Food and Drug Law Commons^™

The Ethics Of Industry-Funded Speakers’ Bureaus—How They Disseminate Innovation And Could Corrupt Medicine, Jennifer E. Miller, Christopher Robertson

Faculty Scholarship

It is often said that a business without marketing is dead. But when a medical product is marketed irresponsibly, it is patients who may pay with their lives. In this context, Wieberdink et al¹ examine participation in industry-sponsored speakers’ bureaus by academic clinical faculty, conceptualizing the practice as a form of conflicted and irresponsible pharmaceutical marketing. Reviewing 129 US allopathic medical school conflict-of-interest (COI) policies, they found that less than 40% prohibit industry speakers’ bureau participation outright, while 19% impose conditional restrictions, such as requiring that faculty retain control over presentation content. Wieberdink et al¹ advocate for a …

Wine Unwelcome: The Constitutional Contours Of Wine Regulation, Alexander Fallone

Brooklyn Journal of Corporate, Financial & Commercial Law

Wine retail shops face a dizzying labyrinth of state laws that severely restrict their ability to ship wine to out-of-state consumers. While the dormant Commerce Clause would normally strike down laws that impose restrictions on interstate commerce, wine (and alcoholic beverages) must contend with Section Two of the Twenty-first Amendment, which gives the states control over the importation and distribution of wine intending to be consumed within their borders. Court of Appeals cases interpreting Supreme Court precedent on the tension between the dormant Commerce Clause and Section Two have practically stripped the dormant Commerce Clause of any power. This Note …

Are Ai-Assisted Drug Technologies Addressing Or Aggravating The Opioid Crisis In The United States?, Abby O'Hern

West Virginia Law Review

The opioid crisis is a significant public health emergency, intensified by the rise of synthetic opioids such as fentanyl. Lawmakers have described fentanyl as “terroristic in nature” due to its often-fatal properties. According to the Center for Disease Control (“CDC”), an estimated 107,543 people died from drug overdoses in the United States in 2023. As fentanyl use has surged, it has increasingly shaped public health policy through harm reduction initiatives, expanded addiction treatment resources, and legislative reforms aimed at curbing overdose deaths. Artificial Intelligence (“AI”) now plays a dual role in this evolving crisis. While AI technologies offer valuable tools …

Rethinking Aquaculture Regulation In A Post-Chevron World, Kamaile A. N. Turčan

Fordham Environmental Law Review

After the Supreme Court overruled Chevron deference in Loper Bright v. Raimondo, commentators warned of the detriment to federal agencies resulting from the loss of judicial deference to agencies’ interpretations of the statutes they administer. This Essay takes a different approach and examines how advocates for agency authority can use this shift away from judicial deference to their advantage—by refocusing litigation strategy toward congressional delegations. Statutory interpretation arguments need no longer focus on whether an agency is intruding on the judicial prerogative to interpret the law and can now focus instead on whether a court is intruding on the …

Agricultural Biotechnology In The Courts: Judicial Opinions And Commentary, Drew L. Kershen

Faculty Articles

Seven jurisdictions from around the world have issued judicial opinions that address fundamental issues about the governance and regulatory systems of agricultural biotechnology. This article summarizes these legal proceedings and describes their impact upon agricultural biotechnology. The article then provides a commentary and critique of the legal proceedings and resulting judicial opinions.

Redressing The Harm Of Accelerated Approval, Laura Karas

Articles

The accelerated approval pathway of the United States Food and Drug Administration (FDA) enables drugs to come to market more quickly than would be possible under a traditional FDA approval pathway. Accelerated approval is based upon the agency's determination that changes in a surrogate or intermediate clinical endpoint are "reasonably likely" to predict a clinical benefit meaningful for patients. In essence, the pathway affords sick patients earlier access to potentially beneficial drugs while trials to confirm clinical benefit continue. Accelerated approval has been likened to a social compromise in which promising drugs enter the market sooner in exchange for a …

Can The Law Protect My Craft? How Gaps In Copyright Of Knitting Patterns Symbolize A Greater Struggle For Protecting Traditionally Feminine Forms Of Intellectual Property, Kysa Walzer

Seattle University Law Review

The purpose of this article is to demonstrate the application of intel-lectual property rights within the context of copyright protection of knit-ting patterns. The article will discuss the underutilization of copyright pro-tection for knitters and crafters and its larger impact upon craft and indus-try traditionally comprised of women. Part I introduces knitting patterns and a short history of copyright protections. Part II discusses the specific areas within knitting patterns and the knitting community which give rise to legal grey areas for copyright protection. Part III discusses the larger implications of copyright and intellectual property in spaces where women traditionally make …

