Food and Drug Law Commons^™

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

A Case For United States Overhaul Of Its Current Biotechnology Regulation Scheme Through The Implementation Of Biotechnology-Specific Legislation To Clarify Existing Uncertainties Seen In The Collective Framework, Jordan Emmert

Cardozo International & Comparative Law Review

The U.S. biotechnology regulatory framework, established by the 1986 Coordinated Framework and its 1992 Update, is outdated and insufficient to address modern biotechnology products, particularly genetically modified organisms (GMOs). While efforts such as the Obama Administration’s 2015 Memorandum and the 2016 Update aimed to modernize the system, they failed to resolve jurisdictional ambiguities and regulatory gaps, leading to inconsistent agency enforcement and public distrust. The note argues that updating the statutory framework is essential to align U.S. regulations with international norms, ensure public safety, and maintain global competitiveness.

Administering Health Innovation, Rachel E. Sachs

Cardozo Law Review

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent and Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly …

The Antitrust Duty To Charge Low Prices, Ramsi A. Woodcock

Cardozo Law Review

Over the past forty years, antitrust has come to embrace a goal of consumer welfare maximization that cannot be achieved solely through condemnation of collusive or exclusionary conduct. To address cases in which firms achieve the power to raise prices and harm consumers without engaging in collusive or exclusionary conduct, antitrust should impose a general duty on businesses to charge a price no higher than economic cost. Courts would not need to set prices to enforce this duty, because violations would be punishable only by nominal damages, and shame, rather than by an injunction setting a reasonable price. Although the …

How Subterranean Regulation Hinders Innovation In Assisted Reproductive Technology, Myrisha S. Lewis

Cardozo Law Review

Most scholars believe assisted reproductive technology is subject only to minimal regulation, especially by the federal government. This belief I contend, is wrong. In this Article, I examine agency documents, statements by officials, and letters that the U.S. Food and Drug Administration (FDA) has sent to physicians and researchers over the past fifteen years to reveal an overlooked regulatory program. The FDA has been targeting new forms of assisted reproductive technology that involve small genetic modifications (advanced assisted reproductive technologies or AARTs) through regulatory actions that receive little public, media, or scholarly attention. I term this method of regulation "subterranean …

Union Co-Ops And The Revival Of Labor Law, Ariana R. Levinson

Cardozo Journal of Conflict Resolution

This article, as the first to identify and suggest solutions for the numerous labor law issues that must be addressed when establishing a union co-op, contributes to the existing literature on workerownership and cooperative economics. This article proceeds in four sections. The first section provides background about what union co-ops are, why unionization makes sense in the co-op setting, and the initiative to scale up union cooperatives. The second section, drawing on original interview data, provides background about the Cincinnati Union Co-op Initiative and Our Harvest, the first union worker-owned co-op that the Cincinnati Union Co-op Initiative incubated. The third …

Utilizing Adr As A Vehicle For Effective Communication And Success Of Payment In Urgent Care, Stephanie R. Goldberg

Cardozo Journal of Conflict Resolution

Section II of this Note provides background on urgent care and ADR. Section III will elaborate on current payment procedures and explain some of the pitfalls that create a need for a supplementary payment solution. Section IV lays out a four-step plan incorporating a logical progression of ADR techniques that would enable quality of care and ease and success of financial arrangements, and vastly improved patient-provider relations. The feasibility of this plan will be demonstrated through application of its steps to hypothetical examples, representative of various realistic patient experiences, in Section V. This plan is intended to aid the millions …

The Penal Construction Of Drug-Related Offenses In The Context Of "Asian Values" - The Rise Of Puntitive Anti-Drug Campaigns In Asia, Michelle Miao

Cardozo International & Comparative Law Review

This article examines the penal construction of drug-related offenses as "the most serious offenses" in the context of "Asian values ". It explains that there are at least three ways in which the serious nature of drug-related criminality is constructed - populism, moral culpability and security - all of which are deeply embedded in the political culture and practices in Asian countries which adopt a punitive approach to drug-related offenses. The article explores social and political discourses in support of state reliance on harsh penal sanctions to tackle complex drug-related problems. It shows that these discourses are frequently exploited and …

A Legal Approach To Combating Terrorist Organization Funding Through The Counterfeit Market, Amanda Kusnierz

Cardozo International & Comparative Law Review

The note argues that counterfeiting has become a critical funding mechanism for terrorist organizations, particularly radical Islamic jihadist groups, due to its profitability and relative anonymity. Current legal frameworks, such as the Anti-Counterfeiting Trade Agreement (ACTA) and material support laws like section 2339B of the USA PATRIOT Act, are insufficient to address this threat effectively. The analysis highlights the need for stricter penalties, increased consumer awareness, and international cooperation to disrupt the financial networks supporting terrorism through counterfeiting.

