Food and Drug Law Commons^™

"Serving Time And It's No Longer A Crime: An Analysis Of The Proposed Cannabis Administration And Opportunity Act, Its Potential Effects At The Federal And State Level, And A Guide For Practical Application By Local Government", R. Allyce Bailey

University of the District of Columbia Law Review

There has been much recent discussion surrounding cannabis use with some researchers supporting the use of medical marijuana, some investors relishing in the recently booming cannabis and CBD industry, and some states decriminalizing marijuana and even harsh controlled substances. As it appears, at least some public opinion is changing regarding marijuana, but the law has not effectively caught up to that change. Bias in the criminal justice system has led to the over-policing of, higher conviction rates, and harsher sentences for minorities. Thus, the decriminalization of marijuana alone does not remedy the grave disproportionate negative effects on populations of color …

Using Insurance To Regulate Food Safety: Field Notes From The Food Produce Sector, Timothy D. Lytton

New Mexico Law Review

Foodborne illness is a public health problem of pandemic proportions. In the United States alone, contaminated food sickens an estimated 48 million consumers annually, causing 128,000 hospitalizations and 3,000 deaths. Nowhere is this crisis more acute than in the fresh produce sector, where microbial contamination in growing fields and packing houses has been responsible for many of the nation’s largest and deadliest outbreaks.

This Article examines emerging efforts by private insurance companies to regulate food safety on farms that grow fresh produce.

Previous studies of using insurance to regulate food safety rely on economic theories that yield competing conclusions. Optimists …

A Helper For Patenting The “Unpredictable”: Artificial Intelligence, Shuang Liu

Minnesota Journal of Law, Science & Technology

No abstract provided.

The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard

Catholic University Law Review

When the history of the first year of the United States Government’s response to the COVID-19 virus is written, there is likely to be mention of the still unexplained vehemence with which then president Donald J. Trump made use of his access to social media to promote seldom used anti-malaria drug, hydroxychloroquine, for both the prevention and treatment of COVID-19 despite the active growing opposition of most of the world’s scientists, including his own government scientists. While the use of drugs developed and approved by the FDA for different purposes to combat new diseases, off-label prescribing, is legal in the …

Legalization Without Disruption: Why Congress Should Let States Restrict Interstate Commerce In Marijuana, Scott Bloomberg, Robert A. Mikos

Pepperdine Law Review

Over the past twenty-five years, states have developed elaborate regulatory systems to govern lawful marijuana markets. In designing these systems, states have assumed that the Dormant Commerce Clause (“DCC”) does not apply; Congress, after all, has banned all commerce in marijuana. However, the states’ reprieve from the doctrine may soon come to an end. Congress is on the verge of legalizing marijuana federally, and once it does, it will unleash the DCC, with dire consequences for the states and the markets they now regulate. This Article serves as a wake-up call. It provides the most extensive analysis to date of …

Making Your Robotic Surgery Systems General Purpose: A Possible Preventive Measure For Induced And Contributory Infringement Liability Arising In Medical Procedures, Mengmeng Du

Minnesota Journal of Law, Science & Technology

No abstract provided.

Biotechnology Patent Law Top Ten Of 2020: Valeant Victorious, Falling Eagle, And Successful Slayback, Kevin E. Noonan, Andrew W. Torrance

Texas A&M Journal of Property Law

This Article discusses the Top 10 BioTechnology Patent Cases of 2020. Suffice it to say that biotechnology patent law will continue to vigorously evolve, and we plan to continue our coverage of its evolution beyond the current trilogy of Biotechnology Patent Law Top Tens. As in previous years, we admit it was difficult to choose precisely ten top biotechnology patent law decisions. There are certainly others we did not include that warrant close attention for their reasonings, rules, and future implications. Nevertheless, both we and our readers can count, so we have done our best to select what we consider …

Beefing Up Skinny Labels: Induced Infringement As A Question Of Law, Garrett T. Potter

Notre Dame Law Review

This Note proposes a novel argument for improving the application of induced infringement by splitting its elements into separate questions of fact and law, incorporating the relevant perception and reasoning of both judge and jury. Part I provides a primer of the Hatch-Waxman Act and interactions (and lack thereof) between the USPTO and FDA in regulating pharmaceutical compositions. Part II assesses the historical landscape that led to the codification of induced infringement. Part III concludes by proposing an alternate approach by treating an element of induced infringement as a question of law, rather than a question of fact, and sets …

The Arkansas Ll.M. Program: Forty Years Of Leadership, Susan A. Schneider

Journal of Food Law & Policy

The University of Arkansas School of Law has been a leader in agricultural law education for over forty years through its innovative LL.M. Program in Agricultural and Food Law. This essay memorializes the history of this signature Program and charts its progress through the decades as agricultural law issues evolved and the discipline expanded.

