Food and Drug Law Commons^™

Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff

Pepperdine Law Review

No abstract provided.

Vaccines And The Law, Michael Sanzo Ph.D.

Pepperdine Law Review

The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …

Water Rights Management In New Mexico And Along The Middle Rio Grande: Is Awrm Sufficient?, Carol Romero-Wirth, Susan Kelly

Publications

No abstract provided.

Executives Should Think Twice Before Accepting Pleas 'Related To Fraud': The Expansion Of Exclusion Under The Park Doctrine, Abraham Gitterman

Student Articles and Papers

No abstract provided.

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

The Gray Zone In The Power Of Local Municipalities: Where Zoning Authority Clashes With State Law, Skye L. Daley

The Journal of Business, Entrepreneurship & the Law

This article will explore the oft-overlooked area of police powers granted to local municipalities by the California Constitution through the lens of marijuana dispensaries. These dispensaries, and the obstacles they face, provide the perfect vantage point from which to survey the current status of zoning power in California. This article will consider the extent and limits of what is known as the “police powers” of local municipalities: the power of cities, towns and counties to regulate, restrict, and proscribe the way in which land can be utilized within its borders. If local municipalities are the creation of the state--indeed, an …

Where Are Your Drugs Really Made And Who Is Regulating It?, Floyd Trillis Iii

In the Balance

No abstract provided.

Groundwater In New Mexico, Darcy Bushnell

Publications

No abstract provided.

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

Publications

No abstract provided.

Kirtland Afb - Bulk Fuels Facility Spill: Regulatory Authority Under Rcra And History, New Mexico Environment Department, University Of New Mexico - School Of Law

Publications

No abstract provided.

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 …

Breakfast And Lunch Participation In Massachusetts Schools, Center For Social Policy, University Of Massachusetts Boston, Massachusetts Budget And Policy Center, Massachusetts Law Reform Institute, Eos Foundation

Center for Social Policy Publications

The Center for Social Policy at the University of Massachusetts Boston (CSP), the Massachusetts Budget and Policy Center (MassBudget), and the Massachusetts Law Reform Institute (MLRI), with support from the Eos Foundation, established a research team to examine school food and related programs in Massachusetts.

While the team developed an overview of all federally funded food programs in Massachusetts, the focus of our work was on school meal programs and several aspects of the Supplemental Nutritional Assistance Program (SNAP). The full project is composed of several individual pieces of research and analysis, most of which were primarily undertaken by one …

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 …

Beyond The Core: Incorporating Transnational Crimes Into The Rome Statute, Regina Menachery Paulose

Cardozo Journal of International and Comparative Law

The article argues that the International Criminal Court (ICC) should expand its jurisdiction to include transnational organized crime, such as drug trafficking, counterfeiting, and arms trade, to address the growing global threat posed by these crimes. While the Rome Statute currently excludes such crimes, the ICC’s role as a court of last resort and its independence make it an ideal institution to prosecute transnational organized crime, fostering international cooperation and enhancing deterrence. The article advocates for a unified definition of transnational organized crime and the inclusion of select crimes from the United Nations Convention against Transnational Organized Crime (CATOC) and …

Patent Infringement In The Context Of Follow-On Biologics, Janet Freilich

Faculty Scholarship

This Article fills a gap in the literature by conducting a comprehensive analysis of patent infringement in the context of follow-on biologics. Patent infringement is an important topic because, like small molecule generic drugs, follow-on biologics are likely to begin their life facing infringement suits. Because it is tremendously expensive to develop a follow-on biologic, it is vital that there be consistency in how they are treated in the courts once the inevitable patent infringement suits arrive. If follow-on biologics companies cannot predict how their product will be received in court, they may decide it is not worth the risk …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

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.