Food and Drug Law Commons^™

The Pricelessness Of Life Vs. Profiting From Illness: A Call For Change To The Pricing Model For Lifesaving Drugs In The United States, Aubri L. Swank

Duquesne Law Review

Pharmaceutical drug prices in the United States are at the highest costs yet seen, and it looks like these prices are still continuing to climb. While people in the United States are struggling to pay for necessary medications, the prices of those same medications are drastically lower in other countries.

This Article directly analyzes the issue of pharmaceutical pricing in the United States through two specific lifesaving drugs, insulin and epinephrine. Both drugs are prescriptions required to keep some people alive, and both are related to manufacturing companies with questionable, overwhelming control of the markets. While there has been recent …

Not So Juris-Prudent: The Misguided Movement To Abandon Chevron Deference Through The Lens Of Mifepristone And The Attacks On Fda Autonomy, Ella Seltzer

Upper Level Writing Requirement Research Papers

No abstract provided.

Woke Capital Revisited, Jennifer S. Fan

Seattle University Law Review

Inclusive corporate leadership is now at the forefront of discussions related to corporate governance. Two corporate theories help to explain the rise in prominence of diversity, equity, and inclusion (“DEI”) efforts in corporate leadership. First, an expanded definition of corporate purpose which elevated the idea of the importance of stakeholders, contributed to the momentum from business and legal quarters for broader corporate inclusion. Second, the increasing publicness of corporations—the social expectation of how large, typically public corporations should act given their position of power—also led to corporations becoming more active in the DEI space. It is against this backdrop that …

When Congress Passes The Buck: How Russia’S Invasion Of Ukraine Exposed Flaws In Granting The President Sanctioning Powers, Artem M. Joukov, Samantha M. Caspar

Seattle University Law Review

The United States (U.S.) Constitution provides few limitations on endowing the Executive Branch with powers to govern foreign trade, which was initially granted to the Legislature. In a world where global trade dominates, the power over foreign trade can be more important than the power over domestic matters. Leaving unrestrained trade authority to the Executive Branch may cause hazards for Americans and foreigners alike. Russia’s war in Ukraine demonstrates the flaws in permitting the Executive Branch to unilaterally sanction foreign states. This Article demonstrates how reactive Executive Branch policies infringed on the welfare and safety of American citizens and foreigners …

Pedaling Backwards: Examining The King County Board Of Health’S Choice To Repeal Its Bicycle Helmet Law, Schuyler M. Peters

Seattle University Law Review

In Part I, this Comment will explain the Helmet Law itself and the timeline that ultimately led to its repeal. Part II will focus on the positive impact of the Helmet Law, the dangers associated with the repeal, why the repeal should not have occurred in the manner it did, and what societal costs stem from the BOH’s decision. Part III will address the actions that must be taken to revoke this repeal and the reasons behind these alternative pathways, including an Equity Impact Review study specifically on the consequences of repeal, a collaborative outreach program to bring helmets to …

Burning Questions: Changing Legal Narratives On Cannabis In Indian Country, Robin M. Rotman, Sam J. Carter

Faculty Publications

In the not-so-distant past, thoughts of Cannabis legalization in the United States were radical. In the present day, the narratives around Cannabis are changing. The term “present day” affixes this Article to early 2023, a snapshot in time. To understand the current legal narratives surrounding Cannabis, and what they might become in the future, it is important to examine the history of Cannabis law and policy in United States. This Article begins by discussing Cannabis regulation in the United States, from the rise of federal regulation to the gradual deregulation by states with tacit federal consent. The Article then examines …

Towards Critical Environmental Justice Approach In Multicultural Divided States: Lessons From The Israeli Regulative System, Manal Totry-Jubran

Fordham Environmental Law Review

This article draws upon the evolving framework of the Critical Environmental Approach in examining the conceptualization and manifestation of the Environmental Justice approach and its pillars within the regulatory system of multicultural and divided societies. These are states comprised of marginalized ethnic and minority groups that frequently face instances of social and environmental injustice. Employing this perspective through a case study show that gradual and anecdotic but unorganized and incoherent incorporation of Environmental Justice pillars lacks the capacity to effectively address long-standing historical environmental injustices and fails to challenge the prevailing social framework. In fact, it runs the risk of …

2023 Update: A Water Rights Manual For Mutual Domestic Water Consumers Associations, Utton Center, Zackeriah Carpenter, Gregory Chakalian, Darcy S. Bushnell

Publications

This is the 2023 update of the Water Rights Manual. The archival version is also available in our digital repository. 

