Law Commons^™

Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp

All Faculty Scholarship

In Lundbeck the Eighth Circuit affirmed a district court’s judgment that a merger involving the only two drugs approved for treating a serious heart condition in infants was lawful. Although the drugs treated the same condition they were not bioequivalents. The Eighth Circuit approved the district court’s conclusion that they had not been shown to be in the same relevant market.

Most mergers that are subject to challenge under the antitrust laws occur in markets that exhibit some degree of product differentiation. The Lundbeck case illustrates some of the problems that can arise when courts apply ideas derived from models …

Revisiting The Original Tea Party: The History Of Regulating Food Consumption In America, Alison Peck

Law Faculty Scholarship

In response to concerns over rising obesity rates, state and federal policymakers have introduced laws that seek to internalize the public health costs of consuming unhealthy foods. These laws range from taxes on sugared beverages to mandatory nutritional information disclosures and beyond. Vocal opponents to such laws, including many Tea Party members, characterize such laws as government overreaching into the private sphere. That opposition often evokes Revolutionary images and ideology, with references to the Boston Tea Party, the Founding Fathers, and the framing of the Constitution. This article challenges the symbolism used by these opponents by examining the pre-Revolutionary non-importation …

Pliva V. Mensing And Its Implications, Brian Wolfman, Dena Feldman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers facing failure-to-warn claims from state-law liability, and may also have implications for preemption jurisprudence more generally, says attorney Brian Wolfman and co-author Dena Feldman in this BNA Insight. The authors analyze the ruling, and offer their views on the questions that PLIVA raises about the ongoing vitality of the presumption against preemption, the standard for determining ‘‘impossibility’’ preemption, and the propriety of deference to an agency’s views on preemption.

Creating A More Efficient And Effective Food Safety System In Memphis And Shelby County, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

The taste of a fresh-picked peach on a warm summer day is one of life’s simple joys. A store-bought peach can never truly replicate the experience. But in Memphis, getting that peach from the farmer’s tree into the customer’s hand is not as simple as one would assume. The fruit cannot be simply picked from the tree and then sold from the back of a produce truck. Instead, someone wanting to sell these fruits from his truck must obtain a permit and conform to outdated rules, such as the requirement for the truck to remain in motion at all times …

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …

Community Growth And Land Use, Susan Kelly

Publications

No abstract provided.

Brief Of Aarp And The National Legislative Association On Prescription Drug Prices As Amici Curiae In Support Of Petitioners, Sean Flynn

Amicus Briefs

This brief was written in support of Vermont’s Prescription Confidentiality Law, which regulates the confidentiality of prescription records and protects them from being used by pharmaceutical companies as a “targeting tool” to identify doctors most susceptible to sales messages.

Antitrust And Patent Law Analysis Of Pharmaceutical Reverse Payment Settlements, Herbert J. Hovenkamp

All Faculty Scholarship

Patent settlements in which the patentee pays the alleged infringer to stay out of the market are largely a consequence of the Hatch-Waxman Act, which was designed to facilitate the entry of generic drugs by providing the first generic producer to challenge a pioneer drug patent with a 180 day period of exclusivity. This period can be extended by a settlement even if the generic is not producing, and in any event all subsequent generic firms are denied the 180 day exclusivity period, significantly reducing their incentive to enter.

The Circuit Courts of Appeal are split three ways over such …

Winter 2011 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Rethinking Addiction: Drugs, Deterrence, And The Neuroscience Revolution, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This article connects the debate about addiction with the fundamental criminal law principle of deterrence. It seeks to bridge the gap between the competing medical and criminal justice approaches by exploring addiction in light of recent research about the brain, gender differences, and what works best from both a treatment and justice perspective. To sharpen the issues, the article deliberately focuses on the emotionally freighted subject of pregnant drug users. This approach will illuminate prevailing assumptions about how biological, genetic, cultural, and other environmental factors shape human behavior and challenge conventional understandings of deterrence in light of new research on …

Drug Policy In Context: Rhetoric And Practice In The United States And The United Kingdom, Richard C. Boldt

Faculty Scholarship

The history of narcotics use and drug control in the U.S. before passage of the Harrison Act in 1914 is similar in important respects to that in the U.K. during the same period. Although the two countries’ paths diverged significantly over the ensuing decades, there has been a convergence of sorts in recent years. In the United States, the trend lines have moved from an active “war on drugs” in which criminal enforcement and punishment have been the primary rhetorical and practical instruments of policy to an evolving approach, at least at the federal level, characterized by a somewhat more …

The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

No abstract provided.

Memory And Punishment, O. Carter Snead

Journal Articles

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered - by the offender, by the sentencing authority, …

Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe

UF Law Faculty Publications

Genetically engineered plants and animals have become and will continue to constitute a large part of the food we consume. The United States is the world's largest producer of genetically modified foods, making American consumers the most exposed population to these products. Agricultural biotechnology patents spur and support innovation. Accordingly, patent law is one of the main contributors to this phenomenon that has changed not only the kinds of food we eat, but the nature of the agri-business industry that produces these foods. This Article takes on an area of concern involving the patenting of food that has remained unexplored: …

The Future Of Food Eco-Labeling: Organic, Carbon Footprint, And Environmental Life-Cycle Analysis, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This Article discusses public and private efforts to inform consumers about environmentally preferable food choices. Part II describes the environmental consequences of the modern food system. Part III describes existing public and private eco-labeling regimes, including organic labeling, carbon footprint labeling, and country of origin labeling.

