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Articles 121 - 150 of 191
Full-Text Articles in Food and Drug Law
Border Patrol, Carl E. Schneider
Border Patrol, Carl E. Schneider
Articles
Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …
Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone
Toward A More Communitarian Future? Fukuyama As The Fundamentalist Secular Humanist, June Carbone
Michigan Law Review
With The End of History and the Last Man, Francis Fukuyama established himself as the prophet of liberal democracy and free markets, heralding their triumph as the only form of governance capable of commanding legitimacy. Asked to reflect on his predictions a decade later, Fukuyama concluded that the greatest threat to liberalism comes from biotechnology because it alone has the potential to remake the human nature that liberal democracy was designed to serve. Fukuyama makes a compelling case that biotechnology may produce developments that should concern us; he is ironically less persuasive in articulating a liberal-democratic framework for governing the …
Reaching Through The Genome, Rebecca S. Eisenberg
Reaching Through The Genome, Rebecca S. Eisenberg
Book Chapters
The past two decades have been a period of rapid evolution in the science of biotechnology and therefore in patent strategies, if not in patent law itself. Patent law takes a long time to catch up with science, and commentators take a long time to catch up with the law, but patent lawyers don’t have that luxury. They have to keep ahead of the game, figuring out claiming strategies that allow their clients to capture the value of future discoveries. I want to discuss some of these strategies today.
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Patents, Product Exclusivity, And Information Dissemination: How Law Directs Biopharmaceutical Research And Development, Rebecca S. Eisenberg
Other Publications
It's a great honor for me to be invited to deliver the Levine Distinguished Lecture at Fordham, and a great opportunity to try out some new ideas before this audience. As some of you know, I've been studying the role of patents in biomedical research and product development ("R&D") for close to twenty years now, with a particular focus on how patents work in "upstream" research in universities and biotechnology companies that are working on research problems that arise prior to "downstream" product development. But, of course, the patent strategies of these institutions are designed around the profits that everyone …
Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas
Disciplining Globalization: International Law, Illegal Trade, And The Case Of Narcotics, Chantal Thomas
Michigan Journal of International Law
This Article is the first in a series of studies of the globalization of illicit markets. My theses are as follows: First, the increase in international trade in illicit products and services parallels the growth in international trade more generally that accompanies the phenomenon of globalization. Second, at the same time that most international trade law has moved toward a posture of liberalization, there has been a movement to strengthen the prohibition and punishment of trade in illicit transactions. Third, the mechanisms that have developed to regulate this prohibition constitute a significant development in the international legal order.
Going To Pot, Carl E. Schneider
Going To Pot, Carl E. Schneider
Articles
In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Allowing universities to patent the results of government-sponsored research sometimes works against the public interest.
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Bayh-Dole Reform And The Progress Of Biomedicine, Arti K. Rai, Rebecca S. Eisenberg
Articles
Advances in fundamental biomedical research play an important and growing role in the development of new therapeutic and diagnostic products. Although the development of pharmaceutical end products has long been a proprietary enterprise, biomedical research comes from a very different tradition of open science. Within this tradition, long-standing norms call for relatively unfettered access to fundamental knowledge developed by prior researchers. The tradition of open science has eroded considerably over the past quarter century as proprietary claims have reached farther upstream from end products to cover fundamental discoveries that provide the knowledge base for future product development.
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Key Disclosure Issues For Life Sciences Companies: Fda Product Approval, Clinical Test Results, And Government Inspections, William O. Fisher
Michigan Telecommunications & Technology Law Review
The government, particularly the Food and Drug Administration ("FDA"), heavily regulates the life sciences industry. FDA actions can have an extraordinary influence on the fortunes of biotechnology companies. Timely FDA approval of a drug or medical device can permit a company to exploit an inviting market window. FDA product approval is, in turn, tied to clinical test results which demonstrate "efficacy" and safety. Delayed approval, unfavorable test results, or the denial of an FDA application may ruin a company. Beyond the FDA product approval process and related testing lie FDA inspections and the possibility that the government will investigate charges …
Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity
Seeds Of Distrust: Federal Regulation Of Genetically Modified Foods, Thomas O. Mcgarity
University of Michigan Journal of Law Reform
This Article describes and evaluates the existing federal regulatory regime for protecting public health from risks posed by foods derived from GM plants. Part I briefly describes the technology involved in genetically modifying plants and relates the ongoing debates over the risks and benefits of GM food plants. Part II examines in detail the regulatory regime that has evolved in the United States to regulate the safety of GM foods, focusing in particular upon the pervasive role that the substantial equivalence doctrine has played in that regime. Finally, Part III suggests a more precautionary approach toward regulating GM foods that …
