Food and Drug Law Commons^™

Interactions, Iteration And Early Institutionalization: Competing Lessons Of Globalgap’S Legitimation, Donal Casey

Transnational Business Governance Interactions Working Papers

Since its inception, GLOBALGAP has transformed from an informal grouping of retailers into a highly elaborate regulatory organisation. This chapter critically examines GLOBALGAP’s development. I argue that, through an iterative process of legitimation, actual and anticipated interactions with state, market and civil society actors led GLOBALGAP to develop structures, practices and processes that sought to enhance representation and participation of structurally weaker parties such as smallholders, whilst also addressing concerns relating to the exclusionary effect of its standards. I tease out how, as non-state regulatory organisations emerge and develop, they respond to actual and anticipated governance interactions in order to …

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Articles in Law Reviews & Other Academic Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

Life, Liberty, [And The Pursuit Of Happiness]: Medical Marijuana Regulation In Historical Context, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

The struggle for access to medical marijuana differs from most other battles for therapeutic freedom in American history because marijuana also has a popular, though controversial, nontherapeutic use—delivery of a recreational high. After considering struggles over the medical use of alcohol during prohibition as a precedent, this chapter relates the history of medical marijuana use and regulation in the United States. The bulk of the chapter focuses on the medical marijuana movement from the 1970s to present. This campaign has been one of the prime examples of a successful extrajudicial social movement for freedom of therapeutic choice. With the exception …

A Mathematical Solution To The Sine Of Madness That Is Pharmaceutical Compulsory Licensing Under The Trips Agreement And The Doha Declaration, Ashley E. Sperbeck

Marquette Intellectual Property Law Review

A viable economic solution is necessary to address the shortcomings, textual ambiguities, and deficiencies engulfing international patent protection, leading to the inability of LDCs facing public health crises or national emergencies and lacking pharmaceutical manufacturing facilities to obtain generic pharmaceuticals. This Note poses a solution to this problem via another Amendment to the TRIPS Agreement and the Doha Declaration, which provides a mathematical framework to determine when and under what circumstances a compulsory license should be granted. Furthermore, this Note contemplates establishment of a WTO subcommittee to oversee this proposed solution and to ensure compliance with this Amendment. This concrete …

Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

The Surprising Reach Of Fda Regulation Of Cannabis Even After Descheduling, Sean M. O'Connor, Erika Lietzan

American University Law Review

No abstract provided.

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Tribal Sovereign Immunity As A Defense At The Patent Trial And Appeal Board? Or A Violation Of U.S. Antitrust Laws?, Samantha Roth

Marquette Intellectual Property Law Review

This Comment will address two primary issues. First, it will analyze the basis of sovereign immunity rights of tribes, with a focus on the relationship between intellectual property rights and sovereignty. Second, it will discuss whether this arrangement violates the antitrust laws of the United States. This Comment concludes that even if a claim of tribal sovereign immunity is legitimate, it is likely that such an arrangement still violates the relevant antitrust claims.

Finding A Forest Through The Trees: Georgia-Pacific As Guidance For Arbitration Of International Compulsory Licensing Disputes, Karen Mckenzie

Marquette Intellectual Property Law Review

This paper will examine the challenges of international compulsory licensing by examining the issue historically and legally as well as offer possible solutions. Thus, this paper will explore the challenge of balancing corporate interests against the affordability and availability of pharmaceuticals by focusing on discrete situations in developing countries, the history of compulsory licensing, and how the World Health Organization (the “WHO”) and the WTO have attempted to tackle these challenges through compulsory licensing, and it will suggest a possible framework for use in arbitration, which balances equities through a Georgia-Pacific analysis.

