Food and Drug Law Commons^™

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 …

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 …

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.

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 …

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 …

The Role Of Pressure Groups And Problem Definition In Crafting Legislative Solutions To The Opioid Crisis, Taleed El-Sabawi

Faculty Publications

Organized interest groups and federal administrative agencies have historically been influential in defining problem drug use during nationwide crisis. As such, the manner in which these pressure groups defined the problem may have influenced or, at least, provided support for legislators’ decisions to shy away from a criminal justice approach and towards acceptance of a more “health-oriented” — one that did not comprehensively address demand factors or demonstrate a commitment to reforming U.S. drug policy to meet international standards of best practice. In an effort to provide a snapshot of what such involvement may look like, this article explores the …

Patents And The Pharmaceutical Industry: Curbing The Abusive Practices Employed By Blockbuster Drug Companies To Prolong Market Exclusivity, Kelley Chandler

Cornell Journal of Law and Public Policy

Patent law in the pharmaceutical space presents unique challenges. Interactions between patent terms, the FDA, the drug development process, and the need for quality medical solutions create a complex dynamic which leads to uncertainty. This uncertainty makes it difficult to discern between solutions which might be effective, and solutions which will spawn new challenges where they so intently sought to eliminate old ones. Although Hatch-Waxman was a success in many ways, in other ways it has proven to frustrate the purposes behind its enactment. The suggestions presented here are a sound starting point for alleviating some of the burden plaguing …

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.

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.

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.

Ships In The Night: Resolving Administrative Conflict Between Fda- And Patent-Related Legislation, Carlos Garcia, Jonathan Stroud

American University Law Review

No abstract provided.

The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan

Faculty Publications

This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …

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.

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 …

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

American University Law Review

No abstract provided.

Marijuana Legalization, Racial Disparity, And The Hope For Reform, Michael Vitiello

Lewis & Clark Law Review

The criminalization of marijuana is rooted in a deeply racist history and has devastated minority communities. Studies show that usage of the drug is consistent across racial groups, but arrests of minorities are nevertheless higher than arrests of white offenders. Indeed, those kinds of disparities have persuaded some voters and policy makers to support legalization of marijuana.

California’s initiative, Proposition 64, passed in November 2016 and is now being implemented statewide. Drafters of Proposition 64 were aware of the racial disparity in enforcement of marijuana laws and attempted to offer a remedy. This Article asks whether Proposition 64 can achieve …

Zoning, Race, And Marijuana: The Unintended Consequences Of Proposition 64, Alexis Holmes

Lewis & Clark Law Review

This Article revisits the campaign to legalize cannabis in California with Proposition 64. It then dissects the localism within the new California regulations and how it conflicts with the social justice goals central to the spirit of Proposition 64’s passage. With local governments retaining control over marijuana in their jurisdictions, land use takes on new importance with respect to how marijuana will be controlled. The problem is that the land use system, like the criminal law apparatus, has yet to overcome systemic racism that is inherently part of its design. Proposition 64 wrongly relied on local control to regulate marijuana …

If It Looks Like A Duck: Equal Protection, Selective Prosecution, And Geographic Differences In The Federal Prosecution Of Marijuana Crimes Under The Controlled Substances Act, Zachary Nelson

Lewis & Clark Law Review

State legalization of marijuana for medical purposes has skyrocketed since California first authorized medical marijuana in 1996. Today, citizens in 33 states can use marijuana for medical purposes. While each state maintains distinct regulatory systems and eligibility requirements, the core result of these state medical marijuana programs is that citizens in 33 states can lawfully possess and use marijuana. Yet federal law makes any use of marijuana illegal under the Controlled Substances Act (CSA). Through the Supremacy Clause, this illegality is controlling and preemptive in every state; that is, even if a state makes marijuana legal for certain purposes, an …

Cannabis Law, The Constitution, And The Aba Model Rules, Hayley Hollis

Lewis & Clark Law Review

Though a growing number of states have legalized recreational or medical cannabis use, cannabis is still categorized as a Schedule I substance under the Controlled Substances Act, and its use, possession, and cultivation are federal offenses. This conflict between state and federal law creates a unique challenge for the legal community. Unless states with legalized cannabis programs have amended their state rules of professional conduct or provided advisory opinions on the matter, local attorneys assume a great deal of risk when representing clients within the cannabis industry.

