Food and Drug Law Commons^™

Cornography: Perverse Incentives And The United States Corn Subsidy, Anthony Kammer

Journal of Food Law & Policy

Among the most important functions we have afforded to the U.S. Congress is the power to reshape social and economic incentive structures through legislation. Proceeding from the enumerated powers under the Constitution and using a complex toolbox of legislative and regulatory innovations, the federal legislature has enormous power to transform the types of behavior that people will perceive as self-interested throughout our economy and thus how those same people are likely to act. Congress can, among other things, create new forms of criminal and civil liability, establish entitlement systems, subsidize industries, encourage behavior through the tax code, regulate interactions among …

Intellectual Property, Traditional Knowledge, And Biodiversity In The Global Economy: The Potential Of Geographical Indications For Protecting Traditional Knowledge-Based Agricultural Products, Teshager W. Dagne

PhD Dissertations

The relationship between international regimes regulating intellectual property, traditional knowledge and biodiversity has received much attention in recent times. Of the many complex and controversial issues in contemporary international legal discourse on this matter, the protection of traditional knowledge (TK) stands out as a significant challenge. Choices abound in the search for modalities to regulate rights to use and control TK systems and their underlying biodiversity. In recent times, the protection of geographical indications (GIs) has emerged as an option for protecting TK. Despite the considerable enthusiasm over it, there is appreciable research dearth on how far and in what …

Misappropriation And Patenting Of Traditional Ethnobotanical Knowledge And Genetic Resources, Maxim V. Gubarev

Journal of Food Law & Policy

Four-fifths of all pharmaceuticals have been developed from natural plant resources, and native plant resources similarly play a significant role in the development of new and improved crops.

The Costs And Impacts Of Rising Food Prices Among Low-Income Households, Elaine Waxman

Journal of Food Law & Policy

The pressure of rising food prices on low-income households is often assumed to be primarily an issue for developing economies, where fluctuations in food staple prices can have dramatic consequences for food security and social and political stability. Observers often note that Americans benefit from relatively low food prices and spend far less to feed their families than their counterparts in many other parts of the world. Indeed, the average American household spent 7.6% of their household expenditures on food purchases at home in 2009, while the comparable percentage exceeded 40% of household expenditures in diverse countries such as Mexico, …

Put A Cork In It: The Use Of H.R. 161 To End Direct Wine Shipping Throughout The States Once And For All, Victoria H. Jones

Journal of Food Law & Policy

Due to Congress' recent agenda, oenophiles throughout the country are up in arms about the possible threat to their beloved wine. Wine lovers and other alcohol enthusiasts face the very real fear that access to their favorite products may soon be heavily restricted. This is in large part attributed to the fact that House Resolution 1161 would effectively change the ways in which states regulate alcohol shipment. The possible implications of this bill range from the forced shutdown of many wineries and distilleries due to lack of funding, to the smaller effects of regulation such as the inability of customers …

European Union Food Law Update, Emilie Majster

Journal of Food Law & Policy

Nutrition is increasingly important in both the European Union (EU) and in global food-related policy making. Governments, which up until recently have focused on regulating food products based on a food safety perspective, are now turning to regulate from a nutritional aspect.

Cows V. Capitalists: Visions Of A Post-Carbon Economy, Alison Peck

Journal of Food Law & Policy

I was tempted to entitle this book review something like, "Why the Farm Bill Is the Key to Our Energy Future (Hint: It's Not About Ethanol, Methane Emissions, or Carbon Sinks)." But in addition to being too long to fit across the header of a law review page, such a title would have been slightly misleading. Actually, in Simon Fairlie's view, our future is about ethanol, methane emissions, and carbon sinks - but not in the way our current agricultural policies understand and deal with these subjects.

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of the developments in Canadian food law and policy in 2011. This update considers the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.

Global Food Security: In Our National Interest, David P. Lambert

Journal of Food Law & Policy

All Americans have a direct stake in the problem of global hunger, which has many dimensions. For most of us it is a profound moral issue, and we are guided by our faith to respond.

New Mexico Ex Rel. State Engineer V. Aamodt, No. 66cv6639 (D.N.M.), New Mexico State Engineer

Publications

No abstract provided.

Childhood Obesity: Balancing The Nation's Interest With A Parent's Constitutional Right To Privacy, Denise Cohen

Cardozo Public Law, Policy & Ethics Journal

The note argues that governmental intervention into parental rights regarding childhood obesity is constitutionally justifiable under strict scrutiny, as it serves the compelling interests of both the child's well-being and societal welfare. While the constitutional right to privacy in parenting is fundamental, it is not absolute, and the growing public health crisis of childhood obesity necessitates narrowly tailored measures to hold parents accountable. The analysis proposes that existing legal frameworks, such as neglect statutes, can be effectively applied to address severe cases of childhood obesity, balancing individual rights with public health needs.