Is Usda Organic A Seal Of Deceit: The Pitfalls Of Usda Certified Organics Produced In The United States, China And Beyond, Chenglin Liu

Faculty Articles

American consumers' appetite for organic foods (organics) has dramatically increased since Congress passed the Organic Foods Production Act (OFPA) in 1990. Because the domestic organic food industry has been unable to meet the growing demand for these products, U.S. groceries have increasingly relied on imported organics. Studies show that 40% of organic foods consumed in the United States are imported from over 100 foreign countries.

To regulate organic food production, the United States Department of Agriculture (USDA) accredits certifying agents, which in turn certify organic farms and handlers according to U.S. organic standards. Certifying agents can be state agencies or …

Unpredictability In Patent Law And Its Effect On Pharmaceutical Innovation, Christopher M. Holman

Faculty Works

In recent years, the major innovator pharmaceutical companies have experienced two pronounced and significant trends: a decreasing output of innovative new drugs and cutbacks in research and development (R&D) investment. The two phenomena probably are not unrelated and raise significant concerns for a society intent upon providing affordable health care for an aging population. While the root causes of these trends are complex and diverse, we should not overlook the critical role patents play in creating the necessary incentives for the substantial investment required to develop pharmaceutically-interesting chemical compounds into actual drugs and to take them through the clinical trials …

The Commerical Speech Doctrine In Health Regulation: The Clash Between The Public Interest In A Robust First Amendment And The Public Interest In Effective Protection From Harm, David Orentlicher

Scholarly Works

No abstract provided.

What’S Wrong With Race-Based Medicine?, Dorothy E. Roberts

All Faculty Scholarship

This article is based on the 2010 Dienard Memorial Lecture on Law and Medicine at University of Minnesota and part of a larger book project, Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-first Century (The New Press, 2011). In June 2005, the Food and Drug Administration approved the first pharmaceutical indicated for a specific race. Its racial label elicited three types of criticism – scientific, commercial, and political. I discuss the first two controversies en route to what I consider the main problem with race-based medicine – its political implications. By claiming that race, a …

Food, Law & The Environment: Informational And Structural Changes For A Sustainable Food System, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This Article considers legal, theoretical, and practical steps to a more sustainable food model. Part I discusses the underlying reasons for problems in the current food system, including those manifested in law, and the perceived benefits of creating a new agricultural paradigm. Part II discusses the major agricultural and food programs that have become more common in shaping a different food system model, specifically focusing on direct marketing (for example, farmers markets and community-supported agriculture) and the organic movement as it relates to small farmers. Part III argues that in order to change modern American food consumption, two changes must …

Three Statutory Regimes At Impasse: Reverse Payments In Pay-For-Delay Settlement Agreements Between Brand-Name And Generic Drug Companies, Rudolph J.R. Peritz

Articles & Chapters

No abstract provided.

Small, Slow, And Local, Mary Jane Angelo

UF Law Faculty Publications

The United States is in the middle of a significant cultural shift. Until very recently, United States citizens and policy-makers were willing to accept, or at least tolerate, what has become our food status quo--a highly subsidized, centralized, industrial food system that is environmentally harmful and unsustainable and encourages unhealthy eating habits. Many citizens and policy-makers are now demanding that we re-evaluate our entire agricultural system from farm to table and look for ways to develop a new food paradigm that is environmentally sound, sustainable, socially equitable, and that makes healthy whole foods available to all.

During the summer of …

Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …

Litigating Together: Social, Moral, And Legal Obligations, Elizabeth Chamblee Burch

Scholarly Works

In a post-Class Action Fairness Act world, the modern mass-tort class action is disappearing. Indeed, multi-district litigation and private aggregation through contracts with plaintiffs’ law firms are the new mass-tort frontier. But something’s amiss with this “nonclass aggregation.” These new procedures involve a fundamentally different dynamic than class actions: plaintiffs have names, faces, and something deeply personal at stake. Their claims are independently economically viable, which gives them autonomy expectations about being able to control the course of their litigation. Yet, they participate in a familiar, collective effort to establish the defendant’s liability. They litigate from both a personal and …

Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax

Faculty Scholarship

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company’s decision-making process regarding full disclosure on a particular new drug.

Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter “industry”) and explains how some of the publications promote misleading information. Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. Part IV of this article addresses whether industry publications are …

Provigil: A Commentary, Daniel A. Crane

Articles

Michael Carrier's case study on Provigil' offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. These settlements purported to allow generic entry before the expiration of the patent period, but, according to Carrier, the promise of early entry was negated by the second prong of Cephalon's anticompetitive strategy. During the time that it had …