Food and Drug Law Commons^™

The Cost Of Novelty, Will Nicholson Price Ii

Articles

Patent law tries to spur the development of new and better innova­tive technology. But it focuses much more on “new” than “better”—and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innova­tion”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not only …

The Doctrine Of Wilful Blindness In Drug Offences: Adili Chibuike Ejike V Public Prosecutor [2019] 2 Slr 254, Rennie Whang

Research Collection Yong Pung How School Of Law

In Adili Chibuike Ejike v Public Prosecutor [2019] 2 SLR 254, the Court of Appeal clarified the operation of the wilful blindness doctrine in the context of knowing possession for drug offences. In particular, it affirmed wilful blindness as a doctrine of substantive rather than evidential law, which applies as a limited extension to the legal requirement of actual knowledge. The court then articulated a three-part test for the finding of wilful blindness in relation to knowledge as an ingredient of possession. However, it left open the content of the doctrine as applied to the element of knowledge in drug …

The Ip Of Ipas, Stephen Wolfson, Brian Roth, Chase Scott, Dustin Watts, Charles Hicks, Shivani Patel

Other Colloquium, Conferences, and Symposia

Hosted by the Journal of Intellectual Property Law, this panel brought Brian Roth (Southern Brewing Co.), Chase Scott (Taylor, Feil, Harper & Lumsden, P.C.), and Dustin Watts (Terrapin Beer Co.) together with Stephen Wolfson (Research & Copyright Services Librarian, UGA Law School) and students from the Journal of Intellectual Property Law to discuss how breweries are navigating intellectual property issues. Free koozies to commemorate the event were distributed.

Voluntary Licensing Of Pharmaceuticals: The Strategy Against Compulsory Licensing, Daniel D. Kim

Intellectual Property Brief

No abstract provided.

Non-Transparent Pbm Cash Flows: Balancing Market Forces Under A Reluctant Legislative Regime, John Mcguinness

William & Mary Business Law Review

No abstract provided.

Fighting America’S Best-Selling Product: An Analysis Of And Solution To The Opioid Crisis, Ashley Duckworth

Washington and Lee Journal of Civil Rights and Social Justice

Deaths from drug overdoses have doubled over the last ten years and are now the leading cause of accidental death in the United States. Although some overdoses may have involved more than one drug, prescription and/or illicit opioids were involved in many of these drug overdose fatalities. The Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC), and Congress have enacted a string of regulations, statutes, and programs since the early 1990s, but nothing has seriously improved the opioid epidemic as it stands. If anything, the use of opioids has persisted. Many people want pharmaceutical companies to …

The Budding Hemp Industry: The Effect Of Texas House Bill 1325 On Employment Drug Policies, Meina Heydari

Student Scholarship

Contemporary attitudes toward cannabis use in the United States have shifted from War on Drugsera prohibition toward decriminalization over the past two decades. As states that do not seek to decriminalize marijuana nonetheless enact legislation legalizing CBD, policy tensions arise. In 2019, Texas joined the ranks of states that legalized hemp and hemp-derived products with the passage of House Bill 1325. In light of this legislation, this Article discusses the implications of legalized cannabidiol (CBD) on employment drug policies in Texas. The benefits of CBD legalization must be weighed against the practical implications to effectively balance policies that aim to …

Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi

Faculty Publications

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized …

Illegitimate Medical Purpose: Resolving The Fundamental Flaw In Criminal Prosecutions Involving Physicians Charged With Overprescribing Prescription Opioids, Jacob C. Hanley

Duquesne Law Review

No abstract provided.

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.