Food and Drug Law Commons^™

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 …

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 …

Speech Regulation And Tobacco Harm Reduction, Jonathan H. Adler, Jacob James Rich

Faculty Publications

Part I of this essay describes what is currently understood about the relative health risks of ENDS [electronic nicotine delivery systems] and other vaping products, particularly as compared to combustible cigarettes.

Part II of this essay describes the current regulatory regime governing tobacco products and how this regime has been applied to ENDS and other vaping products.

Part III of this essay explains how the FDA’s regulatory regime hampers the ability of ENDS manufacturers to inform consumers about the relative risks of their products and the potential use of ENDS as smoking cessation aids.

Part IV explains why this regulation …

Public Primacy In Corporate Law, Dorothy S. Lund

Seattle University Law Review

This Article explores the malleability of agency theory by showing that it could be used to justify a “public primacy” standard for corporate law that would direct fiduciaries to promote the value of the corporation for the benefit of the public. Employing agency theory to describe the relationship between corporate management and the broader public sheds light on aspects of firm behavior, as well as the nature of state contracting with corporations. It also provides a lodestar for a possible future evolution of corporate law and governance: minimize the agency costs created by the divergence of interests between management and …

Stakeholder Governance As Governance By Stakeholders, Brett Mcdonnell

Seattle University Law Review

Much debate within corporate governance today centers on the proper role of corporate stakeholders, such as employees, customers, creditors, suppliers, and local communities. Scholars and reformers advocate for greater attention to stakeholder interests under a variety of banners, including ESG, sustainability, corporate social responsibility, and stakeholder governance. So far, that advocacy focuses almost entirely on arguing for an expanded understanding of corporate purpose. It argues that corporate governance should be for various stakeholders, not shareholders alone.

This Article examines and approves of that broadened understanding of corporate purpose. However, it argues that we should understand stakeholder governance as extending well …

The Limits Of Corporate Governance, Cathy Hwang, Emily Winston

Seattle University Law Review

What is the purpose of the corporation? For decades, the answer was clear: to put shareholders’ interests first. In many cases, this theory of shareholder primacy also became synonymous with the imperative to maximize shareholder wealth. In the world where shareholder primacy was a north star, courts, scholars, and policymakers had relatively little to fight about: most debates were minor skirmishes about exactly how to maximize shareholder wealth.

Part I of this Essay discusses the shortcomings of shareholder primacy and stakeholder governance, arguing that neither of these modes of governance provides an adequate framework for incentivizing corporations to do good. …

The Structure Of Corporate Law Revolutions, William Savitt

Seattle University Law Review

Since, call it 1970, corporate law has operated under a dominant conception of governance that identifies profit-maximization for stockholder benefit as the purpose of the corporation. Milton Friedman’s essay The Social Responsibility of Business is to Increase Its Profits, published in September of that year, provides a handy, if admittedly imprecise, marker for the coronation of the shareholder-primacy paradigm. In the decades that followed, corporate law scholars pursued an ever-narrowing research agenda with the purpose and effect of confirming the shareholder-primacy paradigm. Corporate jurisprudence followed a similar path, slowly at first and later accelerating, to discover in the precedents and …

Corporate Law In The Global South: Heterodox Stakeholderism, Mariana Pargendler

Seattle University Law Review

How do the corporate laws of Global South jurisdictions differ from their Global North counterparts? Prevailing stereotypes depict the corporate laws of developing countries as either antiquated or plagued by problems of enforcement and misfit despite formal convergence. This Article offers a different view by showing how Global South jurisdictions have pioneered heterodox stakeholder approaches in corporate law, such as the erosion of limited liability for purposes of stakeholder protection in Brazil and India, the adoption of mandatory corporate social responsibility in Indonesia and India, and the large-scale program of Black corporate ownership and empowerment in South Africa, among many …

Robo-Voting: Does Delegated Proxy Voting Pose A Challenge For Shareholder Democracy?, John Matsusaka, Chong Shu

Seattle University Law Review

Robo-voting is the practice by an investment fund of mechanically voting in corporate elections according to the advice of its proxy advisor— in effect fully delegating its voting decision to its advisor. We examined over 65 million votes cast during the period 2008–2021 by 14,582 mutual funds to describe and quantify the prevalence of robo-voting. Overall, 33% of mutual funds robo-voted in 2021: 22% with ISS, 4% with Glass Lewis, and six percent with the recommendations of the issuer’s management. The fraction of funds that robo-voted increased until around 2013 and then stabilized at the current level. Despite the sizable …

Stakeholder Governance On The Ground (And In The Sky), Stephen Johnson, Frank Partnoy

Seattle University Law Review

Professor Frank Partnoy: This is a marvelous gathering, and it is all due to Chuck O’Kelley and the special gentleness, openness, and creativity that he brings to this symposium. For more than a decade, he has been open to new and creative ways to discuss important issues surrounding business law and Adolf Berle’s legacy. We also are grateful to Dorothy Lund for co-organizing this gathering.

In introducing Stephen Johnson, I am reminded of a previous Berle, where Chuck allowed me some time to present the initial thoughts that led to my book, WAIT: The Art and Science of Delay. Part …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

How To Interpret The Securities Laws?, Zachary J. Gubler

Seattle University Law Review

In discussions of the federal securities laws, the SEC usually gets most of the attention. This makes some sense. After all, it is the agency charged with administrating the securities laws and regulating the industry as a whole. It makes the majority of the laws; it engages in enforcement actions; it reacts to crises; and it, or sometimes even its individual commissioners, intervene publicly in policy debates. Often overlooked in such discussion, however, is the role of the Supreme Court in shaping securities law, and a new book by Adam Pritchard and Robert Thompson demonstrates why this is an oversight. …