Food and Drug Law Commons^™

Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann

Law Faculty Scholarship

There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Squashing The Superbugs: A Proposed Multifaceted Approach To Combatting Antibiotic-Resistant Bacteria , Lauren Orrico

Journal of Law and Health

Section II of this Note will provide background on the practices of the United States farming system, which fosters the creation of antibiotic-resistant bacteria. This section will also provide background on the detrimental effects that antibiotic resistance has on human health and will briefly describe the legal history of food and drug regulations. After establishing an informational foundation, Part III will elaborate on current laws and describe the legal authority of key players, before pointing out the shortcomings in current animal feed policy and recommending the development of further regulation in this area. Additionally, Part III will propose new legislation …

Food Art: Protecting "Food Presentation" Under U.S. Intellectual Property Law, 14 J. Marshall Rev. Intell. Prop. L. 1 (2014), Cathay Smith

UIC Review of Intellectual Property Law

In 2006, a scandal broke in the culinary world. It was alleged that Robin Wickens, chef at (now closed) Interlude restaurant in Melbourne, Australia, had copied dishes by renowned American chefs Wylie Dufresne, Jose Andres, and Grant Achatz. It is not uncommon for chefs to borrow recipes from other chefs, and there has been a long culture of sharing in the cuisine industry. However, what made Wickens’ actions scandalous was that he had purportedly copied the artistic presentation and plating of other chefs’ dishes, not just their recipes.

This Article examines whether chefs can protect the artistic presentation or plating …

3(D) View Of India’S Patent Law: Social Justice Aspiration Meets Property Rights In Novartis V. Union Of India & Others, 13 J. Marshall Rev. Intell. Prop. L. 719 (2014), Saby Ghoshray

UIC Review of Intellectual Property Law

Not many constitutional decisions from developing countries find themselves at the center of global debate like the Indian Supreme Court’s Novartis decision invalidating the Gleevec patent. The patent was invalidated under amended Section 3(d) of the Indian Patents Act, which was amended to address some of the concerns of imbalance between the maximalist and minimalist cultures in the pharmaceutical context. Section 3(d) of the Indian Patent Act introduced a new threshold of patent eligibility for pharmaceutical innovation that requires applicants to demonstrate enhanced efficacy of their products. The objective of this Article is to get beyond the reactionary reviews of …

Morning-After Decisions: Legal Mobilization Against Emergency Contraception In Chile, Fernando Muñoz León

Michigan Journal of Gender & Law

In Chile, the Criminal Code bans all forms of abortion. Furthermore, the Constitution—drafted and enacted by the Military Junta led by General Augusto Pinochet—was inspired by a conservative version of Catholic natural law championed by prominent Chilean constitutional law scholars. This Article traces the emergence, development, and ultimately the defeat of a persistent legal mobilization driven by natural law-inspired litigants, politicians, and scholars against levonorgestrel-based emergency contraception, also known as the morning-after pill. In their decade-long efforts at legal mobilization, these natural law litigants used every tool of the Chilean legal system to challenge the legality and the constitutionality of …

Food Miles: Environmental Protection Or Veiled Protectionism?, Meredith Kolsky Lewis, Andrew D. Mitchell

Michigan Journal of International Law

Eat local. Such a small phrase yet such a loaded proposition. Buying food from nearby sources has become a popular objective. This aim is associated with helping farmers in one’s country or region; observing the seasonality of one’s location; eating fresher foods; striving for food security; and protecting the environment. One of the unmistakable messages of the “locavore” movement is that importing food—particularly food that comes from far away—causes environmental harm. The theory is that transporting food long distances results in the release of high levels of greenhouse gases (GHGs) into the atmosphere and is thus a dangerous contributor to …

The Penumbra Of The United States’
 Foreign Corrupt Practices Act: Brazil’S Clean Companies Act And 
Implications For The Pharmaceutical
 Industry, Beverley Earle, Anita Cava

Richmond Journal of Global Law & Business

No abstract provided.

