Food and Drug Law Commons^™

Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh

Elisabeth Haub School of Law Faculty Publications

Eco-labels present a promising policy tool in the effort to achieve sustainable consumption. Many questions remain, however, about the extent to which eco-labels can contribute to sustainability efforts and how to maximize their effectiveness. This Article deploys research from evolutionary psychology, behavioral law and economics, and norm theory to offer specific insights for the design and implementation of eco-labels to enhance their influence on sustainable consumer choice. Notably, this research suggests possibilities for eco-labels to shape or expand consumer preferences for green goods, and thereby enhance eco-label influence on consumer behavior by extending it beyond eco-minded consumers. We suggest that …

The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly

Washington and Lee Law Review

No abstract provided.

Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman

Washington and Lee Law Review

No abstract provided.

Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck

SMU Science and Technology Law Review

No abstract provided.

What Is Useful And Novel? The Collision Between Intellectual Property Protection And Regulation Regarding Medical Devices, James Sutherland

Cybaris®

No abstract provided.

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 …

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 …

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 …

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common …

Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney Ii, Katherine E. Legel

Marquette Law Review

None

School Of Law Faculty And Professional Staff, Journal Editors

Journal of Food Law & Policy

No abstract provided.

The Blight Of The Bumblebee: How Federal Conversation Efforts And Pesticide Regulations Inadequately Protect Invertebrate Pollinators From Pesticide Toxicity, Emily Helmick

Journal of Food Law & Policy

This article explores the Endangered Species Act's conservation efforts towards the Rusty-Patched Bumblebee as a case study that highlights the gaps in protections afforded to invertebrate pollinators. It focuses on how the law does not adequately protect endangered invertebrate pollinators from inadvertent pesticide poisoning and introduces the threat that this poses to our food system.

Comments On The World Bank’S Draft Guidance Note For Borrowers Ess5: Land Acquisition, Restrictions On Land Use And Involuntary Resettlement, Columbia Center On Sustainable Investment

Columbia Center on Sustainable Investment Staff Publications

In December 2017, CCSI sent comments to the World Bank regarding its Draft Guidance Note for Borrowers ESS5: Land Acquisition, Restrictions on Land Use and Involuntary Resettlement.

CCSI’s overarching comments on the Guidance Note were that:

• Its description of affected persons and their rights contradicts and undermines international consensus on land governance supported by the Bank
• It fails to provide any guidance on when involuntary resettlement should be considered unavoidable or how Borrowers can prioritize project designs that actually minimize displacement or other harms
• It fails to put rights-holders (or “affected stakeholders”) at the center of solutions
• Its discussion of …

Food Law & Policy: An Essential Part Of Today's Legal Academy, Emily M. Broad Leib, Baylen J. Linnekin

Journal of Food Law & Policy

This Article updates the authors’ seminal 2014 Wisconsin Law Review article, "Food Law & Policy: The Fertile Field’s Origins and First Decade," which was the first scholarly work to detail the fascinating origins and explosive growth of the legal field of Food Law & Policy. Using the same ten criteria the authors developed to measure the growth of Food Law & Policy for the 2014 article, this Article measures and details the field’s impressive growth since that time.

Journal Of Food Law & Policy - Fall 2017, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Editoral Board, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

The Fda's Guidance On Dietary Supplement Naming And The Emperor's New Clothes, Neal D. Fortin

Journal of Food Law & Policy

In 2016 the FDA revised the agency’s guidance on dietary supplement labeling. This modification permits the term “dietary supplement” be the entire statement of identity for a dietary supplement. This is an error in the interpretation of the plain language of the Food, Drug, and Cosmetic Act, the plain language of 21 C.F.R. § 101.3(g); and does not comport with numerous rules of statutory interpretation. Moreover, this change violates the Administrative Procedures Act and the FDA’s rules on notice and comment. This change is a disguised rescission of 21 C.F.R. § 101.3(g) without a proper opportunity for the public to …

The Role Of Non-Profit Organizations In Shaping Food Law And Corporate Responsibility In The United States, Melissa M. Card

Journal of Food Law & Policy

This article assesses whether the United States should adopt an institutional process similar to Europe’s through giving non-profit organizations a role in shaping food law and corporate responsibility. Part I provides a comparative analysis of genetically engineered product regulations in the US and the EU. Part II explains how the institutional processes of the US and the EU led to the varying regulations. Part III asserts that the United States should change its institutional process through allowing public universities and private colleges to influence food law and corporate responsibility.

Small Sustainability Supply: How Small Business And Lean Manufacturing Can Change Supply Chains, Carlos Lopez

Sustainable Development Law & Policy

No abstract provided.