Digital Commons Network^™

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 …

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 …

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 …

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.

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.

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 …

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.

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 …

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 …

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.

Is There A Doctor In The (Station) House?: Reassessing The Constitutionality Of Compelled Dwi Blood Draws Forty-Five Years After Schmerber, Michael A. Correll

West Virginia Law Review

The vast majority of Fourth Amendment jurisprudence of the last century has been dedicated to parsing the physical and in- tangible boundaries of the home, developing the expectation of privacy, and, as of late, exploring the constitutional implica- tions of an increasingly electronic society. In the midst of this development, one major area has quietly fallen by the wayside - the preservation of bodily integrity. As technology has ren- dered the human body an ever-increasing source of crucial evi- dence, the Supreme Court has remained largely silent on the government's power to harvest information through medical procedures. Since the Court's …

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 …

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 …

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: …

Blood Transfusions, Jehovah’S Witnesses, And The American Patients’ Rights Movement, Charles Baron

Charles H. Baron

The litigation to protect Jehovah’s Witnesses from unwanted blood transfusions, which their theology considers a violation of the biblical prohibition against drinking blood, has produced important changes in both the right to refuse treatment and in the preferred treatment methods of all patients. This article traces the evolution of the rights of competent medical patients in the United States to refuse medical treatment. It also discusses the impact this litigation has had on the medical community’s realization that blood transfusions were neither as safe nor as medically necessary as medical culture posited.

Short Summaries Of Two Main Speeches, Evgenia Pavlovskaia

Evgenia Pavlovskaia

This paper contains short summaries of two main speeches made during the NELN+ Conference in Lund in October 2011. The first speaker, Nicolas de Sadeleer from Belgium, talked about the issues of precautionary measures in situations of scientific uncertainty. He presented an overview of the relevant EU case-law from the General Court and the Court of Justice. The central question that was highlighted concerned the space left to the EU Commission and Council to determine how “safe is safe”. The second speaker, Hillevi Eriksson from Sweden, reflected on the results of her research within the topic “Knowledge Needed for Climate …

Requirements Of A Valid Islamic Marriage Vis-À-Vis Requirements Of A Valid Customary Marriage In Nigeria, Olanike Sekinat Odewale Mrs

Olanike Sekinat Adelakun

The Rise Of U.S. Food Sustainability Litigation, Stephanie Tai

Stephanie Tai

This article provides one of the first critical looks at the interface between the values of the sustainable food movement and its rising use of litigation. In particular, it focuses on two growing areas of food sustainability litigation: challenges to CAFOs and challenges to the use of genetically modified organisms (GMOs) in the food system. These areas were chosen because they involve growing sectors of U.S. agriculture over which members of the sustainable food movement have raised significant concerns.

The article begins by describing the sustainable food movement, including how the movement fits in with factors that sociologists use to …