A New Exclusionary Rule To Protect Bodily Integrity And Discourage Pretext Stops, Josephine Ross

Seattle University Law Review

The author proposes a novel state-level exclusionary rule to reduce racial profiling and protect bodily autonomy during police encounters. The current Fourth Amendment jurisprudence fails to deter pretextual stops and frisks because the exclusionary rule often turns on officer fault and "good faith," allowing racially motivated practices to go unchecked. As federal rollbacks on diversity and data collection hinder efforts to track racial bias, the author argues for a statutory evidentiary rule that automatically excludes drug evidence found during (1) traffic stops, (2) pat-downs for weapons, and (3) consent searches, regardless of an officer’s intent or the legality of the …

Navahine V. HawaiʻI Dept. Of Transportation: The Keiki Will Lead Us, Catherine Smith

Seattle University Law Review

The author analyzes the landmark case Navahine v. Hawaiʻi Department of Transportation, which culminated in the world’s first constitutional climate settlement. Catherine Smith, serving as an expert for the youth plaintiffs, situates the case within Hawaiʻi’s legal tradition of prioritizing children’s rights and intergenerational equity. She explores the evolution of children’s constitutional protections, contrasting Hawaiʻi’s progressive jurisprudence with the dominant adult-centric legal framework on the mainland. She critiques four recurring analytical missteps in U.S. courts that marginalize children’s interests and highlights Hawaiʻi’s public trust doctrine and cultural values, such as the Aloha Spirit, as models for addressing climate-related harms. …

Constitutional Futurism As Pedagogy, Jeremiah Chin

Seattle University Law Review

Constitutional Law has transformed from a course on history to a discussion of current events. Cases like Students for Fair Admissions v. Harvard College, Dobbs v. Jackson Women’s Health Organization, and Loper Bright Enterprises v. Raimondo reveal that the study of constitutional law is not a static, or even linear, discussion of constitutional text and history. Law is a shifting, changing enterprise that reflects social constructions of power, authority, and identity. How do we teach, learn, and understand constitutional law that is so laden with history, riddled with theories of consistency and adherence to precedent, but ultimately subject …

Table Of Contents

Seattle University Law Review

Table of Contents

Volume 48 Masthead

Seattle University Law Review

Volume 48 Masthead

Keynote Address: Community Over Constitution, Riddhi Mukhopadhyay

Seattle University Law Review

In this keynote address, Riddhi Mukhopadhyay challenges the veneration of the U.S. Constitution by highlighting its origins in exclusion and its continued failure to protect marginalized communities. Drawing from her experience in civil legal aid and gender justice, she argues that the Constitution was drafted to consolidate power among white, wealthy men and continues to reflect that legacy through racial, gender, and class-based inequities. While acknowledging the significance of constitutional amendments and landmark cases, Mukhopadhyay emphasizes that meaningful change has always come from community-led action, not top-down reform. Additionally, Mukhopadhyay calls on lawyers and legal advocates to center community, practice …

The Lost Child: A Critique On Transracial Adoption Rhetoric, Hallie Conyers-Tucker

Seattle University Law Review

Transracial adoption in the United States reflects a deeply rooted history of colonialism, cultural assimilation, and racial hierarchy, masked by rhetoric focused on the “best interest of the child.” The author critiques that rhetoric and traces how adoption practices and policies, both domestic and international, have evolved to reinforce systemic inequities. Through historical analysis of the forced adoption of Native American, Black, and Asian children, it reveals how the best interest standard has been wielded not to protect children but to uphold political and racial ideologies. The author argues that the prevailing adoption framework relies on child-saving and color-blind narratives …

A Global Reconstruction: Black Internationalism And The Human Rights Regime, Britta Redwood

Seattle University Law Review

Black American advocates for civil, political, and economic rights have long taken an internationalist approach and fostered connections with international organizations and transnational movements. This engagement has also been a generative force and played role in shaping international law. Beginning in the early years of the twentieth century, Black intellectuals and leaders, spearheaded by the NAACP and the UNIA, focused on human rights as a means for addressing and repairing the harms wrought by slavery, Jim Crow, and racism. From the Paris Peace Conference of 1919 through the Universal Declaration of Human Rights, the Genocide Convention, and the drafting of …

The Gap: Addressing The Missing Piece In HawaiʻI’S Anti-Discrimination Laws On Credit And Lending, Wendy Mun