Patent Prophylaxis: Expanding Access To Prep Through 28 U.S.C. § 1498, Jonathan A. Bell

William & Mary Law Review

Part I of this Note details the discovery of Truvada for PrEP [pre-exposure prophylaxis] and the ongoing patent infringement litigation brought by HHS [United States Department of Health and Human Services], discusses the patents currently held by CDC and Gilead, and examines the shortcomings of infringement litigation as a means to expand access to the drug. Part II analyzes the mechanism of march-in rights under the Bayh-Dole Act and discusses two previously attempted applications for the HIV-management drug ritonavir to demonstrate why march-in rights will always fail to expand access to life-saving medications or reduce costs to consumers. Part III …

The 1994 Federal Crime Bill: An Evaluation Of The Past, Present, And Future Of Its Impact On The Criminal Justice System, Jade R. Philpot

Honors College Theses

The 1994 Violent Crime Control and Law Enforcement Act was signed into law in response to the crack cocaine and crime epidemic of the 1980s. In this thesis I address the major elements of this bill, the racial, financial, and ethical conflicts that arose thereafter, and the reforms that should be implemented today to correct said conflicts.

Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu

Fordham Law Review

The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …

The Rise Of Concentrated Animal Feeding Operations, Their Effects, And How We Can Stop Their Growth, Andrea Prisco

Dickinson Law Review (2017-Present)

Dramatic changes in the agricultural industry over the last century have led to the rise of concentrated animal feeding operations– industrial facilities that raise a large number of animals in confined spaces. Animals raised in these facilities suffer from poor quality of life and abuse. For humans, these facilities have had adverse effects on the environment and public health, but they are also associated with high productivity and low food costs. This Comment analyzes the effects of concentrated animal feeding operations on animal well-being, the environment, and public health. This Comment also analyzes current federal legislation that helps combat the …

Advance To The Nearest Dispensary: How Quebec's Marijuana Monopoly Is A Model For Future Legalized States, Jason Levine

Cardozo International & Comparative Law Review

The note argues that a state-run monopoly model for marijuana sales, inspired by Quebec's approach, could more effectively promote public health and reduce black-market competition compared to the current license authorization model used in U.S. states like Colorado and California. By centralizing control over pricing, distribution, and product regulation, a monopolistic structure could address challenges such as high taxes, slow transition phases, and the dominance of illegal markets. The analysis draws parallels to alcohol sales frameworks and highlights how a government-run system could avoid federal tax burdens under Section 280E of the Internal Revenue Code.

The Tin Man Needs A Heart: A Proposed Framework For The Regulation Of Bioprinted Organs, Linda Foit

Fordham Law Review

Each day, seventeen people die in the United States while waiting for an organ transplant. At least part of this need could be met by bioprinting, a technology that allows the on-demand production of custom-sized organs from a patient’s own cells. The field of bioprinting is progressing rapidly: the first bioprinted organs have already entered the clinic. Yet, developers of bioprinted organs face significant uncertainty as to how their potentially lifesaving products will be regulated—and by which government agency. Such regulatory uncertainty has the potential to decrease investment and stifle innovation in this promising technological field. This Note examines how …

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S. F. Orubu, John Rex, Christine Årdal, Muhammad H. Zaman

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to patient access to effective antibacterial therapy.

Endnotes

Sustainable Development Law & Policy

No abstract provided.

Climate Migration Beyond The Refugee Framework: Creating Bridges Between Human Rights And International Climate Law, Mara Elisa Andrade

Sustainable Development Law & Policy

No abstract provided.

Accounting For Climate Change In United States Regional Ocean Planning: Comparing The Obama And Trump National Ocean Policies To A Climate-Forward Approach, Taylor Goelz

Sustainable Development Law & Policy

No abstract provided.

Swallowing The Rule: Why Ferc’S “Immediate Need Exemption” Frustrates Competitive And Climate-Smart Electricity Sector Transmission Planning Under Order No. 1000, Philip Killeen

Sustainable Development Law & Policy

No abstract provided.

“At What Cost?’: The Future Of Securities Enforcement In Climate Change Litigation, Angela Washington

Sustainable Development Law & Policy

No abstract provided.

About Sdlp

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Because our publication focuses on reconciling the tensions found within our ecosystem, it spans a broad range of environmental issues such as sustainable development; trade; renewable energy; environmental justice; air, water, and …

Editor's Note, Keanu Bader, Alexis Bauman

Sustainable Development Law & Policy

No abstract provided.

Endnotes

Sustainable Development Law & Policy

Endnotes

Risk Regulation And Management Against Illegal Wildlife Trade: Europe And America, Olonyi Bosire

Sustainable Development Law & Policy

Introduction

The source or initial crime in the illegal wildlife trade chain is mostly committed beyond the shores of North America and Europe. However, the two regions continue to be massive destination markets and key transit hubs for illegal wildlife products. Illegal trade networks are shadowy and therefore problematic to study. This helps explain the wide valuation of illegal wildlife trade currently estimated by the Global Environment Facility (“GEF”) as ranging between 7 and 23 billion dollars per annum.

Policies and strategies to pre-empt or respond to illegal wildlife trade keep evolving as appreciation grows for the previously underestimated complexities, …

The Truth Is Always In Style: Targeting Greenwashed Advertising In The Fashion Industry, Sydney Helsel

Sustainable Development Law & Policy

H&M’s 2019 “Conscious Collection” promotional images juxtapose lush green gardens with a hazy city skyline in the background. The collection, which advertises itself as “[t]he short cut to sustainable choices,” is just one example of many fashion brands’ attempts to capitalize on the increased demand for sustainable products. Each year, the fashion industry consumes approximately ninety-three billion cubic meters of water and produces an estimated ten percent of the world’s carbon emissions. The environmental effects of the fashion industry can be seen in images of the dried up Aral Sea in Uzbekistan and in the dye and chemical filled black …

The Overfished Pacific Bluefin Tuna: The Tragedy Of A Highly Migratory Fish Species, Theresa Geib

Sustainable Development Law & Policy

Introduction

The ocean is an abundant resource; however, overutilization is becoming an increasing threat to biodiversity. Approximately 90% of the ocean’s fisheries are overexploited, fully exploited, or have collapsed entirely. The issue of overfishing arose in the mid-1900s after the industrialization of the fishing industry. Once dominated by local fishermen, the industry now features commercial fleets with the technology to locate, extract, and process large numbers of specific fish species. An early 2000s study reported that only 10% of large ocean fish remained after years of industrial fishing, including the highly migratory Pacific Bluefin Tuna (“PBT”).

In 2016, the PBT …

An Opportunity That Should Not Be Missed: Applying Chinese Policy That Promotes Efficient Air Conditioning To Countries That Need It, Xiaopu Sun, Houfu Yan, Shekun Wang, Tad Ferris

Sustainable Development Law & Policy

Introduction

As the world warms, the growing use of air conditioners (“ACs”) and other cooling equipment becomes essential for human comfort and public health. In addition, cooling-equipment energy and refrigerant consumption also presents tremendous climate mitigation opportunities. The most efficient ways to capture much of the climate benefit lie in the hands of a small number of AC manufacturing and exporting countries, including China, which manufactures over 80% of global room ACs with a large amount of this cooling equipment destined for export. This article highlights one of China’s policies, the “Same Line, Same Standard and Same Quality” policy (“Same-Line …

About Sdlp

Sustainable Development Law & Policy

The Sustainable Development Law & Policy Brief (ISSN 1552-3721) is a student-run initiative at American University Washington College of Law that is published twice each academic year. The Brief embraces an interdisciplinary focus to provide a broad view of current legal, political, and social developments. It was founded to provide a forum for those interested in promoting sustainable economic development, conservation, environmental justice, and biodiversity throughout the world.

Because our publication focuses on reconciling the tensions found within our ecosystem, it spans a broad range of environmental issues such as sustainable development; trade; renewable energy; environmental justice; air, water, and …

Editor's Note, Keanu Bader, Alexis Bauman

Sustainable Development Law & Policy

Dear Readers,

The Sustainable Development Law & Policy Brief (SDLP) is celebrating twenty-one years of legal scholarship on issues related to environmental, energy, and international development law. We are honored to be the Editors-in-Chief at this pivotal moment in SDLP’s history. Over the past twenty one years, SDLP has addressed cutting-edge legal issues developing within international environmental law. This year is no different, as the COVID-19 Pandemic has impacted our communities, we rose to the challenge to continue to publish articles that push the limits of legal theory and policy, while giving a space for students to …