Digital Commons Network^™

Enough Excuses On Drug Importation: A New Transnational Paradigm For Fda Regulation And Lower Us Drug Prices, Gabriel Levitt

Brooklyn Journal of International Law

The US Food and Drug Administration (FDA), which enforces drug safety laws, asserts that under most circumstances the importation of prescription drugs is illegal. Yet because of high drug prices in the United States, over the past couple of decades, tens of millions of Americans have imported prescription drugs for personal use. For many, this was their only way to afford them. A unique array of federal laws, regulations, and policies, including the de facto decriminalization of the practice of personal drug importation, have in effect permitted personal drug importation. The same exceptions, however, are not available for commercial drug …

Reducing Food Scarcity: The Benefits Of Urban Farming, S.A. Claudell, Emilio Mejia

Journal of Nonprofit Innovation

Urban farming can enhance the lives of communities and help reduce food scarcity. This paper presents a conceptual prototype of an efficient urban farming community that can be scaled for a single apartment building or an entire community across all global geoeconomics regions, including densely populated cities and rural, developing towns and communities. When deployed in coordination with smart crop choices, local farm support, and efficient transportation then the result isn’t just sustainability, but also increasing fresh produce accessibility, optimizing nutritional value, eliminating the use of ‘forever chemicals’, reducing transportation costs, and fostering global environmental benefits.

Imagine Doris, who is …

Journal Of Food Law & Policy - Spring 2023, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Constitutional Confidentiality, Natalie Ram, Jorge L. Contreras, Laura M. Beskow, Leslie E. Wolf

Washington and Lee Law Review

Federal Certificates of Confidentiality (“Certificates”) protect sensitive information about human research subjects from disclosure and use in judicial, administrative, and legislative proceedings at both the state and federal levels. When they were first authorized by Congress in the 1970s, Certificates covered sensitive information collected in research about drug addiction use. Today, however, they extend to virtually all personal information gathered by biomedical research studies. The broad reach of Certificates, coupled with their power to override state subpoenas and warrants issued in the context of law enforcement, abortion regulation, and other police powers typically under state control, beg the question whether …

Deserving Life: How Judicial Application Of Medical Amnesty Laws Perpetuates Substance Use Stigma, Scott Koven

Washington and Lee Law Review

To combat the continued devastation wrought by the opioid crisis in the United States, forty-eight states have passed medical amnesty (or “Good Samaritan”) laws. These laws provide varying forms of protection from criminal punishment for certain individuals if medical assistance is sought at the scene of an overdose. Thus far, the nascent scholarly conversation on medical amnesty has focused on the types of statutory protections available and the effectiveness of these statutes. To summarize, although medical amnesty laws have helped combat drug overdose, the statutes are replete with arbitrary limitations that cabin their life-saving potential.

This Note extends the dialogue …

The War On Drugs Or The War On Drug Users? Supervised Consumption Site In The United States As A Harm Reduction Strategy To Fight The Opioid Epidemic, Mary Crevello

Marquette Benefits and Social Welfare Law Review

Exploring the U.S. response to the opioid crisis, this study critically examines supervised consumption sites (SCSs) as a pragmatic approach. The historical framework of the "war on drugs" is scrutinized, highlighting its limitations and the necessity to shift from punitive measures towards more effective harm reduction strategies. Due to escalating opioid-related fatalities and inadequate harm reduction methods, the potential of SCSs is evaluated for short-term intervention. The Department of Justice's (DOJ) role in facilitating temporary measures to enable SCS operations is assessed, underscoring the urgency for a stable legislative framework to comprehensively address the crisis.

This research advocates for embracing …

Prioritizing Regional Wildlife Conservation By Rejuvenating The Western Hemisphere Convention On Nature Protection, Shade Streeter, David Hunter, William Snape Iii

Sustainable Development Law & Policy

Last year, parties to the Convention on Biological Diversity (“CBD”), representing nearly every nation, signed a milestone agreement committing, among other things, to conserve thirty percent of Earth’s lands and oceans to stave off the rapid diminution of the planet’s biodiversity. Implementing these global commitments will require not only strong domestic measures, but also enhanced regional cooperation targeting the conservation of the region’s migratory wildlife and shared resources. Although the United States is the sole major holdout from the CBD, it can still reassert its leadership in regional wildlife conservation by rejuvenating the Convention on Nature Protection and Wildlife Preservation …

Unclos, Undrip & Tartupaluk: The Grim Tale Of Hans Isle And Graense, Christopher Mark Macneill

