Food and Drug Law Commons^™

Pressing Washington's Wine Industry Into The Twenty-First Century: Rethinking What It Means To Be A Winery, Rebecca Thompson

Washington Law Review

Washington’s wine industry is growing, and the ways in which Washington winemakers craft and sell their product are changing. Traditional “brick and mortar” wineries coexist with so-called “virtual wineries,” which typically purchase grapes from growers and contract with other wineries or custom crush facilities to access winemaking equipment. The virtual winery is an incubator model and contributes to the rich diversity of Washington’s wine industry. Washington’s current winery licensing statute, RCW 66.24.170, does not clearly apply to virtual wineries because it links the concept of a winery with a particular physical location and fails to delineate exactly what types of …

Canada's Marihuana Medical Access Regulations: Up In Smoke, Carolynn Conron

Electronic Thesis and Dissertation Repository

The Supreme Court of Canada has interpreted the constitutional principles entrenched in the Canadian Charter of Rights and Freedoms to mean that everyone in Canada has a constitutional right to access necessary medical treatment without fear of criminal sanction. The latest research suggests cannabis (marihuana) provides a unique medicinal benefit that, for some individuals, is necessary. The federal criminal prohibition of cannabis deprives many individuals of a potentially beneficial medicine and stigmatizes them with a criminal record.

Without a valid medical cannabis access system, the criminal prohibition is invalid. The current Marihuana Medical Access Regulations were recently struck down. Parliament …

Leveraging The Dialectical Theory In Case Study Analysis: Genzyme's Ethical Dilemma, Andrei Duta

The Journal of Business, Entrepreneurship & the Law

This paper provides the theoretical framework for a case study that I share with students in my courses. The dialectical theory is used to analyze ethical conundrums pertaining to Genzyme, a successful bio-tech corporation based in Boston, Massachusetts that manufactures treatments for serious diseases such as kidney problems, immune diseases, and cancer. We discuss questions such as: is Genzyme acting unethically when averaging extremely high profit margins on drugs for rare diseases? Is the company taking advantage of the lack of pharmaceutical choices that patients have when addressing their ailments? The dialectical theory provides the framework and vocabulary for discussing, …

Would State-Mandated Labels For Biotech Foods Violate World Trade Agreements?, Drew Kershen

Drew L. Kershen

No abstract provided.

Farm To School In Mississippi: A Step-By-Step Guide To Purchasing Mississippi Products, Harvard Law School Food Law And Policy Clinic, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

In a state with rich agricultural resources, lasting traditions of family farming, and a climate conducive to year-long growing seasons, why are Mississippi’s school children eating fruits and vegetables predominantly shipped from other states and countries? Farm to school programs that connect Mississippi farmers with schools offer a promising way to increase fruit and vegetable consumption for students while improving the economic viability of local farms. This step-by-step purchasing guide aims to help school food service directors in Mississippi start to purchase locally grown foods to be served in school meals.

A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus

University of Michigan Journal of Law Reform

To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.

Always Ask For A Brand-Name Drug: Trying To Untangle The Holding In Pliva V. Mensing, Elizabeth M. Lafayette

West Virginia Law Review

No abstract provided.

Enhancing Food Safety: The Role Of The Food And Drug Administration, Lewis Grossman

Lewis A. Grossman

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. …

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law in …

Prosecutorial Discretion Revisited, Siyuan Chen

Siyuan CHEN

Quek Hock Lye is the latest of three very recent Court of Appeal decisions that addresses the constitutional challenge against the exercise of prosecutorial discretion in the context of the Misuse of Drugs Act (the other two decisions being Ramalingam Ravinthran v Attorney General and Yong Vui Kong v Public Prosecutor). In Quek Hock Lye, the appellant Q was convicted of participating in a criminal conspiracy with W and S to traffic in not less than 62.14 grams of diamorphine (thus attracting the mandatory death penalty). Before Q’s trial began, W had pleaded guilty to a separate charge of possession …

Summer 2012 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Food Fight: A Case Study Of The Community Food Security Coalition’S Campaign For A Fair Farm Bill, Marni Salmon

Capstone Collection

The farm bill is an all-encompassing piece of legislation that is reauthorized approximately every five years and establishes federal policy for everything from farm subsidies and crop insurance to energy, conservation, food stamps and school lunches. The current law expires at the end of September 2012. Reauthorization of the farm bill represents the single largest opportunity to reform the policies that shape food systems in the United States. The Community Food Security Coalition (CFSC) is campaigning to improve access to healthy food by increasing links with family farmers and to strengthen local and regional food systems. This case study traces …

Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel

Georgia Journal of Public Policy

Discussions about public policy relating to alcohol cause a polarizing reaction to many people in this country, particularly in the South. The state of Georgia, for example, has a long history of policies regulating alcohol which reflects its membership as part of the “Bible Belt” where Sunday is regarded as a holy day and therefore alcohol cannot and should not be purchased on this day. Given that the impetus of alcohol control policy has generally widened the availability of alcohol since the Prohibition, the moral concerns of voters regarding alcohol regulation have been superseded in the public debate with safety …

American Indian Water Right Settlements, Darcy Bushnell

Publications

No abstract provided.

Dynamics Of Land Use/Land Cover Changes And Its Implication On Food Security In Anyigba, North Central, Nigeria, Tokula E. Arome, Sunday P. Ejaro (Phd)

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

This study assessed land use/land cover changes and its effect on Agricultural land in Anyigba. The objectives were to identify and delineate different land use / land cover categories, assess the rate of change that occurred and examine the impact of land use/land cover change on food security using satellite remote sensing data collected at three different years (1987 Land sat TM, 2001 Land Sat TM and 2011 Land Sat ETM). The study utilized GIS software such as Idrisi Andes academic and ArcGIS 9.3. The study area covers approximately 31.8km2, and four major land use/cover classes were utilized (built up, …

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 …

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

Publications

No abstract provided.

An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans

Mary Ann Chirba

Trying to buy a mercury thermometer at the local pharmacy these days will result in a deluge of information regarding the risks of mercury and the proper disposal protocol for mercury thermometers as hazardous waste. Yet, inquiring about the risks of placing mercury in one’s mouth, in the form of a dental filling, is likely to meet with resounding assurances of safety from the dental profession. While such comforting disclaimers are meant to ease patient concerns, many continue to worry about the safety of dental mercury. This article will begin by describing the many safety concerns that surround the use …

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 …