Regulating By Repute, David Zaring

Michigan Law Review

Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …

Medicines That Kill, Lina Ahmed Abushouk

Annual Undergraduate Conference on Health and Society

The prevalence of counterfeit drugs on the African continent has been increasing at an alarming rate. “Medicines that Kill” is a research paper that attempts to analyze the factors that make African countries particularly susceptible to this global threat. Nigeria, a country that has had some of the highest rates of counterfeit drugs in the world, is the main case study for this paper. Its efforts to combat the issue are compared and contrasted with those of Tanzania and Kenya in an attempt to understand what aspects of the issue are unique to Africa and the methods that have been …

Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy

Michigan Law Review

In Granholm v. Heald, the Supreme Court held that states must treat instate and out-of-state alcoholic beverages equally under the dormant Commerce Clause and established a heightened standard of review for state alcohol laws. Yet in dictum the Court acknowledged that the three-tier distribution system-a regime that imposes a physical presence requirement on alcoholic beverage wholesalers and retailers-was "unquestionably legitimate." Though the system's physical presence requirement should trigger strict scrutiny, lower courts have placed special emphasis on Granholm's dictum, refusing to subject the three-tier distribution system to Granholm's heightened standard of review. This Note argues that the dictum should be …

Playing By Market Rules: Anti-Doping Policy In The European Union, Kayla Mcculley

Claremont-UC Undergraduate Research Conference on the European Union

No abstract provided.

Doctors, Patients, And Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Cardozo Law Review

This Article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century; and regulatory necessity due to the limits of science and the innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based on genetic expression). Although both factors have changed immensely, the standard for drug approval …

The New England Food System In 2060: Envisioning Tomorrow's Policy Through Today's Assessments, Margaret Sova Mccabe, Joanne Burke

Law Faculty Scholarship

This Essay analyzes how the New England states' planning processes are envisioning revitalized local, state, and regional food systems. This Essay has five parts. First, it begins with examining compelling reasons for promoting more sustainable food systems based on national and global trends, and identifies strategies for promoting regional food systems approaches with a brief introduction to the major influences on the national and New England food system. Second, it describes the states' planning efforts and their enabling legislation or source of authority.

The Essay then introduces the New England Food Vision 2060 (the Vision) an emerging discussion of food …

Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson

University of Michigan Journal of Law Reform Caveat

Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …

Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer

UIC Law Review

No abstract provided.

The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven

Journal of Health Care Law and Policy

No abstract provided.

Hot, Crowded, And Legal: A Look At Industrial Agriculture In The United States And Brazil, David N. Cassuto

Elisabeth Haub School of Law Faculty Publications

Over the last sixty years, industrial agriculture has expanded in the United States and throughout the world, including in Brazil. Any benefit this expansion has brought comes at significant environmental and social costs. Industrial agriculture is a leading contributor to global climate change, air and water pollution, deforestation, and dangers in the workplace. This Article discusses the impact of industrial animal agriculture in the U.S. and Brazil. It also examines the laws pertaining to industrial agriculture in both countries and provides a comparative analysis of the two legal regimes. Finally, this Article concludes with the observation that although the price …

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications & Technology Law Review

Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …

Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan

University of Michigan Journal of Law Reform Caveat

One of the lasting vestiges of Richard Nixon’s presidency is the infamous “War on Drugs,” a forty-year-old effort aimed at curtailing “illicit drug consumption and transactions in America.” Although the goal behind the policy—a reduction in the rate of substance abuse—may be altruistic, the War on Drugs has dismally failed to achieve its goals and has exacerbated existing problems. Specifically, laws dealing with crack cocaine result in a “heavily disproportionate impact on black defendants;” in 2008 “blacks comprised 79.8 percent of those convicted for crack cocaine-related offenses,” whereas “whites comprised only 10.4 percent.” More generally, these laws illustrate a fundamental …

Patents Vs. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both?, Yaniv Heled

Faculty Publications By Year

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (also known as the Healthcare Bill). BPCIA sets up a framework for the approval of generic biologics and provides for up to 12.5 years of market exclusivity for FDA approved bio-pharmaceutical products. The exclusivity is intended to run in parallel and in addition to any patents that may apply to such approved bio-pharmaceutical products, which would also grant the developers of these products monopolies in the underlying technologies on which such bio-pharmaceutical products …

The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon

Kentucky Law Journal

No abstract provided.

The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012), Alexandros Stamatoglou

UIC Law Review

No abstract provided.

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Villanova Law Review (1956 - )

The article presents information on the pharmaceutical companies manufacturing brand-name drugs and the issues related to pharmaceutical sales representative (PSR). The intensive sales training program, the exempt from overtime pay based on the U.S. Fair Labor Standards Act and the economic justice and security of low income group are discussed. The court decision of Smith v. Johnson & Johnson, white-collar exemptions and employee misclassification are also discussed.

Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012), Benjamin Liu

UIC Review of Intellectual Property Law

Countries after countries are adopting a controversial regulatory system of linking the market approval for pharmaceuticals to the status of potentially blocking patents as part of their bilateral and multilateral trade agreement package with the United States. Surprisingly, China took up pharmaceutical patent linkage in the absence of any treaty obligations and became the first country to adopt this regulatory regime outside of North America, despite the presence of a flourishing generics pharmaceutical industry and its developing country status. In fact, the Chinese regulation promised more intellectual property ("IP") protection than what even the United States FDA is capable of …

Superweeds And Suspect Seeds: Does The Genetically-Engineered Crop Deregulation Process Put American Agriculture At Risk, Margaret Sova Mccabe

Law Faculty Scholarship

The federal government’s regulatory approach to genetically engineered (GE) crops, known as “The Framework”, is now twenty-five years old. Despite two and half decades of a consistent regulatory regime, GE crop and food regulation remains controversial. This article suggests that regulatory science and its tenets of independence, transparency, and public science should guide reforms of The Framework so that it is an efficient and reliable regulatory system. The article has four parts: 1) it provides a brief overview of the history of GE crop regulation; 2)it describes the key attributes of The Framework and related regulatory documents, with particular focus …

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.