Food and Drug Law Commons^™

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.

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 …

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 …

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 …

Defining "Healthy" On Food Labels: One Step Forward, Two Steps Back, Alexia Brunet Marks

Publications

Few definitions of the mid-twentieth century have survived into the twenty-first century. It is worth asking, then, why the definition of "health," articulated seventy-five years ago by the World Health Organization, has endured into the present. The 1948 definition reads as follows: "[h]ealth is a state of complete physical, mental[,] and social well-being and not merely the absence of disease or infirmity." Aspirational in tone, the definition resonates with the surge among consumers towards healthier foods and overall well-being. However, in addition to wartime and pandemic concerns, today's threats to achieving "health" include climate change and a rise in diet-related …

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 …

Re/Descheduling Marijuana Through Administrative Action, Scott Bloomberg, Alexandra Harriman, Shane Pennington

Oklahoma Law Review

No abstract provided.

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 …

Use Of Artificial Intelligence In Drug Development, Louise C. Druedahl, Nicholson Price, Timo Minssen, Dipl Jur, Ameet Sarpatwari

Articles

Considerable focus has been placed on the health care applications of artificial intelligence (AI). Already, machine learning, a subset of AI that involves “the use of data and algorithms to imitate the way that humans learn” has been used to predict diseases, while AI-powered smartphone apps have been developed to promote mental health and weight loss. Owing in part to such successes, the market for AI in health care has been forecasted to increase more than 1000% between 2022 and 2029, from $13.8 billion to $164.1 billion. One area of substantial promise is drug development, which is poised to benefit …

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.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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.

The Sffa V. Harvard Trojan Horse Admissions Lawsuit, Kimberly West-Faulcon

Seattle University Law Review

Affirmative-action-hostile admissions lawsuits are modern Trojan horses. The SFFA v. Harvard/UNC case—Students for Fair Admissions, Inc. v. President & Fellows of Harvard College and Students for Fair Admissions, Inc. v. University of North Carolina, et. al., decided jointly—is the most effective Trojan horse admissions lawsuit to date. Constructed to have the distractingly appealing exterior façade of a lawsuit seeking greater fairness in college admissions, the SFFA v. Harvard/UNC case is best understood as a deception-driven battle tactic used by forces waging a multi-decade war against the major legislative victories of America’s Civil Rights Movement, specifically Title VI and Title VII …

Feeding The Good Fire: Paths To Facilitate Native-Led Fire Management On Federal Lands, Kevin Burdet

Seattle University Law Review

In 2003, nearly twenty Native American reservations were devastated by wildfires that originated on adjacent federal lands. The San Pasqual Reservation’s entire 1,400 acres were burned along with over a third of its homes, and seventy-five percent of the Rincon Reservation was burned, taking twenty homes with it. These devastating fires, along with others in 2002, brought about the Tribal Forest Protection Act of 2004 (TFPA), which offered hope for Tribes to propose projects on bordering or adjacent federal lands and protect reservation lands in the process. Unfortunately, twenty years later, the TFPA has had a marginal effect in enabling …

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 …

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 …

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 …

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.

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 …

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 …

Tele-Induction Of Buprenorphine For Opioid Use Disorder: Regulatory Flux And Public Confusion, Stacey A. Tovino

Fordham Law Review

No abstract provided.

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 …