Food and Drug Law Commons^™

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

The Indian Pharmacopoeia: Enabling Open Access And Crafting A ‘Sovereign Function Exception’ For Government Works, Aparajita Lath

National Law School Journal

Standardisation of drugs and access to such standards are important levers for effective drug regulation. The Indian Pharmacopoeia, the official book of standards for drugs in the country prescribed by the Union government under the Drugs and Cosmetics Act 1940, are legally binding and enforceable. Not only do the standards have the force of law but are also government-created. The Indian Pharmacopoeia Commission (IPC), a division of the Union Department of Health and Family Welfare, has a legal monopoly over creating and publishing this compendium. Though it is legally binding, the Indian Pharmacopoeia is neither in the public domain …

Beneath The Label - Evaluating The Fda Approval Of Copenhagen Classic Snuff As A Modified Risk Tobacco Product, Yisroel Grabie, Tafani Chowdhury, Sudeep Acharya

HCA Healthcare Journal of Medicine

In this review, we critically evaluate the Food and Drug Administration's modified risk tobacco product (MRTP) status granted to a smokeless tobacco product (March 2023), Copenhagen Classic Snuff (CCS). This new status necessitates an assessment of the product CCS use and its public health impacts. We assess the impact of CCS as it relates to the reduction of lung cancer risk and the potential increased risk for nasopharyngeal cancer, chronic rhinitis, nicotine dependence, and other health hazards. Concerns persist regarding nicotine's harm and public misperception due to risk reclassification, and caution should be maintained to discourage novel snuff users. Advocating …

Purdue’S Side Effects: Using Due Process To Realign Mass Tort Bankruptcies, William A. Organek

BYU Law Review

In Harrington v. Purdue Pharma, the United States Supreme Court held that victims of the opioid crisis could not be forced to release their independent claims against the Sacklers, who owned and controlled Purdue, without the victims’ consent. Such releases had become a controversial mainstay of mass tort bankruptcy filings. Yet Purdue was decided on narrow, textualist grounds, leaving as a side effect many seemingly disparate and difficult questions unanswered. This Article argues that Purdue and its open issues should be analyzed through a broader due process lens in tension with some aspects of current bankruptcy practice but consistent with …

The Opioid Crisis: How The United States And Countries Abroad Are Making Strides, Maura Mcginnity

DePaul Journal of Health Care Law

The opioid epidemic has been an ongoing problem in the United States since the 1980s. The United States has had a very negative attitude towards individuals suffering from addiction. This attitude is clearly shown through the United States’ handling of the opioid crisis. Hundreds of thousands of individuals have died due to opioids. In the forty years since this epidemic became prevalent, the United States has still failed to implement a country-wide solution to combat the crisis. Certain states, like New York and Illinois, have made strides toward helping individuals suffering from opioid use disorder, but nationally, the country is …

محددات الحقوق البيئية بالمغرب وواقع ممارستها, Mansour Ennaama

Journal of the Association of Arab Universities for Research in Higher Education مجلة اتحاد الجامعات العربية للبحوث في التعليم العالي

استعرض المقال الإطار النظري والقانوني للتشريع البيئي في المغرب، بالإضافة إلى تحليل التحديات التي تعترض تطبيقه وآفاق تحسينه. وتبرز الدراسة وجود فجوة بين النصوص القانونية البيئية وواقع الممارسة في المغرب مما يقلل من فعالية هذه التشريعات في حماية البيئة. كما تعيق التحديات المؤسسية والإدارية والمالية التطبيق الفعال لهذه التشريعات، إذ تواجه المؤسسات المعنية بحماية البيئة تحديات كبيرة تتعلق بنقص التنسيق والتداخل في الصلاحيات، مما يؤدي إلى ضعف في التنفيذ والمراقبة، حيث تعاني الجهات المسؤولة عن حماية البيئة من نقص في التمويل، مما يؤثر سلباً على قدرتها على تنفيذ البرامج البيئية وصيانة البنية التحتية البيئية. كما أن هناك حاجة ملحة لتعزيز …

Consumer (Mis)Understanding Of Dietary Supplement Labels, Jason Iuliano, Madison Kilbride

Texas A&M Law Review

“Helps lower cholesterol levels” and “helps promote healthy cholesterol levels.” Both of these claims are found on pharmacy products. And to ordinary consumers, the message is the same: take this pill and improve your cholesterol. Nevertheless, Congress has placed these statements in two very different regulatory categories. The former is classified as a disease claim, and the latter as a structure/function claim. Whereas products making disease claims require years of clinical trials and analyses before regulatory approval can be granted, products making structure/function claims do not even require governmental review before they can be sold to consumers. This bifurcated regulatory …