Sustainable Development Law & Policy

“Inuit have lived in the Arctic from time immemorial.” The Arctic, in the face of climate change, has become a hot spot for exploration, resource extraction, and increased shipping and scientific activity. “[The] Inuit . . . have had a common and shared use of the sea area and the adjacent coasts” among their own communities, and contemporaneously with the world. This vast circumpolar Inuit Arctic region includes land, sea, and ice stretching from eastern Russia (Chukotka region) across the Berring Strait, to Alaska, the Canadian Arctic, and Greenland, representing an Inuit homeland known as Nunaat. Hans Isle, a small …

The Great Climate Migration: A Critique Of Global Legal Standards Of Climate-Change Caused Harm, Mariah Stephens

Sustainable Development Law & Policy

Approximately 2.4 billion people, or about forty percent of the global population, live within sixty miles (one hundred kilometers) of a coastline. The United Nations (“U.N.”) determined that “a sea level rise of half a meter could displace 1.2 million people from low-lying islands in the Caribbean Sea and the Indian and Pacific Oceans, with that number almost doubling if the sea level rises by two metres.” The U.N. also reports that “sudden weather-related hazards” have internally displaced an annual average of 21.5 million people since 2008. Within the next few decades, this number is likely to continue to increase. …

The Future Of Crypto-Asset Mining: The Inflation Reduction Act And The Need For Uniform Federal Regulation, Liz Guinan

Sustainable Development Law & Policy

Crypto-asset mining is energy-intensive and environmentally harmful, presenting challenges and opportunities for federal, state and local governments, regulators, and society as a whole. As of December 2021, the United States has thirty-eight percent of the global crypto network hash rate, which is the total amount of computational power used to mine and process crypto transactions, making the United States the world’s largest crypto-asset mining industry. The total electricity consumption of crypto-asset mining in the United States is estimated to be around 121.36 terawatt-hours (“TWh”) per year, which is equivalent to the electricity consumption of approximately 10.9 million households in the …

Editors' Note, Rachel Keylon, Meghen Sullivan

Sustainable Development Law & Policy

For more than two decades, the Sustainable Development Law and Policy Brief (“SDLP”) has published works analyzing emerging legal and policy issues within the fields of environmental, energy, sustainable development, and natural resources law. SDLP has also prioritized making space for law students in the conversation. We are honored to continue this tradition in Volume XXIII.

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

Deterrence Defeats Doping: How Arbitration Can Resolve Major League Baseball's Performance-Enhancing Drug Problem, Brice Barnes

Pepperdine Dispute Resolution Law Journal

This article analyzes MLB’s PED policy and proposes amending the policy by arbitrating the agreement to create one that further deters players from using PEDs. The remainder of this article is divided into five parts: Part II discusses the significance of the PED issue and why resolution is necessary; Part III discusses the history of PED use in baseball and the efforts by the League to address it; Part IV proposes the solution of arbitration and explains how the process might work; Part V addresses potential objections to that solution; and finally, Part VI concludes.

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

Narkoterorisme Sebagai Ancaman Bonus Demografi : Perspektif Sekuritisasi Ketahanan Nasional, Ade Aryanti Fahriani, Bagus Ridho Akustyo, Saur Martha Agustina

Jurnal Kajian Stratejik Ketahanan Nasional

The proliferation of narcotics issues in Indonesia has grown increasingly complex, impacting social security and national resilience. The substantial profit from the narcotics trade presents opportunities as a financing avenue for acts and terrorist groups. The integration of narcotics trade with illicit activities creates the potential for connection and convergence between drug trafficking criminal organizations and terrorist organizations, as known as narcoterrorism. Despite the forthcoming demographic bonus in Indonesia, the younger generation is overshadowed by radical ideologies, and the abuse and illicit trafficking of narcotics, which could jeopardize the quality of the demographic bonus. Therefore, there is a perceived need …

America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa

Brooklyn Law Review

A resurgence in federally approved psychedelic research has spawned the Psychedelic Renaissance, and with each study it becomes increasingly clear that psychedelics have the potential to revolutionize mental health treatment. However, if Congress fails to reform the industry’s patent procedures, threats to innovation in the budding field of psychedelic medicine will manifest in their ugliest form. Psychedelics are a class of hallucinogenic drugs that primarily trigger substantially altered states of consciousness, including psychological, visual, and auditory changes. Medical research on psychedelics has produced staggering results that indicate psychedelics have the potential to be significantly more effective in treating mental illnesses …

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia

DePaul Journal of Health Care Law

Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …

Smoky Wine Variety: How Federal Crop Insurance Hinders Grape Growers Affected By Wildfire Smoke, London T. Weston

Texas A&M Journal of Property Law

This Note comparatively argues that while both Californian and Australian grape growers lose millions of dollars from crops damaged by wildfire smoke taint, the two countries support and insure their farmers very differently. When both areas of the world are susceptible to the damaging effects of climate change, why are the producers not susceptible to the same type of crop relief? After a careful analysis of the types of insurance the United States and Australian governments offer grape growers, the inequity stands between the systematic approach to insuring citizens against wildfires. In America, federal crop insurance only protects crops touched …

More Than They Bargained For: Ab 257 And An Alternative Approach To Labor Law In California's Fast-Food Industry, Alex Reid

University of Cincinnati Law Review

No abstract provided.

