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Articles 1201 - 1230 of 2826

Full-Text Articles in Food and Drug Law

What Motivates Legislators To Act: Problem Definition & The Opioid Epidemic, A Case Study, Taleed El-Sabawi Jan 2018

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 …

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Defining The Opioid Epidemic: Congress, Pressure Groups, And Problem Definition, Taleed El-Sabawi Jan 2018

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 …

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Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown Jan 2018

Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown

Elisabeth Haub School of Law Faculty Publications

In their article, Forging Food Justice Through Cooperatives in New York City, Dan DePasquale, Surbhi Sarang, and Natalie Bump Vena (the “Authors”) argue that consumer-owned and worker-owned cooperatives hold promise as a means for advancing policy objectives associated with “food justice,” namely building community wealth and power and providing more affordable access to healthy food in low-income and minority communities. Looking to examples of legislation and policies in other jurisdictions, they advocate for a wide range of policies to promote the viability of cooperatives in New York City, including reforms to cooperative corporation laws and strategies for better allocating funding …

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Crafting Next Generation Eco-Label Policy, Jason J. Czarnezki, Katrina F. Kuh Jan 2018

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 …

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Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd Jan 2018

Serving Up Allergy Labeling: Mitigating Food Allergen Risks In Restaurants, Marie C. Boyd

Faculty Publications

Allergens in restaurant food cause many allergic reactions and deaths. Yet no federal, state, or local law adequately protects people from these harms. Although federal law requires the labeling of “major food allergens” in packaged food, there are no allergen labeling requirements for restaurant-type food. In addition, existing food safety requirements for restaurants are inadequate to prevent allergen cross contact.

The existing legal scholarship on food allergens in restaurants is limited. Much of the legal scholarship on labeling in restaurants focuses on menu labeling — the provision of calorie and other nutrition information to combat obesity. The requirements of Section …

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“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton Jan 2018

“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton

Articles

As a tide of marijuana legalization sweeps across the United States, there is a surprising lack of scrutiny as to whether the benefits of recreational marijuana outweigh the risks. Notably, marijuana edibles present special risks to the population that are not present in smoked marijuana. States that have legalized recreational marijuana are seeing an increase in edible-related calls to poison control centers and visits to emergency rooms. These negative reactions are especially prevalent in vulnerable populations such as children, persons with underlying preexisting conditions, and out-of-state marijuana novices. Unfortunately, research on edible marijuana is scant and state regulatory regimes are …

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A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan Jan 2018

A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan

Faculty Publications

This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …

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The Opioid Epidemic And Rural American: Why The Usda Should Lead The Response, Lexy Gross Jan 2018

The Opioid Epidemic And Rural American: Why The Usda Should Lead The Response, Lexy Gross

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

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The Off-Label Use Of Pom Wonderful: Using Section 43(A) To Eliminate Misleading Off-Label Drug Promotion, Christopher A. Hurley Jan 2018

The Off-Label Use Of Pom Wonderful: Using Section 43(A) To Eliminate Misleading Off-Label Drug Promotion, Christopher A. Hurley

Washington and Lee Law Review

No abstract provided.

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Delaying Competition: How Sound Public Policy And Rigorous Antitrust Scrutiny Can Be Applied To Controversial Patent Settlements, 17 J. Marshall Rev. Intell. Prop. L. 655 (2018), Sam Hensel Jan 2018

Delaying Competition: How Sound Public Policy And Rigorous Antitrust Scrutiny Can Be Applied To Controversial Patent Settlements, 17 J. Marshall Rev. Intell. Prop. L. 655 (2018), Sam Hensel

UIC Review of Intellectual Property Law

The rising costs of prescription drugs are a growing concern for many Americans. The restraint of trade for pharmaceutical drugs is a cause of rising costs for consumers, as companies seek to push potential competitors out of the market to maintain profits. This unlawful restraint of trade will be discussed in this comment. Specifically, this comment will focus on "Pay for Delay" agreements, mostly between generic versus brand name pharmaceutical manufacturers. The proliferation of these agreements only leads to an unsustainable market that discourages innovation and advancement, and promotes fraud, as invalid patents are used as leverage to prevent generics …

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The Demise Of Drug Design Litigation; Death By Federal Preemption, Aaron D. Twerski Jan 2018

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

American University Law Review

No abstract provided.

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Using The Public Nuisance Doctrine To Combat Antibiotic Resistance, Amanda Purcell Jan 2018

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

American University Law Review

No abstract provided.

