Food and Drug Law Commons^™

On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder

Articles, Book Chapters, & Popular Press

The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …

I Want You To Panic: Leveraging The Rhetoric Of Fear And Rage For The Future Of Food, Iselin Gambert

Journal of Food Law & Policy

"Humanity Is About to Kill 1 Million Species in a Globe-Spanning Murder-Suicide. Only 11 Years Left to Prevent Irreversible Damage from Climate Change." Doomsday headlines like these are terrifying. But are they enough to make us act? The causes of the current climate crisis are many, but the science is clear that the meat and dairy industry shoulders much of the blame. Given the role the animal agriculture industry plays in perpetuating the climate crisis, combined with the harms the industry imposes on the animals and workers within it, politicians and governments—given their degree of power and influence—should ostensibly be …

The Right To Food Comes To America, Wendy Heipt

Journal of Food Law & Policy

The people of Maine recently exercised an opportunity no citizen of this country has ever had before: the ability to vote on whether to enshrine a right to food in their state constitution. This Essay provides an overview of Maine’s experience with food rights in order to explain how the state came to occupy this unique position.

France's Organisme De Défense Et De Gestion: A Model For Farmer Collective Action Through Standard Development And Brand Management, Christopher J. Bardenhagen, Philip H. Howard, Marie-Odile Noziéres-Petit

Journal of Food Law & Policy

Quality-based food production, often with a regional dimension, can provide farmers with new, value added markets. It can also provide consumers with access to place based high-quality products, and may benefit local economies through increased commerce. French Organismes de Défense et de Gestion (ODGs) illustrate a mode of quality-based agri-food business organization. ODGs focus on the development of production standards, as well as management of the intellectual property related to those standards. This mode, which is commonly used in Europe, has not often been used in the United States, despite its potential for regional food system development. The ODG mode …

China's Food Pagodas: Looking Forward By Looking Back?, Yifei Li, Dale Jamieson

Journal of Food Law & Policy

In this Article we provide a close analysis of the Chinese Dietary Guidelines – the Food Pagoda. Our focus on the dietary guidelines is motivated by two main considerations. First, the guidelines represent the most comprehensive, nationwide, state sponsored effort to educate the people of China about food. Like citizens in most countries, Chinese people are presented with numerous, often competing, messages from scientists, food gurus and online influencers. The dietary guidelines are different in that they are backed by an entire suite of governmental resources for nationwide dissemination through hospitals, schools, public billboards, TV and radio ads, among others. …

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs

Faculty Scholarship

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

High Time For A Change: How The Relationship Between Signatory Countries And The United Nations Conventions Governing Narcotic Drugs Must Adapt To Foster A Global Shift In Cannabis Law, Alexander Clementi

Brooklyn Journal of International Law

Since the early 1970’s, the inclusion of cannabis and its byproducts in the United Nations Single Convention on Narcotic Drugs has mandated a strict prohibition on cultivation and use of the substance, which has led to a largely global practice of criminalization and imprisonment of anyone found to be in its possession. Yet recently, mostly in response to growing public health concerns, countries like Uruguay, Portugal, The Netherlands, Canada, and the United States have enacted laws which seek to decriminalize or even legalize cannabis use and possession. Yet, cannabis remains classified as a Schedule IV narcotic under the Single Convention, …

Agents Of Bioshield: The Fda, Emergency Use Authorizations, And Public Trust, Kirstiana Perryman

Georgia Law Review

The SARS-CoV-2 pandemic spurred the U.S. Food & Drug Administration (FDA) to utilize the Emergency Use Authorization (EUA) procedure more than ever before. The pandemic pushed the relatively obscure procedure into public consciousness, making it a frequent topic of discussion and debate. The EUA procedure permits the FDA Commissioner to authorize the introduction of drugs, devices, or biological products into interstate commerce for use in an actual or potential emergency. To issue an authorization, the FDA Commissioner must determine that it is “reasonable to believe,” based on the “totality of the evidence,” that the product “may be effective.” This standard …

The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein

Brooklyn Law Review

In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …

Out Of Sight, Out Of Mind: Analyzing Inhumane Practices In Mississippi’S Correctional Institutions Due To Overcrowding, Understaffing, And Diminished Funding, Ariel A. Williams