The Utton Center prepared this Water Rights Manual to assist Mutual Domestic Water Consumers Associations (MDWCAs) with the development, protection and management of their water rights.

This manual provides an introduction to and defines Water Rights in New Mexico, as well as to acquire and have recognized Water Rights. This document also covers water management and planning, and provides additional resources.

A Legislative Call-To-Action: Applying Capture Theory To Combat The Risk Of Private Industry’S Excess Influence Over The Fda’S Regulation Of Livestock Antibiotics, Nathaniel Richey

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Moving Away From Masking Pain: A Need For Modernization In Pain Management, Tori Collins

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

50 Shades Of Green: How Inconsistencies In State Regulatory Regimes Threaten To Doom The Legal Cannabis Market In The United States, Shawn Harkins

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Delta-Late: How The Contentious And Hazy Legal Status Of Delta-8 Thc Reveals Kentucky’S Need For Federal Regulatory Guidance, Georgiana Ledford

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

Eliminating Cash Bail In Washington State—Amending Criminal Rule 3.2, Simran Kaur

Seattle University Law Review

This Note discusses the following three parts. Part I provides an overview of the cash bail system, its history, and its contemporary use in Washington state. Part II presents the effects of bail on pretrial release, analyzing low-income and racial inequalities and the adverse impacts it can have on the accused. Part III focuses on solutions and alternatives to the cash bail system, using other states as case studies.

Selective Patronage, Omari Scott Simmons

Seattle University Law Review

Contemporary academic corporate governance narratives have a blind spot. They focus on institutions, rules, regulations, processes, procedures, intermediaries, and market forces. Yet, missing in this narrative, is the impact of corporate leadership. Ignoring the “black box” of corporate leadership, particularly individual actors, renders an incomplete descriptive assessment as well as potential miscalculations. The examination of key historical figures and their corporate activism provides an important lens through which to identify potential challenges and opportunities related to the contemporary ESG movement.

Generally, this essay examines corporate leadership’s potential to address socio-political issues through the prism of Civil Rights Movement activism. Specifically, …

Promoting Corporate Diversity: The Uncertain Role Of Institutional Investors, Jill Fisch

Seattle University Law Review

Two developments are having an impact on corporate decisions. One is the increased engagement by institutional intermediaries and a shift in the focus of that engagement from corporate governance to environmental and social issues. The other is a heightened societal awareness of diversity, equity, and inclusion (DEI) issues, particularly the importance of diversity in corporate leadership. This Article considers the intersection between the two. It describes how institutional investors have focused their attention on increasing diversity in corporate leadership, the potential motivations for that focus, and the impact of that focus, to date. It highlights the tensions that result from …

America’S Hidden Citizens: The Untold Stories Of The Unconscionable Deportations Of Its International Adoptees, Halley Cody

Seattle University Law Review

This Note addresses how the U.S. should rectify the harms it has perpetrated on non-citizen adoptees by amending the current deportation statutes to prevent their deportation. Part I addresses the history of adoption in the U.S. and related effects on immigration law. Part II highlights the stories of Adam Crapser and Philip Clay, who were adopted by American families who failed to naturalize them as minors, and who were subsequently deported after they sustained criminal records. Part III examines the policy goals behind deportation as a consequence of criminal convictions, as well as remedies instituted to prevent unwarranted deportation and …

Inadequate Privacy: The Necessity Of Hipaa Reform In A Post-Dobbs World, Katherine Robertson

Seattle University Law Review

Part I of this Comment will provide an overview of HIPAA and the legal impacts of Dobbs. Part II will discuss the anticipatory response to the impacts of Dobbs on PHI by addressing the response from (1) the states, (2) the Biden Administration, and (3) the medical field. Part III will discuss the loopholes that exist in HIPAA and further address the potential impacts on individuals and the medical field if reform does not occur. Finally, Part IV will argue that the reform of HIPAA is the best avenue for protecting PHI related to reproductive healthcare.

On The Appeal Of Drug Patent Challenges, Charles Duan

American University Law Review

Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.

This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation …

Regulating Organic, Sarah J. Morath

American University Law Review

Even highly regulated labels, such as the organic label, have the potential for greenwashing. As recently as January 2023, a grain seller was indicted in federal court for a $43 million scheme that involved the sale of non-organic grain as USDA-certified organic. But today’s organic market is also full of sellers who follow the current federal organic regulations but fail to demonstrate the spirit of the organic movement—forgoing soil, animal welfare, and community for profit. I call this nuanced form of greenwashing quasi-greenwashing. It arises when a business complies with a rule or standard but takes advantage of consumer misunderstanding …