Food and Drug Law Commons^™

Pandemic, Protests, And Prison Reform? Why 2020 Is A Catalyst To Rethink Drug Policy, Keelia Lee

St. Thomas Law Review

This Article will argue for the abandonment of the current criminal justice system as it relates to drug offenses and for its replacement with a medical model to address the healthcare problem of addiction. The medical model approach calls for complete decriminalization of all controlled substances coupled with better rehabilitation and reintegration policies. This Article argues the criminalization of drugs has targeted minorities under the guise of keeping communities safe. It will look at the differences between the United States and Portugal, a country that has implemented the medical model, while also analyzing recent legislation in the United States addressing …

Trapped In The Binary Divide: How Forced Contraceptives Violate The World Anti-Doping Code, Alexandria Adkins

American University International Law Review

No abstract provided.

Revisiting Cook V. Food And Drug Administration: A Lens For Analyzing The Current State Of Fda Enforcement And Assurance Of Product Quality – Increased Oversight Or Not Enough?, Catherine Gould

Upper Level Writing Requirement Research Papers

No abstract provided.

Recalibrating Suspicion In An Era Of Hazy Legality, Deborah Ahrens

Seattle University Law Review

After a century of employing varying levels of prohibition enforced by criminal law, the United States has entered an era where individual states are rethinking marijuana policy, and the majority of states have in some way decided to make cannabis legally available. This symposium Article will offer a description of what has happened in the past few years, as well as ideas for how jurisdictions can use the changing legal status of cannabis to reshape criminal procedure more broadly. This Article will recommend that law enforcement no longer be permitted use the smell of marijuana as a reason to search …

When Food Is A Weapon: Parental Liability For Food Allergy Bullying, D'Andra Millsap Shu

Marquette Law Review

Food allergies in children are rising at an alarming pace. Increasingly, these children face an added threat: bullies targeting them because of their allergies. This bullying can take a life-threatening turn when the bully exposes the victim to the allergen. This Article is the first major legal analysis of food allergy bullying. It explores the legal system’s failure to adequately address the problem of food allergy bullying and makes the case for focusing on the potential tort liability of the bully’s parents. Parents who become aware of their child’s bullying behavior and fail to take adequate steps to stop it …

Marijuana Law Reform In 2020 And Beyond: Where We Are And Where We’Re Going, Sam Kamin

Seattle University Law Review

With another presidential election now looming on the horizon, both political parties and both sides of the marijuana law reform debate are once again preparing for the possibility of a seismic change in how marijuana is regulated in the United States. In this Article, I lay out the state of marijuana law and policy in the United States today with an eye toward that uncertain future. I describe the differential treatment of marijuana under state and federal law and the tensions this causes for those seeking to take advantage of marijuana law reform in the states. I analyze recent changes …

A Commitment To The Whole Athlete: Embracing The Role Of Cannabinoids In Collegiate Athletics, Kelli Rodriguez Currie

Seattle University Law Review

Cannabinoids can be a highly effective way for athletes to combat various kinds of pain associated with intense training. Derivatives of cannabis, such as marijuana, have been used for centuries as a form of pain relief. Part I of this Article discusses how cannabinoids are used in sports medicine. Part II discusses the different approaches to marijuana and cannabidiol use across sports leagues. Part III highlights the inconsistencies between the NCAA’s approach to testing for substance abuse and its investment in student-athletes’ well-being. Part IV discusses how the NCAA must focus on student-athlete health. Finally, Part V concludes that the …

Tiptoeing Through The Landmines: The Evolution Of States’ Legal Ethics Authority Regarding Representing Cannabis Clients, Karen E. Boxx

Seattle University Law Review

Despite the continued federal classification of cannabis as an illegal drug, states have legalized the possession, use, production, and sale of cannabis. In order to do so, the states have created complex regulatory schemes to control and monitor the cannabis industry and satisfy the federal government concerns, such as use by minors and organized crime involvement. First, this Article presents the ethical dilemma of cannabis lawyering. Second, this Article describes the history, evolution, and current status of the various states’ pronouncements on a lawyer’s ethical duties with respect to the business and use of cannabis that may be legal under …

Our Federalism On Drugs, Jonathan Adler

Faculty Publications

Over the past decade, voters and legislatures have moved to legalize the possession of marijuana under state law. Some have limited these reforms to the medicinal use of marijuana, while others have not. Despite these reforms marijuana remains illegal under federal law. Although the Justice Department has not sought to preempt or displace state-level reforms, the federal prohibition casts a long shadow across state-level legalization efforts. This federal-state conflict presents multiple important and challenging policy questions that often get overlooked in policy debates over whether to legalize marijuana for medical or recreational purposes. Yet in a “compound republic” like the …

A Quixotic Quest For Definition: Perceptions Of “Organic” And Implications For The Environment And For Market Participants, Becky L. Jacobs, Chelsea Jacobs

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Executive Summary On Ensuring Economic Viability And Sustainability Of Coffee Production, Jeffrey D. Sachs, Kaitlin Y. Cordes, James Rising, Perrine Toledano, Nicolas Maennling

Columbia Center on Sustainable Investment Staff Publications

Coffee, the world’s favorite beverage, provides livelihoods for at least 60 million people across dozens of countries. Yet this beloved drink is experiencing a sustainability crisis. A sustained decline in world coffee prices has squeezed coffee producers, and thrown a tremendous number of producers below the global extreme poverty line of US$1.90 per day. This briefing note presents our research into sustainability within the coffee sector, including the results of our analytical and empirical modeling, and provides several recommendations.

