Food and Drug Law Commons^™

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

When The Weeds Strike Back: Rethinking Aphis's Regulation Of Genetically Engineered Plants Post-National Family Farm Coalition V. Vilsack, Reagan Powers

Celebrating WCL Student Authors

No abstract provided.

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Brief Of 12 Narcolepsy Patients, Public Interest Organizations, Medical Professionals, And Professors Of Law And Medicine As Amici Curiae In Support Of Defendants-Appellees (Amended To Add Further Signatories), Charles Duan

Amicus Briefs & Court Filings

A prior copy of this brief was filed, inadvertently omitting one signatory. This brief has accordingly been amended to correct the error, reflected in the Certificate as to parties and the Appendix.

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

Fraud In Feeding Our Future: An Analysis Of “The Largest Pandemic Relief Fraud Scheme Yet”, Alena Johnston

Criminal Law Practitioner

Since the 1930s, the public school system in the United States has provided a distinct place for students to develop, learn, and grow.  Public schools level the playing field for students in academics, allowing them to receive an education at no direct cost. However, students from economically disadvantaged backgrounds continue to face challenges, and their inability to secure nutritious meals can affect their ability to perform academically. In 1946, President Harry Truman signed the National School Lunch Act, forming the first Child Nutrition Program in the United States to remedy the food security issue.

 The program was implemented as “a …

Criminalizing Transgender Care, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

Since 2021, twenty-four states, in extraordinarily quick succession, have enacted statutes banning physicians from prescribing puberty blockers and cross-sex hormones to minors for treatment of gender dysphoria. Although the Food and Drug Administration has not approved these drugs for this use, off-label prescribing is a common practice, and leading medical organizations all agree that this off-label use of puberty blockers and sex hormones is an essential component of transgender medical care. These state laws thus represent an extreme, and unprecedented, interference with the provision of standard-of-care medicine. This article, after exploring the ongoing litigation challenging these bans, argues that they …

U'Wa Indigenous People Vs. Columbia: Potential Applications Of The Escazu Agreement, Ariana Lippi

Sustainable Development Law & Policy

Though the case is ongoing, and results are still to be seen, it in many ways sets a precedent for indigenous communities in Latin America seeking redress for environmental and cultural injustices. With Colombia’s recent ratification of The Escazú Regional Agreement (the Agreement herein) in 2022, this case presents a unique opportunity for implementation of the Agreement and greater accountability within existing domestic legislation.

Natural Resources In The Arctic: The Equal Distribution Of Uneven Resrouces, Ganeswar Matcha, Sudarsanan Sivakumar

Sustainable Development Law & Policy

This paper analyses the governance machine in place at the Arctic and examines the application of the principles of “common heritage of mankind” at the Arctic. This paper also offers some tentative propositions aimed at protecting Out Bound investment rights and how the World Trade Organization or other countries, like the U.S., can intercede in the Arctic investment sphere and attempt to regulate along with the United Nations Convention for the Law of the Sea.

Incentivizing Sustainability In American Enterprise: Lessons From Finnish Model, Vasa T. Dunham

Sustainable Development Law & Policy

The disparate climate performances of Finland and the United States, two of the wealthiest countries in the world, bring to light the question of how corporate responsibility has been inspired in each jurisdiction. Having established the urgency of the climate crisis and the importance of corporate behavior in optimizing a given country’s approach to protection of the global environment, an examination of each nation’s legal frameworks may shed light on features of the corporate regime that are effective in advancing sustainability goals and those that are not.22 Part I of this paper establishes a comparative framework by providing background on …

Editor's Note, Shade Streeter, Reagan Ferris

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.

Petition Power, Erika Lietzan

American University Law Review

The law cannot be kept secret. We cannot comply with rules that we do not know. Nor can we question their legitimacy, which is both our right and our duty as citizens. And yet, a substantial body of law applied in this country is difficult for anyone but federal agency insiders to piece together. Rather than publishing regulations that lay out standards of conduct for the future, many agencies interpret the law, and articulate and implement new policies, as they go. Those subject to the law they implement are left to piece the rules together by studying whatever information is …

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.

Endnotes

Sustainable Development Law & Policy

No abstract provided.

Using Federal Public Lands To Model A New Energy Future: Why The Biden Administration Should Prioritize Renewable Energy Development On Public Lands, Meghen Sullivan

Sustainable Development Law & Policy

Oil and gas extraction on public lands and waters is responsible for twenty percent of U.S. greenhouse gas emissions. If American public lands were their own country, they would be the fifth-largest greenhouse gas emitter in the world. As of 2020, only twenty percent of total U.S. electricity generation came from renewable energy sources. While renewable energy development on public lands has increased, most renewable energy comes from private lands. However, public lands contain immense renewable energy potential; for example, it is estimated that half of this country’s geothermal resources are found on public lands. Despite underutilized renewable energy potential …

Crumbling Crown Jewels: Addressing The Impact Of Recreational Overuse In America's National Parks, Ellen Spicer

