Food and Drug Law Commons^™

The Implications Of Post-Phase 1 And "Off-Label" Treatment Use Of Experimental Drugs: How Expansive Should Expanded Access Be?, Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Demythologizing Phosita: Applying The Non-Obviousness Requirement Under Canadian Patent Law To Keep Knowledge In The Public Domain & Foster Innovation, Matthew Herder

Articles, Book Chapters, & Popular Press

The Supreme Court of Canada recently revised the doctrine of non-obviousness in a pharmaceutical “selection patent” case, Apotex Inc. v. Sanofi-Synthelabo Canada Inc. Although cognizant of changes to the same doctrine in the United States and the United Kingdom, a critical flaw in how the doctrine is being applied in Canada escaped the Court’s attention. Using content analysis methodology, this article shows that Canadian courts frequently fail to characterize the “person having ordinary skill in the art” (PHOSITA) for the purpose of the obviousness inquiry. The article argues that this surprisingly common analytical mistake betrays a deep misunderstanding of innovation, …

Marketing Mothers' Milk: The Commodification Of Breastfeeding And The New Markets For Breast Milk And Infant Formula, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

This paper explores the commodification of women and biological processes, the confusion of scientific evidence with social agendas, and the conflict between marketing and public health. I assert that key actors in the healthcare marketplace - government, businesses, and doctors – have acted to enable weak medical and scientific evidence to be manipulated by ideological and profit-making partisans in a poorly regulated market. I focus on the unique role of the medical profession, which has acted with government and the private sector to shape the markets in human milk and infant formula. In a striking parallel to the pharmaceutical industry, …

The Role Of Litigation In Combating Obesity Among Poor Urban Minority Youth: A Critical Analysis Of Pelman V. Mcdonald's Corp., Ashley B. Antler

Cardozo Journal of Equal Rights & Social Justice

The note argues that litigation, particularly when focused on low-income urban minority youth, could serve as a strategic tool to address childhood obesity by reframing the issue and catalyzing policy and industry change. It critiques the Pelman v. McDonald's Corp. lawsuit for failing to address the socioeconomic and racial disparities underlying obesity rates, thereby missing an opportunity to advance meaningful solutions. The analysis suggests that public health litigation, when strategically framed, can complement broader advocacy efforts and push for environmental changes to combat the obesity epidemic.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Journal Articles

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Journal Articles

This Commentary is part of a colloquy on race-based genetics research.

Dying To Wait: How The Abigail Court Got It Wrong, Juan Joel Tovanche

Journal of Law and Health

At age twenty-one, Abigail Kathleen Burroughs met a fate usually reserved for aged men who have spent much of their lives drinking and smoking. Diagnosed with cancer at nineteen, Abigail battled the squamous cell carcinoma that invaded her body even as she struggled to maintain her characteristic optimism. Abigail struggled with more than her illness, however. In the last years of her life, Abigail and her family also wrestled with Food and Drug Administration (FDA) regulations that denied her access to medication that could have saved her life. The policy at issue was the FDA's practice of progressive testing, which …

The Public’S Right To Health: When Patient Rights Threaten The Commons, Elizabeth Weeks Leonard

Scholarly Works

This Article offers a contemporary examination of traditional public health objectives to address social problems not amenable to individual resolution. Taking the tradition a step further, it defines a "public health right" that may justify certain government actions that otherwise appear to impair individual rights. For example, lawmakers are considering whether current regulations on prescription drugs should be loosened to allow terminally ill patients to access drugs before they have been tested and approved for the general public. This Article concludes that expanding access to experimental drugs would violate the public health right to scientific knowledge and new drug development. …

An Economic Justification For Open Access To Essential Medicine Patents In Developing Countries, Sean Flynn, Aidan Hollis, Mike Palmedo

Scholarly Articles in Law Reviews & Journals

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which …

Canadian Food Law Update, Patricia L. Farnese

Journal of Food Law & Policy

Provided below is an overview of developments in Canadian food law and policy in 2008. This update primarily analyzes regulatory and policy developments by the federal government. This focus reflects the significance of federal activities in the food policy realm. As this is the first Canadian update to appear in the Journal of Food Law & Policy, it is appropriate to include a brief summary of the Canadian regulatory framework for food. The regulatory framework provides the necessary context to identify trends driving recent changes in Canadian food law and policy.

