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Articles 271 - 300 of 301
Full-Text Articles in Food and Drug Law
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
University of Michigan Journal of Law Reform
This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …
Peru's Too Expensive - I'Ll Get My Cheese From Chile: The Agricultural Market Access Provisions Of The U.S.-Chile Fta And The U.S.-Peru Tpa, Guillermo Gabriel Zorogastua
Peru's Too Expensive - I'Ll Get My Cheese From Chile: The Agricultural Market Access Provisions Of The U.S.-Chile Fta And The U.S.-Peru Tpa, Guillermo Gabriel Zorogastua
Florida State University Journal of Transnational Law & Policy
No abstract provided.
Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick
Tax And Economic Policy Responses To The Medicaid Long-Term Care Financing Crisis: A Behavioral Economics Approach, Diane Lourdes Dick
Cardozo Public Law, Policy & Ethics Journal
The article examines the escalating strain on Medicaid due to rising long-term care costs and an aging population, emphasizing the ineffectiveness of current policies promoting private insurance. It critiques traditional economic models for neglecting behavioral factors like emotional resistance to planning for aging and underestimating future care needs. The analysis concludes that voluntary measures, such as tax incentives and partnership programs, are insufficient and advocates for a universal compulsory program to ensure adequate preparation for long-term care, thereby reducing Medicaid reliance.
Winning The Battle, But Perhaps Losing The War: Endorsing Deregulation Of Emergency Contraception At The Expense Of Derogating Abortion, Melissa Bond
Cardozo Journal of International and Comparative Law
No abstract provided.
United States Food Law Update, Michael Tingey Roberts, Margie Alsbrook
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
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.
Animal Identification And Traceability Under The Us National Animal Identification System, Margaret Rosso Grossman
Animal Identification And Traceability Under The Us National Animal Identification System, Margaret Rosso Grossman
Journal of Food Law & Policy
The identification of animals has a long history in the United States. Since the late nineteenth century, livestock producers have used brands to mark their animals. Ear tags and other marks now identify individual animals or animals from a specific producer, but not all livestock are identified to facilitate traceability.
European Union Food Law Update, Nicole Coutrelis
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 …
'Beastly Bureaucracy' Animal Traceability, Identification And Labeling In Eu Law, Bernd M.J. Van Der Meulen, Annelies A. Freriks
'Beastly Bureaucracy' Animal Traceability, Identification And Labeling In Eu Law, Bernd M.J. Van Der Meulen, Annelies A. Freriks
Journal of Food Law & Policy
This contribution discusses animal traceability, identification and labeling requirements in European Union (EU) law. The requirements are lex specialis to more general requirements in EU food law. The aim is to set out this body of EU law and provide some understanding regarding its background. Along with the article by Margaret Rosso Grossman, it enables the reader to compare the EU system to the United States system.
A Complete Property Right Amendment, John H. Ryskamp
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.
Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy
Un-Fair Trade As Friendly Fire: The Australia-Usa Free Trade Agreement, Benedict Sheehy
ExpressO
Trade, economists and trade theorists advise, is a mutually beneficial exercise. Among this group, a particular set of advocates, claim that “Free Trade” is in the interest of all parties. As will be demonstrated, Free Trade is not truly “free” but an exercise of foreign policy and the implementation of policies favouring wealthy corporate interest groups. Free Trade is controlled by wealthy nations who have stacked the rules in favour of themselves, and in particular their corporate interests, and against the poor producers in poor nations. This control is used contrary to fairness, economic and ecological logic. Fair trade, by …
Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu
Why It Is Time To Eliminate Genomic Patents, Together With Natural Extracts Doctrine That Have Supported Such Patents, Allen K. Yu
ExpressO
The constitutional purpose of intellectual property is to “promote the progress of science and useful arts.” Given the utilitarian basis of patents, it is critical that policies and laws must be continually adjusted to reflect the needs of new technologies. When the law tries to shield itself from rather than confront the realities of underlying technologies, patents end up actually subverting rather than promote technological progress. This paper explores why the natural extracts doctrine belongs to the class of doctrines that subvert progress. The doctrine, established over a century ago to enable the patenting of purified compounds for use as …
Bond Repudiation, Tax Codes, The Appropriations Process And Restitution Post-Eminent Domain Reform, John H. Ryskamp
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.
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
ExpressO
This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
Global Pharmaceutical Patent Law In Developing Countries- Amending Trips To Promote Access For All, Angela J. Anderson
ExpressO
This comment will analyze the need to amend and revise the current global pharmaceutical patent system under TRIPS to take into account the needs of developing countries and overall public health. This comment will emphasize that the current international trade rules, which although administered by the WTO, are dictated by developed country governments and powerful pharmaceutical companies, and therefore, without reform will further diminish the access of poor people in developing countries to vital medicines. Part II of this comment will provide a general overview of the international trade law governing patents on pharmaceuticals focusing specifically on the development of …
From Harm To Robustness: A Principled Approach To Vice Regulation, Jim Leitzel
From Harm To Robustness: A Principled Approach To Vice Regulation, Jim Leitzel
ExpressO
John Stuart Mill’s harm principle maintains that adult behavior cannot justifiably be subject to social coercion unless the behavior involves harm or a significant risk of harm to non-consenting others. The absence of harms to others, however, is one of the distinguishing features of many manifestations of “vices” such as the consumption of alcohol, nicotine, recreational drugs, prostitution, pornography, and gambling. It is with respect to vice policy, then, that the harm principle tends to be most constraining, and some current vice controls, such as prohibitions on drug possession and prostitution, violate Mill’s precept. In the vice arena, we seem …
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
Breaking The Bank: Revisiting Central Bank Of Denver After Enron And Sarbanes-Oxley, Celia Taylor
ExpressO
No abstract provided.
