Food and Drug Law Commons^™

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study of …

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 …

Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi

Faculty Publications

The passage of the Comprehensive Addiction and Recovery Act of 2016 evidences a shift in federal legislative support from criminal justice oriented legislative alternatives to more health oriented legislative alternatives to addressing the ongoing Opioid Epidemic. Such a shift was preceded by a redefinition of problem drug use in the policy discourse from an issue of deviancy to a health issue. However, the redefinition of problem drug use as a health issue, has been dominated by policy narratives and causal stories that do not define problem drug use in a manner that aligns with a multi-modal public health oriented legislative …

Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines

Nevada Law Journal

No abstract provided.

Constructing A "Creative Reading": Will Us State Cannabis Legislation Threaten The Fate Of The International Drug Control Treaties?, Michael Tackeff

Vanderbilt Journal of Transnational Law

While marijuana remains illegal at the federal level in the United States, state-level efforts to legalize cannabis have gained enormous momentum in recent years. The federal government, which possesses only limited power to stop this trend, has responded by grudgingly allowing such efforts to proceed, maintaining that its inaction on the issue comports with the international drug control regime. This presents a particularly complex problem for international policymakers and legal scholars, who worry that this state-federal conflict may render international drug treaties meaningless. This Note argues that the federal government's strategy is a productive lens through which to view an …

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 …

What Motivates Legislators To Act: Problem Definition & The Opioid Epidemic, A Case Study, Taleed El-Sabawi

Faculty Publications

This article explores why federal legislators may have been motivated to treat the current opioid crisis as a health issue, when past drug problems have been treated as a criminal justice issue. Using theories from political science, policy studies and sociology, this article summarizes leading theories of legislative behavior and applies them to the current opioid crisis, in an effort to better understand what motivates legislators to enact legislation to solve pressing social problems in a way that reframes the problem. Part II of this article provides an overview of the Comprehensive Addiction and Recovery Act, its significance, and how …

Using The Public Nuisance Doctrine To Combat Antibiotic Resistance, Amanda Purcell

American University Law Review

No abstract provided.

The Demise Of Drug Design Litigation; Death By Federal Preemption, Aaron D. Twerski

American University Law Review

No abstract provided.

Pharming Out Data: A Proposal For Promoting Innovation And Public Health Through A Hybrid Clinical Data Protection Scheme, Lea M. Gulotta

Vanderbilt Journal of Transnational Law

The pharmaceutical industry, one of the largest industries in the world, is rapidly becoming globalized. Clinical trials, which are required for drugs to be approved for human use, are increasingly performed outside of the pharmaceutical company's home country in an attempt to save money. This is mainly due to drug development's steep costs, and the high risks involved in an industry where only 12 percent of products that begin development ever make it to market. In order to help offset these risks and encourage innovation, many countries offer clinical trial data certain protections through patents, market exclusivity, or trade secret …

Guns N' Ganja: How Federalism Criminalizes The Lawful Use Of Marijuana, Ira P. Robbins

Scholarly Articles in Law Reviews & Journals

Federalism is a vital tenet of our Republic. Although federal law is the supreme law of the land, our Constitution recognizes the integral role that state law plays in the national scheme. Like any pharmaceutical drug that withstands rounds of clinical testing, state law functions as a laboratory in which Congress can evaluate and potentially adopt novel policies on a nation-wide basis. Most of the time, federal and state law exist harmoniously, complementing one another; other times, however, the two systems clash, striking a dissonant chord.

In the United States, state marijuana laws are currently on a crash course with …

Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik

Vanderbilt Journal of Entertainment & Technology Law

How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …