Law Commons^™

Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder

Articles, Book Chapters, & Popular Press

The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing upon a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.

Altering United States Drug Policy And Shifting The Focus Of Drug Use From Conviction Toward Drug Addiction Treatment, Natalie Marra

Honors Projects

While these substances were not always controlled by law, drug use has been as issue throughout time going back thousands of years and continues to be a concern in the twenty-first century. Possession, distribution, and manufacturing of controlled substances outside of what is considered legal can lead to fines and or jail time and can also increases the severity of other crimes committed either due to or under the influence of drugs. As of Saturday June 10th, 2023, 44.5% of Federal inmates are incarcerated for drug offenses, including possession, distribution, and manufacturing1. Drug offenses make up the largest percentage of …

Prioritizing Regional Wildlife Conservation By Rejuvenating The Western Hemisphere Convention On Nature Protection, Shade Streeter, David Hunter, William Snape Iii

Sustainable Development Law & Policy

Last year, parties to the Convention on Biological Diversity (“CBD”), representing nearly every nation, signed a milestone agreement committing, among other things, to conserve thirty percent of Earth’s lands and oceans to stave off the rapid diminution of the planet’s biodiversity. Implementing these global commitments will require not only strong domestic measures, but also enhanced regional cooperation targeting the conservation of the region’s migratory wildlife and shared resources. Although the United States is the sole major holdout from the CBD, it can still reassert its leadership in regional wildlife conservation by rejuvenating the Convention on Nature Protection and Wildlife Preservation …

Unclos, Undrip & Tartupaluk: The Grim Tale Of Hans Isle And Graense, Christopher Mark Macneill

Sustainable Development Law & Policy

“Inuit have lived in the Arctic from time immemorial.” The Arctic, in the face of climate change, has become a hot spot for exploration, resource extraction, and increased shipping and scientific activity. “[The] Inuit . . . have had a common and shared use of the sea area and the adjacent coasts” among their own communities, and contemporaneously with the world. This vast circumpolar Inuit Arctic region includes land, sea, and ice stretching from eastern Russia (Chukotka region) across the Berring Strait, to Alaska, the Canadian Arctic, and Greenland, representing an Inuit homeland known as Nunaat. Hans Isle, a small …

The Great Climate Migration: A Critique Of Global Legal Standards Of Climate-Change Caused Harm, Mariah Stephens

Sustainable Development Law & Policy

Approximately 2.4 billion people, or about forty percent of the global population, live within sixty miles (one hundred kilometers) of a coastline. The United Nations (“U.N.”) determined that “a sea level rise of half a meter could displace 1.2 million people from low-lying islands in the Caribbean Sea and the Indian and Pacific Oceans, with that number almost doubling if the sea level rises by two metres.” The U.N. also reports that “sudden weather-related hazards” have internally displaced an annual average of 21.5 million people since 2008. Within the next few decades, this number is likely to continue to increase. …

The Future Of Crypto-Asset Mining: The Inflation Reduction Act And The Need For Uniform Federal Regulation, Liz Guinan

Sustainable Development Law & Policy

Crypto-asset mining is energy-intensive and environmentally harmful, presenting challenges and opportunities for federal, state and local governments, regulators, and society as a whole. As of December 2021, the United States has thirty-eight percent of the global crypto network hash rate, which is the total amount of computational power used to mine and process crypto transactions, making the United States the world’s largest crypto-asset mining industry. The total electricity consumption of crypto-asset mining in the United States is estimated to be around 121.36 terawatt-hours (“TWh”) per year, which is equivalent to the electricity consumption of approximately 10.9 million households in the …

Editors' Note, Rachel Keylon, Meghen Sullivan

Sustainable Development Law & Policy

For more than two decades, the Sustainable Development Law and Policy Brief (“SDLP”) has published works analyzing emerging legal and policy issues within the fields of environmental, energy, sustainable development, and natural resources law. SDLP has also prioritized making space for law students in the conversation. We are honored to continue this tradition in Volume XXIII.

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

Deterrence Defeats Doping: How Arbitration Can Resolve Major League Baseball's Performance-Enhancing Drug Problem, Brice Barnes

Pepperdine Dispute Resolution Law Journal

This article analyzes MLB’s PED policy and proposes amending the policy by arbitrating the agreement to create one that further deters players from using PEDs. The remainder of this article is divided into five parts: Part II discusses the significance of the PED issue and why resolution is necessary; Part III discusses the history of PED use in baseball and the efforts by the League to address it; Part IV proposes the solution of arbitration and explains how the process might work; Part V addresses potential objections to that solution; and finally, Part VI concludes.

