act),'with its famous Delaney Clause, the Food …

Book Review Of Passion: An Essay On Personality , Richard F. Devlin Frsc

Articles, Book Chapters, & Popular Press

Passion is a cogently structured, compel Jingly argued and seductively enthralling masterpiece which, in years to come, will undoubtedly stand out as an inspirational source for many who seek social transformation. Unger's style, in this essay at least, is lucid and inviting. Substantively, Passion demonstrates not only the depth of his penetrating intellect but also his command of an array of' disciplines. Unger's polymathy is all the more impressive when we remember that ours is an era in which idiosyncratic specialization is the norm.

The Hardest Drug: Heroin And Public Policy, Michigan Law Review

Michigan Law Review

A Review of The Hardest Drug: Heroin and Public Policy by John Kaplan