Food and Drug Law Commons^™

Dark Accounting Matter, Colleen Honigsberg

Seattle University Law Review

Physicists calculate that approximately 85% of the matter in the universe is composed of “dark matter” that “does not absorb, reflect, or emit electromagnetic radiation and is therefore difficult to detect.” The S&P 500 currently trades at a price-to-book value of 4.2, suggesting that book value accounts for less than 20% of the S&P 500’s market value. The remaining 80% appears nowhere in these firms’ balance sheets—it is invisible to contemporary accounting techniques and constitutes “dark accounting matter.”

Some “dark accounting matter” is composed of factors commonly described as components of “ESG.” Human capital, for example, is an intangible asset …

The Employees’ Dilemma: Balancing Internal Reporting, Whistleblowing, And Insider Trading Risks, Geeyoung Min

Seattle University Law Review

The Essay examines how recent developments in insider trading regulations and whistleblower reward programs can lead to unintended and counterproductive results of discouraging employees from using internal reporting channels within corporate compliance programs. While the presence of a robust and well-functioning corporate compliance program is a critical factor both in mitigating the level of public enforcement actions against companies and in protecting corporate managers from liability in private litigation, these programs often provide little incentive for employees to report potential misconduct internally.

Corporate compliance programs are designed to promote the upward information flow within the company, which is essential for …

How The Antidiscrimination Law Of Commercial Transactions Really Works, Helen Norton

Seattle University Law Review

A variety of businesses now cite 303 Creative when seeking First Amendment protection for their refusal to serve certain customers based on those customers’ protected class status. How this litigation will play out remains to be seen. But future courts need not, and should not, repeat the 303 Creative Court’s misunderstanding of how the antidiscrimination law of commercial transactions actually works.

Part I of this Essay explains the Court’s longstanding understanding of the antidiscrimination law of commercial transactions, and then describes the Court’s failure to engage with this precedent in 303 Creative. Part II then identifies the 303 Creative decision’s …

The Right To 'Trip:' Navigating Psilocybin-Assisted Psychotherapy Under The Right To Try Pathway, Caitlyn S. Greenspun

Loyola University Chicago Law Journal

This Comment explores the legal, ethical, and regulatory challenges surrounding the use of psilocybin-assisted psychotherapy for terminally ill patients under the federal Right to Try (RTT) Act. While psychedelics like psilocybin are demonstrating extraordinary therapeutic potential, particularly in easing end-of-life psychological distress, patients remain barred from access due to the Controlled Substances Act (CSA) and the Drug Enforcement Administration's (DEA) narrow interpretation of its authority. Through a comprehensive analysis of legislative history, regulatory frameworks, and administrative law principles, this Comment argues that the DEA's position not only misinterprets the statutory relationship between the RTT Act and the CSA, but also …

Remediating Public Health Crises Through Litigation: Lessons From Oklahoma In The Tobacco And Opioid Epidemic Litigations, Caroline Beckworth

Oklahoma Law Review

No abstract provided.

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

High Hopes, Clouded Realities: Minnesota's Cannabis Legalization And The Hidden Health Risks, Allison Crescimanno

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Green Dividends: A Case Study In Green Dividends And The Conditions For Private Ordering Solutions, Anne M. Tucker

Seattle University Law Review

This Essay introduces a novel private ordering solution to facilitate corporate investments in pro-social and environmental initiatives: Green dividends. Green dividends are an optional increase in shareholder dividends that are returned to the company to be reinvested in environmental initiatives or kept by a shareholder.

Green dividends pose an alternative to the current gridlocked debate that corporations can’t, won’t, shouldn’t, and shouldn’t even try to act in pro-social or environmental ways. Turning the common refrains on their head converts each narrative into an element for a successful private ordering solution: authority, accountability, shareholder buy-in, and government- backed enforcement. With Green …

Does Climate Disclosure Work To Reduce Greenhouse Gas Emissions? Emerging Evidence Suggests Cautious Optimism, Cynthia A. Williams

Seattle University Law Review

Significant regulatory resources have been spent developing global, voluntary climate and sustainability disclosure standards, such as the TCFD, TNRD, and ISSB’s Sustainability and Climate Disclosure standards, or domestically required disclosures, such as in the EU and in the U.S. Thus, it is important to evaluate whether this disclosure, particularly voluntary, qualitative disclosure, will have the power to shift the allocation of capital, will have a significant effect on the management of climate risk within firms, and ultimately will reduce climate change risk and biodiversity loss.