Food Democracy Ii: Revolution Or Restoration?, Neil D. Hamilton
Food Democracy Ii: Revolution Or Restoration?, Neil D. Hamilton
Journal of Food Law & Policy
Author's Note: This essay is a companion to the essay 'Food Democracy, "which appears in 9 Drake Journal of Agricultural Law 9 (2004). In that essay, the author discussed many of the progressive trends that are helping reshape America's food system. These trends have a common denominator in their reflection of the democratic tendencies of the American populace. The desire of an increasing number of consumers to eat better food and to have access to the information, choices, and alternatives that make better food available are helping drive shifts in food production and marketing. Accompanying these shifts are political and …
European Union Food Law Update, Nicole Coutrelis
European Union Food Law Update, Nicole Coutrelis
Journal of Food Law & Policy
The purpose of this update is to present the main events that have taken place each six months in the food law sector in the European Union (E.U.). This presentation will cover June through December 2004, but is not exhaustive. This update will not include detailed discussions of regulations, such as authorizations of new additives for animal feed or registrations of new geographic names. Instead it will concentrate on fundamental topics and focus on food, which excludes from our scope questions regarding the management of agricultural products (Common Agricultural Policy, or CAP). However, some questions which legally pertain to the …
Do European Union Non-Tariff Barriers Create Economic Nuisances In The United States?, Thomas P. Redick, Michael J. Adrian
Do European Union Non-Tariff Barriers Create Economic Nuisances In The United States?, Thomas P. Redick, Michael J. Adrian
Journal of Food Law & Policy
The European Union's new traceability system for biotech crops will lead to the proliferation of non-tariff barriers affecting biotech crops. This, in turn, will lead to economic dislocation and attendant liability in the United States, which is losing billions of dollars in export trade. A chain of complex legal problems will arise for United States-based companies as they strive to trace particular genetically modified (GM) events and avoid commingling. The European Union (E. U) tracing law for biotech crops applies at each stage of commodity commerce, from grain shippers leading back through elevators, growers, and seed companies. Warranty liability could …
Revising Seed Purity Laws To Account For The Adventitious Presence Of Genetically Modified Varieties: A First Step Towards Coexistence, A. Bryan Endres
Revising Seed Purity Laws To Account For The Adventitious Presence Of Genetically Modified Varieties: A First Step Towards Coexistence, A. Bryan Endres
Journal of Food Law & Policy
Adoption of genetically modified (GM) seed varieties in the United States, Canada, and South America continues to expand, with GM crops comprising almost 76 million hectares and over 93 percent of the total biotech cropland worldwide. As an increasing number of farmers plant GM varieties, the potential for adventitious mixture of genetically modified DNA with products produced via organic and conventional (non-GM) methods also increases. Many consumers of organic and identity-preserved products, however, object to the adventitious presence of genetically modified DNA at even low levels. Accordingly, the ability of farmers to choose between conventional, organic, or GM crop production …
United States Food Law Update, Michael T. Roberts, Margie Alsbrook
United States Food Law Update, Michael T. Roberts, Margie Alsbrook
Journal of Food Law & Policy
The one constancy about food law in the United States is change, especially in a rapidly-developing food industry. Innovations in food technology, shifts in popular culture and tastes, concerns of safety and nutrition, pressures from international markets, all contribute to the changing landscape of food law. These changes are reflected in new federal statutes, regulations, administrative decisions, and judicial decisions.
Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland
Modern Bootlegging And The Prohibition On Fair Prices: Last Call For The Repeal Of Pharmaceutical Price Gouging, Luke W. Cleland
ExpressO
This article discusses the recent passage of the Medicare Prescription Drug, Modernization and Improvement Act of 2003, and the executive and judicial decisions affecting the ability of the general public to access foreign pharmaceutical markets. The article examines the recent actions taken by the U.S. government, explore various state movements within the United States aimed at reducing pharmaceutical drug prices, outline the process of pharmaceutical drug prices in foreign countries, and advocate for a workable integration of all available mechanisms to feasibly reduce prescription drug prices for the benefit of both U.S. consumers and U.S. drug companies. As avenues to …
Securing Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese
Securing Truth For Power: Informational Strategy And Regulatory Policy Making, Cary Coglianese
ExpressO
No abstract provided.
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 …
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 …
Charting The Future Course For Corporate Management Of Health Risks, Michael S. Baram
Charting The Future Course For Corporate Management Of Health Risks, Michael S. Baram
Faculty Scholarship
Corporations engage in technological activities of benefit to society, but thereby also create new health risks for workers, consumers, and communities. Government regulatory agencies deal with this chronic problem by conducting risk analyses and imposing various duties on private firms. Despite agency efforts and corporate compliance, health risks continue to arise and take their toll. To what extent will private firms voluntarily assume greater responsibility for preventing these health risks? This question is of increasing social importance, because the limitations of regulatory efforts are now obvious, whereas health risks are now being identified at what appears to be an increasing …
Products Liability Based Upon Violation Of Statutory Standards, Joseph H. Ballway Jr.
Products Liability Based Upon Violation Of Statutory Standards, Joseph H. Ballway Jr.
Michigan Law Review
Regulatory enactments controlling production and distribution can give rise in several different ways to civil liability on behalf of persons injured by non-conforming merchandise. For instance, if a statute codifies existing common-law rules of negligence, its effect is merely to place the weight of legislative authority behind ordinary negligence principles. Since an injured party's recovery under such a provision still depends largely upon his proving in the traditional manner that a defendant failed to exercise due care, this kind of statute merits no further discussion. On the other hand, if particular legislation expressly states that a violator may be subjected …