Honors Theses

The purpose of this research is to examine the political, social, and economic factors which have led to inhumane conditions in Mississippi’s correctional facilities. Several methods were employed, including a comparison of the historical and current methods of funding, staffing, and rehabilitating prisoners based on literature reviews. State-sponsored reports from various departments and the legislature were analyzed to provide insight into budgetary restrictions and political will to allocate funds. Statistical surveys and data were reviewed to determine how overcrowding and understaffing negatively affect administrative capacity and prisoners’ mental and physical well-being. Ultimately, it may be concluded that Mississippi has high …

Organic Waste Bans: Beyond The Compost Heap, David Lee

Journal of Food Law & Policy

Food waste and food insecurity are strange bedfellows, but in the United States they shamelessly walk hand-in-hand. The USDA’s Supplemental Nutrition Assistance Program (“SNAP”) and the Emergency Food Assistance Program (“TEFAP”) are two federal programs that provide for large numbers of people in the United States. Local food recovery and donation programs serve their communities as the “backbone of the America hunger response" efforts. While many American households continue to report their struggles with food insecurity, heaping piles of good food go to waste. The repercussions of wasted food are vast, taxing American wallets, wasting our resources with every bit …

The Pandemic, Climate Change And Farm Subsidies, Allen H. Olson, Edward J. Peterson

Journal of Food Law & Policy

Many people believe that once the COVID-19 pandemic has passed, life will return to the way it was. This belief is both unrealistic and dangerous. It is unrealistic because the virus will be around for years if not indefinitely. The timeframe for the worst of the pandemic will depend on our ability to administer effective vaccines worldwide and the public’s willingness to accept continued social distancing in the meantime. The damage done to public health, the economy and individuals is already substantial and will get worse. Recovery will be slow and incomplete. The belief that life will return to the …

Farm And Food Worker Inequity Exposed And Compounded By Covid-19, Kimberly M. Bousquet

Journal of Food Law & Policy

Of the 2.4 million farm-working laborers in the United States, upwards of 73% are immigrants. And, according to the Economic Policy Institute, immigrants make up nearly 22% of all workers in the U.S. food industry, including 27% of food production workers, 37% of meat processing industry workers, 34% of commercial bakery workers, and 31% of fruit and vegetable preservation work. Another study found that “[p]eople of color make up the majority of essential workers in food and agriculture (50%) and in industrial, commercial, residential facilities and services (53%).” Many of these workers--if not the majority in some sectors--are undocumented and/or …

Understanding Modern History Of International Food Law Is Key To Building A More Resilient And Improved Global Food System, Michael T. Roberts

Journal of Food Law & Policy

This article advocates the need for a history of the development of modern international food law and suggests an analytical approach to complement the chronicling of events. Comprehension of this history will help elucidate the evolution of a complicated modern global food system, including its resiliency and vulnerability as demonstrated by Covid-19, thereby providing valuable context for change in the system where needed. This essay makes the case for such a history in three parts. First, it briefly demonstrates the need for a historical perspective through a critical examination of a journal article that speaks to Covid-19 food security in …

Iowa Land And Landowners: Fear Or Opportunity, Neil D. Hamilton

Journal of Food Law & Policy

Our relation to the land changed as modern agriculture changed. Today many issues involving the land seem to focus on fear and conflict, revealing a fragility of agriculture surprising for how it confounds the expected image of strength and stability. In many ways, our fragile relation to the land contrasts to the optimism of the relation in the past, in the years of settlement and expansion. Part of the change reflects the adverse impacts of modern agriculture catching up with us, and part stems from a society more willing to focus on issues of equity, inclusion, and inequality. The good …

Addressing Food Insecurity In The United States During And After The Covid-19 Pandemic: The Role Of The Federal Nutrition Safety Net, Sheila Fleischhacker, Sara N. Bleich

Journal of Food Law & Policy

Food insecurity has been a direct and almost immediate consequence of the coronavirus disease 2019 (COVID-19) pandemic and its associated ramifications on unemployment, poverty and food supply disruptions. As a social determinant of health, food insecurity is associated with poor health outcomes including diet related chronic diseases, which are associated with worst COVID-19 outcomes (e.g., COVID-19 patients of all ages with obesity face higher risk of complications, death). In the United States (US), the federal nutrition safety net is predominantly made up of the suite of 15 federal nutrition assistance programs that the US Department of Agriculture (USDA) administers and …

The Opioid Crisis Or Climate Change: Which Is More Likely To Succeed Under The Tobacco Litigation Model?, Elizabeth W. De Leon