In this Article, several interrelated questions will be discussed. First, what does the empirical evidence …

The Alchemy Of Sin: Turning Tobacco Sin Tax Revenue Into Public Health Gold, Audre L. Sylvester

Lewis & Clark Law Review

This Note proposes a reallocation of tobacco excise tax revenue towards health and education programs related to tobacco cessation. Revenue collected from federal excise taxes on tobacco products is currently used to support the daily and long-term operations of the United States while tobacco cessation and education programs remain underfunded and underutilized. This Note examines the history of these “sin taxes,” their modern-day function, and the issues that arise from the current allocation of sin tax revenue to support the argument that revenue from federal sin taxes on tobacco products should be exclusively allocated to a dedicated federal trust fund …

An Integrated Approach Can Improve China’S Food Additives Security, Qian Li, Jingru Hou, Jennifer S. Stevenson, Cihui Liu

Faculty Articles

In China, the development of food additives remains a critical challenge in food additives security research. We discuss an integrated approach that can improve China’s food additives security, including technical management, standards implementation, and punitive damages regime. Through this integration, we identify that technical management, standards implementation, and punitive damages regime are each complementary to each other. Technical management helps reduce the inherent risks of food additives beforehand. Standards implementation helps prevent and control risks of food additives use halfway. Punitive damages regime helps relieve secondary risks arising from food additives use. Crucially, this integration enhances the suitability of food …

The Grass Is Not Always Greener: How The Legalization Of Recreational Cannabis Across The United States Is At Odds With Incarceration And Continued Punishment, Marc Sendra

Washington and Lee Journal of Civil Rights and Social Justice

Whether you call it Mary Jane, skunky funky, green, ganja, reefer, or just plain-old cannabis, this special green plant doused in purple and orange accents has become a popular topic of discussion within the legal community and American culture. Cannabis has been held in “high” regard for its scientific advances in the medical industry, alongside its recreational usage, enjoyed by laughs and giggles, munchies, and plenty of water, leading to a wave of medical and recreational legalization.

Incentives for legalization come at the onset of promising medical research, economic growth motives, and social justice, reflecting upon a comprehensive approach that …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

Jbs’S Initial Public Offering: Threats To Environmental And Human Rights, Kayla Thompson

Indiana Journal of Law and Social Equality

This paper centers around the decision to be made regarding JBS, the world’s largest meat company, wanting to list shares on the New York Stock Exchange (NYSE), and the environmental and social impacts that could result from the Security and Exchange Commission’s (SEC) approval. JBS has been at the center of various controversies over the last several years, including sourcing cattle from ranches acquired through illegal deforestation, engaging in greenwashing practices, incorrectly reporting greenhouse gas emissions, and engaging in human rights abuses. Many environmental groups have filed complaints with the SEC concerning JBS’s bid to list on the NYSE. The …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

The Future Of Ai Regulation In Drug Development: A Comparative Analysis, Gabriela Lenarczyk, Timo Minssen, W. Nicholson Price Ii, Arti Rai

Articles

As artificial intelligence (AI) transforms drug development, regulatory frameworks are evolving to oversee its implementation, particularly at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This paper makes three contributions to understanding emerging regulatory approaches. First, we offer a comparative analysis of how these agencies have responded to AI-driven advances, incorporating new US executive orders and the European Union (EU)’s AI Act. Second, we propose a novel analytical framework to understand regulatory divergence: the FDA’s flexible, dialog-driven model contrasts with the EMA’s structured, risk-tiered approach, reflecting broader institutional and political-economic differences. While the former encourages …

A Market-Based Approach To Effective Slaughterhouse Line Speed Regulation, Kailey Mcneal

Animal Law Review

The nature of animal agriculture in the United States is heavily industrialized and profit-centered. Industrial animal agriculture maximizes profits and production by employing low-wage workers to do significant loads of labor. Slaughterhouses’ implementation of faster line speeds reflects this tactic. As the industry continues to increase line speeds to boost profits, workers, animals, and the environment continue to face augmented risks to their health and safety. Nonetheless, slaughterhouse line speeds at the federal level remain largely un- and under-regulated. The current federal regulatory scheme is unduly influenced by industry interests, prioritizes profit over safety, and lacks effective enforcement mechanisms. Through …

The 340b Drug Pricing Program: Administration, Litigation, And Reform, Ryan P. Knox, Ameet Sarpatwari

Oklahoma Law Review

No abstract provided.