Food and Drug Law Commons^™

Trick Or Treat? How A U.S. Patent Over A Method For Processing Sugarcane Wrongly Alarmed The Colombian Panela Industry, Carter Ostrowski

University of Cincinnati Law Review

No abstract provided.

Legal And Ethical Implications Of U.S. And Canadian Vaccine Contracts: The Impact Of Vaccine Nationalism On The Global Pandemic Response, Ryan S. Tahiri

University of Miami Inter-American Law Review

This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These “pre-purchases,” many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations …

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 …

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 …

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 …

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

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, …

A Solution To The Hard Problem Of Soft Law, Keagan Potts

Michigan Journal of Environmental & Administrative Law

Administrative Agencies often rely on guidance documents to carry out their statutory mandate. Over the past few decades, the Food and Drug Administration (FDA) has been criticized for using soft law guidance documents to exercise powers beyond those authorized by Congress. Since attacks on the use of guidance documents persist and agencies need soft law to respond quickly and flexibly to rapid technological growth, it is essential to develop a solution that preserves this crucial regulatory mechanism and prevents its abuse. The most likely alternative to soft law guidance is formal regulation, which must be developed through the notice-and-comment process. …

The Dope On Marijuana Consumption And Impaired Driving, Samuel D. Hodge, Jr., Lauren Williams

Cleveland State Law Review

Marijuana is the most frequently used psychotropic drug in the United States, following alcohol consumption. Its use is becoming socially acceptable as more and more states legalize recreational consumption. Nevertheless, marijuana is still a drug, and individuals must understand that it has adverse health effects and potential therapeutic benefits.

Marijuana can influence a user’s judgment and impair a person’s driving abilities. A significant problem with its consumption and driving is that there is no statistical link to show what level of marijuana in the blood causes impairment. Roadside tests for the appropriate blood alcohol content to show intoxication are well …

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

Estate Planning For Cannabis Business Owners: An Introduction, Bridget J. Crawford, Jonathan G. Blattmachr

Elisabeth Haub School of Law Faculty Publications

As more states legalize cannabis sales, estate planners may increasingly be called upon to advise clients with interests in cannabis-related businesses. This essay seeks to assist estate planners in two ways. First, it aims to raise general awareness of cannabis business owners' unique concerns. Second, the essay provides an overview of some of the fundamental issues about which cannabis business owners are likely to seek estate planning advice: business formation matters, wealth transfers, the ability of trusts to own cannabis-related businesses, and gift, estate, and income tax considerations.

In most states that permit legal cannabis sales, there is limited (or …

The Public Health Turn In Reproductive Rights, Rachel Rebouché

Washington and Lee Law Review

Over the last decade, public health research has demonstrated the short-term, long-term, and cumulative costs of delayed or denied abortion care. These costs are imposed on people who share common characteristics: abortion patients are predominantly low income and disproportionately people of color. Public health evidence, by establishing how law contributes to the scarcity of services and thereby entrenches health disparities, has vividly highlighted the connections between abortion access, race, and income. The contemporary attention to abortion law’s relationship to inequality is no accident: researchers, lawyers, and advocates have built an infrastructure for generating credible empirical studies of abortion restrictions’ effects. …

Alternative Solutions For Government Intervention In Climate Crisis Markets: Price Gouging And The Pandemic Egg Market Case Study, S. Byron Frazelle

William & Mary Environmental Law and Policy Review

The cost of a thing is the amount of what I will call life which is required to be exchanged for it, immediately or in the long run.

The incredible, edible egg.

Fires in California, hurricanes along the Gulf, a worldwide pandemic—it is evident that the year 2020 was defined by great crises, most of which were direct results of or exacerbated by climate change. The effects of these crises on broader American society, in particular that of the COVID-19 pandemic, are just beginning to be realized. Nearly every aspect of American life has been impacted by the pandemic and …

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …

Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli

Faculty Scholarship

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspects to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights …

Martinez-Cuevas V. Deruyter Brothers And Covid-19: Is It Time To Re-Examine Farmworker Labor Protections?, Margaret Todd, Sarah Everhart

Journal of Food Law & Policy

In the fall of 2020, in the midst of the COVID-19 global pandemic, a closely divided (5-4) Washington Supreme Court, in Martinez-Cuevas v. Deruyter Bros. Dairy Inc.1, held that dairy workers, despite a state wage and hour law2 specifically exempting agricultural workers, are entitled to overtime pay. The Court based its decision, in part, on the dangerous nature of the work performed by the dairy workers.3 Although the decision was specific to dairy workers in Washington, the majority of U.S. farmworkers are not entitled to overtime wages while working jobs that are generally considered dangerous and have been made more …

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 …

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 …

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 …

Journal Of Food Law & Policy - Spring 2021, Journal Editors

Journal of Food Law & Policy

No abstract provided.

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 …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

Food For Thought: Intellectual Property Protection For Recipes And Food Designs, Kurt M. Saunders, Valerie Flugge

Duke Law & Technology Review

As any chef will tell you, cooking and food preparation is a creative, sometimes innovative, endeavor. Much thought and time is invested in selecting ingredients, developing the process for preparing the dish, and designing an interesting or appealing look and feel for a food item. If this is true, then it should come as no surprise that recipes, food designs, and other culinary creations can be protected by various forms of intellectual property, namely: trade secrets, design and utility patents, trade dress, but usually not copyright. This article considers how intellectual property law has been applied to protect recipes and …

Fixing The Business Of Food: Aligning Food Company Practices With The Sdgs, Sustainable Development Solutions Network, Columbia Center On Sustainable Investment, Sanda Chiara Lab, Barilla Center For Food And Nutrition

Columbia Center on Sustainable Investment Staff Publications

The food sector confronts significant sustainable development challenges. It both contributes to, and suffers from, environmental degradation, especially human-induced climate change and deforestation. Although it can provide farming communities with livelihoods and incomes, it also can fuel land grabs that undermine community rights and wellbeing. The sector feeds the growing global population, but also contributes to the epidemics of obesity and metabolic diseases, while chronic malnutrition has continued to worsen in the years since adoption of the Sustainable Development Goals (SDGs).

In light of these challenges and opportunities, a number of frameworks, guidance documents, and standards have aimed to create …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

BYU Law Review

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

United States Food Law Update, Michael Tingey Roberts

Journal of Food Law & Policy

This update summarizes significant changes and developments in food law over the first half of 2005. Not every change in national food law for the first half of 2005 is included; instead, this update is limited to significant changes in national law. New developments in state law, while certainly important and deserving of attention, are beyond the scope of this update. These updates provide a starting point for scholars, practitioners, food scientists, and policymakers determined to understand the shaping of food law in modem society. Tracing the development of food law through these updates also builds an important historical context …

European Union Food Law Update, Nicole Coutrelis

Journal of Food Law & Policy

Update on European Union Food Law 2005