The Intemperate Regulation Of Alcohol, Bradley R. Greenman

The Journal of Business, Entrepreneurship & the Law

This comment will not argue the legitimacy of the policy aims of the Twenty-First Amendment, rather, it will argue the current regulatory and legal apparatuses which govern the alcohol industry are no longer moored to the original moral and philosophical values the Temperance Movement, or those morals and values which carried over into the Twenty-First Amendment. To aid in understanding the current state of alcohol regulation, Section II will outline the history of liquor regulation in the United States from the Founding to the present. Second, Section II will examine the history of legislation and regulation of alcohol that led …

Vertical Farming: A Bottom-Up Approach, Michael Martinez

Seattle Journal of Technology, Environmental & Innovation Law

The twenty-first century will require innovative solutions to address the effects of climate change. Vertical farming is one solution that could help conserve a significant amount of freshwater and reduce the agricultural industry’ s overuse of pesticides and intensive tilling practices, which contributes to soil erosion and pesticide runoff. There has been significant investment in vertical farming in every region of the United States; however, the cost to produce foods with vertical farming remains more costly than traditional farming, which is in large part due to the substantial amount of electricity needed to power all the technology required to grow …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Which Came First: The Chicken Or The Chick'n? An Fda Amendment Proposal To Reconcile Conflicting Interests In Plant-Based Meat Labeling, Katie Justison

William & Mary Law Review

“The issue is, what is chicken?” As the market for plant-based meats grows, state legislators are left with the question of what the words “chicken” and “burger” mean on food labels. In response to lobbying from the traditional meat industries, states followed suit with the dairy industry and created regulations and restrictions that carve out a meat industry monopoly on meat-related terms. Commercial speech restrictions such as these are guided by the Central Hudson test. Using that test, this Note will argue that while certain state regulations pass constitutional muster, others impose unconstitutional speech restrictions. This Note will draw particularly …

Direct-To-Consumer Advertising Of Prescription Drugs: Constitutionally Protected Speech Or Misinformation?, Matthew Griffin

William & Mary Law Review Online

This Note will argue that the United States can and should regulate direct-to-consumer (DTC) prescription drug advertisements on television more strictly—preferably by proscribing them altogether. In Part I, this Note will discuss the issues of soaring drug prices, disappointing health care outcomes, a glut of misleading drug advertisements affecting the doctor-patient relationship and personal health, and the problem with the current approach to prescription drug advertising. Part I will also discuss the misleading nature of DTC prescription drug advertisements and some examples of the harm they have caused. Additionally, Part I will propose a solution that focuses on limiting the …

Serving Up The Truth On America’S Failing Organic Food System, Leah M. Elefante

Brooklyn Law Review

The organic food market in the United States has grown from a niche subset into an integral component of American food consumption. The current laws regulating the organic industry, including the recently adopted Strengthening Organic Enforcement (SOE) final rule, do not align with the average consumer’s understanding as they navigate the many options in grocery stores. This note analyzes the history and evolution of the organic food market in the United States, the process by which food producers become organic certified, and the pitfalls of the current system, which relies on definitions crafted by politicians, not scientists, and allows many …

The Food Distribution Program On Indian Reservations: Past, Present, And Future, Samantha Doss

Arkansas Law Review

In 2018, the United States Department of Agriculture (USDA) proposed replacing much of the Supplemental Nutrition Assistance Program (SNAP) with “America’s Harvest Box,” a program that would directly distribute a package of non-perishable food items to low-income families. The proposal was met with intense controversy. Many hunger advocates, grocery retailers, and former government officials spurned the idea, citing logistics challenges, nutrition concerns, and stigmatization associated with a direct distribution system. However, a few Indigenous advocates were quick to point out that a direct commodity distribution system has been in place in the United States for generations, often overlooked due to …

Opioid Litigation Panel, Rick Mountcastle, Paul Farrell, Eric Eyre, Patrick C. Mcginley

University of Richmond Law Review

On February 17, 2023, the University of Richmond Law Review hosted a symposium entitled Overlooked America: Addressing Legal Issues in Rural America. A portion of the event focused on the ongoing opioid epidemic in the United States, including the causes and effects of certain actions taken by players in the pharmaceutical industry. The Opioid Litigation Panel, transcribed below, brought together four of the most prominent leaders in the fight for justice in the opioid epidemic: Mr. Rick Mountcastle, Mr. Paul Farrell, Mr. Eric Eyre, and Professor Patrick McGinley. The University of Richmond Law Review was so honored to have …

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

University of Richmond Law Review

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …