Digital Commons Network^™

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 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 …

A Paper Tiger? Prosecutorial Regulators In China’S Civil Environmental Public Interest Litigations, Chunyan Ding, Huina Xiao

Fordham Environmental Law Review

In July 2015, China’s national legislature brought in prosecutor-led civil environmental public interest litigation (“EPIL”) for thirteen selected provincial areas of the country. After a two-year legal experiment, this prosecutor-led civil EPIL system was then established nationwide in July 2017. Yet, can it be said that prosecutorial regulators in China are in fact a paper tiger? Drawing upon content analysis of the 655 prosecutor-led civil EPILs and in-depth interviews with twelve frontline prosecutors and judges, this article examines the dynamics of regulatory practice and the motivation of the Chinese prosecutorial organs to engage in environmental regulation through litigation. Based upon …

Environmental Racism: Using Environmental Planning To Lift People Out Of Poverty, And Re-Shape The Effects Of Climate Change & Pollution In Communities Of Color,, William C.C. Kemp-Neal

Fordham Environmental Law Review

In the mid-1900s the United States began to see a rise in concern for environmental awareness issues. In the early days the movement focused on things like clean air, water and pollution but by the 1970s-1990s many prominent environmental awareness groups began to form focused on the idea that in order to avert climate change the principal goal needed to be to reduce global greenhouse gas emissions. In 1987 a report was released called Toxic Waste and Race, which outlined an intimate link between the placement of environmental hazardous waste sites in communities of color, and greater instances of polluted …

Squaring The Cercla: Superfund And The Superfund Task Force, Manny Marcos

Fordham Environmental Law Review

The Superfund Task Force recently released its final report on the implementation of its recommendations for improving the Superfund program. The Task Force was given five goals for improving the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA’s”), implementation. These goals are to expedite cleanup and remediation, re-invigorate responsible party cleanup and reuse, encourage foreign investment, promote redevelopment and community revitalization, and engage with partners and stakeholders. While the Task Force’s recommendations have improved CERCLA’s implementation, many of CERCLA’s structural flaws remain intact. Specifically, CERCLA still has a severe shortage of funding, an unfair liability scheme, perverse incentives, …

The Yoga Analogy: Scaling-Up The U.S.’S Renewable Energy Sector Mindfully With New Technologies, Evolving Standards, Public Buy-In, Data Sharing, And Innovation Clusters, Kimberly E. Diamond

Fordham Environmental Law Review

This paper focuses on innovative renewable energy devices, exploring how scientifically-based industry standards that continuously evolve with engineering design technology, the public’s buy-in and feeling of connectedness with groundbreaking devices, and innovation clusters that accelerate device development through data sharing and public-private partnerships can all help advance the U.S.’s domestic renewable energy industry.

Part I analyzes challenges inherent to scaling- up novel renewable energy technologies while simultaneously developing the industry standards regulating them. Part II uses the Block Island Wind Farm, an offshore wind demonstration project, and Pavegen’s globally-deployed arrays of piezoelectric smart flooring tiles as examples illustrating the importance …

Climate Change, Competition & Conflict Along The River Nile: The Great Ethiopian Renaissance Dam & Shifting Customary International Water Law, Salma Shitia

Fordham Environmental Law Review

Decade-long negotiations between the Arab Republic of Egypt and the Federal Democratic Republic of Ethiopia surround the decision to build the hydroelectric power plant along the River Nile. For much of Ethiopia, the Grand Ethiopian Renaissance Dam represents a beacon of prosperity. For countless Egyptians, the structure embodies a potential catastrophe. Grounded in threats of displacement for Egyptian agricultural communities, some have compared the Grand Ethiopian Renaissance Dam crisis to disasters culminating in mass migration.