Who Can Afford It?: The Patient Protection And Affordable Care Act's Failure To Regulate Excessive Cost-Sharing Of Prescription Biologic Drugs , Michael Callam

Journal of Law and Health

This Note will discuss how the PPACA’s abbreviated approval pathway for biological products creates an expedited procedure to bring less expensive biologic drugs to the market, but ultimately fails to make those biologic drugs affordable because of its lack of provisions limiting insurers’ use of excessive cost-sharing requirements. Part II provides an overview of prescription drugs, compares biologics with traditional prescription drugs, and provides a brief legislative history of prescription drug laws. Part III analyzes the impact of the abbreviated approval pathway on biologic drugs’ costs to prescribed patients. It also examines the PPACA’s effects on biologics inclusion into health …

Smoking Out A Compromise: Splitting The Difference Through A Public Policy Approach To Resolving The Graphic Cigarette Warning Label Circuit Split, Amelia B. Larsen

Cleveland State Law Review

The imposition of graphic warning labels is necessary; the tobacco market exploits the lower class by capitalizing on their under-education regarding the negative health consequences of smoking. This injustice can be corrected by providing the most direct and clear communication imaginable to consumers to ensure they are completely informed of the peril they are placing themselves in when they choose to smoke—the graphic warning labels provide this kind of communication. This Note discusses why the FDA’s warning labels meet First Amendment constitutional scrutiny and serve a substantial governmental interest regarding the country’s public health, socioeconomic equality, and economy. Part II …

Greenwashing And Self-Declared Seafood Ecolabels, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The credibility and veracity of an environmental claim depends on a high degree of transparency, clarity, and trust. Businesses that utilize ecolabels to market the environmental performance of their seafood products often turn to third-party certifications to minimize the potential for greenwashing and provide a level of verification and independence. Others rely on a riskier approach by developing their own self-declared or first-party ecolabels. Seafood retailers and suppliers considering the creation and use of an ecolabel, certification, or seal to be used in the marketing of seafood products should ensure compliance with applicable Food and Drug Administration and United States …

Bad Medicine: Ftc V. Actavis, Inc. And The Missed Opportunity To Resolve The Pay-For-Delay Problem, Susan Schipper

Maryland Law Review

No abstract provided.

Water Governance Challenges In New Mexico's Middle Rio Grande Valley: A Resilience Assessment, Melina Harm Benson, Dagmar Llewellyn, Ryan Morrison, Mark Stone

Publications

No abstract provided.

Jump In Before It's Too Late: Protecting And Increasing Streamflows In New Mexico, Sharon Wirth

Publications

Freshwater ecosystems need adequate streamflow to supply clean water for humans and maintain healthy habitat for wildlife. Over-appropriation, overuse, climate change, and drought plague New Mexico's rivers, taxing many rivers beyond sustainability. Despite the myriad of problems caused by little or no water in our rivers, policies and procedures to protect and increase streamflows in New Mexico are limited. While most Western states have made demonstrable progress in alleviating various legal and technical barriers to protecting and increasing streamflows, New Mexico has made only limited, recent progress towards solutions for our drying rivers. This article takes a critical look at …

Developing The Law Of The River: The Integration Of Law And Policy Into Hydrologic And Socio-Economic Modeling Efforts In The Willamette River Basin, Adell Louise Amos

Publications

A legal and policy infrastructure -- referred to as a "law of the river" -- exists for every river basin in the U.S. an can be as important as natural processes in terms of managing the future of the resource. Because of the way that water law and policy have evolved in the U.S., this infrastructure involves a matrix of state and federal law that governs the choices that policymakers, end users, and agencies make. This "law of the river" provides the context in which decisions are made and not made. It also draws the boundaries within which decision makers …

Fraud In The Market, Samuel R. Wiseman

Scholarly Publications

No abstract provided.