From Pay-For-Delay To Product Hopping: The Limited Utility Of Antitrust Law In The Pharmaceutical Industry, Joseph Fielding

Cardozo Law Review

The note examines the intersection of patent law and antitrust policy, particularly in the context of pharmaceutical drug competition. It argues that while antitrust enforcement is an effective solution to address "pay-for-delay" agreements, it is less suitable for resolving "product-hopping" issues. Instead, the article contends that closing regulatory loopholes in the Hatch-Waxman framework would be a more effective approach to curbing anticompetitive product-hopping practices. The analysis focuses on two key cases—Federal Trade Commission v. Actavis, Inc. and Schneiderman v. Actavis LLC—to illustrate the legal and economic implications of these strategies.

Up In Smoke? Unintended Consequences Of Retail Marijuana Laws For Partnerships, Lauren A. Newell

Cardozo Law Review

The article examines the legal challenges faced by partnerships in Colorado's retail marijuana industry due to the conflict between state and federal laws. While Colorado has legalized marijuana, federal law continues to classify it as illegal, creating uncertainty and risks for partnerships operating in this sector. The illegal purpose doctrine and preemption issues further complicate the legal landscape, threatening the validity and protections of such partnerships. The analysis highlights the need for legislative or judicial solutions to address these conflicts and provide clarity for businesses.

Religion In The Time Of Measles: Prescriptions For Minimizing The Public Health Threats Associated With Religious Exemptions From Mandatory Vaccinations, Victor Diego Gonzalez

Cardozo Public Law, Policy & Ethics Journal

The note examines the legal and public health tensions surrounding childhood vaccination mandates, emphasizing the balance between individual rights and societal interests. It argues that while states have the authority to compel vaccinations under their police powers, the proliferation of nonmedical exemptions, particularly philosophical ones, undermines herd immunity and public health. The analysis advocates for stricter criteria for religious exemptions and educational measures to address vaccine hesitancy, while cautioning against eliminating religious exemptions entirely to avoid public backlash.

Is It Time To Pay Attention? Critiquing The Cognitive Enhancement Drug Policies And Appeals Process In United States Collegiate Sports, David Swiedler

Cardozo Journal of Conflict Resolution

This Note examines PED use in college sports, focusing primarily on cognitive enhancing drugs as an example of a common lethal PED, and the current NCAA drug-testing regulations and disciplinary process to explore its efficiency and fairness. Then, the Note proposes changes to the NCAA protocol, specifically changes to the appeals process for student-athletes who fail drug tests for PED use and request a review of the disciplinary actions taken against them by the NCAA.

Abilify, Brintellix, Champix: The Abcs Of Fda Proprietary Name Disputes, M. Dinora Smith

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Product Hopping: Antitrust Liability And A Per Se Rule, Justine Amy Park

Cardozo Arts & Entertainment Law Journal

No abstract provided.

What’S Wrong With Sentencing Equality?, Richard A. Bierschbach, Stephanos Bibas

Articles

Equality in criminal sentencing often translates into equalizing outcomes and stamping out variations, whether race-based, geographic, or random. This approach conflates the concept of equality with one contestable conception focused on outputs and numbers, not inputs and processes. Racial equality is crucial, but a concern with eliminating racism has hypertrophied well beyond race. Equalizing outcomes seems appealing as a neutral way to dodge contentious substantive policy debates about the purposes of punishment. But it actually privileges deterrence and incapacitation over rehabilitation, subjective elements of retribution, and procedural justice, and it provides little normative guidance for punishment. It also has unintended …

The Death Penalty Experiment: State-Sanctioned Laboratories Of Death, Steffi Yellin

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

High Time For Change: How Legalizing Marijuana Could Help Narrow The Racial Divide In The United States, Gene Taras

Cardozo Journal of International and Comparative Law

The note argues that legalizing marijuana in the United States could significantly reduce the racial disparities perpetuated by the war on drugs. It traces the origins of marijuana prohibition to racially motivated policies and highlights how these laws disproportionately affect minority communities. By examining international models and domestic legalization efforts, the article suggests that ending prohibition could address systemic inequities and generate economic benefits.