This battle for natural resource access has intensified as climate change exacerbates the region’s dire conditions. Specifically, exhaustible resource allocation amid climate change indicates that …

Beyond Equity: Shared Natural Resources And Human Rights, Criminal Law, And The Use Of Force, Eian Katz

Fordham Environmental Law Review

Transboundary resource disputes are often analyzed by reference to two nebulous and conflicting principles that have emerged in international environmental law: “equitable and reasonable utilization” and “no significant harm.” Frequently overlooked in this context is the potential value of other canons of international law—especially human rights law, criminal law, and the rules governing the use of force—in adding definition to the muddled contours of these foundational precepts. This Article therefore undertakes an assessment of sovereign rights and obligations regarding shared natural resources which arise from these other bodies of law. In doing so, it offers new lenses through which to …

Covid-19 Impacts: How A Global Pandemic Amid The Sunsets Of The Ptc And Itc Made The U.S. Wind And Solar Industries More Resilient, Kimberly E. Diamond

Fordham Environmental Law Review

A cataclysmic event is sometimes the necessary catalyst for companies within certain industries to re- examine, radically shift, and replace their standard practices with technologically-advanced alternatives. In the United States, the occurrence of the Coronavirus pandemic (“COVID-19”) during the sunsets of the Production Tax Credit (“PTC”) and the Investment Tax Credit (“ITC”) created a unique confluence of factors that produced a perfect storm tantamount to such a cataclysmic event for companies in the wind and solar industries, particularly developers. Over the years, the domestic utility-scale wind industry has come to rely heavily upon the PTC, while the domestic utility- scale …

Illegal Discharge: Exploring The History Of The Criminal Enforcement Of The U.S. Clean Water Act, Dr. Joshua Ozymy, Dr. Melisssa L. Jarrell

Fordham Environmental Law Review

The criminal prosecution of defendants that violate federal clean water laws has been ongoing for roughly four decades. Yet, we continue to have a poor understanding of how federal prosecutors use the U.S. Clean Water Act (“CWA”) to charge and prosecute criminals and the outcomes of those prosecutions. We use content analysis to analyze 2,588 federal criminal prosecution case summaries, 1983-2019, to gain a better historical understanding of how the CWA has been used as a prosecutorial tool, to bring out the major themes in the prosecutions, and quantify sentencing outcomes. Findings from the 828 CWA prosecutions undertaken during this …

Red Tide: A Blooming Concern For Florida Manatees, Shannon Price Esq.

Fordham Environmental Law Review

Although red tides are a common and natural occurrence around the coast of Florida, within the last few decades they have intensified and become much more deadly. Several identifiable human-caused factors exacerbate the size, concentration, and duration of the harmful algae bloom and disturb the environment’s natural balance. The Florida Gulf Coast provides all the algae’s necessary requirements for survival, the perfect storm to create a resilient super bloom that annihilates its host ecosystem.

This article explains the plight of Florida manatees who, like other marine animals and plants, are being injured or killed by this algae crisis. It also …

"Eco" Your Own Way: An Argument For State-Specific Climate Change Legislation, Amanda Voeller

Fordham Environmental Law Review

The consequences of climate change seriously and immediately threaten the American way of life, but proposed federal legislation like the Green New Deal is overly broad, unrealistic, and inefficient. The most effective way for the United States to combat climate change is not with a one-size-fits-all plan like the Green New Deal, but with federal legislation that incentivizes states and cities to enact and enforce individualized, local climate legislation. Different states and cities have different climates, available energy sources, and transportation needs, so the federal government should use financial incentives to encourage states and cities to pass tailor-made bills and …

The Use Of Regular Militaries For Natural Disasters After A Major Event Where The Military Was Seen As A Failure - The Somalia Effect In The Age Of Black Lives Matters And Covid-19, Donald D.A. Schaefer

Fordham Environmental Law Review

This is written as a continuation of Dr. Schaefer’s recent article entitled, “The Use of the Regular Militaries for Natural Disaster Assistance: Climate Change and the Increasing Need for Changes to the Laws in the United States, China, Japan, the Philippines, and Other Countries.” 2 Perhaps few other areas have affected so many people than the Covid-19 pandemic. Coupled with this has been the struggle over the use of force by the military and police in the age of “black lives matters” and the movements that have been transpired as a result. With the increased global warming likely to continue …

Innovative Regulatory And Financial Parameters For Advancing Carbon Capture And Storage Technologies, Zen Makuch, Slavina Georgieva & Behdeen Oraee-Mirzamani

Fordham Environmental Law Review

No abstract provided.

