Food and Drug Law Commons^™

The History And Future Of Genetically Modified Crops: Frankenfoods, Superweeds, And The Developing World, Brooke Glass-O'Shea

Journal of Food Law & Policy

In a 1992 letter to the New York Times, a man named Paul Lewis referred to genetically modified (GM) crops as "Frankenfood," and wryly suggested it might be "time to gather the villagers, light some torches and head to the castle." Little did Lewis know that his neologism would become the rallying cry for activists around the world protesting the dangers of genetic engineering. The environmental activist group Greenpeace made great use of the "Frankenfood" epithet in their anti-GM campaigns of the 1990s, though they have since backed away from the word and the hardline stance it represents. But genetically …

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …

Breaking Patents, Daniel R. Cahoy

Michigan Journal of International Law

In the 1970s and 1980s, the Boeing aircraft company worked to address the rising cost of jet fuel by inventing lighter metal alloys for use in aerospace materials. Among its discoveries was a method of producing aluminum-lithium alloys with high "fracture toughness," and in 1989, Boeing received a patent for the process. Five years later, another aerospace company working as a National Aeronautics and Space Administration (NASA) contractor, Lockheed Martin, was attempting to solve a similar problem related to materials used in the space shuttle. Lighter materials were necessary for future shuttle missions to transport components of the International Space …

Community Growth And Land Use, Susan Kelly

Publications

No abstract provided.

Dynamic Patent Governance In Europe And The United States: The Myriad Example, Kali Murray, Esther Van Zimmeren

Cardozo Journal of International and Comparative Law

This Article examines the emerging elements of a new model for patent governance. It is divided into four parts. In Section One, we develop a model of dynamic patent governance. This model extends the theoretical framework of network governance, to explain the emergence of networks in the decisionmaking infrastructure for the public and private actors in the patent system. Dynamic patent governance widens this theoretical framework in two key ways. First, dynamic patent governance, within its formal dimensions, is based on the idea that heterogeneous administrative actors regulate the grant and enforcement of patents. This challenges a perspective that sees …

Mary Jane's New Dance: The Medical Marijuana Legal Tango, Michael Berkey

Cardozo Public Law, Policy & Ethics Journal

The note examines the legal and social dynamics surrounding medical marijuana, tracing its historical use, the evolution of regulatory policies, and the ongoing conflicts between federal, state, and local laws. It highlights the shift in societal perception and the growing acceptance of medical marijuana, despite persistent legal challenges.

The Analyses Of State And Federal Medical Marijuana Laws And How They Apply To Employment, Lizaveta Sergeev

UNLV Theses, Dissertations, Professional Papers, and Capstones

The purpose of this study is to analyze and discuss the current discrepancies in the legal system as it applies to medical marijuana in the employment sector. The laws regarding the legalization of medical marijuana are relatively new and have many constraints when applied to employment. On the federal level, medical marijuana remains illegal. Many states have passed some form of legislation legalizing medical marijuana. Unfortunately, only two states have laws that protect users from being discriminated in employment. This leaves employers and employees uncertain about what actions to take when dealing with medical marijuana in the employment sector.

The International Control Of Illegal Drugs And The U.N. Treaty Regime: Preventing Or Causing Human Rights Violations?, Daniel Heilmann

Cardozo Journal of International and Comparative Law

The international drug control regime, established to preserve human health and welfare, faces criticism for prioritizing criminalization and punishment over education, harm reduction, and human rights. The regime's prohibition-oriented approach, while comprehensive, is challenged by modern human rights standards and the evolving illegal drug market. The article examines whether the regime remains effective and aligned with contemporary human rights principles, emphasizing the need to balance control measures with human rights protections.

Population Health Through Inclusive Urban Planning: Healthier Communities And Sustainable Urban Development In Indian Cities, Shriya Malhotra

Sustainable Development Law & Policy

No abstract provided.

Mobile Phones: Reshaping The Flow Of Urban-To-Rural Remittances, Bethany Brown

Sustainable Development Law & Policy

No abstract provided.

Out Of The Garden Of Eden: Moving Beyond The Rights-Based Agenda In The Urban Sector, Benjamin Bradlow

Sustainable Development Law & Policy

No abstract provided.

Cultivating Urban Forests Policies In Developing Countries, Janet A. Choi

Sustainable Development Law & Policy

No abstract provided.

About Sdlp

Sustainable Development Law & Policy

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 & Court Filings

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.

Public Non-Commercial Use' Compulsory Licensing For Pharmaceutical Drugs In Government Health Care Programs, Pier Deroo

Michigan Journal of International Law

Suppose a relatively prosperous nation with universal public health coverage faces an HIV/AIDS crisis. It refuses to negotiate with the patent-holding manufacturers of the best antiretrovirals (ARVs) available, instead issuing compulsory licenses. Compulsory licenses permit the generic drug manufacturers designated in the compulsory licenses to make, use, import, and sell the patented ARVs without the permission of the patent owners, increasing competition and lowering prices. Realizing that drugs are much cheaper without patents, the nation decides to issue another round of compulsory licenses for an extensive list of patented drugs for its universal health care program. While improving public access …

Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook

Michigan Telecommunications & Technology Law Review

Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

UIC Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …

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 …

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 …

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.

Teva V. Eisai: What's The Real Controversy, Grace Wang

Michigan Telecommunications & Technology Law Review

This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …

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

Publications

No abstract provided.

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 …

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 Food Safety Modernization Act: Keeping Dinner Safe And Farmers In The Fields, Sarah K. Baker

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

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 …

Patent Office As Biosecurity Gatekeeper: Fostering Responsible Science And Building Public Trust In Diy Science, 10 J. Marshall Rev. Intell. Prop. L. 423 (2011), Brian J. Gorman

UIC Review of Intellectual Property Law

When the fields of intellectual property law and biotechnology intersect, most analysis is driven byeconomic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free from oversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of syntheticbiology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government …

Warning, This Decision Will Increase The Cost Of Prescription Drugs: How The Supreme Court’S Misapplication Of Preemption Doctrine In Wyeth V. Levine Portends Devastating Consequences For Oklahoma, Tyler R. Barrett

Oklahoma Law Review

No abstract provided.

Small, Slow, And Local: Essays On Building A More Sustainable And Local Food System, Mary Jane Angelo, Amelia Timbers, Matthew J. Walker, Joshua B. Donabedian, Devon Van Noble, Erik Phillips-Nania, Emily Parish, Jennifer L. Perez

UF Law Faculty Publications

A collection of essays that have strong arguments in favor of shifting from our existing centralized industrial agricultural system to a more localized system. This shift will reduce reliance on fossils fuels, which are used to make pesticide and fertilizer inputs and to transport foods long distances, thereby reducing contributions to climate change and decreasing environmental impacts. The shift will also provide social and economic benefits to local communities, improved health and a more sustainable, secure, and resilient food supply. To achieve such a shift, however, it will be necessary to overcome existing legal, economic, and social barriers and to …

Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel

The Science Journal of the Lander College of Arts and Sciences

The following is an excerpt of the introduction to this article: Olestra, a fat-substitute comprised of sucrose that has been esterified with fatty acids (Blume 1995), has been the subject of much controversy ever since its creation. Olestra is not absorbed (Mattson and Nolen 1972) because it cannot be hydrolyzed by pancreatic lipases (Mattson and Volpenhein 1972) or taken up across the enterocyte microvillus membrane (Freston et al. 1997), and thus, cannot be utilized for energy. Olestra has physical and organoleptic properties similar to those of traditional triglycerides (Jandacek and Webb 1978) and is emulsified together with triglyceride (Freston et …