Food and Drug Law Commons^™

Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher

O'Neill Institute Papers

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted …

Shooting Stars And Dancing Fish: A Walk To The World We Want, Tony Oposa

Environmental Law Program Publications @ Haub Law

From the foreword by Durwood Zaelke, President, Institute for Governance & Sustainable Development, Washington, DC.

“Since the beginning of time, human knowledge and culture have been passed down through stories. Short stories, songs, prayers, poems, even paintings can stick in your mind forever. These have always been the most powerful ways we learn and remember.

Tony is not only one of the world’s greatest lawyers, he is also one of the world’s greatest storytellers.

This book, in which he generously shares his experiences, his scars, and most importantly his humanity, is Tony’s gift to generations to come.

But he does …

Big Pharma Versus Inter Partes Review: Why The Pharmaceutical Industry Should Seek Logical Hatch-Waxman Reform Over Inter Partes Review Exemption, 50 J. Marshall L. Rev. 337 (2017), Francisco Javier Espinosa

UIC Law Review

No abstract provided.

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …

Value Hypocrisy And Policy Sincerity: A Food Law Case Study, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

t is tempting to say that in 2017 there is a unique problem of hypocrisy in politics, where words and behaviors are so often in opposition. In fact, hypocrisy is nothing new. A robust legal and psychological literature on the importance of procedural justice demonstrates a longstanding concern with developing more just governing processes. One of the important features of this scholarship is that it does not focus only on the consequences of policymaking, in which behaviors, but not words, are relevant. Instead, it respects the intrinsic importance of fair process, lending credence not only to votes but also to …

The Uncharted Waters Of Competition And Innovation In Biological Medicines, Erika Lietzan

Faculty Publications

In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines, generally made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life–threatening diseases are biological medicines.

We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition. Scholars and courts considering this question may be tempted to reason from, …

Muddying The Waters: Catfish Inspection Authority Transitions To The Food Safety And Inspection Service, Michelle Johnson-Weider

Journal of Food Law & Policy

The Food and Drug Administration regulates the safety and labeling of almost all food in the United States other than meat, poultry, and egg products, which fall under USDA’s Food Safety and Inspection Service (FSIS). Effective September 1, 2017, FSIS assumed inspection responsibility for catfish after years of Congressional lobbying by the small domestic catfish industry. This article examines how this unlikely legislative victory was won against free trade advocates representing much larger economic interests.

Regulatory Obstacles To Harm Reduction: The Case Of Smoking, Jonathan H. Adler

Faculty Publications

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible …

Mandatory Labeling Of Bioengineered Foods, Andrew Williams

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Weeding Out Social Welfare Organizations And The Public Policy Doctrine, Jake R. Miller

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Avoiding The Chaos Of Maryjane - A Conventional Approach To Intellectual Property Protection Of Marijuana, 17 J. Marshall Rev. Intell. Prop. L. 278 (2017), Kaylee Willis

UIC Review of Intellectual Property Law

Whether you are considering the ever-popular recreational use, or recent medicinal developments, marijuana is a highly discussed controversial substance. With revenue from marijuana into the billions of dollars, it is no wonder it has been trying to reach into the intellectual property arena. This comment specifically looks into the patent arena and the obstacles that come with an attempt to seek, and enforce protection of marijuana-based patent applications. With the USPTO’s plant and utility patent options, there is perhaps more than one way to pass marijuana-based substances as patent-eligible subject matter. The largest obstacle for this type of intellectual property …

Regulating Milk: Women And Cows In France, Mathilde Cohen

Faculty Articles and Papers

Animal milk, most commonly cow’s milk, is one of the most heavily regulated commodities in both France and the United States. With the increasing popularity of breastfeeding and the possibility of pumping, freezing, and storing breast milk, a cottage industry has emerged for people wishing to buy, sell, or donate milk produced by humans. Yet the legal landscape for human milk remains inchoate, prompting public health officials and medical professionals to call for tighter regulation. Animal and human milk are typically viewed as two distinct substances with little in common beyond a name. In contrast, this Article highlights the analogies …

Criminal Law—When Apples Tatse Like Oranges, You Cannot Judge A Book By Its Cover: How To Fight Emerging Synthetic "Designer" Drugs Of Abuse, Andrew Payne Norwood

University of Arkansas at Little Rock Law Review

No abstract provided.