Lessons From Renewable Energy Diffusion For Carbon Dioxide Removal Development, Anthony E. Chavez

Fordham Environmental Law Review

No abstract provided.

Regaining Control Over The Climate Change Narrative: How To Stop Right-Wing Populism From Eroding Rule Of Law In The Climate Struggle In India, Binit Agrawal

Fordham Environmental Law Review

No abstract provided.

Textiles As A Source Of Microfiber Pollution And Potential Solutions, Lea M. Elston

Fordham Environmental Law Review

No abstract provided.

Towards A Human Right To Food: Implications For Urban Growing In Baltimore City, Maryland, Becky L. Witt

Fordham Urban Law Journal

No abstract provided.

Making Sense Of Drug Regulation: A Theory Of Law For Drug Control Policy , Kimani Paul-Emile

Faculty Scholarship

This article advances a new theory of drug regulation that addresses two previously unexamined questions: how law-makers are able to regulate drugs differently irrespective of the dangers the drugs may pose and independent of their health effects, and the process followed to achieve this phenomenon. For example, although tobacco products are the leading cause of preventable death in the U.S. they can be bought and sold legally by adults, while marijuana, a substantially safer drug, is subject to the highest level of drug control. This article posits a conceptual model for making sense of this dissonance and applies this model …

The Fordham Law Drug Policy Reform Project: America's Oldest War: The Efficacy Of United States Drug Policy, John Nicholas Iannuzzi, Graham Boyd, Asa Hutchinson

Fordham Urban Law Journal

The Fordham Law Drug Policy Reform Project planned and executed the debate, "America's Oldest War: The Efficacy of United States Drug Policy," on April 23, 2002 at the end of the organization's first year. The goal of the debate was to bring to one forum the leading voices at both ends of the drug policy spectrum. Professor John Nicholas Iannuzzi moderated, giving each speaker three minutes to answer each question from the floor. Over one hundred and twenty professionals, students, and community members attended the debate.

Engaging The Debate: Reform Vs. More Of The Same, Kevin B. Zeese

Fordham Urban Law Journal

This Essay dispels common myths put forward by drug war advocates and describes more effective alternatives available than present policy contemplates. We all want to prevent adolescent drug abuse, protect the health and safety of the community, deny drug profits to terrorists and other criminals, and develop a drug policy that works and is based on our common humanity, as well as on research and reality, rather than myth and rhetoric. The essential paradigm shift that needs to occur is to move away from a policy dominated by law enforcement . . . and toward a policy based on public …

Report Of The Task Force On The Use Of Criminal Sanctions To The King County Bar Association Board Of Trustees

Fordham Urban Law Journal

The King County formed the Task Force on the Use of Criminal Sanctions as part of the King County Bar Association's Drug Policy Project to examine current criminal sanctions related to the non-medical use of drugs both in Washington and on the federal level. The founders charged the Task Force with the goal of assessing the effectiveness of criminal sanctions in reducing both illegal drug use and drug-related crime, and assessing the public costs associated with the use of criminal sanctions. The Task Force drew specific conclusions regarding the state response to drug use and the provision of drug addiction …

An Effective Drug Policy To Protect America's Youth And Communities, Asa Hutchinson

Fordham Urban Law Journal

Drug abuse and addiction, and the government's response to these problems, are frequently and appropriately a topic for public debate. Law enforcement has made significant advances in both reducing the number of people using illegal drugs and in the fight against traffickers. Legalization of illegal drugs would not elinate the black market or eliminate drug-related violence. The facts on the issue make a strong case for a national policy geared toward effective drug abuse education and prevention, and treatment for people dependent on illegal drugs. Our nation should also continue to conduct research to determine the most effective means of …