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa

Brooklyn Law Review

A resurgence in federally approved psychedelic research has spawned the Psychedelic Renaissance, and with each study it becomes increasingly clear that psychedelics have the potential to revolutionize mental health treatment. However, if Congress fails to reform the industry’s patent procedures, threats to innovation in the budding field of psychedelic medicine will manifest in their ugliest form. Psychedelics are a class of hallucinogenic drugs that primarily trigger substantially altered states of consciousness, including psychological, visual, and auditory changes. Medical research on psychedelics has produced staggering results that indicate psychedelics have the potential to be significantly more effective in treating mental illnesses …

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia

DePaul Journal of Health Care Law

Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …

Smoky Wine Variety: How Federal Crop Insurance Hinders Grape Growers Affected By Wildfire Smoke, London T. Weston

Texas A&M Journal of Property Law

This Note comparatively argues that while both Californian and Australian grape growers lose millions of dollars from crops damaged by wildfire smoke taint, the two countries support and insure their farmers very differently. When both areas of the world are susceptible to the damaging effects of climate change, why are the producers not susceptible to the same type of crop relief? After a careful analysis of the types of insurance the United States and Australian governments offer grape growers, the inequity stands between the systematic approach to insuring citizens against wildfires. In America, federal crop insurance only protects crops touched …

More Than They Bargained For: Ab 257 And An Alternative Approach To Labor Law In California's Fast-Food Industry, Alex Reid

University of Cincinnati Law Review

No abstract provided.

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price

Law & Economics Working Papers

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (IRA) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

The Intemperate Regulation Of Alcohol, Bradley R. Greenman

The Journal of Business, Entrepreneurship & the Law

This comment will not argue the legitimacy of the policy aims of the Twenty-First Amendment, rather, it will argue the current regulatory and legal apparatuses which govern the alcohol industry are no longer moored to the original moral and philosophical values the Temperance Movement, or those morals and values which carried over into the Twenty-First Amendment. To aid in understanding the current state of alcohol regulation, Section II will outline the history of liquor regulation in the United States from the Founding to the present. Second, Section II will examine the history of legislation and regulation of alcohol that led …

Vertical Farming: A Bottom-Up Approach, Michael Martinez

Seattle Journal of Technology, Environmental & Innovation Law

The twenty-first century will require innovative solutions to address the effects of climate change. Vertical farming is one solution that could help conserve a significant amount of freshwater and reduce the agricultural industry’ s overuse of pesticides and intensive tilling practices, which contributes to soil erosion and pesticide runoff. There has been significant investment in vertical farming in every region of the United States; however, the cost to produce foods with vertical farming remains more costly than traditional farming, which is in large part due to the substantial amount of electricity needed to power all the technology required to grow …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Which Came First: The Chicken Or The Chick'n? An Fda Amendment Proposal To Reconcile Conflicting Interests In Plant-Based Meat Labeling, Katie Justison

William & Mary Law Review

“The issue is, what is chicken?” As the market for plant-based meats grows, state legislators are left with the question of what the words “chicken” and “burger” mean on food labels. In response to lobbying from the traditional meat industries, states followed suit with the dairy industry and created regulations and restrictions that carve out a meat industry monopoly on meat-related terms. Commercial speech restrictions such as these are guided by the Central Hudson test. Using that test, this Note will argue that while certain state regulations pass constitutional muster, others impose unconstitutional speech restrictions. This Note will draw particularly …

Development Of A Cannabinoid Testing Method Using Blood Collection Cards And Lc-Ms/Ms, Lindsey K. Reynolds, Matt J. Vergne

Student Works

Cannabis is one of the most widely used drugs in the world. Marijuana is a type of cannabis with high amount of Δ9-tetrahydrocannabinol (Δ9-THC) which is psychoactive and intoxicating. Δ9-THC affects alertness and concentration, reducing driving skills when one is intoxicated. Law enforcement of driving under the influence of drugs (DUID) is difficult for police because there is no rapid way to test for Δ9- THC intoxication at the scene of an accident or police stop. Currently, police have to take suspects to a facility to acquire blood samples for testing and the average time before testing is more than …

Direct-To-Consumer Advertising Of Prescription Drugs: Constitutionally Protected Speech Or Misinformation?, Matthew Griffin

William & Mary Law Review Online

This Note will argue that the United States can and should regulate direct-to-consumer (DTC) prescription drug advertisements on television more strictly—preferably by proscribing them altogether. In Part I, this Note will discuss the issues of soaring drug prices, disappointing health care outcomes, a glut of misleading drug advertisements affecting the doctor-patient relationship and personal health, and the problem with the current approach to prescription drug advertising. Part I will also discuss the misleading nature of DTC prescription drug advertisements and some examples of the harm they have caused. Additionally, Part I will propose a solution that focuses on limiting the …