The National Bioengineered Foods Disclosure Standard & Absence Claims: The Cost Of The Butterfly, Cahlen Cheatham

Texas A&M Law Review

The National Bioengineered Foods Disclosure Standard (“NBFDS”) is a step in the right direction in providing a uniform labeling standard for genetically engineered organisms (“GEOs”) that meet the statutory definition of “bioengineered.” Importantly, the law provides a consensus that GEOs are safe and that labeling standards should be uniform across the United States. However, the law largely fails to settle the broader debate and the issues associated with GEO labeling. Namely, the NBFDS’s use of the term “bioengineered” causes additional confusion, and terms like “genetic modification” and “genetic engineering” remain ambiguous. Furthermore, the Final Rule promulgated by the U.S. Department …

When Poison Is On The Menu: Proposing The Adoption Of Ireland’S Stricter Allergen Regulations In America’S Food Establishments, Katherine Fitzgerald

Journal of Law and Policy

In the modern era, a growing number of children and adults have been diagnosed with deadly food allergies. For the approximately 33 million Americans who have at least one food allergy, restaurants, aside from the home, are the most likely place where deadly reactions could occur. In order to adapt to this expanding and sensitive population, the federal government should pass legislation that protects these citizens from suffering a preventable, untimely death. Luckily, the legislators of the European Union, and specifically Ireland, have already put food labeling legislation in place that serves to protect those with food allergies. This Irish …

The Ethics Of Advertising Unhealthy Food To Children: A Study On Potential Advertising Policy Restrictions And Their Effects On Children Of Disadvantaged Minority Groups, Riley M. O'Neal

Honors Theses

According to the Centers for Diseases Control and Prevention, one in five children in America have obesity. Black and Hispanic children experience obesity at higher rates than children of other racial groups. With obesity rates increasing, what should be done to stop this increase? One partial solution is to restrict the advertisements of foods high in sugar fat, and/or refined grains directed towards children. Advertisements may be restricted in their mode (i.e., the media through which they are viewed) or their content (i.e., the substance of the advertisement or product packaging). While these restrictions on advertising may help lower overall …

No Lawyer, No Jail: A Critical Case Study Of Pragmatism And The Flaws Of “Purposeful” Decision Making In Argersinger V. Hamlin, Alisa Smith, Sarah K. Stice

Seattle University Law Review

By releasing conference notes and internal communications, Supreme Court Justices provide insight into the otherwise private decisionmaking process, shedding light on how case outcomes and legal reasoning are framed and negotiated. The watershed case of Argersinger v. Hamlin (1972) extended the constitutional right to counsel to some, but not all, misdemeanor defendants. The case was argued twice, and the Court relied on empirical and authoritative sources to answer complex and practical questions about requiring counsel. This case study employs critical discourse analysis to uncover what influenced the Justices’ decisions and how they framed, shaped, and constructed social realities to foreground …

Modern Day Colonialism Through HawaiʻI’S Quiet Title And Partition Laws, Cheyann Fujii

Seattle University Law Review

This Note will attempt to highlight important aspects of Hawaiian history to provide readers with a clear picture on how Native Hawaiians are still impacted by colonialism, specifically when plaintiffs bring a quiet title or partition action against Native Hawaiian owners of kuleana lands. Before colonization, the concept of private land ownership did not exist in Hawai‘i, and Native Hawaiians adopted a feudal system by dividing land into geographical areas. Missionaries and businessmen brought Western ideas to Hawai‘i and influenced legislation such as the Great Māhele and the Kuleana Land Act of 1850, which solidified the concept of private property. …

Data Advantage And Merger Review: Can Entrenchment Theory Reform Antitrust Enforcement?, Shin-Ru Cheng

Seattle University Law Review

A merger involving giant digital companies is likely to dampen competition, as it allows those companies to combine and control data access, enabling them to entrench their dominant positions in relevant markets and extend those positions into related markets. While competition law in many jurisdictions aims to prohibit mergers that may substantially lessen competition or create a monopoly, arguably the review of digital mergers is failing because antitrust agencies lack an effective approach to identify data-generated anticompetitive harms. This Article demonstrates that entrenchment theory, recently reintroduced in the 2023 U.S. Merger Guidelines, would help reform the process of antitrust enforcement. …

Defining Deference: Impacts Of Abandoning Chevron On Emerging Technology Governance And Administrative Law, R. Aubrey Davis Iii

Seattle University Law Review

Emerging technologies, particularly Artificial Intelligence (AI), often lead to unforeseen legal outcomes. Notable abuses in areas such as facial recognition, employment bias, and housing discrimination are well known. However, legislative responses to these issues either have been largely reactive or there has been no legislative response at all. In lieu of legislation, agencies have sought to fill the gap. For example, the Federal Communications Commission (FCC) recently proposed a rule mandating voter notification for all AI-generated political phone calls citing the Telephone Consumer Protection Act (TCPA) of 1991 as authority. However, the TCPA was originally passed to curtail telemarketing, not …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Caution: Potholes In E-Scooter Data Collection, Dakota Rakestraw

Seattle University Law Review

Lime scooters keep ending up in major waterways in Washington state metro areas, a testament to the ubiquity of e-scooters in the metropolitan landscape. How they get there is unclear. Why they get there is even murkier. Perhaps the answer lies in the implications of modern geolocation data collection through e-scooters and gaps in current data collection regulation curbing individual liberties.

Since September 2020, electric scooters have run Seattle’s streets and have dramatically overtaken ridesharing bike trips. For example, from September 2020 to September 2021, there were about 1.4 million scooter and bike trips with September 2021 seeing 300,000 scooter …

Machinists Preemption In The New Administrative Law, Andrew J. Ziaja

Seattle University Law Review

This Article assesses Machinists preemption—a labor-specific form of implied field preemption—while freshly considering implications both for and of new developments in administrative law. The radical transformation of administrative law in the Supreme Court, particularly its newfound emphasis on clear-statement rules, provides opportunities to reconsider the Machinists rationale. Aligning with scholars who have called to question the doctrine’s “ossifying” influence on labor and employment policy, it argues that the modern-day version of Machinists preemption clashes with the Supreme Court’s newly constrained view of delegated power and its differing conceptions of the major questions doctrine.

On the other hand, Machinists preemption might …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

The Race To Erase: Destruction Of Government Documents Undermines Freedom-Of-Information Laws, Frank D. Lomonte

Seattle University Law Review

In August 2019, reporters with Chattanooga’s daily newspaper, the Times Free Press, filed what seemed to be a routine request for access to emails and other public records held by their local county government. The seemingly unremarkable request set the newspaper’s staff on a months-long journey of unpleasant surprises. The first was a demand to pay the county $717 in advance before being allowed to inspect the documents. The second was that—during prolonged haggling over the fee assessment— the county attorney’s office simply destroyed almost all of the disputed records. Third, and most glaringly, the journalists discovered that Tennessee law …

When You’Re Arrested For A Felony In Seattle, You’Ll Meet Me., Austin Field

Seattle University Law Review

In this Essay, Austin Field, a practicing public defender, uses a first-person perspective to describe what it is like to meet a criminal defendant for the first time. He explains the process from start to finish, detailing everything from the way he introduces himself to how bail works.

"I’ll ask you for your name. Most of the time, you tell me. I check your name against my list. On any given day I’m supposed to interview between five and fifteen people. I have a lot of questions for you. We only have about ten minutes."

The Public Square In A Private-Property Obsessed Country: What New York City’S Pops Regulations Get Right And Why Other Cities Should (Mostly) Copy Them, Carson Mcgregor

Seattle University Law Review

When New York City (NYC) was first becoming the metropolitan monolith it is today, it had a problem: the city streets were chock full of skyscrapers, and sunlight, air, and usable open space were at a premium. In response, the City promulgated its first Privately Owned Public Spaces (POPS) regulations, which allowed developers to build skyward in exchange for providing public space on the street level. Unfortunately, in July of 2023, the New York Times (NYT) discovered that New Yorkers received only a fraction of what they were promised. Building owners received billions of dollars’ worth of added floor space, …

Intellectual Property Or Modern Folklore? The Problem With Open Gaming Licenses In Tabletop Gaming, Rosie Midget

Seattle University Law Review

This Note addresses how courts and legislatures should address “Open Gaming Licenses” commonly attached to tabletop roleplaying games (TTRPGs), which game publishers use to promote a false image of accessibility—misleading consumers and building goodwill from the misunderstanding. Part I discusses what TTRPGs are, including the defining features of the hobby and culture surrounding it, as well as the unique interplay between publishers and players. Part II explores the question of which elements in a TTRPG system may be subject to copyright protection. Part III examines these elements in practice using Wizards of the Coast’s Dungeons and Dragons TTRPG as a …

Food Inspections: Searching For Contamination (And Solutions) In A Haystack, Abigail Schneider, Benjamin Kelly, Michael S. Sinha

Journal of Food Law & Policy

Food recalls in the United States often reveal serious mismanagement and structural issues in both government and private industry, yet they have become unremarkable and even expected in our modern world. The procedure employed by the U.S. Food and Drug Administration (“FDA”) to monitor food manufacturing is a valuable process which protects every person who lives in the United States. However, the effects of monitoring as a tool for oversight is limited if there is no efficient response when problems arise. FDA inspects pharmaceutical, cosmetic, and food manufacturing facilities both domestically and abroad. When those inspections reveal the presence of …

