Food and Drug Law Commons^™

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 …

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.

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.

From Streets To Stats: A Statistical Analysis Of The Quantity Of Illegal Narcotics Seized In The United States, Zachary T. Strickland

Tenor of Our Times

This study aims to determine how seven different variables affect the total quantity of illegal narcotics seized. These seven variables include four dichotomous and three continuous variables, each striving to teach readers how they relate to the quantity of narcotics seized across specific states. My goal for this project is to figure out if there is any relationship to help law enforcement fight the war on drugs. With the continuing apparent rise of this war, this study is crucial in determining potential relationships between a state's characteristics and the quantity of illegal narcotics they forcibly take possession of. I further …

We Shall Overcome: The Evolution Of Quotas In The Land Of The Free And The Home Of Samba, Stella Emery Santana

Seattle University Law Review

When were voices given to the voiceless? When will education be permitted to all? When will we need to protest no more? It’s the twenty-first century, and the fight for equity in higher education remains a challenge to peoples all over the world. While students in the United States must deal with the increase in loans, in Brazil, only around 20% of youth between the ages of twenty-five and thirty-four have a higher education degree.

The primary objective of this Article is to conduct an in-depth comparative analysis of the development, implementation, and legal adjudication of educational quota systems within …

Pacific Islands And The U.S. Military: The Legal Borderlands Of The Environmental Movement, Sonia Lei

Seattle University Law Review

Climate change remains an urgent, ongoing global issue that requires critical examination of institutional polluters. This includes the world’s largest institutional consumer of petroleum: the United States military. The Department of Defense (DoD) is a massive institution with little oversight, a carbon footprint spanning the globe, a budget greater than the next ten largest nations combined, and overly generous exemptions to environmental regulations and carbon reduction targets. This Comment examines how this lack of accountability and oversight plays out in the context of three Pacific islands that have hosted U.S. military bases for decades. By considering the environmental impact of …

Petition Power, Erika Lietzan

American University Law Review

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 …

Weed Like Our Money Back: Amending Pennsylvania’S Medical Cannabis Law For Insolvent Cannabusinesses, Nikolajs V. Gaikis

Dickinson Law Review (2017-Present)

In 2016, Pennsylvania joined what is now 37 states and the District of Columbia in legalizing medical cannabis. The Commonwealth’s cannabusinesses share in a struggle that is common in other legal jurisdictions: operating within the confines of the Controlled Substances Act and the Bankruptcy Code. Insolvent individuals and businesses that profit from cannabis or hold cannabis assets cannot declare bankruptcy because cannabis is a Schedule I drug. Under state law, other insolvency alternatives like an assignment for the benefit of creditors, receiverships, and compositions with creditors exist as potential alternatives.

Pennsylvania’s insolvent cannabusinesses are in a uniquely poor position because …

Realizing The Right To Food In Maine: Insights From International Law, Smita Narula

Elisabeth Haub School of Law Faculty Publications

In November 2021, Maine made history as the first U.S. state to constitutionally recognize the right to food. Maine’s right to food amendment— which sought to address widespread food insecurity and corporate control of the food supply—proclaims food as a “natural, inherent and unalienable right,” and empowers Mainers to grow and consume food of their own choosing, affirming their right to food sovereignty. This Article makes three key contributions to scholarly examinations of this historic amendment. First, it situates the amendment within the broader landscape of domestic and global struggles for the right to food and food sovereignty. Second, the …

The Consumer’S Choice To Boycott, Agnes Bresee

Seattle University Law Review

In the wake of employees losing their jobs upon voicing their political opinions concerning Israel, Harvard and Columbia law students’ job offers being rescinded upon expressing support for Palestine, and the names and social media profiles of individuals who support Palestine being collected and listed on Canary Mission, such backlash may leave many Americans wondering what form of resistance to settler-colonialist apartheid is acceptable in the twenty-first century. Recently, the movement to collectively boycott brands like Starbucks, which sued its Worker’s Union for a tweet expressing support for Palestine; Disney, which donated money to Israel; and McDonald’s, where a location …

Squatters Squabbles: The Use Of Mediation To Provide Beneficial Solutions To Adverse Possession Claims In New Jersey, Bayla Zohn

Cardozo Journal of Conflict Resolution

In our society, law is a complex and ever-evolving field, constantly adapting to fit our needs. Yet, there are certain legal matters we would expect to have clear and obvious resolutions. Property ownership should be simple and unambiguous, governed by "established legal rules and precepts." Examine a deed, survey the stated legal owner of the tract of land, and your answer should be uncomplicated. Yet, there are a multitude of complex laws that allow individuals to obtain legal ownership of land in a seemingly illicit fashion.

A Different Approach To Agency Theory And Implications For Esg, Jonathan Bonham, Amoray Riggs-Cragun

Seattle University Law Review

In conventional agency theory, the agent is modeled as exerting unobservable “effort” that influences the distribution over outcomes the principal cares about. Recent papers instead allow the agent to choose the entire distribution, an assumption that better describes the extensive and flexible control that CEOs have over firm outcomes. Under this assumption, the optimal contract rewards the agent directly for outcomes the principal cares about, rather than for what those outcomes reveal about the agent’s effort. This article briefly summarizes this new agency model and discusses its implications for contracting on ESG activities.

Overseeing The Administrative State, Jill E. Fisch

Seattle University Law Review

In a series of recent cases, the Supreme Court has reduced the regulatory power of the Administrative State. Pending cases offer vehicles for the Court to go still further. Although the Court’s skepticism of administrative agencies may be rooted in Constitutional principles or political expediency, this Article explores another possible explanation—a shift in the nature of agencies and their regulatory role. As Pritchard and Thompson detail in their important book, A History of Securities Law in the Supreme Court, the Supreme Court was initially skeptical of agency power, jeopardizing Franklin Delano Roosevelt (FDR)’s ambitious New Deal plan. The Court’s acceptance …

The Sec, The Supreme Court, And The Administrative State, Paul G. Mahoney

Seattle University Law Review

Pritchard and Thompson have given those of us who study the SEC and the securities laws much food for thought. Their methodological focus is on the internal dynamics of the Court’s deliberations, on which they have done detailed and valuable work. The Court did not, however, operate in a vacuum. Intellectual trends in economics and law over the past century can also help us understand the SEC’s fortunes in the federal courts and make predictions about its future.

A Hard Pill To Swallow: The Abysmal Mental Health Standards Of Detained Immigrant Children In The United States, Rama Bankesly

Seattle University Law Review

After setting foot into the U.S., unaccompanied children must learn to navigate academic and legal systems while receiving little support and carrying the heavy burden of effects of trauma on their mental health. They need access to mental health care from qualified professionals, but as this Comment will explain, they systematically fail to receive care, as can be seen in cases like Doe v. Shenandoah Valley Juv. Ctr. Comm’n. In Shenandoah, an unaccompanied child arrived in the U.S. and was placed in a facility that failed to provide remotely adequate mental health care and in fact was subjected …

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 …

Tackling The Thicket: A Comparative Analysis Of Biologic Drugs And Biosimilars In The United States And Abroad, Lauren Cutler

Cardozo International & Comparative Law Review

The note examines the legal and regulatory landscape surrounding biologic drugs and biosimilars in the United States and Europe, focusing on patent protections, litigation trends, and the impact of biosimilar competition on drug pricing. It highlights the challenges posed by patent thickets and evergreening strategies employed by brand-name biologic manufacturers, which delay biosimilar market entry and maintain high drug prices. The analysis underscores the differences in regulatory frameworks and market dynamics between the U.S. and Europe, emphasizing the need for policy reforms to enhance competition and affordability in the biologic market.

Students For Fair Admissions: Affirming Affirmative Action And Shapeshifting Towards Cognitive Diversity?, Steven A. Ramirez

Seattle University Law Review

The Roberts Court holds a well-earned reputation for overturning Supreme Court precedent regardless of the long-standing nature of the case. The Roberts Court knows how to overrule precedent. In Students for Fair Admissions v. Harvard (SFFA), the Court’s majority opinion never intimates that it overrules Grutter v. Bollinger, the Court’s leading opinion permitting race-based affirmative action in college admissions. Instead, the Roberts Court applied Grutter as authoritative to hold certain affirmative action programs entailing racial preferences violative of the Constitution. These programs did not provide an end point, nor did they require assessment, review, periodic expiration, or revision for greater …

Empirically Assessing 510(K) Device Safety, George Horvath

Akron Law Faculty Publications

Innovations in medical device technology hold the potential to improve health outcomes across the populace. Nearly half of all medical devices that enter the U.S. market each year are regulated by the Food and Drug Administration (FDA) under the 510(k) pathway. If FDA regulation of 510(k) devices stifles innovation, health outcomes will suffer over time because beneficial devices would not reach patients; on the other hand, if regulation facilitates innovation, health outcomes could improve. Most discussions of innovation under the 510(k) pathway have been either excessively reductionist (such as claims that the pathway stifles innovation) or wholly pessimistic (notably, the …

State Drug Laws, Mason Marks

Fordham Law Review

States have long enacted drug laws that depart from federal laws and regulations. In the early twentieth century, several states prohibited marijuana while it remained federally unregulated. In the 1960s, states started criminalizing psychedelic substances. Shortly thereafter, in the early 1970s, they started reversing the trend to criminalize drugs by reducing or eliminating criminal penalties associated with personal marijuana use. State-level decriminalization accelerated in the 1990s and 2000s.

More recently, states have extended drug policy reforms to other substances, including psychedelics, stimulants, and opioids. Some states have eliminated criminal penalties while others have replaced criminal penalties with fines or diversion …

Expecting Medication Surveillance, Jennifer D. Oliva

Fordham Law Review

In response to federal financial incentives and mandates, all fifty states, the District of Columbia, and three U.S. territories administer electronic prescription drug monitoring programs (PDMPs). Federal and state policymakers justified the implementation and enhancement of ubiquitous prescription drug monitoring by contending that expansive state drug surveillance was a necessary weapon in the war against the American drug overdose crisis. As is often the case with tools designed for law enforcement surveillance, however, PDMPs have proven susceptible to mission creep. Although pioneer PDMPs were paper-based systems that limited their surveillance to a narrow class of heavily regulated controlled substances, modern …