Drug Policy Alternatives- A Response From The Bench, John Curtin

Fordham Urban Law Journal

The article begins by discussing the tremendous financial and social cost incurred by drug use and regulation. It then discusses some positive efforts to deal with the problem such as legalization and decriminalization. The article then states that it will take time to figure out the extent of legalization needed, and until that is figured out we need to focus efforts on harm reduction. The article then addresses whether the constitution bans drugs at all. Finally, the article concludes by stating that we can never hope to fully eliminate drug use, we can only hope to contain it, and gives …

Our Drug Laws Have Failed - So Where Is The Desperately Needed Meaningful Reform?, David C. Leven

Fordham Urban Law Journal

The article begins by stating that the harsh drug laws of New York have failed to have an effect on the amount of drug dealers and instead have led to overcrowding of prisons with non-addict drug users. It states that the laws must be modified to give greater sentencing to judges, increasing diversion of non-violent offenders to rehabilitation. The article then delineates the problems resulting from current drug law and the criticism thereof. It then states the attempted reforms of drug laws that have been insufficient. The article concludes by suggesting proposals to solve the problems delineated, including proportionate sentences, …

Thinking About Drug Law Reform: Some Political Dynamics Of Medicalization, Fredrick Polak

Fordham Urban Law Journal

The article begins by stating that many people believe that medicalization offers the most reasonable approach to drug policy because it offers a dignified approach to treatment of addicts. However, it risks being a form of repression itself because it may define abstinence as the only acceptable treatment outcome. The article then explores the position of the medical profession in drug policy. It then looks at the negative political and social aspects and consequences of an abstinence-directed medicalization policy. The article concludes by stating that if abstinence is always the treatment goal then medicalization will be even less voluntary and …

From Free Trade To Prohibition: A Critical History Of The Modern Asian Opium Trade, Alfred W. Mccoy

Fordham Urban Law Journal

The article begins by exploring America's current war on drugs and how it represents a misuse of its power and misperception of the global narcotics trade. It continues and puts forth that Asia's opium production may soon increase to levels that will defeat the war on drugs now being waged by the United State and United Nations and goes into the the extent of Opium production in Asia. It then looks at a history of Opium trade, including the era which began prohibition and then the cold war, which began the expansion of the Asian opium trade. The article then …

Is Our Drug Policy Effective, Jefferson M. Fish

Fordham Urban Law Journal

The article begins by stating that the time has come for a reexamination of our drug policy. It continues by discussing the two day conference "Is Our Drug Policy Effective?" "Are There Alternatives?" organized by several committee's. Because of space constraints, the article mainly delves into two topics, certain substances both licit and illicit with regard to both their physiological effects and the policies governing them, and also the disproportionate emphasis placed by the war on drugs on combating marijuana. The article then gives summaries of the speakers at the conference. These include: Objectives of our drug policy, overviews of …

Institutionalizing Innovation: The New York Drug Court Story, John Feinblatt, Greg Berman, Aubrey Foxx

Fordham Urban Law Journal

The article begins by discussing the problems that drug use is causing in the American Criminal Justice System. The article then discusses the use of "drug courts," which have proven effective in reducing drug use and recidivism. It then looks at the potential benefit of drug courts to the criminal justice system and states some of the questions pertaining to drug courts, such as limits and the requirement of specialized judges. The article concludes by looking at what critics have said about the use of drug courts, and by stating that the drug court idea is worth trying.

Charleston Policy: Substance Or Abuse, The , Kimani Paul-Emile

Faculty Scholarship

In 1989, the Medical University of South Carolina (MUSC) adopted a policy that, according to subjective criteria, singled out for drug testing, certain women who sought prenatal care and childbirth services would be tested for prohibited substances. Women who tested positive were arrested, incarcerated and prosecuted for crimes ranging from misdemeanor substance possession to felony substance distribution to a minor. In this Article, the Author argues that by intentionally targeting indigent Black women for prosecution, the MUSC Policy continued the United States legacy of their systematic oppression and resulted in the criminalizing of Black Motherhood.