Food and Drug Law Commons^™

Citizen Petitions: An Empirical Study, Michael A. Carrier, Daryl Wander

Cardozo Law Review

In recent years, brand-name drug companies have engaged in an array of conduct that has delayed generic competition. While some of the activity - such as settlements between brand and generic firms and "product hopping" from one drug version to another - has received attention, another behavior has, until now, flown under the radar.

This Article examines the activity of "citizen petitions." A citizen petition is a request for the U.S. Food and Drug Administration (FDA) to take an action such as evaluating a drug's safety or effectiveness. When used appropriately, it could raise awareness of legitimate concerns with a …

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, …

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.

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.

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.

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 …

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

Publications

No abstract provided.

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.

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.

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.

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.

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

Publications

No abstract provided.

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 …