Health Law and Policy Commons^™

Blue Sky Thinking In A Red Sky World, Camila Bustos, Joshua Ulan Galperin, Margot J. Pollans, Laurie Jamile Beyranevand, Rebecca Bratspies, Cinnamon Carlane Hirokawa, Sarah Fox, Keith H. Hirokawa, Sarah Matsumoto, Anthony Moffa, Laura Mott, Jessica Owley, Gabriel Pacyniak, Melissa Powers, Paul Rink, Kristin Van De Biezenbos, Leehi Yona

Elisabeth Haub School of Law Faculty Publications

In 2004, visionary environmental leader Gus Speth's book Red Sky at Morning warned that “[a] global crisis has unfolded quickly ... but so far we seem unable to step from the path to disaster.” More than 20 years later, we have made great gains, but the fundamental transition Speth envisioned did not come to pass, and global environmental deterioration continues to intensify at an alarming pace. Approaching Speth's “red sky world” with “blue sky thinking,” members of the 2025 Environmental Law Collaborative explored new strategies for a more sustainable future. This latest in a biannual series of essays covers a …

The Retreat Of Federal Power And The Rise Of Post-Supremacy Federalism, Victoria Grace Litman

Cleveland State Law Review

This Article introduces the theory of post-supremacy federalism to describe a structural condition in which federal law remains formally binding, but enforcement has durably receded or collapsed. Unlike frameworks grounded in intergovernmental friction or negotiated cooperation, this account begins from federal retreat—the cumulative erosion of enforcement capacity across judicial, administrative, legislative, and executive institutions. Post-supremacy federalism arises when three conditions are met: (1) federal law remains intact; (2) enforcement retreats; and (3) no formal devolution occurs. In this vacuum, states are not merely filling gaps. They are governing by default—under laws that still bind but no longer structure governance in …

Drug War Repair Guarantees, Amber Baylor

Washington and Lee Law Review

Drug legalization, especially cannabis legalization, is a critical step forward in states’ willingness to address systemic disparities, privacy intrusions, violence, and other harms of the drug war. Yet, reforms center on legalization and repair through a narrow lens, focused on changes to the penal code. The public has found that narrow forms of legalization cannot serve their purported reparative purpose. Narrowly drawn legalization is illusory. Drug war harms and punishment for legalized substance use continue. Legalization reforms are vulnerable to political trends, resulting in rollback and retrenchment of drug war operations.

Legalization cannot deliver on its reparative terms without guarantees. …

Birthdate Phaseout To A Nicotine Free Generation, Katharine Silbaugh

University of Richmond Law Review

This Article explores the Nicotine Free Generation (“NFG”) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: prohibition or a legal age-gate, such as twenty-one, for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the twenty-one …

Probing The Prevalence Of Pharmaceutical Corruption, Marc A. Rodwin

Suffolk University Law School Faculty Works

This article reviews the history and current evidence of systematic pharmaceutical industry corruption.  It draws on studies by the OECD on international corruption; reports of the Securities and Exchange Commission; studies of the Public Citizen health Research Group of settlement agreements between federal and state authorities and pharmaceutical firm; the history of the Medicare and Medicaid Anti-Kickback Act; professional and industry codes of ethics; the literature on institutional corruption; and studies of conflicts of interest.  These sources support findings of systemic corruption since the mid-20th century. The paper also explores the relationship between classic corruption, institutional corruption and conflicts of …

Birthdate Phaseout To A Nicotine Free Generation, Katharine B. Silbaugh

Faculty Scholarship

This Article explores the Nicotine Free Generation ("NFG") policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: prohibition or a legal age-gate, such as twenty-one, for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the twenty-one …

Preempting Pre-Approval: Clarifying Preemption Doctrine For Product-Liability Suits Against Brand-Name Drug Manufacturers, Nicholas G. Wallenburg

Vanderbilt Law Review

One of the most important issues for product-liability lawsuits against drug manufacturers today is federal preemption. Plaintiffs injured by prescription drugs regularly turn to state tort law for a remedy. Defendants in these cases—often brand-name drug manufacturers—frequently invoke preemption doctrine to argue that the Food and Drug Administration’s (“FDA”) rigorous approval process for prescription drugs has displaced state causes of action. While the text of the Food, Drug, and Cosmetics Act does not clearly address this issue, the U.S. Supreme Court has relied on a so-called “impossibility” theory of preemption: When a drug manufacturer cannot comply with the duties imposed …