Protecting Wisconsinites From Trolls: The Federal Circuit's "Bad Faith" Preemption And Its Restrictive Effect, Andrew Salomone

Marquette Intellectual Property Law Review

In this comment, I use Wis. Stat. Ann. § 100.197 (“Wisconsin’s anti-PAE statute”) to demonstrate the significant degree to which the Federal Circuit’s current preemption regime restricts states’ abilities to regulate the behavior of PAEs. In Part II, I summarize Wisconsin’s legislative response to PAEs. In Part III, I contrast the Federal Circuit’s preemption doctrine and the Supreme Court’s doctrine as it relates to state laws similar to anti-PAE statutes. Paying particular attention to Wisconsin’s patent notification statute, I provide a brief preemption analysis in Part IV. Finally, in Part V, I conclude by arguing that the severe consequences of …

What Are We Really Eating?: An Analysis Of Food Labeling Transparency, Lily Van Petten

Fordham Undergraduate Law Review

Understanding a nutrition label can often be like deciphering ancient hieroglyphics. This Note examines the ethical and legal constraints of food nutrition labeling with specific key words such as “all-natural” and “superfood” in the United States. The subject of nutrition in the law is first explored through the 2018 lawsuit Rice v. National Beverage Corp. Many educated, nutritionally informed citizens still do not have a clear grasp of what chemicals and other synthetic ingredients they are consuming when buying popular brands. Large food companies use persuasive marketing to attract consumers, especially through misrepresenting nutritional data. In this case specifically, Lenora …

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

Legal Discrimination Against Organ Transplant Candidates: Medicinal Marijuana And The Double-Edged Sword, 52 Uic J. Marshall L. Rev. 859 (2019), Kyle Jorgensen

UIC Law Review

No abstract provided.

Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang

Washington International Law Journal

The WTO Agreements emphasize free trade, which links with diversity, deregulation, and decentralization. China, on the other hand, emphasizes uniformity and centralization, especially regarding the political control and the one-party system of “democratic dictatorship.” China’s joining the WTO, therefore, may be considered as a development that changes the regulatory structure to become more diverse, deregulated, and decentralized. This paper, however, finds the opposite. Under the WTO law, China is encouraged to move towards greater uniformity and centralization with its decentralized and non-uniform settings under the market policy. Moreover, the WTO’s uniform and centralized encouragements can be integrated into the rule-by-man …

Exploring Legal And Policy Responses To Opioids: America's Worst Public Health Emergency, James G. Hodge Jr., Chelsea Gulinson, Leila F. S. Barraza, Walter G. Johnson, Drew Hensley, Haley R. Augur

South Carolina Law Review

No abstract provided.

Federalization's Folly, Stephen F. Smith

Journal Articles

Overcriminalization and overpunishment are the two key features of federal criminal law today, yet the constant drumbeat to “federalize” criminal law has accomplished precious little in terms of public safety. The failed drug war proves as much: federal prosecutors have filled the nation’s prisons with low-level drug dealers and drug users serving long sentences, but drugs remain widely available at greater purity and lower prices throughout the land — and drug overdoses are at record highs. Instead of focusing on areas of federal comparative advantage, such as terrorism, international drug trafficking, and organized crime, federal prosecutors waste scarce resources “playing …

On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin

University of Richmond Law Review

The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

Commercial Speech Protection As Consumer Protection, Felix T. Wu

Articles

The Supreme Court has long said that “the extension of First Amendment protection to commercial speech is justified principally by the value to consumers of the information such speech provides.” In other words, consumers—the recipients or listeners of commercial speech—are the ones the doctrine is meant to protect. In previous work, I explored the implications of taking this view seriously in three contexts: compelled speech, speech among commercial entities, and unwanted marketing. In each of those contexts, adopting a listener-oriented approach leads to the conclusion that many forms of commercial speech regulation should receive far less First Amendment scrutiny than …

A Higher Authority: Canada’S Cannabis Legalization In The Context Of International Law, Antonia Eliason, Robert Howse

Michigan Journal of International Law

Part I of this Article provides an overview of some of the key terms and provisions of Canada’s Cannabis Act. Part II looks at the Cannabis Act in the context of the International Drug Conventions, examining how the various convention provisions might apply, looking first at the Single Convention and then at the 1988 Convention and how that convention fits with Canadian constitutional provisions. Part III focuses on the international human rights framework and how the Cannabis Act might be viewed as compatible with international human rights law even where incompatible with the International Drug Conventions. This Part also offers …