Food and Drug Law Commons^™

If Hard Drugs Were Legalized, Would More People Use Them?, David Borden

Cardozo Public Law, Policy & Ethics Journal

The article argues that criminal prohibition of drugs, including heroin, cocaine, and marijuana, causes significant harms such as public health crises, violent criminal activity, and civil liberties violations. It challenges predictions that legalization would lead to greatly increased drug use or harm, citing evidence that other factors, such as availability and social stigma, play a larger role in drug use decisions. The author advocates for ending prohibition and replacing it with regulation and public health programs tailored to each drug, emphasizing that legalization could reduce both individual and societal harm.

Failing To Warn In The Context Of Rare Side Effects, Morris Dweck

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

Depicting The Graphic Truth: The Heated Controversy Over Cigarette Warning Labels And The Boundaries Of First Amendment Protection, Brian Fedele

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

Unequal Protection Under The Law: Why Fda Should Use Negotiated Rulemaking To Reform The Regulation Of Generic Drugs, Marie Boyd

Cardozo Law Review

The duty to ensure the safety of drug products, through adequate warnings or other means, should ultimately rest with the drug's manufacturer regardless of whether the drug is a generic drug or a brand-name drug. Recent U.S. Supreme Court holdings, however, suggest that while the manufacturer of a brand-name drug is always responsible for its label's content, this is not the case for generic drugs. In addition, by holding that failure-to-warn claims against generic drug manufacturers based on state law are preempted, the Court has removed the protections and compensation that state tort law can provide consumers of generic drugs …

Rebalancing Pay-For-Delay: Why No-Authorized Generic Agreements Should Be Subject To Higher Antitrust Scrutiny, David C. Kurlander

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Examining The § 271(E)(1) Safe Harbor Of The Hatch-Waxman Act: A Legislative Proposal Granting Mandatory Post-Marketing Exceptions, Jessica Chao

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Fair Or Foul? Major League Baseball's Use Of A Tortious Interference Lawsuit As A Means Of Investigation, Michael S. Beck

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Pregnant Pause: The Exclusion Of Pregnant Women From Clinical Research As Sex Discrimination, Richard M. Weinmeyer

Cardozo Journal of Equal Rights & Social Justice

The article argues that the exclusion of pregnant women from clinical research constitutes sex discrimination. This exclusion, rooted in historical and regulatory factors, has led to a significant lack of data on how medications affect pregnant women, putting their health at risk. The author advocates for legislative action to shift the research culture from exclusion to inclusion, ensuring that pregnant women receive necessary medical treatments with proper research backing.

High Federalism: Marijuana Legalization And The Limits Of Federal Power To Regulate States, David S. Schwartz

Cardozo Law Review

The conflict between state marijuana legalization and the blanket federal marijuana prohibition of the Controlled Substances Act (CSA) has created a federalism crisis in which the duties of state officials to adhere to state or federal law are unclear. Current federalism doctrine cannot even tell us whether or not a local police officer who encounters a person in state-authorized possession of marijuana must arrest the person and seize the marijuana. The two most clearly applicable federalism doctrines - the Tenth Amendment anti-commmandeering doctrine and federal preemption of state law under the Supremacy Clause - offer only unsatisfactory answers. Anti-commandeering doctrine …

Alcohol And Obesity Law In Canada, The United Kingdom, And Australia, M. Neil Browne, Nancy K. Kubasek

Cardozo Journal of International and Comparative Law

The article examines the legal frameworks governing disability discrimination related to alcohol dependence and obesity across Canada, the United Kingdom, and Australia. It highlights the varying degrees of protection afforded to individuals with these conditions under human rights legislation and employment laws. The analysis underscores the tension between recognizing these conditions as disabilities and balancing employer responsibilities, while also exploring the evolving nature of legal protections in light of recent court rulings and shifting societal attitudes.

The Crisis Of Over-Medicating Children In Foster Care: Legal Reform Recommendations For New York, Jessica Setless

Cardozo Journal of Equal Rights & Social Justice

No abstract provided.

Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes

Cardozo Journal of Equal Rights & Social Justice

The note argues that front-of-package (FOP) labeling on children's food products is insufficient and often misleading, failing to meet basic nutritional standards. It advocates for the adoption of uniform, science-based labeling standards developed by an objective body like the Institute of Medicine (IOM) to help parents make healthier choices. The analysis highlights the limitations of self-regulation by manufacturers and the need for stronger governmental oversight to address deceptive practices and improve public health outcomes.

Beyond The Core: Incorporating Transnational Crimes Into The Rome Statute, Regina Menachery Paulose

Cardozo Journal of International and Comparative Law

The article argues that the International Criminal Court (ICC) should expand its jurisdiction to include transnational organized crime, such as drug trafficking, counterfeiting, and arms trade, to address the growing global threat posed by these crimes. While the Rome Statute currently excludes such crimes, the ICC’s role as a court of last resort and its independence make it an ideal institution to prosecute transnational organized crime, fostering international cooperation and enhancing deterrence. The article advocates for a unified definition of transnational organized crime and the inclusion of select crimes from the United Nations Convention against Transnational Organized Crime (CATOC) and …

Citizen Petitions: An Empirical Study, Michael A. Carrier, Daryl Wander

Cardozo Law Review

In recent years, brand-name drug companies have engaged in an array of conduct that has delayed generic competition. While some of the activity - such as settlements between brand and generic firms and "product hopping" from one drug version to another - has received attention, another behavior has, until now, flown under the radar.

This Article examines the activity of "citizen petitions." A citizen petition is a request for the U.S. Food and Drug Administration (FDA) to take an action such as evaluating a drug's safety or effectiveness. When used appropriately, it could raise awareness of legitimate concerns with a …

Childhood Obesity: Balancing The Nation's Interest With A Parent's Constitutional Right To Privacy, Denise Cohen

Cardozo Public Law, Policy & Ethics Journal

The note argues that governmental intervention into parental rights regarding childhood obesity is constitutionally justifiable under strict scrutiny, as it serves the compelling interests of both the child's well-being and societal welfare. While the constitutional right to privacy in parenting is fundamental, it is not absolute, and the growing public health crisis of childhood obesity necessitates narrowly tailored measures to hold parents accountable. The analysis proposes that existing legal frameworks, such as neglect statutes, can be effectively applied to address severe cases of childhood obesity, balancing individual rights with public health needs.

Doctors, Patients, And Pills - A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski

Cardozo Law Review

This Article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century; and regulatory necessity due to the limits of science and the innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based on genetic expression). Although both factors have changed immensely, the standard for drug approval …

Introduction, Justin Hughes

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Dynamic Patent Governance In Europe And The United States: The Myriad Example, Kali Murray, Esther Van Zimmeren

Cardozo Journal of International and Comparative Law

This Article examines the emerging elements of a new model for patent governance. It is divided into four parts. In Section One, we develop a model of dynamic patent governance. This model extends the theoretical framework of network governance, to explain the emergence of networks in the decisionmaking infrastructure for the public and private actors in the patent system. Dynamic patent governance widens this theoretical framework in two key ways. First, dynamic patent governance, within its formal dimensions, is based on the idea that heterogeneous administrative actors regulate the grant and enforcement of patents. This challenges a perspective that sees …

The International Control Of Illegal Drugs And The U.N. Treaty Regime: Preventing Or Causing Human Rights Violations?, Daniel Heilmann

Cardozo Journal of International and Comparative Law

The international drug control regime, established to preserve human health and welfare, faces criticism for prioritizing criminalization and punishment over education, harm reduction, and human rights. The regime's prohibition-oriented approach, while comprehensive, is challenged by modern human rights standards and the evolving illegal drug market. The article examines whether the regime remains effective and aligned with contemporary human rights principles, emphasizing the need to balance control measures with human rights protections.

Mary Jane's New Dance: The Medical Marijuana Legal Tango, Michael Berkey

Cardozo Public Law, Policy & Ethics Journal

The note examines the legal and social dynamics surrounding medical marijuana, tracing its historical use, the evolution of regulatory policies, and the ongoing conflicts between federal, state, and local laws. It highlights the shift in societal perception and the growing acceptance of medical marijuana, despite persistent legal challenges.

