Food and Drug Law Commons^™

An Information Prescription For Prescription Drug Regulation, Anita Bernstein, Joseph Bernstein

Faculty Scholarship

No abstract provided.

United States Food Law Update: Food Allergy Labels, Reaching Organic Equivalence, Misbranding Litigation And Regulatory Takings, A. Bryan Endres, Michaela N. Tarr

Journal of Food Law & Policy

The start of 2009 found the nation transitioning to a new presidential administration, speculating on the impact new appointees to the executive branch may have on regulatory priorities and monitoring a bill' making its way through Congress that seeks a substantial overhaul of the food regulatory system. This version of the Food Law Update will analyze two major developments in food allergy labeling: finalization of rules requiring the labeling of Cochineal extract/ carmine and an analysis of the proposed "gluten-free" product labels. The update next discusses the execution of an equivalency agreement between the United States and Canada with respect …

European Union Food Law Update, Emilie H. Leibovitch

Journal of Food Law & Policy

In June 2009, citizens of the European Union elected a new European Parliament. Some Members of the European Parliament (MEPs) were reelected while some were not. The majority party is the EPP, the Group of the European People's Party, and the Group of the Progressive Alliance of Socialists & Democrats has the second majority of the seats. The elections were still governed by the Treaty of Nice, since up until very recently, the future of the Treaty of Lisbon was still uncertain. The Treaty of Lisbon was up until now rejected by a few Member States, who, by their reluctance …

Contemporary Water Issues, Susan Kelly

Publications

No abstract provided.

Punishing Pharmaceutical Companies For Unlawful Promotion Of Approved Drugs: Why The False Claims Act Is The Wrong Rx, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

This article criticizes the shift in focus from correction and compliance to punishment of pharmaceutical companies allegedly violating the Food, Drug, & Cosmetic Act (FD&C Act) prohibitions on unlawful drug promotion. Traditionally, the Food and Drug Administration (FDA) has addressed unlawful promotional activities under the misbranding and new drug provisions of the FD&C Act. Recently though, the Justice Department (DOJ) has expanded the purview of the False Claims Act to include the same allegedly unlawful behavior on the theory that unlawful promotion “induces” physicians to prescribe drugs that result in the filing of false claims for reimbursement. Unchecked and unchallenged, …

Land & Water Planning: Another State's Perspective - Water Resources Regional Plan Policies, Kathleen M. Chavez, P.E.

Publications

No abstract provided.

On The Limits Of Supremacy: Medical Marijuana And The States' Overlooked Power To Legalize Federal Crime, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Using the conflict over medical marijuana as a timely case study, this Article explores the overlooked and underappreciated power of states to legalize conduct Congress bans. Though Congress has banned marijuana outright, and though that ban has survived constitutional scrutiny, state laws legalizing medical use of marijuana constitute the de facto governing law in thirteen states. This Article argues that these state laws and (most) related regulations have not been, and, more interestingly, cannot be preempted by Congress, given constraints imposed on Congress's preemption power by the anti-commandeering rule, properly understood. Just as importantly, these state laws matter, in a …

Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier

Michigan Law Review

A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …

Constitutional Flaw?, Carl E. Schneider

Articles

Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …

Wyeth V. Levine And Its Implications, Brian Wolfman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.

After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …

Journal Of Food Law & Policy - Spring 2009, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Food Justice As Crime Prevention, Avi Brisman

Journal of Food Law & Policy

In December 2008, Governor David Paterson (D-NY) proposed an 18 percent tax on nondiet sodas and fruit drinks containing less than 70 percent natural fruit juice. While the tax was part of a broader budget proposal designed to address New York State's fiscal crisis - a plan that that included new taxes and tax hikes on 137 items and services' - state officials promoted the "obesity tax," as the soft drink levy came to be called, as a public health measure.

The Slow Food Story: Politics And Pleasure, Emily Reynolds

Journal of Food Law & Policy

Geoff Andrews' historical account of the development of "Slow Food" is an inspiring and descriptive story detailing the rise and impact this movement has had on a worldwide scale. Beginning with the movement's origins, first in Italy, in the 1960s and 1970s, Andrews is able to provide readers with an understanding of the motives behind founder Carlo Petrini's desire to develop the Slow Food way of thinking. This in-depth examination of the culture and politics behind the Slow Food movement both critiques the modern fast-pace world in which we live, and also promotes the idea that Slow Food's alternative ideals …

Whatever Happened To Old Mac Donald's Farm… Concentrated Animal Feeding Operation, Factory Farming And The Safety Of The Nation's Food Supply, Julie Follmer, Roseann B. Termini

Journal of Food Law & Policy

Today, livestock farming is a far stretch from the nostalgic notion of animals grazing in green pastures, roaming free in the fresh country air and returning at the end of the day to a cozy barn. Simply stated, livestock farming is a large scale business, where tens of thousands of animals are swiftly raised industrial-style for maximum profit. Under the "factory farm" model, large corporate owned operations grow quantities of animals for slaughter for human consumption as food. In fact, livestock farms now raise 40% of all animals in the United States.