Tell Me How It Ends: The Path To Nationalizing The U.S. Pharmaceutical Industry, Fran Quigley

University of Michigan Journal of Law Reform

The U.S. medicines system is broken. Millions of Americans suffer and some even die because they cannot afford medicines discovered by government-funded research. At the same time, corporations holding monopoly patent rights to those medicines collect some of the largest profits in modern capitalist history.

It does not have to be this way. The global legacy of treating essential medicines as a public good and the robust U.S. history of government seizure of private property for the public interest reveals a better path: the United States should nationalize its pharmaceutical industry.

U.S. statutory law already provides broad powers for the …

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Welcome To The World Of Tomorrow: An Exploration Of Cell-Based Meats And How The Fda And Usda May Protect Intellectual Property Rights, Sean A. Grafton

Catholic University Journal of Law and Technology

Lab-grown meats are ready to be sold in United States markets. However, the meat product needs approval from regulators such as the Food and Drug Administration (“FDA”) and the United States Department of Agriculture (“USDA”). The regulation approval process takes a significant amount of time. This approval period will cut into the lab-grown meat producers’ patent time, rendering a period of the patent ineffective.

This Comment analyzes the effect of, and possible changes to, our current laws on the emerging lab-grown meat market. To look at this problem, this Comment compares FDA and USDA regulations, analyzes the Hatch-Waxman Act, and …

Innovating Federalism In The Life Sciences, Myrisha S. Lewis

Faculty Publications

This Article challenges the view that the US. Food and Drug Administration (FDA) has exclusive Jurisdiction over life sciences innovations. Many current and forthcoming life sciences innovations are "innovative therapies" such as gene editing, gene therapy, and regenerative stem cell treatments, which are actually "hybrids" of state and federal Jurisdiction. Thus, both state and federal Jurisdiction coexist: federal Jurisdiction exists to the extent that these medical innovations use drugs or biologics, but state Jurisdiction exists to the extent that these innovations are procedures regulated by states as the practice of medicine.

This Article argues that the regulation of numerous current …

From Petri Dish To Main Dish: The Legal Pathway For Cell-Based Meat, Brian P. Sylvester, Nathan A. Beaver, Kara Schoonover, Jonathan I. Tietz

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

Meat grown outside an animal is no longer simply science fiction, and the market is poised for introduction of a variety of so-called cell-based meat products. Commercializing these products will require a clear regulatory path forward. In this Article, we explore that legal pathway. We introduce the concepts of cellular agriculture and cell-based meat, including the science, the state and history of the industry, and the general regulatory background, in which the USDA and FDA are the major players. Further, we explore in particular regulatory aspects of food safety and labeling in the context of cell-based meat. Overall, we contend …

Planting The Seed: A Proposal For A Farm Operation Test Under The Fsma Produce Safety Rule, Sophia Kruszewski, Samuel Ingraham

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Faculty Scholarship

No abstract provided.

Deadly Delay: The Fda's Role In America's Covid-Testing Debacle, Barbara J. Evans, Ellen Wright Clayton

UF Law Faculty Publications

In response to the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) published a series of 2020 guidance documents on how to seek Emergency Use Authorizations (EUAs) for new SARS-CoV-2 tests. These guidance documents suggest EUAs are needed for laboratory-developed tests (LDTs), a type of test created and used in-house by high-complexity clinical laboratories that already are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). These CLIA-regulated laboratories traditionally have provided a rapid response to emerging epidemics. Many laboratories viewed the FDA’s 2020 guidance documents as having a practical binding effect even though the FDA lacked clear …

How Come Mary-Jane Is Not On Workers’ Comp?: Requiring Rhode Island Workers’ Compensation Insurers To Reimburse Employees For Medical Marijuana, Devon Q. Toro

Roger Williams University Law Review

No abstract provided.

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester

Faculty Publications & Other Works

No abstract provided.

Minor Advances, Major Consequences: Hatch-Waxman Administers Exclusivity For Drug Delivery Devices, Taylor Stemler

Mitchell Hamline Law Review

No abstract provided.

The Burden On Society From Eleventh-Hour "Citizen Petitions" Filed To Slow Generic Drugs, Feldman Robin

Maryland Law Review Online

No abstract provided.

Cannabis Legalization In State Legislatures: Public Health Opportunity And Risk, Daniel G. Orenstein, Stanton A. Glantz

Marquette Law Review

Cannabis is widely used in the United States and internationally despite its illicit status, but that illicit status is changing. In the United States, thirty-three states and the District of Columbia have legalized medical cannabis, and eleven states and D.C. have legalized adult use cannabis. A majority of state medical cannabis laws and all but two state adult use laws are the result of citizen ballot initiatives, but state legislatures are beginning to seriously consider adult use legislation. From a public health perspective, cannabis legalization presents a mix of potential risks and benefits, but a legislative approach offers an opportunity …