Texas A&M Law Review

Societal problems can occasionally have legal solutions, and several tools exist to implement change, including litigation and regulation. However, what elements make a societal problem more suitable for litigation or regulation? This Article examines four different societal issues (tobacco use, obesity, opioid addiction, and climate change) to determine whether litigation or regulation is the more appropriate route for success. The tobacco litigation serves as a successful example, while the fast food litigation serves as an unsuccessful example. Six signs of success are derived from the tobacco litigation: a large settlement agreement, evidence of corporate wrongdoing, change in public opinion, the …

Coronavirus "Cures" And The Courts, Chad G. Marzen, Michael Conklin

William & Mary Business Law Review

The coronavirus pandemic has drastically affected nearly every aspect of American life. Unfortunately, it has also created an opportunity for those willing to exploit vulnerable citizens by selling fake “cures.” This Article analyzes a lawsuit against televangelist Jim Bakker for doing just that. This Article also calls for increased protection for individuals when a global health pandemic and national emergency have been declared. This Article advocates a novel proposal—the enacting of a federal statute making it a felony for an individual to knowingly sell a fraudulent cure for any disease that has been designated a pandemic by the World Health …

The Tobacco Control Act’S Pmta And Mrtp Provisions Mean To Protect The Usa From Any New Tobacco Products That Will Not Reduce Health Harms—But Fda Isn’T Cooperating, Eric N. Lindblom

Journal of Health Care Law and Policy

No abstract provided.

Social Justice As A Necessary Guide To Public Health Disaster Response, Stephen S. Hanson

Journal of Health Care Law and Policy

No abstract provided.

The Future Of The Agricultural Industry – Is Blockchain A New Beginning?, Ryan Bisel

Seattle University Law Review

As we advance into a digital era, we begin to depend on technological innovations to rapidly help develop and update processes and methods within different industries. Blockchain technology—popularized by cryptocurrency—is slowly making its debut in the agricultural supply chain. Implementing a blockchain requirement for suppliers would be beneficial because it would allow agricultural suppliers and distributors to track their products in a more efficient manner. However, there are four potential legal issues that are foreseeable: (1) preemption, (2) overlapping regulatory authority, (3) applying current legal rules to new technology, and (4) contracting. This Note will specifically focus on issues of …

Putting Paper To Pen: Generation Juul's Case For Harm Reduction, Liz Emanuel

Indiana Law Journal

Part I of this Note soberly explores and delineates the perceived and real threats of vaping for America’s youth, concluding with an analysis of the socioeconomic and developmental health effects of nicotine addiction. Part II delves into the federal government’s response to e-cigarettes as well as the powers and limitations of federal regulation under the Food and Drug Administration’s (FDA) “Deeming Rule” and the potential effectiveness of an increase in the national tobacco purchase age or a federal ban on flavored vaping products. Part III discusses the realistic benefits of taking a harm reduction approach to youth vaping in the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents and Special Thanks.

In The Name Of Public Health: Misoprostol And The New Criminalization Of Abortion In Brazil, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article explores the criminal regulation of misoprostol as a controlled drug in Brazil as a new form of abortion criminalization. A qualitative analysis of Brazilian case law shows how the courts use a public health rhetoric of unsafe abortion to criminalize the distribution of misoprostol in the informal sector. Rather than an invention of the local bench, this judicial rhetoric reflects global public health discourse and policy on unsafe abortion and the double life of misoprostol as both an essential medicine and a controlled drug. In contrast to previous studies, the article shows that abortion criminalization is not the …

Securing Safe Supply During Covid-19 And Beyond: Scoping Review And Knowledge Mobilization, Matthew Bonn, Natasha Touesnard, Brianna Cheng, Michael Pugliese, Emilie Comeau, Claire Bodkin, Thomas D. Brothers, Leah Genge, Matthew Herder, Candis Lepage, Ayden Scheim, Dan Werb, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Background

Safe supply is defined as the legal and regulated provision of drugs with mind and/or body altering properties that have been typically accessible only through the illegal drug market. In response to the coronavirus disease 2019 (COVID-19) pandemic and related social/physical distancing measures, efforts have been made to scale up and increase access to safe supply programs in an effort to reduce overdose and other drug- and drug policy-related risks. However, it remains unclear whether these efforts taken thus far have meaningfully mitigated the barriers to safe supply experienced by People Who Use Drugs (PWUD), both during and beyond …

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents