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Private Regulation And Foreign Conduct, Adam I. Muchmore 2010 Penn State Law

Private Regulation And Foreign Conduct, Adam I. Muchmore

Journal Articles

Current U.S. policy on safety regulation for imported food is based largely on ex post measures. Several reform proposals seek to strengthen the ex ante component of this regulatory program. These proposals rely on one or more of three basic strategies: direct extraterritorial regulation; delegation of regulatory authority to private entities; and delegation of regulatory authority to foreign government agencies. This paper explores the ability of each strategy to respond to several principal-agent problems relevant to imported-food safety: the regulatory license problem; interest group capture; and the reality of bribery and threats in many food-exporting countries. Through the lens ...


How To Cut The Cheese: Homonymous Names Of Registered Geographic Indicators Of Foodstuffs In Regulation 510/2006, Kaiko Shimura 2010 Boston College Law School

How To Cut The Cheese: Homonymous Names Of Registered Geographic Indicators Of Foodstuffs In Regulation 510/2006, Kaiko Shimura

Boston College International and Comparative Law Review

Since the 15th century, European states have sought to protect certain foodstuffs originating from a designated geographic location. When multilateral and bilateral agreements failed to establish sufficient protection amongst the European Community member states, the European Community sought to establish uniform standards of protection by adopting Regulation 2081/92 in 1992. While an important step in the harmonization of varying European state practices, Regulation 2081/92 failed to address the problem of names that are homonymous to registered, protected names. In 2006, the European Community attempted to address this issue in Regulation 510/2006. This Note explores the issue of ...


Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova McCabe 2010 University of New Hampshire School of Law

Balancing Consumer Protection And Scientific Integrity In The Face Of Uncertainty: The Example Of Gluten-Free Foods, Margaret Sova Mccabe

Legal Scholarship

In 2009, gluten-free foods were not only "hot" in the marketplace, several countries, including the United States, continued efforts to define gluten-free and appropriate labeling parameters. The regulatory process illuminates how difficult regulations based on safe scientific thresholds can be for regulators, manufacturers and consumers. This article analyzes the gluten-free regulatory landscape, challenges to defining a safe gluten threshold, and how consumers might need more label information beyond the term "gluten-free." The article includes an overview of international gluten-free regulations, the Food and Drug Administration (FDA) rulemaking process, and issues for consumers.


Emerging Law Addressing Climate Change And Water, Prof. Elizabeth Burleson 2010 SelectedWorks

Emerging Law Addressing Climate Change And Water, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

The World Economic Forum recognizes that while restrictions on energy affect water systems and vice versa, energy and water policy are rarely coordinated. The International Panel on Climate Change predicts that wet places will become wetter and dry places will become dryer. Transboundary water, energy and climate coordination can occur through international consensus building.


Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker 2010 John Marshall Law School

Deadly Delay / Postponed Pills, 10 J. Marshall Rev. Intell. Prop. L. 254 (2010), Christopher R. Walker

The John Marshall Review of Intellectual Property Law

Since 1984, generic pharmaceuticals have continued to grow, and are an important element in our national struggle to increase affordable health care options in the United States. The Hatch-Waxman Act has played a pivotal role in helping to create a regulatory environment that fosters the development of generic pharmaceuticals, thereby increasing access to lower-cost alternatives to more expensive drugs. An important part of balancing the interests of the generic manufacturers against those of the primary pharmaceutical makers is the thirty-month stay provision of the Hatch-Waxman Act. This comment begins by taking a look at the history of the Hatch-Waxman Act ...


How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette 2010 Yale Law School

How Many Patents Does It Take To Make A Drug - Follow-On Pharmaceutical Patents And University Licensing, Lisa Larrimore Ouellette

Michigan Telecommunications and Technology Law Review

As described by Professors Dan Burk and Mark Lemley, drugs are[...] special because of the low number of patents per product: "In some industries, such as chemistry and pharmaceuticals, a single patent normally covers a single product. Much conventional wisdom in the patent system is built on the unstated assumption of such a one-to-one correspondence." Although many have repeated this one-patent, one-drug assumption, there has been little empirical analysis of how many patents actually protect each drug. In fact, most small-molecule drugs are protected by multiple patents. The average was nearly 3.5 patents per drug in 2005, with over ...


It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü 2010 University of Michigan Law School

It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü

Michigan Telecommunications and Technology Law Review

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by ...


"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane 2010 University of Michigan Law School

"Per Se Illegality For Reverse Payment Settlements?" Review Of "Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Daniel A. Crane

Reviews

Congratulations to Mike on a very fine book. I will confine my comments to Mike's chapter on patent settlements (Chapter 15), which I understand will also be coming out as an article in the Michigan Law Review.1 Patent settlements involving "reverse payments" are a huge topic on which I and many others have spilled much ink already.2 Representative Bobby Rush (President Obama's erstwhile nemesis from Chicago's South Side) has just introduced legislation that would ban reverse payments.' I will not regurgitate my entire spiel on patent settlements here, but instead just try to highlight my ...


Bundling Public And Private Goods: The Market For Sustainable Organics, Margot J. Pollans 2010 Elisabeth Haub School of Law at Pace University

Bundling Public And Private Goods: The Market For Sustainable Organics, Margot J. Pollans

Pace Law Faculty Publications

Modern agriculture has vast environmental externalities. The pesticides, fertilizers, and sediments in irrigation runoff pollute surface and groundwater; single-crop farms destroy biodiversity; and massive amounts of fossil fuels are burned in agricultural production, post-harvest processing, and shipping. Nevertheless, farming operations have largely escaped the post-1970 expansion of federal environmental regulation. Compounding the problem, federal farm policy has encouraged the very farming practices that most cause this degradation.