European Union Food Law Update, Emilie H. Leibovitch

Journal of Food Law & Policy

The European Union (EU) is facing major institutional challenges because Ireland rejected the Treaty of Lisbon last summer. The Treaty of Lisbon aims at modifying the institutional framework of the EU; more precisely, it aims in part at modifying the interaction of the various EU regulatory bodies with one another, as well as the interaction between the EU regulatory bodies and the national ones. The next few months will be decisive in determining whether the Treaty of Lisbon will finally replace the Treaty of Nice.

The Deregulatory State, Lawrence O. Gostin

O'Neill Institute Papers

Public health can be achieved only through collective action, not through individual endeavor. Collective goods are essential conditions for health, but can be secured only through a well-regulated society. Yet, successive governments have eroded health and safety protections, with serious consequences. Think about the death of miners, lead in children’s toys, industrial solvents in toothpaste, salmonella in peanut butter, e-coli in spinach, and unsafe or ineffective pharmaceuticals such as COX-2 inhibitors or non-statin cholesterol medications.

Conservatives have waged a campaign against the administrative state that has created and reinforced deep-seated concerns about over-bearing government, particularly at the national level. The …

Big Food's Trip Down Tobacco Road: What Tobacco's Past Can Indicate About Food's Future, Joshua Logan Pennel

Buffalo Public Interest Law Journal

No abstract provided.

Statins And Adverse Cardiovascular Events In Moderate-Risk Females: A Statistical And Legal Analysis With Implications For Fda Preemption Claims, Theodore Eisenberg, Martin T. Wells

Cornell Law Faculty Publications

This article presents: (1) meta-analyses of studies of cardioprotection of women and men by statins, including Lipitor (atorvastatin), and (2) a legal analysis of advertising promoting Lipitor as preventing heart attacks. The meta-analyses of primary prevention clinical trials show statistically significant benefits for men but not for women, and a statistically significant difference between men and women. The analyses do not support (1) statin use to reduce heart attacks in women based on extrapolation from men, or (2) approving or advertising statins as reducing heart attacks without qualification in a population that includes many women. The legal analysis raises the …

Jumping On The Next Bandwagon: An Overview Of The Policy And Legal Aspects Of The Local Food Movement, Marne Coit

Journal of Food Law & Policy

This article is an exploration of this new and growing local food movement. It is not a cohesive movement, nor is it one that is organized by a particular group. Rather, it is a grassroots movement comprised of people who are interested, for various reasons, in obtaining food grown or produced where they live or in producing this food themselves. The purpose of this article is to explore what the local food movement is, why consumers are interested in basing their food purchasing choices on where their food originates, current and future regulation of local food, and where this movement …

European Union Food Law Update, Emilie H. Leibovitch

Journal of Food Law & Policy

The following European Union Food Law Update will address significant changes in European Union (EU) food law that occurred between 2006 and early 2008. The update will be different from the previous ones, as it will instead be organized by the subject areas addressed by the developments. The published regulations, proposals, cases, and other relevant news will thus be incorporated under their corresponding topic headings.

Addressing The Global Tragedy Of Needless Pain: Rethinking The United Nations Single Convention On Narcotic Drugs, Allyn L. Taylor

O'Neill Institute Papers

The lack of medical availability of effective pain medication is an enduring and expanding global health calamity. Despite important medical advances, pain remains severely under-treated worldwide, particularly in developing countries. This article contributes to the discussion of this global health crisis by considering international legal and institutional mechanisms to promote wider accessibility to critical narcotic drugs for pain relief.

