Food and Drug Law Commons^™

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 …

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

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 …

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 …

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 …

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, …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

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 …

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 …

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. …

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 …

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 …

Amgen Enablement And Its Undue Burden On An Overburdened Biomedical Industry, Carter Chippi

Journal of Law and Health

This paper examines the Supreme Court decision in Amgen Inc. v. Sanofi and its profound impact on the patentability of biotechnology inventions, particularly biologic drugs. By virtually eliminating the possibility of claiming genera patents, the decision exacerbates existing challenges within the biologic sector, including high development costs and rigorous regulatory hurdles. The analysis sets forth the enablement requirement’s precedent, emphasizing historical case law and the unforeseen implications of setting a stringent standard for biotechnology patents. This paper further critiques suggested industry compromises, deeming them insufficient to address the ramifications of Amgen, and proposes legislative intervention. Options include granting biologics …

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

University of Miami Law Review

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. …

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

All Faculty Scholarship

The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …

A Masque Of Red Death: The Fda's "Individual Risk-Based" Blood Donor Final Guidance Report Is A Poorly Constructed Facade Covering Continued Animus Toward Queer Men, Gerald Dryden

Cardozo Journal of Equal Rights & Social Justice

The note argues that the FDA's blood donation guidelines discriminatorily target queer men, perpetuating stigma and failing to align with contemporary science. These guidelines, while aiming to protect blood recipients, are unconstitutional and not tailored to avoid discrimination, thus requiring revision to reflect current scientific understanding and eliminate bias.

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Brief Of 12 Narcolepsy Patients, Public Interest Organizations, Medical Professionals, And Professors Of Law And Medicine As Amici Curiae In Support Of Defendants-Appellees (Amended To Add Further Signatories), Charles Duan

Amicus Briefs & Court Filings

A prior copy of this brief was filed, inadvertently omitting one signatory. This brief has accordingly been amended to correct the error, reflected in the Certificate as to parties and the Appendix.

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Re-Imagining Tomorrow: A Technology, Innovation Law, And Ethics Symposium On Addictive Technology And Children, Margaret Chon

Seattle University Law Review

In this Foreword, Professor Margaret Chon introduces Seattle University's Technology, Innovation Law, and Ethics (TILE) program, the 2024 TILE Symposium, and Dr. Gaia Bernstein’s Unwired: Gaining Control Over Addictive Technologies.

Keynote Address: The Movement To Protect Kids From Addictive Technologies, Gaia Bernstein

Seattle University Law Review

In this keynote address, I describe my personal journey starting with a school outreach program I created in 2017 to address technology overuse among kids. While I initially advocated for self-help methods, I grew to recognize that the tech industry bore responsibility. This realization led me to write Unwired: Gaining Control over Addictive Technologies, which focused on collective action to pressure the tech industry to redesign its addictive products.

I then describe the movement to control addictive technologies and protect kids, which has gained momentum since the end of the pandemic. This movement combines grassroots parent activism with legal-political action. …