A Critical Look At A New Iowa Law Allowing Minors To Serve Alcohol, Tom Hubbard

Journal of Food Law & Policy

In the never-ending tug-of-war of today’s charged political climate, the child labor discussion has been caught right in the crosshairs. While the Biden administration promised to crack down on child labor law violations (with varying degrees of success), more states continue making it easier for children to work. Because of this, the opportunity to exploit a progressively younger workforce will continue to grow. Amidst this backdrop, this article focuses particularly on a new Iowa law that expands child labor across the state. While there are many states seeking to roll back child labor law protections, Iowa’s new law seems to …

Food For Thought: Funding The National School Lunch Program While Simultaneously Providing Tax Incentives To Farmers, Carter Wade

Journal of Food Law & Policy

This note will focus primarily on the National School Lunch Program (“NSLP”) and propose a solution aimed at reducing the costs of implementing it. It begins with a historical background into how the NSLP came to be and the various adaptations and programs that came out of it. This note then covers current programs and organizations that have arisen to support nutritional education and provide healthy meals to school children. It then compares several contribution-based tax incentive programs, which serve as inspiration for the final proposed tax incentive program for farmers in the closing section. Through the years, rising costs …

Negotiating Food Security, Maria Cudowska

Journal of Food Law & Policy

In the United States and worldwide, nutrition and food emerge as both high-profile public policy targets and as fundamental aspects of the right to self-determination. This Article examines how national security impacts food security in the United States. It explores conflicts and synergies between municipal, state, and federal law developments related to the right to food and investigates recent developments in how those commitments have been negotiated. The challenge and nebulous justiciability of the right to food can be in part attributed to existing global and national systems, which include supply chains, welfare programs, and foreign investment in the U.S. …

Ai V. Mqd: Navigating New Regulatory Challenges In The Life Sciences, Hayden W. Smith

William & Mary Law Review

This Note proceeds in four parts. Part I introduces AI as an emerging technology in the life sciences, the FDA’s inherited regulatory regime, and challenges under the MQD [major questions doctrine]. Part II explores how hypervigilant regulation obstructs innovation and exposes agencies to judicial challenges. Part III offers solutions to safely and effectively navigate the major questions landscape within a framework that fosters AI innovation. This Note proposes a solution that conceptually balances growth in the life sciences with the statutory elements required for a safe and effective regulatory scheme.

This abstract has been taken from the author's introduction.

Abortion Travel Restrictions Under The Dormant Commerce Clause After National Pork Producers Council V. Ross, Katherine Bartley

Fordham Law Review

Since Dobbs v. Jackson Women’s Health Organization, twelve states have banned abortion entirely, and seven states have banned abortion earlier in pregnancy than the standard set in Roe v. Wade. As abortion access dwindles, patients increasingly cross state lines to seek reproductive healthcare. In response, antiabortion state officials and lawmakers have made efforts to restrict interstate travel for abortion care.

This Note examines abortion travel restrictions under the “Dormant” Commerce Clause doctrine, which limits state laws that burden interstate commerce. In 2023, the U.S. Supreme Court affirmed but narrowed the judge-made doctrine in National Pork Producers Council v. …

When Prenatal Care Becomes A Crime, Casey Hunter

Fordham Law Review

For decades, pregnant women have increasingly faced criminalization for their actions and conduct during pregnancy, with Alabama emerging as a focal point due to its aggressive use of section 26-15-3.2: Chemical Endangerment of Exposing a Child to an Environment in Which Controlled Substances Are Produced or Distributed. Originally intended to protect children from the dangers of methamphetamine labs, this law has been reinterpreted to prosecute pregnant women who test positive for controlled substances. Central to these prosecutions are positive drug tests obtained from prenatal health records, causing many women to avoid prenatal care for fear of legal consequences.

This Note …

If You Can’T Beat Hemp, Join Hemp: A Policy Argument For A Federal Regulatory Framework Encompassing Intoxicating Hemp Derivatives And Marijuana And Why Re-Scheduling Marijuana Isn’T The Answer, Frances Alaina Rodriguez

University of Miami Business Law Review

The Agriculture Improvement Act of 2018 (2018 Farm Bill) legalized industrial hemp and its downstream uses by removing hemp from the definition of marijuana under the Controlled Substances Act (CSA). Its enactment led to the explosion of a multi-billion dollar intoxicating hemp derivatives (IHD) market. This boom, combined with growing state–level marijuana legalization, presents a unique opportunity for comprehensive federal cannabis reform.

This Note argues that the traditional pathways for marijuana legalization—rescheduling through the Controlled Substances Act or state-by-state legislation—are inadequate given the emergence of a federally legal but largely unregulated IHD industry. Instead, this Note proposes a unified federal …