Sustainable Development Law & Policy

National Parks are the “crown jewels” of America. However, in recent years they have become subjected to rampant overcrowding and overuse, so much so that they are being loved to death. The 1916 National Park Service (“NPS”) Organic Act calls for the conservation of “the scenery and the natural and historic objects and the wild life . . . and to provide for the enjoyment of the same in such manner and by such means as will leave [park sites] unimpaired for the enjoyment of future generations.” Due to increased visitation, one of the mandates of the NPS is being …

Pedal Into The Future, Elliot Wiley

Sustainable Development Law & Policy

Congress severely weakened the Electric Bicycle Incentive Kickstart for the Environment Act (E-Bike Act) when the bill was absorbed into the Build Back Better Bill. Electricity is the future, yet Congress has defanged a bill that could create significant progress in making bicycling a more accessible option for commuters.

Making Room For The Past In The Future: Managing Urban Development With Cultural Heritage Preservation, Kubra Guzin Babaturk

Sustainable Development Law & Policy

Few would disagree that art and architecture are indispensable aspects of the collective human experiences. But can there be “too much” of it? How much is “too much?” Could art and cultural heritage be a hindrance to progress, urbanization, and sustainability? Which art is worth saving? A growing question is how to balance and reconcile expanding urban needs with efforts to preserve cultural heritage. Many cities across the global face this fresh moral dilemma. Cities like Istanbul, Rome, and Cairo––heirs to great empires, with history and art cursing through every alley, are still modern-day metropolises, with ever-burgeoning populations and social …

Toward A Utah Intentionally Created Surplus Program, Devin Stelter

Sustainable Development Law & Policy

The Colorado River Basin continues to face a now two decade-long drought sparked by the drastic effects of climate change on the region. Climate forecasting predicts that the adverse effects of climate change will only increase in severity in years to come. These effects have led federal, state, tribal, and private actors operating in the basin to search for innovative and effective solutions to the significant water scarcity problems that will persist into the future. A closely linked threat stemming from Colorado River water scarcity is the prospect of a “Compact call” on Upper Basin water by the Lower Basin …

About Sdlp, 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.

Editor's Note, Juliette Jackson, Bailey Nickoloff

Sustainable Development Law & Policy

The Sustainable Development Law and Policy Brief (“SDLP”) is celebrating twenty-two years of legal scholarship on issues related to environmental, energy, natural resources, and international development law. SDLP continues to provide cutting-edge solutions to these legal issues in the face of the global COVID-19 Pandemic, while also transitioning back into a “new normal.” This issue is no different, as we published articles challenging our lawmakers and policy heads to address the impending needs of our communities to develop more sustainable infrastructure—needs that are only exacerbated by man-made climate change. We are proud of the work published, and we are forever …

Endnotes, Sdlp

Sustainable Development Law & Policy

No abstract provided.

Toxic Criminals: Prosecuting Individuals For Hazardous Waste Crimes Under The United States Resource Conservation And Recovery Act, Dr. Joshua Ozymy, Dr. Melissa Jarrell Ozymy

Sustainable Development Law & Policy

The U.S. Resource Conservation and Recovery Act (“RCRA”) contains criminal provisions which allow prosecutors to seek substantial penalties when individuals commit hazardous waste crimes involving significant harm or culpable conduct. However, our empirical understanding of enforcement outcomes is limited. We used content analysis of 2,728 criminal prosecutions derived from U.S. EPA criminal investigations from 1983 to 2021 and examined all prosecutions of individual defendants for RCRA violations. Our results show that 222 prosecutions were adjudicated, with over $72.9 million in monetary penalties, 755 years of probation, and 451 years of incarceration levied at sentencing. Seventeen percent of prosecutions centered on …

It's Time To Trash Consumer Responsibility For Plastics: An Analysis Of Extended Producer Responsibility Laws' Sucess In Maine, Marina Mozak

Sustainable Development Law & Policy

Consumer responsibility for waste is a historic relic, dating back to a time when nearly all of a consumer’s waste was compostable, reusable, or marketable. Today, with the rise of plastics and complex goods like electronics, consumers lack the expertise, time, and ability to personally break down the products they consume for reuse. Much of our household waste goes to the curb and into a single stream of municipal solid waste (“MSW”). This includes a variety of wastes which each require specialized processing. Recycling this complex waste falls to municipalities which are woefully underfunded and underqualified to process such complex …

Ohio House Bills 168 And 110: Just Another Drop In The Bucket For Brownfield Redevelopment?, Mia Petrucci

Sustainable Development Law & Policy

This article examines Ohio House Bills 168 and 110. These House Bills provide liability protection to purchasers of brownfield sites, allocate $500 million dollars to brownfield funding—with $350 million allotted for investigation, cleanup, and revitalization of brownfield sites and $150 million for demolition of vacant/abandoned buildings—and create a new Building Demolition and Site Revitalization Program, for the revitalization of properties surrounding brownfield sites. In the first three Sections of this article, the concept of brownfield redevelopment is introduced, the associated challenges with brownfield projects are discussed, and attempts by federal and state governments to address brownfield remediation challenges in the …