Serving Up The Truth On America’S Failing Organic Food System, Leah M. Elefante

Brooklyn Law Review

The organic food market in the United States has grown from a niche subset into an integral component of American food consumption. The current laws regulating the organic industry, including the recently adopted Strengthening Organic Enforcement (SOE) final rule, do not align with the average consumer’s understanding as they navigate the many options in grocery stores. This note analyzes the history and evolution of the organic food market in the United States, the process by which food producers become organic certified, and the pitfalls of the current system, which relies on definitions crafted by politicians, not scientists, and allows many …

The Recipe For Success: How Local Massachusetts And Rhode Island Restaurants Navigated And Survived Covid Restrictions, Han Lambert

Honors Projects in History and Social Sciences

The COVID-19 pandemic and the government restrictions adopted during the pandemic have had a detrimental impact on the continued survival and growth of many industries, including the restaurant industry. This study identifies critical regulations relating to COVID-19, implemented in Rhode Island and Massachusetts, as well as on a federal level, which directly impacted the restaurant industry. It is essential that certain economic and social factors are isolated as a means of establishing trends. In the case of this study, a mixed methods approach was used. The number of restaurants open, the amount of restaurant revenue, and the level of consumer …

The Food Distribution Program On Indian Reservations: Past, Present, And Future, Samantha Doss

Arkansas Law Review

In 2018, the United States Department of Agriculture (USDA) proposed replacing much of the Supplemental Nutrition Assistance Program (SNAP) with “America’s Harvest Box,” a program that would directly distribute a package of non-perishable food items to low-income families. The proposal was met with intense controversy. Many hunger advocates, grocery retailers, and former government officials spurned the idea, citing logistics challenges, nutrition concerns, and stigmatization associated with a direct distribution system. However, a few Indigenous advocates were quick to point out that a direct commodity distribution system has been in place in the United States for generations, often overlooked due to …

Closing The Uptake Gap: Why Missouri Should Pass The Clean Slate Bill, Chloë Driscoll

SLU Law Journal Online

The proposed Clean Slate Bill, or Missouri House Bill 352, aims to create an automatic expungement process for eligible individuals in Missouri. Less than one percent of eligible Missourians have had their records expunged under the current system, creating what is known as an “uptake gap” that unfairly perpetuates barriers to housing, employment, and education. In this article, Chloë Driscoll advocates for the passage of the Clean Slate Bill, explaining the problems with the current expungement system and the benefits of closing the uptake gap.

Adolescent Use And Co-Use Of Tobacco And Cannabis In California: The Roles Of Local Policy And Density Of Tobacco, Vape, And Cannabis Retailers Around Schools, Georgiana Bostean, Anton M. Palma, Alison A. Padon, Erik Linstead, Joni Ricks-Oddie, Jason A. Douglas, Jennifer B. Unger

Sociology Faculty Articles and Research

Adolescent tobacco use (particularly vaping) and co-use of cannabis and tobacco have increased, leading some jurisdictions to implement policies intended to reduce youth access to these products; however, their impacts remain unclear. We examine associations between local policy, density of tobacco, vape, and cannabis retailers around schools, and adolescent use and co-use of tobacco/vape and cannabis.

We combined 2018 statewide California (US) data on: (a) jurisdiction-level policies related to tobacco and cannabis retail environments, (b) jurisdiction-level sociodemographic composition, (c) retailer locations (tobacco, vape, and cannabis shops), and (d) survey data on 534,176 middle and high school students (California Healthy Kids …

Opioid Litigation Panel, Rick Mountcastle, Paul Farrell, Eric Eyre, Patrick C. Mcginley

University of Richmond Law Review

On February 17, 2023, the University of Richmond Law Review hosted a symposium entitled Overlooked America: Addressing Legal Issues in Rural America. A portion of the event focused on the ongoing opioid epidemic in the United States, including the causes and effects of certain actions taken by players in the pharmaceutical industry. The Opioid Litigation Panel, transcribed below, brought together four of the most prominent leaders in the fight for justice in the opioid epidemic: Mr. Rick Mountcastle, Mr. Paul Farrell, Mr. Eric Eyre, and Professor Patrick McGinley. The University of Richmond Law Review was so honored to have …

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

University of Richmond Law Review

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …

Put Your Money Where Their Mouths Are: A Case For State-Based Investment In Anti-Shaming Policies For School Lunch Programs, Shayna Roth

Northwestern Journal of Law & Social Policy

Despite its goals for feeding hungry students, the federal government’s National School Lunch Program falls short due to a lack of guidance and resources. One consequence of these circumstances is shaming practices where schools use fear, punishment, and socioeconomic segregation tactics to mitigate meal price deficits. The federal government and several state governments attempt, and sometimes succeed, to enact legislation to improve school lunch programs, but efforts are few and far between. This Note draws on effective state laws to advocate for increased legislative action on school meals across all states, specifically addressing and prohibiting shaming practices. Eliminating this barrier …