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Telemedicine Is The New Narcotics Candy Store: Teladoc Opens The Floodgates For The Unrestricted Sale Of Dangerous Drugs, Madeleine Rosuck Jan 2018

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.

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Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim Jan 2018

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 …

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The United States, Mexico, And The War On Drugs In The Trump Administration, James M. Cooper Jan 2018

The United States, Mexico, And The War On Drugs In The Trump Administration, James M. Cooper

Faculty Scholarship

This Article examines the war on drugs as persecuted by the United States and how it has been exported to Mexico. It also explores the increased efforts in the drugs war that the Trump administration, through the U.S. Department of Justice, is pursuing at a domestic level. Part I of this Article provides an outline of the dynamics in the quickly evolving and highly tense relationship between the United States and Mexico. Part II of this Article details the historical background of the U.S.-Mexico border region and demonstrates that the border has long been a contested site. Part III provides …

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Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd Jan 2018

Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd

Faculty Articles

Recent changes in the pharmaceutical industry have spurred an unprecedented wave of mergers and acquisitions. Some researchers and agencies have questioned whether pharmaceutical consolidation could impede drug innovation. However, as I explain in this Article, these concerns are largely based on an outdated understanding of the drug innovation ecosystem. Whereas a few decades ago almost all drug discovery took place inside traditional pharmaceutical companies, today most drug innovation is externally-sourced from biotech companies and smaller firms. Internal R&D is no longer the primary source, or even an important source, of drug innovation. As a result, analyses that focus on the …

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The Fda's Priority Review Voucher Program's Role In Bringing Benznidazle To Chagas Disease Patients In The United States, Lisa Cline Jan 2018

The Fda's Priority Review Voucher Program's Role In Bringing Benznidazle To Chagas Disease Patients In The United States, Lisa Cline

Cybaris®

No abstract provided.

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Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd Jan 2018

Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd

Faculty Publications

Scholars and other commentators have identified failures in the regulation of cosmetics-which depends heavily on voluntary industry self- regulation-and called for more stringent regulation of these products. Yet these calls have largely neglected an important dimension of the problem: the current laissez-faire approach to the regulation of cosmetics disproportionally places women, and particularly women who are members of other excluded groups, at risk. This Article examines federal cosmetics law and regulation through a feminist lens. It argues that cosmetics law and regulation have lagged behind that of the other major product categories regulated by the Food and Drug Administration under …

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Regulatory Silence At The Fda, Jordan Paradise Jan 2018

Regulatory Silence At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

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Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise Jan 2018

Exploring Precision Fda, An Online Platform For Crowdsourcing Genomics, Jordan Paradise

Faculty Publications & Other Works

The U.S. Food and Drug Administration has created an online platform for the next generation sequencing community, enabling users to evaluate biomarker information and share resources. This article examines this online platform and offers several observations about potential legal and regulatory implications.

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Drug Pricing—The Next Compliance Waterloo, Seth Whitelaw, Nicodemo Fiorentino, Jennifer O'Leary Jan 2018

Drug Pricing—The Next Compliance Waterloo, Seth Whitelaw, Nicodemo Fiorentino, Jennifer O'Leary

Mitchell Hamline Law Review

No abstract provided.

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The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly Jan 2018

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

Washington and Lee Law Review

No abstract provided.

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Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman Jan 2018

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.

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What Is Useful And Novel? The Collision Between Intellectual Property Protection And Regulation Regarding Medical Devices, James Sutherland Jan 2018

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

Cybaris®

No abstract provided.

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Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines Jan 2018

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.

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Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen Jan 2018

Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen

Articles

In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …

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All Is Fair In Drugs And War: An Analysis Of "Pay-For-Delay" Agreements And Product Hopping, Sean Boyle Jan 2018

All Is Fair In Drugs And War: An Analysis Of "Pay-For-Delay" Agreements And Product Hopping, Sean Boyle

Valparaiso University Law Review

No abstract provided.

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Union Co-Ops And The Revival Of Labor Law, Ariana R. Levinson Jan 2018

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 …

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Constructing A "Creative Reading": Will Us State Cannabis Legislation Threaten The Fate Of The International Drug Control Treaties?, Michael Tackeff Jan 2018

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 …

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Pharming Out Data: A Proposal For Promoting Innovation And Public Health Through A Hybrid Clinical Data Protection Scheme, Lea M. Gulotta Jan 2018

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 …

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