Nanofood: Legal And Regulatory Challenges, Abu Bakar Munir, Siti Hajar Mohd. Yasin

Journal of Food Law & Policy

Nanotechnology will have a significant impact on food production in a variety of ways, both directly and indirectly. The growth and complexity of nanotechnology in food applications poses new challenges for the existing food regulation as well as the regulatory authority. This article seeks to examine the legal and regulatory challenges posed by the nanotechnology applications in the food industry. This article reviews some of the relevant legislation in the U.S. and E.U. in dealing with nanofood and the industry. This article also provides an assessment on the adequacy of those laws and identifies the possible gaps and weaknesses in …

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Publicity, Pressure, And Environmental Legislation: The Untold Story Of Availability Campaigns, Molly J. Walker Wilson, Megan P. Fuchs

Cardozo Law Review

The availability heuristic - a cognitive rule of thumb whereby events that are easily brought to mind are judged to be more likely - is employed by decision-makers on a daily basis. Availability campaigns occur when individuals and groups strategically exploit this cognitive tendency in order to generate publicity for a particular issue, creating pressure to effect legislative change. This paper is the first to argue that environmental availability campaigns are more beneficial than they are harmful. Because they result in pressure on Congress, these campaigns serve as a catalyst for the enactment of critical new legislative initiatives. Specifically, these …

Ecological Flows In New Mexico - It Has Been Done, Adrian Oglesby

Publications

No abstract provided.

New Mexico Wildlife Conservation Act: Cooperative Action For Native Species Recovery, Stephanie Carman, David Propst

Publications

No abstract provided.

United States Food Law Update: Pasteurized Almonds And Country Of Origin Labeling, A. Bryan Endres

Journal of Food Law & Policy

The last six months of 2008 found the nation occupied with a heated presidential election campaign and the transition to a new party's control of the executive branch. The outgoing president, as is often the case in the waning months of an administration's time in office, attempted to finalize several policy initiatives. This version of the Food Law Update will discuss two major developments with significant long-term impact on the law of food: the implementation of mandatory country of origin labeling (COOL) for most unprocessed agricultural commodities; and the increasing use of the United States Department of Agriculture's (USDA) Agricultural …

Steps To Flow Restoration: Lessons From The Northwest, Reed D. Benson

Publications

No abstract provided.

The Pragmatics Of Allocating Water For Stream Flows, Steve Harris

Publications

No abstract provided.

Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Hunter

The University of New Hampshire Law Review

[Excerpt] “Despite the widespread concern regarding childhood obesity, there is broad divergence of opinion regarding responsibility for the crisis. Whether the government, food industry, or parents are accountable has become the focus of much debate. Public health groups have attempted various strategies to confront childhood obesity, such as litigation, legislation, and government regulation. While many researchers and advocates agree that government should play an affirmative role with respect to childhood obesity, they are very much divided over what that role should be. For example, although none of these acts has become law, eighty-six bills have been proposed regarding obesity since …

An Opiate Of The Masses: Religious Gerrymandering Of Sacramental Intoxication, Mark A. Levine

North Carolina Central Law Review

No abstract provided.

Up In Smoke: Federal Preemption And Medicinal Marijuana Id Cards In County Of San Diego V. San Diego Norml, Douglas Farr

Brigham Young University Journal of Public Law

No abstract provided.

Revisiting The Regulation Debate: The Effect Of Food Marketing On Childhood Obesity, Nicole E. Negowetti

Law Faculty Publications

No abstract provided.

The Chinese Regulatory Licensing Regime For Pharmaceutical Products: A Law And Economics Analysis, Qing Zhang

Michigan Telecommunications & Technology Law Review

China's pharmaceutical market has expanded dramatically in the past twenty years and is expected to become the largest in the world by the year 2050. However, entry to the market remains difficult for many international pharmaceutical manufacturers due to the country's costly and complicated regulatory licensing requirements. This Article provides an overview of the regulatory licensing regime for pharmaceutical products in China. Then, the Article evaluates three key features of the regulatory licensing regime through a law and economics approach. These features include the use of licensing, as contrasted with alternative regulatory and non-regulatory mechanisms; the standards to be met …

Generic Preemption: Applying Conflict Preemption After Wyeth V. Levine, Hannah B. Murray

Michigan Telecommunications & Technology Law Review

If a generic manufacturer does not have control over its safety warnings, can it comply with the obligations posed by state tort liability? State failure-to-warn actions evaluate whether a product manufacturer has met its obligation to warn consumers about known dangers associated with its product. In essence, if a manufacturer knows about a potentially dangerous outcome, it has a duty to warn its consumers. If the generic manufacturer can comply with a state duty to warn only by changing a label that the FDA will not allow it to change, it becomes impossible for the corporation to meet both requirements. …

Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel

Michigan Telecommunications & Technology Law Review

The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …

Platitudes About Product Stewardship In Torts: Continuing Drug Research And Education, Lars Noah

Michigan Telecommunications & Technology Law Review

This Article focuses on one emerging aspect of tort litigation against pharmaceutical manufacturers that, if it gained traction, portends a dramatic (and potentially counterproductive) expansion in the prescription drug industry's exposure to liability. The traditional theories of products liability--mismanufacture, defective design, and inadequate warnings--no longer exhaust the potential obligations of sellers. In addition to increasingly popular claims of misrepresentation and negligent marketing, which seem more like extensions of the three defect categories than entirely novel theories, a growing chorus of commentators would impose on pharmaceutical manufacturers a broader duty to test and educate (aspects of what they call an obligation …