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
The Role Of Patents In Exploiting The Genome, Rebecca S. Eisenberg
Book Chapters
The sequencing of the human genome is a great scientific accomplishment that opens the door to further scientific inquiry of a sort that would otherwise be impossible. In addition to being passionately interested in the patent issues this research presents, as a legal scholar I have a long-standing interest in the role of intellectual property in interactions between the public and private senators and between universities and private firms in research science, with a focus on biomedial research. However, although the Human Genome Project has provided a rich terrain for exploring these issues, I am puzzled that intellectual property issues …
Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse
Democracy, Science, And Free Trade: Risk Regulation On Trial At The World Trade Organization, Robert Howse
Michigan Law Review
Among the most common critiques of globalization is that it increasingly constrains the ability of democratic communities to make unfettered choices about policies that affect the fundamental welfare of their citizens, including those of health and safety, the environment, and consumer protection. Traditionally, free trade rules were about constraining border measures such as tariffs and quantitative restrictions on imports. Increasingly, however, such rules include requirements and constraints addressed directly to domestic regulation. For example, a country's policies with respect to intellectual property rights or its regulatory approach to network industries, such as telecommunications, may now be fundamentally shaped by rules …
Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector
Extraditing Mexican Nationals In The Fight Against International Narcotics Crimes, Joshua S. Spector
University of Michigan Journal of Law Reform
In recent years, Mexican narcotics trafficking has become a major threat to the security of the Americas. Mexican narco-traffickers have used their wealth and violence to corrupt political and judicial systems and avoid effective prosecution or penalty in Mexican courts. Historically, Mexico has refused to extradite its nationals in reliance on Mexican law prohibiting the extradition of nationals in all but "exceptional" cases. This Note argues that Mexico should take a step toward controlling the cross-border narcotics trade and recognize international drug trafficking as an "exceptional" crime. Upon recognizing narcotics crimes as "exceptional," Mexico should then begin extraditing Mexican narco-traffickers …
Food Stamp Trafficking: Why Small Groceries Need Judicial Protection From The Department Of Agriculture (And From Their Own Employees), Elliot Regenstein
Food Stamp Trafficking: Why Small Groceries Need Judicial Protection From The Department Of Agriculture (And From Their Own Employees), Elliot Regenstein
Michigan Law Review
A neon sign in the window of 7-Van Drugs reads "Food Stamps," but the contradictory truth is posted inside on a handwritten sign taped to a thick pane of bulletproof plastic. 7-Van Drugs sits at the intersection of Seven Mile Road and Van Dyke in northern Detroit, where it has "serv[ ed] the community since 1948 at the same corner." Inside 7-Van is an array of staple foods and basic household cleaning items, and there is a small pharmacy in the back. Customers must use a turnstile to pass their purchases through the bulletproof plastic to the cashier. There are …
Proposition 215: De Facto Legalization Of Pot And The Shortcomings Of Direct Democracy, Michael Vitiello
Proposition 215: De Facto Legalization Of Pot And The Shortcomings Of Direct Democracy, Michael Vitiello
University of Michigan Journal of Law Reform
In 1996, California voters passed Proposition 215, officially titled The Compassionate Use Act of 1996, and popularly known as the "medical marijuana" initiative. This initiative allows qualifying people and their caregivers immunity from criminal prosecution when the state attempts to charge them with possession or cultivation of marijuana. Professor Vitiello uses the medical marijuana initiative as a case study illustrating flaws in California's ballot initiative process He examines the history of the initiative process in California, misleading aspects of the campaign for Proposition 215, and ambiguities in the proposition's language. Concluding that the initiative process as it now stands fosters …
A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue
A Critique Of The Proposed National Tobacco Resolution And A Suggested Alternative, Jon D. Hanson, Kyle D. Logue
Articles
The first criticism is that the proposed resolution would not require manufacturers and, in tum, consumers to pay anything approaching the true total costs of cigarettes, costs that we estimate to be at least $7 per pack, a number that is considerably higher than other estimates that have been reported in the media. Our estimate includes some, but not all, of the costs borne ultimately by smokers themselves, by smokers' insurers, and by individuals injured by second-hand smoke. It includes only future costs and excludes many of those. So, for example, the figure includes neither the health-care costs that have …
Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore
Smokers' Compensation: Toward A Blueprint For Federal Regulation Of Cigarette Manufacturers, Jon D. Hanson, Kyle D. Logue, Michael S. Zamore
Articles
Although nothing is certain in Washington, sweeping federal legislation in the cigarette area is more likely now than has ever been the case. Congress is currently considering several proposals for comprehensive federal regulation of the cigarette market, a market that has until now gone largely untouched by government intervention. Among those proposals, the one that has received the most attention, and the one that in fact motivated policy makers to look anew at the problems posed by cigarettes, is the proposed national tobacco resolution (the "Proposed Resolution"). The Proposed Resolution, which has been advanced by a coalition of state attorneys …