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Ayahuasca And Religious Freedom, Andrew C. Michaels

Pepperdine Law Review

Ayahuasca is an ancient and powerful psychedelic brew that has been used for many centuries in the Amazon rainforest, and over past decades has been gaining popularity in western countries such as the United States. The ayahuasca brew contains dimethyltryptamine (DMT) and accordingly is banned by the Controlled Substances Act (CSA). But some groups working with ayahuasca have applied for exemptions under the Religious Freedom Restoration Act (RFRA), and so far, at least five such groups have received exemptions, either via court decision or via agreement with the Drug Enforcement Administration (DEA). However, the factors that courts and the DEA …

Unveiling The Patent Landscape Of Biologic Drugs, Michael D. Frakes, Melissa F. Wasserman

Northwestern University Law Review

It is undeniable that the escalating price of biopharmaceuticals is a critical issue, as high prices limit patients’ access to life-saving medications and strain our healthcare system. Biologics, or large-molecule drugs, which are revolutionizing modern healthcare, are significantly contributing to the escalating cost of prescription drugs. While biologic drugs represent only 2% of all U.S. prescriptions, they comprise close to 50% of net drug spending.

Policymakers have proposed a series of interventions to decrease drug prices that target the patent practices of pharmaceutical firms. Yet due to differences in law, we have a robust source of patenting information for small-molecule …

The New Red Scare: The Shocking Truth Behind The Fda's Unethical Regulation Of Red 40 And Other Synthetic Food Dyes, Angelica Martuscello

Pace Law Review

For decades, the U.S. Food and Drug Administration (FDA) has allowed synthetic food dyes to remain in the American food supply, despite evidence linking them to cancer and behavioral issues in children. These additives offer no nutritional value yet remain common in everyday products. This essay scrutinizes the FDA’s failure to enforce its own legal obligations, particularly its continued approval of synthetic dyes, which were later found to be harmful to human health. Harmful dyes have been kept on the market due to weak oversight, outdated science, and industry lobbying. In 2025, the FDA finally announced a plan to phase …

Outbound Investment Restrictions And International Law’S Challenge, Harlan Grant Cohen

Seattle University Law Review

The Outbound Investment Rule, restricting U.S. investment in certain Chinese advanced technology sectors, has largely been portrayed as an incremental measure, a modest extension to fill loopholes in the existing investment screening regime. But while perhaps the logical next step in the securitization of the economy, the Outbound Investment Rule actually reflects a momentous shift in the relationship between governments and business, one playing out in the United States and around the world and worth attention. Unlike traditional investment screening, the Outbound Investment Rule operates like a sanctions regime, designed not to protect the U.S. economy, but to hamper the …

Resilient Dispute Resolution Systems For International Energy Conflicts, Guillermo J. Garcia Sanchez

Seattle University Law Review

Energy-related conflicts are on the rise, spanning diverse issues such as the impacts of rare mineral mining on local communities, the impacts of sanctions on energy investments due to the Russia-Ukraine war, and the impacts of expanded subsidies on the electric vehicle and solar panel industries. Increasingly, companies, communities, and governments are clashing over the challenges of pursuing disparate and sometimes competing energy policies. This Article argues that dispute resolution mechanisms in the energy investment sector must be fundamentally rethought. Traditional semi-adjudicatory models, which focus on winners and losers, fail to accommodate the complex and multifaceted nature of contemporary energy …

Restricting Data Flows Is A Sign Of Weakness, Nikolas Guggenberger

Seattle University Law Review

There has been a seismic shift in American attitudes toward the free flow of data across borders.  In less than a decade, the United States has transitioned from condemning barriers to digital trade to constructing a digital fortress of its own. It passed legislation requiring TikTok’s parent company to divest its U.S. operations or face a nationwide ban affecting 170 million U.S. users, citing national security concerns about its ties to China and the potential for data surveillance and content manipulation. Upon legal challenge by TikTok on First Amendment grounds, the Supreme Court affirmed the ban’s constitutionality. Recent federal legislation …