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg

Articles

Currently, twenty-eight states and the District of Columbia allow the use of marijuana for medical purposes and permit the conduct of a business marketing of marijuana for that purpose. Eight of those states and the District of Columbia permit the recreational use of marijuana. There is reason to believe that more states will decriminalize the marketing of marijuana. However, marijuana is listed in Schedule 1 of the federal Controlled Substances Act of 1970 (CSA) which makes it illegal under federal law to manufacture or distribute marijuana even when it is legal to do so under local state law. In a …

What Is The Purpose Of The Orphan Drug Act?, Matthew Herder

Articles, Book Chapters, & Popular Press

The Orphan Drug Act (ODA) [1], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Three decades later, a growing proportion of industry research and development (R&D) [2] and regulatory drug approvals [3] target diseases affecting fewer than 200,000 persons in the United States, the prevalence-based threshold of rare disease under the ODA.

In a new article published in PLOS Medicine, Aaron Kesselheim and colleagues document an embedded trend: within the …

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Moving In Opposite Directions? Exploring Trends In Consumer Demand And Agricultural Production, Susan A. Schneider

Mitchell Hamline Law Review

No abstract provided.

Pasture To Package: Ensuring Food Safety Compliance And Animal Welfare Integrity In Grass-Fed Beef Production, Lauren Manning

Mitchell Hamline Law Review

No abstract provided.

Unburdening The Farm: A Dormant Commerce Clause Challenge To Conflicting Standards In Agricultural Production, Bethany Gullman

Mitchell Hamline Law Review

No abstract provided.

The Craft Brewing Boom And Minnesota's Three-Tier System: The Case For Change, Jeffrey C. O'Brien

Mitchell Hamline Law Review

No abstract provided.

Farming And Eating, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

This essay argues that the “us versus them” rhetoric that dominates food and agriculture policy today drives a wedge between farmers and food consumers. Together, farmers and food consumers could form a powerful coalition to challenge the true obstacle to sustainable and equitable food production: concentration of market and political power elsewhere along the food chain.

Much Ado About The Tpp’S Effect On Pharmaceuticals, Emily Michiko Morris

SMU Science and Technology Law Review

No abstract provided.

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

12 Angry Men V. The Agency: Why Preemption Should Resolve This Conflict In Drug Labeling Litigation, Michelle L. Richards

Marquette Law Review

The Supreme Court has found in favor of preemption in tort liability cases involving matters of heavy federal regulation in which Congress has delegated implementation of a statute involving technical subject matter to the agency. It has not been the case, however, in matters concerning the labeling of prescription drugs, despite the fact that the FDA has exclusively regulated drug labeling for more than a century. In fact, the current state of affairs now allows a jury to substitute the judgment of the FDA in approving a label on a name-brand drug for their own in state law failure to …

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.

The Death Of Private Practice: How The Rising Cost Of Healthcare Is Destroying Physician Autonomy, Oliver Owaid

Brooklyn Journal of Corporate, Financial & Commercial Law

Over the past two decades, the number of physicians in private practice has dropped dramatically. This trend is the result of the financial pressure imposed by the federal government in response to the skyrocketing cost of healthcare. Physicians, frustrated by stagnant reimbursement rates in conjunction with increased administrative costs and overhead, are choosing hospital staff employment in favor of private practice. This trend is to the detriment of the physician, the taxpayers, and, most importantly, the patients. Patients treated in hospital outpatient settings have worse outcomes than those treated in private practice. In addition, hospital procedures cost both the government …