The Costs Of Cigarettes: The Economic Case For Ex Post Incentive-Based Regulation, Jon D. Hanson, Kyle D. Logue
The Costs Of Cigarettes: The Economic Case For Ex Post Incentive-Based Regulation, Jon D. Hanson, Kyle D. Logue
Articles
Cigarette smoking causes over 420,000 deaths annually in the United States, roughly twenty percent of all U.S. deaths, making cigarettes the single greatest preventable cause of death in this country. Indeed, tobacco kills more people every year than alcohol, illicit drugs, automobile accidents, violent crime, and AIDS combined. And not only are cigarettes deadly to smokers; they kill nonsmokers as well. According to a recent report from the Environmental Protection Agency (EPA), the "sidestream" or "passive" smoke from cigarettes - so-called environmental tobacco smoke (ETS) - is responsible annually for approximately 3000 lung cancer deaths, between 150,000 and 300,000 lower …
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
Statutory Compliance And Tort Liability: Examining The Strongest Case, Michael D. Green
University of Michigan Journal of Law Reform
Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA's vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues …
Ru 486 Examined: Impact Of A New Technology On An 0 Id Controversy, Gwendolyn Prothro
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 …
Gluttony, William I. Miller
Gluttony, William I. Miller
Articles
Gluttony does not have the grandeur of pride, the often brilliant strategic meanness of envy and avarice, the glory of wrath. It does manage to gain some small allure by its association with lust, its sexy sibling sin of the flesh. Yet there is something irrevocably unseemly about gluttony, vulgar and lowbrow, self-indulgent in a swinish way. Gluttony is not the stuff of tragedy or epic. Imagine Hamlet too fat to take revenge or Homer making his topic the gluttony of Achilles rather than his wrath. With gluttony, compare pride and anger, sins that mark the grand action of revenge, …
When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher
When Discretion Leads To Distortion: Recognizing Pre-Arrest Sentence-Manipulation Claims Under The Federal Sentencing Guidelines, Jeffrey L. Fisher
Michigan Law Review
This Note argues that sentence manipulation should be a legally viable partial defense - a defense that does not warrant complete exoneration, but does warrant a reduced sentence when the government's investigative techniques place a quantity of drugs before the court that overrepresents the defendant's culpability, or individual blameworthiness. Part I describes the policies and objectives that underlie the Guidelines, but then demonstrates how the rigid application of quantity-based sentencing provisions can lead to sentence manipulation that thwarts these goals, particularly the goal of sentencing according to culpability. Part II describes how courts have responded to sentence manipulation claims. It …
Patents: Help Or Hindrance To Technology Transfer?, Rebecca S. Eisenberg
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 …
The Hunger Trap: Women, Food, And Self-Determination, Christine Chinkin, Shelley Wright
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
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.
Voluntary Intoxication: A Defense To Intentional Injury Exclusion Clauses In Homeowner's Policies?, Tracy E. Silverman
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 …
International Regulation And Control Of The Production And Use Of Chemicals And Pesticides: Perspectives For A Convention, Hans-Wolfgang Micklitz
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.
Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier
Beyond The War On Drugs: Overcoming A Failed Public Policy, Kenneth R. Hillier
Michigan Law Review
A Review of Beyond the War on Drugs: Overcoming a Failed Public Policy by Steven Wisotsky
Reforming The Ncaa Drug-Testing Program To Withstand State Constitutional Scrutiny: An Analysis And Proposal, Thomas P. Simon
Reforming The Ncaa Drug-Testing Program To Withstand State Constitutional Scrutiny: An Analysis And Proposal, Thomas P. Simon
University of Michigan Journal of Law Reform
Shortly after year-round testing went into effect, the California Court of Appeal held that the NCAA's original drug testing program violated a student-athlete's right of privacy as protected by the California Constitution. This Note examines the impact of that decision and attempts to design a program that will withstand state constitutional scrutiny. Part I describes the current NCAA drug-testing program. Part II looks at the fourth amendment argument against drug testing of student-athletes. Part III assesses the viability of a federal constitutional attack on NCAA testing, while Part IV discusses a state constitutional challenge. Finally, Part V proposes reform of …
Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta
Narrowing The Scope Of Civil Drug Forfeiture: Section 881, Substantial Connection And The Eighth Amendment, James B. Speta
Michigan Law Review
This Note offers two justifications for narrowing the scope of section 881 forfeiture. Part I argues that courts should apply the substantial connection test to section 881 forfeitures. This Part analyzes the statute using the traditional tools of statutory interpretation. While the text of the statute seems to support the broadest possible interpretation, the legislative history and context of adoption suggest that the substantial connection test is consistent with Congressional intent. In amending section 881, subsequent Congresses have favored application of the substantial connection test. Consistent with this narrower reading, present strategy in the "war on drugs" focuses stiff penalties …