Product Nationality And Corporate Identity, Trang (Mae) Nguyen

Seattle University Law Review

Global supply chains have long depended on a deceptively technical device: the attribution of a “nationality” to goods. A trade law principle, rules of origin assign products an “economic passport” that governs how they are treated at the border, including what markets they may enter and which tariff rates apply. In recent years, however, product nationality has taken on a new and far more ambitious role. As U.S. trade policy increasingly intersects with national security and human rights policy, policymakers rely on nationality-based measures to police supply chain linkages, curb geopolitical issues, and discipline firms for their links to forced …

Global Supply Chain Resilience In Emerging Technologies: A Case Study Of Bitcoin Mining, Kishanthi Parella, Carla L. Reyes

Seattle University Law Review

The United States has put into motion bold plans in critical and emerging technologies to bolster its national and economic security.  For example, the federal government created a national bitcoin strategic reserve and a stockpile of other cryptocurrency; while several states have committed to or are considering similar goals.  However, the security of these reserves is dependent on two types of supply chains within the Bitcoin mining industry: analogue supply chains, relating to the physical components needed for Bitcoin mining, and data supply chains, relating to the complex and layered logistical network of actors that create input into the software …

Third-Party Funding: Balancing Transparency, National Security, And Access To Justice, Victoria Shannon Sahani

Seattle University Law Review

Many lawmakers who have recently become aware of the multi-billion-dollar global third-party funding industry are raising new national security concerns that further complicate preexisting, longstanding debates about transparency, disclosure, access to justice, and the best way to regulate third-party funding. In response, this Article briefly asserts three main points relating to the question of how best to regulate third-party funding. First, this Article explains the third-party funding industry, including its global regulatory landscape and how it serves three distinct populations: consumers, businesses, and law firms. Second, this Article explains that third-party funding is one tool that can help expand access …

The Field Of International Business Transactions Law, Kathleen Claussen

Seattle University Law Review

This Article studies the evolution of the scholarly subfield referred to as the law of “international business transactions” (IBT). It reviews data on academic articles, courses, textbooks and other signifiers of the growth of this research area. Beginning around 1960, scholars began to use the term “international business transactions” and by the 1980s, several law schools were offering a course by that title. A handful of dedicated textbooks soon followed. These data reflect a gradual increase in research on the topic of IBT, particularly in the United States, but also considerable diversity of subject matters covered by those works. The …

Kim Gyeong-Seok And The Origins Of Northeast Asia’S Corporate Accountability Movement For War And Colonialism, Timothy Webster

Seattle University Law Review

For the past three decades, a transnational reparations movement has unfolded across Northeast Asia. Hundreds of victims—assisted by attorneys, academics, and activists—seek remedies from Japan for various atrocities committed during World War II, colonialism, and other historical injustices.  They press their claims in street protests, legislative hearings, dramatic performances, and other fora.  The “comfort women” are the best known of these claimants; their global redress campaign ex-tends from noisy protests outside of Japan’s embassy in Seoul, to mute statues in raucous boroughs of Berlin.  More obscure, though larger in number, were the roughly one million Koreans who performed forced labor …

Navigating Compliance In A Geopolitical Era: The Case Of Chinese Multinationals In The United States, Ji Li

Seattle University Law Review

This Article examines how Chinese multinational companies (MNCs) approach compliance in the United States amid deepening geo-political rivalry and intensified regulatory scrutiny. Drawing on original survey data, this Article maps variations in compliance structures, staffing, and governance mechanisms across Chinese firms and identifies key determinants such as industry-specific regulatory intensity, listing status, and organizational imprinting from headquarters. The analysis employs a dual institutional framework to explain how compliance systems emerge from the interplay between host-state regulatory demands and home-state institutional legacies, producing hybrid structures that blend local adaptation with headquarters-driven replication. Findings reveal that while certain compliance features—such as committee …

Volume 49 Masthead

Seattle University Law Review

Volume 49 Masthead

A Comparative Study Of Chinese And American Approaches To Shaping International Outer Space Law And Norms, Ariel G. Silverman