In 1990, Congress passed the Organic Foods Production Act (OFPA), which created an organic food certification and labeling system. While OFPA's primary purposes are to facilitate the growth of the organic sector ...


Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa 2010 University of Richmond

Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa

Richmond Journal of Law and the Public Interest

Therefore, one approach for a drug maker, knowing of a potential hazard, would be to unilaterally strengthen their warning without prior FDA approval under current regulations to head off any state tort claims for failure to warn. If the FDA ultimately determines not to approve the strengthened label, under explicit authority granted by Congress in the FDCA, drug makers have a strong argument that implicit conflict preemption now applies. As another avenue, drug makers may include a potential warning amounting to a prohibition of the drug's use or method of delivery when seeking initial approval of the warning label ...


Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza 2010 John Marshall Law School

Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza

The John Marshall Law Review

No abstract provided.


Liberty Lost: The Moral Case For Marijuana Law Reform, Eric Blumenson, Eva Nilsen 2010 Suffolk University

Liberty Lost: The Moral Case For Marijuana Law Reform, Eric Blumenson, Eva Nilsen

Indiana Law Journal

Marijuana policy analyses typically focus on the relative costs and benefits of present policy and its feasible alternatives. This Essay addresses a prior, threshold issue: whether marijuana criminal laws abridge fundamental individual rights, and if so, whether there are grounds that justify doing so. Over 700, 000 people are arrested annually for simple marijuana possession, a small but significant proportion of the 100 million Americans who have committed the same crime. In this Essay, we present a civil libertarian case for repealing marijuana possession laws. We put forward two arguments corresponding to the two distinct liberty concerns implicated by laws ...


Volume 10 Issue 3, Sustainable Development Law & Policy 2010 American University Washington College of Law

Volume 10 Issue 3, Sustainable Development Law & Policy

Sustainable Development Law & Policy

No abstract provided.


Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing 2010 American University Washington College of Law

Livestock Animal Cloning: This Steak Is Giving Me Déjà Vu, Blake M. Mensing

Sustainable Development Law & Policy

No abstract provided.


We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson 2010 Elisabeth Haub School of Law at Pace University

We Can Work It Out: Co-Op Compulsory Licensing As The Way Forward In Improving Access To Anti-Retroviral Drugs, Horace E. Anderson

Pace Law Faculty Publications

This Article explores the social and developmental underpinnings of the access problem and describes the legal framework that provides the backdrop for the Waiver's licensing scheme. Part III examines the various lenses, humanitarian, economic, and political, through which the underutilization problem may be viewed and explained. Part IV sets out the structural heart of the Waiver scheme's deficiencies: the notion of the “compulsory” license itself. Part V posits a co-op scheme of licensing that aligns the concerns, goals, and incentives of IP owners, importers, exporters, and consumers. Finally, the Article relates the proposed scheme to more general trends ...


Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa 2010 University of Richmond

Wyeth V. Levine: What Does It Mean And Where Do Pharmaceutical Companies Go From Here, Clay Landa

Richmond Public Interest Law Review

In the recent landmark decision in Wyeth v. Levine, the Supreme Court put drug manufacturers on notice that they can and should be liable for state tort claims for the harm their products cause regardless of Federal Drug Administration ("FDA") approval of the drug's use and warning labels. Part II of this paper analyzes the history and background of federal preemption to give context to the current environment after Wyeth. Part III analyzes the Supreme Court's decision in Wyeth, holding that the FDCA and corresponding regulations do not preempt state tort claims. Finally, Part IV discusses and analyzes ...


From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah 2010 Georgia State University College of Law

From A Constitutional Right To A Policy Of Exceptions: Abigail Alliance And The Future Of Access To Experimental Therapy, Patricia J. Zettler, Seema K. Shah

Faculty Publications By Year

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competence to decide complex policy issues related to science and health care such as those involved in establishing an expanded access program. Congress and FDA should allow only limited access to unapproved therapies because there are significant concerns about the safety and efficacy of unapproved drugs. Moreover, many of the proposals to widen access ...


Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi 2010 Harvard Law School

Between Starvation And Globalization: Realizing The Right To Food In India, Lauren Birchfield, Jessica Corsi

Michigan Journal of International Law

This Article evaluates People's Union for Civil Liberties v. Union of India & Others (PUCL) through multiple lenses, examining: (1) the necessary factors that contributed to the success of the Public Interest Litigation (PIL) and its enforcement and (2) both the implications and limitations of PUCL as it relates to India's larger economic policy framework. We argue that the development and success of the PUCL litigation have depended in part on provisions of the Indian Constitution amenable to the incorporation and promotion of economic and social rights as well as on a unique relationship between civil society and judicial ...


The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness 2010 University of Kentucky College of Law

The Impact Of Wyeth V. Levine On Fda Regulation Of Prescription Drugs, Richard C. Ausness

Law Faculty Scholarly Articles

On March 4, 2009, the United States Supreme Court decided Wyeth v. Levine. In that case, the Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act (FDCA). In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription ...


A Case Study Of The New York City’S Trans-Fat Story For International Application., Andy Tan 2009 University of Pennsylvania

A Case Study Of The New York City’S Trans-Fat Story For International Application., Andy Tan

Andy SL Tan

Heart disease is the leading cause of death in New York City and contributes to significant burden of disease in the United States and internationally. Excessive intake of artificial trans-fatty acids has been causally associated with increased risk of heart disease. This article describes New York City's 2007 trans-fatty acids regulation, which was aimed at lowering the prevalence of heart disease among the city's residents by prohibiting the use of trans-fatty acids in the preparation of food in the city's food outlets. The author describes sequentially: (1) formulation, (2) public consultation, (3) implementation and (4) evaluation of ...


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