Food and Drug Law Commons^™

Prejudice Standards In Washington’S Appellate Courts, Andrew B. Van Winkle

Seattle University Law Review

When an appellate court finds an error to have occurred during a proceeding, the error is not yet subject to correction. In order to merit a remedy, the error must have been sufficiently prejudicial to the aggrieved party’s case. Drawing the line between correctable and non-correctable errors is not an easy task, for it often requires guessing at what was in the minds of jurors and trial judges. To cope with this task, courts have devised various rules and tests for deciding whether an error was likely prejudicial or not. These standards often go by names such as “harmless error,” …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Rethinking Innovation At Fda, Rachel E. Sachs, Nicholson Price, Patricia J. Zeitler

Articles

In several controversial drug approval decisions in recent years, the Food & Drug Administration (“FDA”) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of …

Reducing Prescription Drug Prices: How Competition Can Make Medications Affordable For Patients - Testimony Of Rachel E. Sachs, Rachel Sachs

Scholarship@WashULaw

In this testimony, I will explain how existing law both keeps branded drug prices high but has also enabled the development of lower-cost generic and biosimilar competition for branded prescription drugs and biological products. This competition can be used to promote access to affordable prescription drugs, benefiting not only patients but also our public payers. However, I will also explain the ways in which existing legislative and regulatory efforts have not always succeeded in promoting competition and will offer a path forward for this Committee to examine reforms that not only encourage the approval of lower-cost products but also ensure …

Conjuring The Flag: The Problem Of Implied Government Endorsements, Michael Mattioli

Articles by Maurer Faculty

This Article exposes a harmful form of advertising that exploits government actions like patent issuances, FDA authorizations, and trademark registrations. By calling upon the symbolic power of such regulatory approvals—i.e., “conjuring the flag”—marketers deceive consumers, distort competition, and undermine administrative agencies. Using machine-learning techniques to analyze hundreds of ads across multiple media formats, this Article offers the first comprehensive analysis of this pervasive practice. The study reveals that it is especially prevalent in industry settings where consumers are likely to seek reassurance that a product is safe and effective. Specifically, the examples examined show that patents are mentioned frequently in …

Intersectionality Matters In Food And Drug Law, Colleen Campbell

University of Colorado Law Review

Feminist scholars critique food and drug law as a site of gender bias and regulatory neglect. The historical exclusion of women from clinical trials by the FDA prioritized male bodies as the object of clinical research and therapies. Likewise, the FDA’s prior restriction on access to contraceptive birth control illustrates how patriarchal and paternalistic attitudes within the Agency can harm women’s reproductive health. However, there is little analysis of how race and gender intersect in this domain. This Article uses the regulation of skin-lightening cosmetics products to illustrate why and how intersectionality matters in food and drug law. While the …

A First Amendment Failure: Surrendering To Science Misinformation For Bioengineered Foods, Casey J. Nelson

University of Colorado Law Review

Government-compelled commercial disclosures are not unfamiliar to consumers. Common labels include nutrition facts and ingredient information. The National Bioengineered Food Disclosure Standard, which took full force at the start of 2022, is of a different nature. The new law requires all manufacturers, all importers, and certain retailers of bioengineered foods to disclose on the food’s packaging that it has been produced with bioengineering technology. Even so, a large swath of the public is ignorant of “bioengineering’s” true meaning and bioengineering technology’s true quality. The politically charged and fact-lacking debate on bioengineered foods renders this standard an impermissible coercion of speech …

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 …