Food and Drug Law Commons^™

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 …

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 …

Identifying Youth Appeals In Alcohol Alternative Social Media Content Through Framing, Melina Oneal

West Chester University Master’s Theses

Proposed regulations for alcohol advertising prevent beverage companies from targeting people under the legal drinking age. However, similar regulations for alcohol alternative beverages are less explored, which could allow alcohol alternative products to create awareness for alcoholic beverages among youth. Alcohol alternatives beverages, including no-alcohol and low-alcohol products, are increasing in popularity and can function as compliments to alcoholic products to decrease the total alcohol volume consumed or as substitutes for alcoholic products. Framing theory can be operationalized through the Content Appealing to Youth Index, an index of content elements found in research literature to be appealing to youth, to …

Ductus Exemplo: A Model Municipal Executive Order On Food Waste Reduction, Linda Breggin, Darby Hoover, Jessica Sugarman

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Petition Power, Erika Lietzan

Faculty Publications

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

The Need For Corporate Guardrails In U.S. Industrial Policy, Lenore Palladino

Seattle University Law Review

U.S. politicians are actively “marketcrafting”: the passage of the Bipartisan Infrastructure Law, the CHIPS and Science Act, and the Inflation Reduction Act collectively mark a new moment of robust industrial policy. However, these policies are necessarily layered on top of decades of shareholder primacy in corporate governance, in which corporate and financial leaders have prioritized using corporate profits to increase the wealth of shareholders. The Administration and Congress have an opportunity to use industrial policy to encourage a broader reorientation of U.S. businesses away from extractive shareholder primacy and toward innovation and productivity. This Article examines discrete opportunities within the …

Securities Regulation And Administrative Deference In The Roberts Court, Eric C. Chaffee

Seattle University Law Review

In A History of Securities Law in the Supreme Court, A.C. Pritchard and Robert B. Thompson write, “Securities law offers an illuminating window into the Supreme Court’s administrative law jurisprudence over the last century. The securities cases provide one of the most accessible illustrations of key transitions of American law.” A main reason for this is that the U.S. Securities and Exchange Commission (SEC) is a bellwether among administrative agencies, and as a result, A History of Securities Law in the Supreme Court is a history of administrative law in the Supreme Court of the United States as well.

Delegated Corporate Voting And The Deliberative Franchise, Sarah C. Haan

Seattle University Law Review

Starting in the 1930s with the earliest version of the proxy rules, the Securities and Exchange Commission (SEC) has gradually increased the proportion of “instructed” votes on the shareholder’s proxy card until, for the first time in 2022, it required a fully instructed proxy card. This evolution effectively shifted the exercise of the shareholder’s vote from the shareholders’ meeting to the vote delegation that occurs when the share-holder fills out the proxy card. The point in the electoral process when the binding voting choice is communicated is now the execution of the proxy card (assuming the shareholder completes the card …

Capitalism Stakeholderism, Christina Parajon Skinner

Seattle University Law Review

Today’s corporate governance debates are replete with discussion of how best to operationalize so-called stakeholder capitalism—that is, a version of capitalism that considers the interests of employees, communities, suppliers, and the environment alongside (if not before) a company’s shareholders. So much focus has been dedicated to the question of capitalism’s reform that few have questioned a key underlying premise of stakeholder capitalism: that is, that competitive capitalism does not serve these various constituencies and groups. This Essay presents a different view and argues that capitalism is, in fact, the ultimate form of stakeholderism. As such, the Essay urges that the …

The Esg Information System, Stavros Gadinis, Amelia Miazad

Seattle University Law Review

The mounting focus on ESG has forced internal corporate decision-making into the spotlight. Investors are eager to support companies in innovative “green” technologies and scrutinize companies’ transition plans. Activists are targeting boards whose decisions appear too timid or insufficiently explained. Consumers and employees are incorporating companies sustainability credentials in their purchasing and employment decisions. These actors are asking companies for better information, higher quality reports, and granular data. In response, companies are producing lengthy sustainability reports, adopting ambitious purpose statements, and touting their sustainability credentials. Understandably, concerns about greenwashing and accountability abound, and policymakers are preparing for action.

In this …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

The Marijuana Insurgency: Federalism And Social Reframing In Policy Reform, Matthew P. Cavedon

Seattle University Law Review

After fifty years of federal prohibition, marijuana reform efforts have won political and legal success. These victories hold lessons for anyone seeking to resist federal law without being able to directly affect it.