Did The Mlbpa Strike Out? An Analysis Of Union Liability In Major League Baseball's Anonymous 2003 Steroid Testing, David Adelsberg

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Pharmaceutical Patent Bargains: The Brazilian Experience, Bruno Salama, Daniel Benoliel

Cardozo Journal of International and Comparative Law

In the backdrop of the strict patent regime flatly adopted by the World Trade Organization (WTO) for all countries, a few countries constantly challenge this system through aggressive patent bargains. Within the pharmaceutical sector, noticeably, some countries now threaten to issue or otherwise actually issue compulsory licenses that may sway large pharmaceutical companies into selling drugs with large discounts or into granting voluntary licenses domestically. That is conspicuously the negotiation strategy adopted by Brazil in its negotiations with big international pharmaceutical companies.

This paper explains Brazil's aggressive bargaining approach based on an analysis of two aspects of its political economy. …

Voices From The Field: An Inter-Professional Approach To Managing Critical Information

Cardozo Law Review

No abstract provided.

The Legal Ecology Of Resistance: The Role Of Antibiotic Resistance In Pharmaceutical Innovation, Kevin Outterson

Cardozo Law Review

Antibiotic effectiveness is a common pool resource that can be prematurely depleted through resistance. Some experts warn that we may face a global ecological collapse in antibiotic effectiveness.

Conventional wisdom argues for more intellectual property rights to speed the creation of new antibiotics. Recent theoretical literature suggests that conservation-based approaches may yield superior results. This Article describes a novel typology for organizing these emerging theories and provides an early empirical test of these models using proprietary data on the sales of vancomycin, an important hospital antibiotic for the last three decades.

The results challenge the assumptions in several models and …

Publicity, Pressure, And Environmental Legislation: The Untold Story Of Availability Campaigns, Molly J. Walker Wilson, Megan P. Fuchs

Cardozo Law Review

The availability heuristic - a cognitive rule of thumb whereby events that are easily brought to mind are judged to be more likely - is employed by decision-makers on a daily basis. Availability campaigns occur when individuals and groups strategically exploit this cognitive tendency in order to generate publicity for a particular issue, creating pressure to effect legislative change. This paper is the first to argue that environmental availability campaigns are more beneficial than they are harmful. Because they result in pressure on Congress, these campaigns serve as a catalyst for the enactment of critical new legislative initiatives. Specifically, these …

The Role Of Litigation In Combating Obesity Among Poor Urban Minority Youth: A Critical Analysis Of Pelman V. Mcdonald's Corp., Ashley B. Antler

Cardozo Journal of Equal Rights & Social Justice

The note argues that litigation, particularly when focused on low-income urban minority youth, could serve as a strategic tool to address childhood obesity by reframing the issue and catalyzing policy and industry change. It critiques the Pelman v. McDonald's Corp. lawsuit for failing to address the socioeconomic and racial disparities underlying obesity rates, thereby missing an opportunity to advance meaningful solutions. The analysis suggests that public health litigation, when strategically framed, can complement broader advocacy efforts and push for environmental changes to combat the obesity epidemic.

Steroid Regulation In Professional Sports: Sarbanes-Oxley As A Guide, Sarah R. Heisler

Cardozo Arts & Entertainment Law Journal

No abstract provided.

International Coffee Regulation: A Comparison Of The International Coffee Organization And The Fair Trade Coffee Regimes, Scott B. Weese

Cardozo Public Law, Policy & Ethics Journal

The note examines the challenges in coffee farming due to oversupply and evaluates two regulatory attempts: the International Coffee Organization (ICO) and the Fairtrade Labelling Organization (FLO). While the ICO focuses on sustainability and the FLO on creating demand, both fail to address the root issue of overproduction. The note argues that these efforts are insufficient because they do not reduce supply, suggesting that market correction through producer exit is necessary.

Are We Fighting The Right War?, Alyssa Greenspan

Cardozo Journal of International and Comparative Law

No abstract provided.

State Government Speech In A Federal System, Laura J. Hendrickson

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.