Seattle University Law Review

This article explores convergences and divergencies in the United States and PRC’s responses to the stalemate in the United Nations over the future of outer space resource governance. I do so by systematically analyzing these leading space-faring nations’ policy-positions and tactics deployed to shape norms around three substantive areas of outer space resource governance: rights of ownership and scope of utilization of space resources, mechanization of the “benefits sharing” principle, and the rights and responsibilities of the private sector. I theorize that these leading space-faring nations have adopted divergent approaches due to their differing historical relationships with international law and …

Table Of Contents

Seattle University Law Review

Table of Contents

Antibiotics In Animal Agriculture, The Risks To Health, And Differences In The Us And The Eu, Li-Ting Chou

Seattle Journal of Technology, Environmental, & Innovation Law

No abstract provided.

Pills, Powders, And Proprietary Blends: The Ip And Regulatory Battle Over Dietary Supplement Transparency, Anna Marie Saunders

Journal of Intellectual Property Law

Available in the form of pills, powders, gummies, bars, and countless other options, dietary supplements have become a cornerstone of the health and wellness industry and a popular product amongst health-conscious consumers. Fueled by the rise of social media influencers and a surge in health-awareness following the COVID-19 pandemic, the supplement industry has experienced rapid growth, evolving into a multi-billion-dollar market.  While widely embraced, these products often face criticism due to labeling and marketing practices that leave  consumers with an incomplete understanding of exactly they are consuming.  This tension arises from the unique legal intersection governing dietary supplements.  These products …

The Transatlantic Clinical Trial Transparency Gap, Gabriela Lenarczyk

Journal of Intellectual Property Law

Clinical trial data occupy a contested space between private commercial assets and public goods. While the United States Food and Drug Administration (FDA) has historically shielded these data through expansive trade-secret interpretations, the European Union (EU) has adopted a more open disclosure regime. This Article compares the two regimes and traces how the EU’s two-decade journey toward transparency has become a key reference for researchers and advocates of open data-sharing.

Focusing on EU practices—targeted redactions, time-bound access, granular disclosure guidelines—the paper shows that U.S. objections to broader transparency often rest on overstated concerns about competitive harm. A Filspari (sparsentan) case …

Tracing The Truth: Strengthening U.S. Food Traceability With Lessons From The Eur. Union, Carolina Gomez

University of Miami Business Law Review

The United States (U.S.) has made significant progress in improving food traceability, with the FDA’s Final Food Traceability Rule set to take effect in 2026. This long-overdue regulation aims to improve outbreak response and better protect public health. However, major gaps in the U.S. traceability system remain, leaving consumers exposed to preventable foodborne illness outbreaks. Legislative challenges, including H.R. Bill 7563 and provisions in the Fiscal Year 2025 Agriculture Appropriations bill, threaten to delay or weaken these necessary reforms. Compounding these challenges, on August 7, 2025, the FDA proposed extending the compliance deadline for the rule by 30 months, to …

A New Framework For Drug Pricing Law And Policy, Rachel E. Sachs

Indiana Law Journal

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

The Law’S Failure To Protect Our Drinking Water From Pfas, Emily Levine

Indiana Law Journal

How did per- and polyfluoroalkyl substances (PFAS), the forever chemicals known to harm human health and appear in most Americans’ blood, spread so widely in drinking water? Why didn’t someone with the power and knowledge to stop this crisis step in sooner? Simply imposing limits on PFAS levels in public water systems is the bare minimum to protect American drinking water—a necessary step but only the starting point of a long path toward creating a regulatory framework that can withstand the whims of changing presidential administrations and political influences.

     It is too easy for the EPA Administrator, either out of …

An Incidental Standard For Medical Ai, Nicholson W. Price Ii

Articles

Medical AI is poised to make a major difference in the provision of health. It brings major challenges, though: how can developers and implementers ensure that it will work safely and effectively—especially within the context of complex and highly variable health-care systems? Standards provide one key tool, potentially providing guidelines for everything from privacy to accuracy to how AI interacts with human clinicians. This Essay considers the last of these, describing a powerful quasi-standard from a surprising source: an FDA guidance document that tells developers when certain AI systems are not considered medical devices, and are therefore not regulated by …