The Hang-Up With Hamburg: How Center For Food Safety V. Hamburg Will Alter The Food Industry, Joella Roland

Journal of Business & Technology Law

No abstract provided.

Hatch-Waxman’S Safe-Harbor Provision For Pharmaceutical Development: A Free Ride For Patent Infringers?, 13 J. Marshall Rev. Intell. Prop. L. 445 (2014), Kate Y. Jung

UIC Review of Intellectual Property Law

The Safe-Harbor provision of the Hatch-Waxman Act allows generic drug manufacturers to use a patented invention during pre-market testing of generic drugs. However, the U.S. Court of Appeals for the Federal Circuit’s recent interpretation of the Safe-Harbor provision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. created controversy when it extended the Safe-Harbor exemption to post-FDA approval. This extension was done in an unprecedented manner and would “allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass.” The U.S. Supreme Court has yet to settle this matter, and courts are now faced …

Food Choice: Should The Government Be At The Head Of The Table?, Emily Semands

Oklahoma Law Review

No abstract provided.

Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A), Michael Henry Davis

Law Faculty Articles and Essays

The Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS"), the General Agreement on Tariffs and Trade ("GATT"), and the World Trade Organization ("WTO") debacle has radically altered the traditional ability of nations to adopt whatever patent regime seems appropriate to them. Instead, TRIPS requires all member nations, even those which never thought it appropriate to grant such state monopolies, to afford patent protection to areas which had never been granted before-most dramatically in the area of health related innovations and, most expensively, pharmaceuticals. Until TRIPS, most -- or at least a number approaching half -- countries simply did …

Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings, Gabriella Tzeneva

Indiana Journal of Global Legal Studies

This Note explores the economic and social factors that drive multinational pharmaceutical companies to donate drugs to developing countries and evaluates the effectiveness of such donations in combating medicine shortages. The Note poses that such donations provide necessary economic incentives to drug companies and help curb high medical prices in developed nations while being an essential tool for ameliorating intellectual property requirements imposed by TRIPS. The Note proposes two solutions to further incorporate donations in access to medicine relief efforts and advocates increased international cooperation in the practice.

Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio

Law Student Publications

This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …

Implementing The Food Safety Modernization Act: An Examination Of The Inequitable Impact Of The Proposed Preventive Controls And Produce Safety Rules, Ben Metzger

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Private Parties And The Ffdca: How Creative Litigants Have Circumvented Section 310 And Undermined The Nlea’S Express Preemption Amendments, Joe Dages

Catholic University Law Review

No abstract provided.

23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely

Other Publications

On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.

The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen

Journal of Law and Health

This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.

Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson

Law Student Publications

This article explores whether a graphic warning is possible or preferable in the government's fight against tobacco. Part II outlines a brief history of tobacco regulation in the United States. Part III turns to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and the FDA's initial rulemaking process. Part IV outlines the doctrine of commercial free speech, and Part V discusses why the Rule faced insurmountable challenges under this jurisprudence. Part VI explores how the FDA may overcome these hurdles in its future rulemaking, while Part VII discusses alternative methods through which the government can pursue its anti-tobacco agenda …

Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane

Articles

The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …

The International War Against Doping: Limiting The Collateral Damage From Strict Liability, Thomas W. Cox

Vanderbilt Journal of Transnational Law

The World Anti-Doping Agency (WADA) and the World Anti-Doping Code are largely considered the model for an effective and well-coordinated antidoping regime. This model has allowed numerous sports and various countries to secure the same rules for domestic and international athletes. Within this regime, strict liability for prohibited substances stands as the "cornerstone." Strict liability has allowed antidoping officials to prosecute doping violations through an effective testing regime. However, this principle occasionally implicates innocent athletes with no intention of performance enhancement. This Note proposes that WADA modify its criteria for including substances on the Prohibited List and suspend strict liability …

Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson

University of Richmond Law Review

No abstract provided.