Food and Drug Law Commons^™

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.