Seattle University Law Review

This author addresses the significant gap in Hawaiʻi’s anti-discrimination laws, specifically the lack of explicit protections for LGBTQ+ individuals against credit and lending discrimination. Although federal laws like the Equal Credit Opportunity Act (ECOA) and recent interpretations by the Consumer Financial Protection Bureau (CFPB) extend some protections, they remain vulnerable to shifting federal priorities and interpretations. The author explores how other states, particularly California and Washington, have enacted robust statutory protections that clearly prohibit credit discrimination based on sexual orientation and gender identity. They argue that Hawaiʻi, despite its large LGBTQ+ population, must amend its credit protection laws to reflect …

The U.S. Drug Policy Hamster Wheel: A Critical Discourse Analysis Of Seattle’S New Drug Ordinance, Hallie Conyers-Tucker

Seattle University Law Review

The author critically examines Seattle’s new drug ordinance using Critical Discourse Analysis (CDA) to reveal how legislative language influences the policy's actual effect. Although the ordinance claims to prioritize diversion and community health, the use of permissive language such as “may” and “shall” grants broad discretionary power to law enforcement and undermines the stated intent. The author situates the ordinance within a broader historical context, highlighting how drug policy in the United States has consistently been shaped by racialized and stigmatizing narratives. Additionally, the author argues that meaningful reform requires reframing the discourse around substance use to support public health …

Something Concrete: How Labor Advocates Can Best Respond To The Ambiguity Of Glacier Northwest, Ateş Serifsoy

Seattle University Law Review

The Supreme Court’s much-anticipated decision in Glacier North-west, Inc. v. International Brotherhood of Teamsters Local No. 174 (Glacier) marked a critical moment for workers’ rights under the National Labor Relations Act (NLRA) and the longstanding practice of Garmon preemption. Yet, initial fears of a significant rollback of workers’ rights, driven by sensational headlines, were met with an unexpectedly narrow Court opinion. This Comment examines Glacier’s implications for Gar-mon preemption and the right to strike. It offers the historical background of the doctrine of labor law preemption before Glacier; presents a detailed analysis of Glacier itself, including its …

For The Greater Good: Civil Commitment For Addiction Amid The Overdose Epidemic, Steven P. Meerschaert

Cleveland State Law Review

America is facing a reckoning born of its own duality. Our society is gradually embracing an increasingly permissive stance on recreational drug use, while at the same time we lament the human costs of addiction. What the media has dubbed the “opioid epidemic” has seen increases in drug addiction diagnoses and opioid-involved overdose deaths nearly every year since 1999. In a rush to designate guilty parties and to crown a “gold standard” for treatment options, we have focused on theoretically flawed approaches that fail to follow the science precisely. At the same time, we dismiss validated treatment modalities in their …

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

The Indian Pharmacopoeia: Enabling Open Access And Crafting A ‘Sovereign Function Exception’ For Government Works, Aparajita Lath

National Law School Journal

Standardisation of drugs and access to such standards are important levers for effective drug regulation. The Indian Pharmacopoeia, the official book of standards for drugs in the country prescribed by the Union government under the Drugs and Cosmetics Act 1940, are legally binding and enforceable. Not only do the standards have the force of law but are also government-created. The Indian Pharmacopoeia Commission (IPC), a division of the Union Department of Health and Family Welfare, has a legal monopoly over creating and publishing this compendium. Though it is legally binding, the Indian Pharmacopoeia is neither in the public domain …

Beneath The Label - Evaluating The Fda Approval Of Copenhagen Classic Snuff As A Modified Risk Tobacco Product, Yisroel Grabie, Tafani Chowdhury, Sudeep Acharya

HCA Healthcare Journal of Medicine

In this review, we critically evaluate the Food and Drug Administration's modified risk tobacco product (MRTP) status granted to a smokeless tobacco product (March 2023), Copenhagen Classic Snuff (CCS). This new status necessitates an assessment of the product CCS use and its public health impacts. We assess the impact of CCS as it relates to the reduction of lung cancer risk and the potential increased risk for nasopharyngeal cancer, chronic rhinitis, nicotine dependence, and other health hazards. Concerns persist regarding nicotine's harm and public misperception due to risk reclassification, and caution should be maintained to discourage novel snuff users. Advocating …

Purdue’S Side Effects: Using Due Process To Realign Mass Tort Bankruptcies, William A. Organek

BYU Law Review

In Harrington v. Purdue Pharma, the United States Supreme Court held that victims of the opioid crisis could not be forced to release their independent claims against the Sacklers, who owned and controlled Purdue, without the victims’ consent. Such releases had become a controversial mainstay of mass tort bankruptcy filings. Yet Purdue was decided on narrow, textualist grounds, leaving as a side effect many seemingly disparate and difficult questions unanswered. This Article argues that Purdue and its open issues should be analyzed through a broader due process lens in tension with some aspects of current bankruptcy practice but consistent with …

