Food and Drug Law Commons^™

Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler

Faculty Publications

Recently, a number of states have sought to withdraw or restrain local power. In this Article, which is part of the “Re-Thinking State Relevance” symposium hosted by the Ohio State Law Journal, I write about a state taking the opposite approach, and attempting to affirmatively endow its local governments with additional powers. The state is Maine, and the context is control over local food production and sales. This Article begins by addressing the emergence of the sustainable local foods movement broadly, and reasons for the growth of this movement. It then focuses more pointedly on the food sovereignty movement, considering …

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 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 …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

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 …

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 …

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.

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 …

Regulatory Silence At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

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.

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

Mitchell Hamline Law Review

No abstract provided.

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 …

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 …