To further complicate matters, what happens when a lawyer, who is licensed to …

A Hybrid Approach To Marijuana Federalism, Susan F. Mandiberg

Lewis & Clark Law Review

With the evident indulgence of the United States Department of Justice, states are jumping on the bandwagon of legalizing medicinal and recreational marijuana even though marijuana use is criminalized under the Federal Controlled Substances Act. The possibility that the federal government will at some point decriminalize marijuana use poses a challenge for the construction of a regulatory framework. In short, how should the states and the federal government divide regulatory responsibilities?

There has been significant academic discussion about possible regulatory frameworks to address this issue. Drawing upon existing federalism schemes in the environmental and natural resource area, this Article reviews …

Reefer Madness In Federal Court: An Overview Of How Federal Courts Are Dealing With Cannabis Litigation And Why It Is Necessary To “Dig Into The Weeds”, Blake Marvis

Lewis & Clark Law Review

Litigation stemming from the state-legal cannabis industry has presented many unique questions for federal courts to grapple with. Can federal courts provide equitable relief to state-legal cannabis litigants, despite being in violation of federal law? Can workers in the state-legal cannabis industry sue their employers to recover required minimum wage under federal statutes? Is a contract that is made in a state-legal cannabis market automatically void? This Comment examines the precarious nature of state-legal cannabis litigation in federal courts through a dissection of how litigation has progressed. It also examines the framing of the arguments made in cannabis disputes. Although …

Cannabis And Insurance, Francis J. Mootz Iii, Jason Horst

Lewis & Clark Law Review

Although many states have decriminalized or legalized cannabis, it remains a Schedule 1 drug under the federal Controlled Substances Act. The conflict between federal and state law presents many complicated issues, including problems relating to insurance coverage. Insurance law seeks to balance competing policy interests. On one hand, public policy supports reading insurance policies broadly to indemnify policyholders for their losses. On the other hand, public policy counsels against permitting insurance to indemnify (federally) illegal activity. In this Article, we explore some pressing issues arising from the conflict between these policy considerations and offer some analysis of the conflict in …

Craft Beer And The Rising Tide Effect: An Empirical Study Of Sharing And Collaboration Among Seattle's Craft Breweries, Zahr K. Said

Lewis & Clark Law Review

This qualitative empirical research project studies Seattle’s craft brewing industry as a thriving entrepreneurial ecosystem that displays widespread collaboration and innovation. Drawing on data collected in 22 face-to-face formal interviews conducted with industry participants, the Article explores the community’s attitudes, practices, and norms with respect to collaboration and intellectual property (IP). It joins a growing body of qualitative empirical IP scholarship that maps misalignments between law and practice “on the ground,” seeking to offer a more accurate and pluralistic account of an innovative industry. The craft brewing community in Seattle cooperates extensively while continuing to compete actively for consumers. In …

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 …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Rethinking Consumer Protection: Escaping Death By Regulation, Thomas L. Tacker

Publications

This book is designed to appeal to anyone who is at all interested in topics related to making life better and safer—for all us consumers. Our current approach to consumer protection is extremely flawed; sometimes costing lives rather than saving them. There are better ways to protect ourselves and the people we love.

Fraud, Abuse, And Opioids, Stacey A. Tovino

Faculty Articles

This Article analyzes recent government enforcement actions involving two health care fraud and abuse authorities, including the federal Anti- Kickback Statute and the federal civil False Claims Act, in cases involving opioids. Part II of this Article examines recent government enforcement actions involving the federal Anti-Kickback Statute, which prohibits (among other conduct) the exchange of remuneration for opioid prescriptions, patient referrals for drug testing services, and patient referrals for addiction treatment services if such prescriptions or services are reimbursed in whole or in part by a federal health care program. Part III of this Article examines recent government enforcement actions …

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 …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …