Food and Drug Law Commons^™

Real-World Consequences For Online Actions: The Case For Expanding Employee Harassment Protection Via Employers’ Rights Of Action, Alexander Barnes

Seattle University Law Review

This Note argues for expanding employers’ access to legal remedies that allow them to recoup the costs of protecting their employees from swatting, doxing, and other online harassment arising from their employees’ professional activity. Part I provides a brief description and history of the online harassment problem and its potentially deadly dangers. Part II describes employers’ legal responsibility to take action to protect their employees from harassment aimed at their employees within the scope of their employment. Part III explores common legal remedies that are currently available to employers, using the state of Washington as an example. Part III also …

Foreseeability And Duty In Washington Negligence Law: Leaving The Road Less Traveled By, Leo Linder

Seattle University Law Review

Washington negligence law is a confusing labyrinth of foreseeability that not even Ariadne’s string could guide plaintiffs out of. Foreseeability is implicated in four distinct analyses, several of which overlap considerably. Doctrines that were once questions of law are now questions of fact, and vice versa. Something needs to change.

Washington has taken the novel approach of bifurcating the duty element into two parts—duty’s mere existence, which is a question of law for the court to determine; and duty’s scope, which is a question of fact handed off to the jury to determine. Foreseeability impacts both of these assessments, but …

Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder

Articles, Book Chapters, & Popular Press

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing upon a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

Introducing Biosimilar Competition For Cell And Gene Therapy Products, Brian Canter, Sabine Sussman, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai

Faculty Scholarship

This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs’ complexity, meeting the regulatory requirement of ‘high similarity with no clinically meaningful differences’ will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in …

Reducing Food Scarcity: The Benefits Of Urban Farming, S.A. Claudell, Emilio Mejia

Journal of Nonprofit Innovation

Urban farming can enhance the lives of communities and help reduce food scarcity. This paper presents a conceptual prototype of an efficient urban farming community that can be scaled for a single apartment building or an entire community across all global geoeconomics regions, including densely populated cities and rural, developing towns and communities. When deployed in coordination with smart crop choices, local farm support, and efficient transportation then the result isn’t just sustainability, but also increasing fresh produce accessibility, optimizing nutritional value, eliminating the use of ‘forever chemicals’, reducing transportation costs, and fostering global environmental benefits.

Imagine Doris, who is …

Enough Excuses On Drug Importation: A New Transnational Paradigm For Fda Regulation And Lower Us Drug Prices, Gabriel Levitt

Brooklyn Journal of International Law

The US Food and Drug Administration (FDA), which enforces drug safety laws, asserts that under most circumstances the importation of prescription drugs is illegal. Yet because of high drug prices in the United States, over the past couple of decades, tens of millions of Americans have imported prescription drugs for personal use. For many, this was their only way to afford them. A unique array of federal laws, regulations, and policies, including the de facto decriminalization of the practice of personal drug importation, have in effect permitted personal drug importation. The same exceptions, however, are not available for commercial drug …

Re-Regulating Dietary Supplements, Jessie L. Bekker, Alex Flores, Michael S. Sinha

Journal of Food Law & Policy

In 1994, Congress introduced the Dietary Supplement Health and Education Act (DSHEA) to create a regulatory framework for the dietary supplement industry. Despite the increased market size of dietary supplements, the Food and Drug Administration’s (FDA) pre-market authority to regulate the introduction of dietary supplements into the stream of commerce has remained subdued. Under DSHEA, the FDA has limited authority to review dietary supplements before entering the market. Unlike pharmaceuticals, which must be proven safe and effective prior to approval and marketing, dietary supplements can be sold to consumers without such reassurances. We call on Congress to amend DSHEA to …

The Contradictory Nature Of U.S. Laws And Nutrition Programs And Their Effects On Infant Feeding, Lily Patel

Journal of Food Law & Policy

The contradictory nature of U.S. laws, including the laws concerning infant feeding, though supposedly aligned with policies to promote wellness in Americans, can exacerbate gender and race inequality and work against the National Strategy. The overarching goal of U.S. laws concerning infant feeding is to ensure that infants are fed, nourished, and receive proper nutrition. However, the laws often appear to be directly contradictory to one another in the priorities they are promoting.