Combating The Unfair Competitive Edge: Random Drug Testing Should Be Implemented In Standardized Testing To Deter Illicit And Unfair Use Of Prescription Stimulants, Shawn Romer

Journal of Law and Health

This note will first give an overview of prescription stimulants and will then explore the prevalent number of students who illicitly take prescription stimulants to enhance their academic performance. A description of how illicit use can be harmful to a student follows, and thereafter the note describes the scant current safeguards that currently exist against the use of illicit prescription stimulants. An explanation of the importance of standardized test scores to admissions follows, along with a description of how this importance has motivated students to seek an unfair competitive edge through illicit drug usage, which happens in many sporting competitions. …

There Ain't No Such Thing As A Free Lunch: A Look At State Gift Disclosure Laws And The Effect On Pharmaceutical Company Marketing, 41 J. Marshall L. Rev. 563 (2008), Scott Velasquez

UIC Law Review

No abstract provided.

Two Global Crises Bring Opportunity To International Tobacco Control, Chris A. Bostic

Sustainable Development Law & Policy

No abstract provided.

Usda Organic: Ecopornography Or A Label Worth Searching For?, Blake M. Mensing

Sustainable Development Law & Policy

No abstract provided.

Expedited Partner Therapies For Sexually Transmitted Diseases: Legal And Policy Approaches, James G. Hodge, Erin C. Fuse Brown

Faculty Publications By Year

No abstract provided.

Lawsuits Over Tainted Heparin Manufactured In China: Is The Fda Becoming The Global Healthcare Authority? , Christina Laga

Public Interest Law Reporter

No abstract provided.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Journal Articles

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Beetles For Breakfast: What The Fda Should Be Telling You, Kaycee L. Wolf

Journal of Food Law & Policy

Imagine sitting down to breakfast and eating strawberry yogurt with a glass of grapefruit juice. You think you are eating a healthy meal, but along with vitamins, calcium, and nutrients, you are getting a side of crushed beetles. Cochineal extract and carmine, two color additives derived from the cochineal beetle, color many foods such as strawberry yogurt. When people consume products with color additives, most do not realize that they could be ingesting insects, which can also be potentially dangerous, not to mention possibly unappetizing or upsetting. Imagine that one minute you are sitting down to eat a healthy cup …

Uncapping The Bottle: A Look Inside The History, Industry, And Regulation Of Bottled Water In The United States, Joyce S. Ahn

Journal of Food Law & Policy

"Agu chupa! Agu chupa!" As we drove through the lush rolling hills of northwestern Rwanda, a crowd of young children appeared from the tea fields and repeatedly shouted these words to us. The taxi driver explained that the children wanted our "water bottes." Aware that visitors often drink bottled water, the children run alongside taxis with the hopes of obtaining the plastic bottles. Although Rwandan children typically carry their drinking water in tightly-woven baskets, the modern plastic bottles have become popular and prized possessions.

The Battle Of The Bulge: Evaluating Law As A Weapon Against Obesity, Margaret Sova Mccabe

Journal of Food Law & Policy

"Silly rabbit, Trix are for kids." Since the 1970s, kids have gotten to know the silly rabbit created to promote sugary, fruit-flavored cereal in television ads. Today, "i'm lovin' it" is the McDonald's slogan, but to millions of children the more recognizable symbol is Ronald McDonald. Ronald McDonald is so recognizable that one study pegged recognition of Ronald among American children at 96% and another at 80% by children in nine other countries. Given the "obesity crisis," many question whether these ads should be permitted, with some questioning whether such products are even safe for children's consumption. The Trix Rabbit …

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

O'Neill Institute Papers

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise …

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

O'Neill Institute Papers

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. …

Regulatory Marketing Approval For Pharmaceuticals As A Non-Tariff Barrier To Trade: Analysis Under The Wto's Agreement On Technical Barriers To Trade, Mary Hess Eliason

San Diego International Law Journal

At a fundamental level, pharmaceuticals serve two roles: both as a cure for disease and as a product. As a cure for disease, a drug's value cannot be quantified because it saves lives. As a product, profit analysis shapes every step of a drug's progression to market. In least developed nations the barriers to drug access are not solely economic. National regulatory systems for market approval are being used to prevent external pharmaceutical manufacturers from participating in a national market. This article will address how the regulatory framework of pharmaceutical registration may serve as a barrier to trade in drugs, …