Victory can come from reframing an issue. For marijuana reform, social reframing—not formal legal analysis or material factors—provides the best explanation for how advocates achieved change. Their unconventional political tactics, akin to those used by insurgents in wartime, undercut federal prohibition by winning hearts and minds.

This is an analysis of the sociology of legal change. It is also the story of how ordinary Americans retook personal …

Preempting Red State Restrictions On The Use Of Fda-Approved Drugs In Gender-Affirming Care?, Lars Noah

UF Law Faculty Publications

Some observers recently have wondered whether actions by the U.S. Food and Drug Administration (“FDA”) could federally preempt increasingly common state restrictions on gender-affirming care, particularly prohibitions on the use of puberty blockers and cross-sex hormones in adolescent patients. In theory, such a legal strategy might sidestep the need to lodge increasingly unsuccessful challenges under the Fourteenth Amendment. The Supremacy Clause offers little assistance, however, in attempting to get around these state laws. Indeed, even if the FDA eventually approved such uses for currently marketed drugs, implied preemption doctrine as currently configured probably would not do the trick, though securing …

Legal Pressure To Attend Substance Abuse Treatment, Angelicia Courteau

AUCTUS: The Journal of Undergraduate Research and Creative Scholarship

This paper was written to bring awareness of how the legal system does not take into consideration those who suffer from substance use disorder, as well as ACEs. Brian Luke Burijon’s battle with addiction while incarcerated was used as an example of how the legal system’s one-size-fits-all approach is flawed. Mr. Burijon opted for a treatment he did not feel was ideal for him because the alternative was to remain incarcerated for a long period. Mr. Burijon was unable to tolerate the treatment at the facility and left early, which resulted in his overdose death.

Shareholder Primacy Versus Shareholder Accountability, William W. Bratton

Seattle University Law Review

When corporations inflict injuries in the course of business, shareholders wielding environmental, social, and governance (“ESG”) principles can, and now sometimes do, intervene to correct the matter. In the emerging fact pattern, corporate social accountability expands out of its historic collectivized frame to become an internal subject matter—a corporate governance topic. As a result, shareholder accountability surfaces as a policy question for the first time. The Big Three index fund managers, BlackRock, Vanguard, and State Street, responded to the accountability question with ESG activism. In so doing, they defected against corporate legal theory’s central tenet, shareholder primacy. Shareholder primacy builds …

Verses Turned To Verdicts: Ysl Rico Case Sets A High-Watermark For The Legal Pseudo-Censorship Of Rap Music, Nabil Yousfi

Seattle University Law Review

Whichever way you spin the record, rap music and courtrooms don’t mix. On one side, rap records are well known for their unapologetic lyrical composition, often expressing a blatant disregard for legal institutions and authorities. On the other, court records reflect a Van Gogh’s ear for rap music, frequently allowing rap lyrics—but not similar lyrics from other genres—to be used as criminal evidence against the defendants who authored them. Over the last thirty years, this immiscibility has engendered a legal landscape where prosecutors wield rap lyrics as potent instruments for criminal prosecution. In such cases, color-blind courts neglect that rap …

Time To Abolish The Dea: Evaluating The Agency’S Failures And Calling For Community Investments, Ifetayo Harvey

Fordham Law Review

No abstract provided.

Enhancing 21 U.S.C. §§ 355, 356, And 360 To Encompass Artificial Intelligence-Based Drug Design And Manufacturing Methods, Aj Tsang

Michigan Technology Law Review

Despite newfound attention to how artificial intelligence (AI) may accelerate pharmaceutical development, federal regulators may find that current statutes are ambiguous or silent about their applicability to AI-based drug design and manufacturing methods. This poses a serious problem in the era of Loper Bright and the Major Questions Doctrine. As federal agencies struggle to adjust to courts’ growing demand for Congress to craft clear, explicit, and express delegations of authority, this note develops a statutory framework in which the Food and Drug Administration (FDA) would have more flexibility to regulate the use of AI in advanced drug manufacturing. Guided by …

Beyond Traditional Ip: Addressing Regulatory Barriers, Cynthia M. Ho

Faculty Publications & Other Works

The chapter begins with the genesis of relevant regulatory protections and their general parameters before discussing their prevalence among countries. It then turns to discussion of proposed and actual modification of TRIPS requirements for COVID and how that intersects with these regulatory barriers. The chapter concludes with recommendations.