Free For All: Proposing Legislation To Eliminate Food Insecurity In Arkansas Public Schools, A. Mills Bryant

Journal of Food Law & Policy

Schools serve millions of students daily as one of the largest food distribution sites in the United States. However, more than 13.1 million children in the United States, and almost 150,000 in Arkansas, are food insecure. Before the COVID-19 pandemic, most Arkansas schools offered free and reduced lunch to students at or below the poverty line through participation in the National School Lunch Program (“NSLP”). During COVID-19, Congress passed The Families First Coronavirus Response Act (“FFCRA”) and The Coronavirus Aid, Relief, and Economic Security Act (“CARES”) (hereinafter “The Acts”). This legislation effectively eliminated food insecurity in participating American public schools, …

Chewing The Welfare Cud: A Digested Analysis Of A Consumer Versus Producer-Defined Standard Of Welfare Practices In Animals Raised For Human Consumption, Caitlin C. Robb

Journal of Food Law & Policy

Since the eighteenth century, animal well-being remains a concern for American citizens. Yet, underlying this concern is the thought that while humans should not be cruel to animals, animals are still private property subject to human ownership. Therefore, multi-faceted questions of what constitutes “animal welfare” find a place in modern American debate. One such question becomes: should the producer or the consumer define welfare practice standards of animals raised for human consumption?7 This note provides an answer to this question by first analyzing the robust history of animal welfare in the United States, along with the domestic and international impact …

Journal Of Food Law & Policy - Fall 2023, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Law School News: Rake To Plate: Rwu Law Students Dive Into The Clamming Industry 10-4-2023, Grace Boland

Life of the Law School (1993- )

No abstract provided.

Representations Of Drug-Related Harms In Sentencing: Towards Evidence-Informed, Non-Stigmatizing Approaches, Niki Kiepek

LLM Theses

This thesis explores how the concept of harm is constituted in case law pertaining to the importation, production, possession, and trafficking of drugs in Canada. A specific focus of analysis is whether judges accurately use empirical research to inform decisions. Drugs are understood as a social construct – encompassing psychoactive substances that are both legal and illegal – and as variably regulated in Canadian law. I use critical discourse analysis to examine how harm is represented in case law (n=129), identify which sources influence legal discourses (e.g., past cases, expert testimony, empirical research), and analyze outcomes arising from how harm …

Why U.S. States Need Their Own Cannabis Industry Banks, Christoph Henkel, Randall K. Johnson

Faculty Works

The legal cannabis trade is the fastest growing industry in the United States. In 2019, about 48.2 million Americans used the drug at least once. As such, it is easy to see why the legal cannabis trade may generate annual revenues exceeding $30 billion in Fiscal Year 2022 alone.

One inconvenient truth, however, is that the parties to any cannabis trade may face a range of difficulties due to conflicts between federal and state laws. These difficulties include the fact that many financial institutions are reluctant to handle cannabis proceeds. One reason is that a lack of alignment in terms …

Deserving Life: How Judicial Application Of Medical Amnesty Laws Perpetuates Substance Use Stigma, Scott Koven

Washington and Lee Law Review

To combat the continued devastation wrought by the opioid crisis in the United States, forty-eight states have passed medical amnesty (or “Good Samaritan”) laws. These laws provide varying forms of protection from criminal punishment for certain individuals if medical assistance is sought at the scene of an overdose. Thus far, the nascent scholarly conversation on medical amnesty has focused on the types of statutory protections available and the effectiveness of these statutes. To summarize, although medical amnesty laws have helped combat drug overdose, the statutes are replete with arbitrary limitations that cabin their life-saving potential.

This Note extends the dialogue …

On The Scales Of Private Law: Nano Contracts, Yonathan A. Arbel

Articles

Contracts are falling in scale. New contracting trends and technologies facilitate the formation of smaller scale contracts that have ephemeral duration, token stakes, and narrow scope. These nano contracts embody ephemeral interactions of minuscule value - interactions that were previously far outside the law and away from explicit markets, governed only by social norms. The rise of nano contracts can unlock new transaction types, create opportunities to build wealth, and reduce dependence on private ownership. Yet nano contracts also carry important risks, and their small scale makes them difficult to effectively regulate. At the limit, nano contracts collapse private law …

Constitutional Confidentiality, Natalie Ram, Jorge L. Contreras, Laura M. Beskow, Leslie E. Wolf

Washington and Lee Law Review

Federal Certificates of Confidentiality (“Certificates”) protect sensitive information about human research subjects from disclosure and use in judicial, administrative, and legislative proceedings at both the state and federal levels. When they were first authorized by Congress in the 1970s, Certificates covered sensitive information collected in research about drug addiction use. Today, however, they extend to virtually all personal information gathered by biomedical research studies. The broad reach of Certificates, coupled with their power to override state subpoenas and warrants issued in the context of law enforcement, abortion regulation, and other police powers typically under state control, beg the question whether …

Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu

Faculty Scholarship

This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …

Hydra: Lessons From The World's Largest Darknet Market, Priyanka Goonetilleke, Alex Knorre, Artem Kuriksha

Faculty Scholarship

Research Summary

We present a comprehensive description of Hydra, the largest darknet marketplace in the world until its shutdown in April 2022. We document the main features of Hydra such as dead-drop delivery, feedback and reputation system, escrow, and dispute resolution. Using data scraped from the platform, we quantitatively examine the scale and the structure of the marketplace. We find that it has been highly competitive, geographically covering at least 69% of the Russian population and trading a wide variety of drugs, while also allowing the wholesale trade of drugs and precursors. The dead-drop delivery system used on Hydra was …