Keeping It In The Kitchen: An Analysis Of Intellectual Property Protection Through Trade Secrets In The Restaurant Industry, Sarah Segal

Cardozo Law Review

No abstract provided.

Classwide Arbitration: A Method Of Resolving The "Natural" Food Label Litigations, Angelina Dalia

Cardozo Journal of Conflict Resolution

This Note discusses how classwide arbitration in food labeling disputes can better serve as a resolution method for both parties. Part I will review the current legal landscape surrounding food labeling litigations and the limitations of the FDA's regulatory and enforcement power. It will analyze how the lack of regulation has led to the recent surge in food labeling class actions. Part II will introduce the general benefits and downfalls of mandatory arbitration in comparison to litigation as a means of legal remedy. Furthermore, it will describe the recent trend of incorporating mandatory arbitration clauses and class action waivers in …

Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Introductions, Tatsuya Adachi

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Taxing Legalized Marijuana: How Courts Should Treat Drug Tax Statutes In Light Of The Fifth Amendment's Self-Incrimination Clause And Executive Non-Enforcement Of The Controlled Substances Act, Joseph A. Goldstein

Cardozo Law Review

No abstract provided.

Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck

Cardozo Law Review

While the American public remains preoccupied with the lurching implementation of the Affordable Care Act, the regulation of pharmaceutical companies for their off-label marketing and promotion of drugs features a regulatory environment within the health industry that seems to be in wild flux. Following the Second Circuit's decision in United States v. Caronia, commentators and providers are unsure about the future of federal regulation in this area, with the FDA seeking to minimize the opinion and pharmaceutical companies celebrating its impact. Much of the understandably spirited reaction to the Caronia case has omitted a discussion of the relevant and …

On The Permanence Of Permanent Law: An Argument For The Continued Presence Of The Permanent Law Provisions In The Farm Bill, Kate Giessel

Cardozo Public Law, Policy & Ethics Journal

No abstract provided.

"Pay-For-Delay" Settlements Post-Actavis: Why Mediation Can Tackle The "Unreasonable" Antitrust Settlements, Sheena Ching

Cardozo Journal of Conflict Resolution

This Note discusses the benefits that mediation can have on the reverse payment settlement and antitrust debate, and how it can satisfy the "rule of reason" requirement post-Actavis. Accordingly, Section II discusses the legislative history and policy of the Hatch-Waxman Act. It elaborates on the pioneer drug development process and how the combination of legislation and the inherent nature of drug development resulted in "pay-for-delay" settlements. Section III discusses majority and dissenting opinions in the landmark Supreme Court case FTC v. Actavis as well as the circuit split decisions that led up to the Court's ultimate ruling and …

Depressing Diagnosis: Stringent Particularity Requirement Of The Rule 9(B) Pleading Standard As A Critical Bar To Off-Label Promotion Fraud Whistleblowers, Emily T. Chen

Cardozo Law Review

No abstract provided.

Gene Patents In The Wake Of Association For Molecular Pathology V. Myriad Genetics, Inc.: An International Perspective On Pharmacogenomics, Stephanie S. Lim

Cardozo Journal of International and Comparative Law

Now that the Supreme Court of the United States has held that isolated DNA fragments are not patentable subject matter under 35 U.S.C. §101 in Association for Molecular Pathology v. Myriad Genetics, Inc., thousands of existing isolated gene patents can be invalidated. In the European Union, by contrast, patent protection for human genetic sequences has always been strong and the BRCA gene patents at issue in Myriad are still valid in the European Union. It remains to be seen how the differential gene patent protection regimes in these developed nations will affect the biotechnology industry.

This Note poses that question …

Brew Free Or Die? A Comparative Analysis Of U.S. And E.U. Craft Beer Regulations, Tammy Lam

Cardozo Journal of International and Comparative Law

The note examines the challenges faced by craft beer brewers and small alcohol producers in the United States and the European Union under current regulatory frameworks, particularly the U.S. three-tier system. It critiques the system for constraining small producer growth while favoring large brewers and suggests that adopting elements of the E.U.'s regulatory approach, which prioritizes public health and advertising regulation, could foster growth and promote safe alcohol consumption. The analysis also highlights the need for cultural shifts in U.S. perceptions of alcohol to support smaller producers

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.