The Opioid Crisis: How The United States And Countries Abroad Are Making Strides, Maura Mcginnity

DePaul Journal of Health Care Law

The opioid epidemic has been an ongoing problem in the United States since the 1980s. The United States has had a very negative attitude towards individuals suffering from addiction. This attitude is clearly shown through the United States’ handling of the opioid crisis. Hundreds of thousands of individuals have died due to opioids. In the forty years since this epidemic became prevalent, the United States has still failed to implement a country-wide solution to combat the crisis. Certain states, like New York and Illinois, have made strides toward helping individuals suffering from opioid use disorder, but nationally, the country is …

محددات الحقوق البيئية بالمغرب وواقع ممارستها, Mansour Ennaama

Journal of the Association of Arab Universities for Research in Higher Education مجلة اتحاد الجامعات العربية للبحوث في التعليم العالي

استعرض المقال الإطار النظري والقانوني للتشريع البيئي في المغرب، بالإضافة إلى تحليل التحديات التي تعترض تطبيقه وآفاق تحسينه. وتبرز الدراسة وجود فجوة بين النصوص القانونية البيئية وواقع الممارسة في المغرب مما يقلل من فعالية هذه التشريعات في حماية البيئة. كما تعيق التحديات المؤسسية والإدارية والمالية التطبيق الفعال لهذه التشريعات، إذ تواجه المؤسسات المعنية بحماية البيئة تحديات كبيرة تتعلق بنقص التنسيق والتداخل في الصلاحيات، مما يؤدي إلى ضعف في التنفيذ والمراقبة، حيث تعاني الجهات المسؤولة عن حماية البيئة من نقص في التمويل، مما يؤثر سلباً على قدرتها على تنفيذ البرامج البيئية وصيانة البنية التحتية البيئية. كما أن هناك حاجة ملحة لتعزيز …

Consumer (Mis)Understanding Of Dietary Supplement Labels, Jason Iuliano, Madison Kilbride

Texas A&M Law Review

“Helps lower cholesterol levels” and “helps promote healthy cholesterol levels.” Both of these claims are found on pharmacy products. And to ordinary consumers, the message is the same: take this pill and improve your cholesterol. Nevertheless, Congress has placed these statements in two very different regulatory categories. The former is classified as a disease claim, and the latter as a structure/function claim. Whereas products making disease claims require years of clinical trials and analyses before regulatory approval can be granted, products making structure/function claims do not even require governmental review before they can be sold to consumers. This bifurcated regulatory …

The National Bioengineered Foods Disclosure Standard & Absence Claims: The Cost Of The Butterfly, Cahlen Cheatham

Texas A&M Law Review

The National Bioengineered Foods Disclosure Standard (“NBFDS”) is a step in the right direction in providing a uniform labeling standard for genetically engineered organisms (“GEOs”) that meet the statutory definition of “bioengineered.” Importantly, the law provides a consensus that GEOs are safe and that labeling standards should be uniform across the United States. However, the law largely fails to settle the broader debate and the issues associated with GEO labeling. Namely, the NBFDS’s use of the term “bioengineered” causes additional confusion, and terms like “genetic modification” and “genetic engineering” remain ambiguous. Furthermore, the Final Rule promulgated by the U.S. Department …

When Poison Is On The Menu: Proposing The Adoption Of Ireland’S Stricter Allergen Regulations In America’S Food Establishments, Katherine Fitzgerald

Journal of Law and Policy

In the modern era, a growing number of children and adults have been diagnosed with deadly food allergies. For the approximately 33 million Americans who have at least one food allergy, restaurants, aside from the home, are the most likely place where deadly reactions could occur. In order to adapt to this expanding and sensitive population, the federal government should pass legislation that protects these citizens from suffering a preventable, untimely death. Luckily, the legislators of the European Union, and specifically Ireland, have already put food labeling legislation in place that serves to protect those with food allergies. This Irish …

The Ethics Of Advertising Unhealthy Food To Children: A Study On Potential Advertising Policy Restrictions And Their Effects On Children Of Disadvantaged Minority Groups, Riley M. O'Neal

Honors Theses

According to the Centers for Diseases Control and Prevention, one in five children in America have obesity. Black and Hispanic children experience obesity at higher rates than children of other racial groups. With obesity rates increasing, what should be done to stop this increase? One partial solution is to restrict the advertisements of foods high in sugar fat, and/or refined grains directed towards children. Advertisements may be restricted in their mode (i.e., the media through which they are viewed) or their content (i.e., the substance of the advertisement or product packaging). While these restrictions on advertising may help lower overall …