Food and Drug Law Commons^™

A New Framework For Drug Pricing Law And Policy, Rachel E. Sachs

Indiana Law Journal

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of drug competition into four steps, each of which must be addressed and each of which elevates different institutional actors to key roles. In …

The Law’S Failure To Protect Our Drinking Water From Pfas, Emily Levine

Indiana Law Journal

How did per- and polyfluoroalkyl substances (PFAS), the forever chemicals known to harm human health and appear in most Americans’ blood, spread so widely in drinking water? Why didn’t someone with the power and knowledge to stop this crisis step in sooner? Simply imposing limits on PFAS levels in public water systems is the bare minimum to protect American drinking water—a necessary step but only the starting point of a long path toward creating a regulatory framework that can withstand the whims of changing presidential administrations and political influences.

     It is too easy for the EPA Administrator, either out of …

Jbs’S Initial Public Offering: Threats To Environmental And Human Rights, Kayla Thompson

Indiana Journal of Law and Social Equality

This paper centers around the decision to be made regarding JBS, the world’s largest meat company, wanting to list shares on the New York Stock Exchange (NYSE), and the environmental and social impacts that could result from the Security and Exchange Commission’s (SEC) approval. JBS has been at the center of various controversies over the last several years, including sourcing cattle from ranches acquired through illegal deforestation, engaging in greenwashing practices, incorrectly reporting greenhouse gas emissions, and engaging in human rights abuses. Many environmental groups have filed complaints with the SEC concerning JBS’s bid to list on the NYSE. The …

Legal Implications Of Digital Health Apps Informing Food Allergy Labeling For Consumers' Health And Privacy Protection, Kathy Keunghee Kim

Maurer Theses and Dissertations

This dissertation examines food allergy labeling’s use in a digital format. Allergy information is typically found on food packaging and containers to help consumers identify individually concerned allergens. Given the critical role that food allergy labels play in preventing unexpected allergic reactions before selecting or consuming food, it is essential to comprehend the labeling descriptions. However, current regulations and laws regarding allergy labeling often confuse consumers due to the existence of mandatory and voluntary Precautionary Allergy Labeling (PAL) categories and the absence of laws and regulations that require allergy information for restaurant meals. Technology companies have introduced digital health and …

Legal, Policy, And Environmental Scholars Discuss Global Food Systems At Indiana Law Symposium, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

The Indiana University Maurer School of Law and its Indiana Journal of Global Legal Studies are hosting scholars from around the country Friday and Saturday (Jan. 19-20) for an interdisciplinary discussion on one of the world’s most prevalent problems—food insecurity.

Data from the World Bank estimate more than 780 million people around the world suffered from chronic hunger in 2022. As climate change affects agricultural production and water accessibility, the problem could worsen in coming years.

“A Fragile Framework: How Global Food Systems Intersect with the International Legal Order, the Environment, and the World’s Populations” will bring together legal, policy, …

Conjuring The Flag: The Problem Of Implied Government Endorsements, Michael Mattioli

Articles by Maurer Faculty

This Article exposes a harmful form of advertising that exploits government actions like patent issuances, FDA authorizations, and trademark registrations. By calling upon the symbolic power of such regulatory approvals—i.e., “conjuring the flag”—marketers deceive consumers, distort competition, and undermine administrative agencies. Using machine-learning techniques to analyze hundreds of ads across multiple media formats, this Article offers the first comprehensive analysis of this pervasive practice. The study reveals that it is especially prevalent in industry settings where consumers are likely to seek reassurance that a product is safe and effective. Specifically, the examples examined show that patents are mentioned frequently in …

Encouraging Public Access To Pharmaceuticals Through Modified Protection Of Clinical Trial Data, Scott M. Nolan Ii

IP Theory

Part I of this Article investigates the development of pharmaceuticals and clinical trial data with a focus on patent and data protection. Part II evaluates the effects of protection and the challenges it poses to widespread public pharmaceutical access. Part III discusses two scholarly approaches to the public access issue that focus on clinical data protection and their associated challenges. In light of these scholarly works, Part IV suggests a new approach to clinical trial data protection that aims to improve public pharmaceutical access while maintaining the incentives to invent for drug developers.

Climate Security Insights From The Covid-19 Response, Mark Nevitt

Indiana Law Journal

The climate change crisis and COVID-19 crisis are both complex collective action problems. Neither the coronavirus nor greenhouse gas (GHG) emissions respect political borders. Both impose an opportunity cost that penalizes inaction. They are also increasingly understood as nontraditional, novel security threats. Indeed, COVID-19’s human cost is staggering, with American lives lost vastly exceeding those lost in recent armed conflicts. And climate change is both a threat accelerant and a catalyst for conflict—a characterization reinforced in several climate-security reports. To counter COVID-19, the President embraced martial language, stating that he will employ a “wartime footing” to “defeat the virus.” Perhaps …

Trust The Science But Do Your Research: A Comment On The Unfortunate Revival Of The Progressive Case For The Administrative State, Mark Tushnet

Indiana Law Journal

This Article offers a critique of one Progressive argument for the administrative state, that it would base policies on what disinterested scientific inquiries showed would best advance the public good and flexibly respond to rapidly changing technological, economic, and social conditions. The critique draws on recent scholarship in the field of Science and Technology Studies, which argues that what counts as a scientific fact is the product of complex social, political, and other processes. The critique is deployed in an analysis of the responses of the U.S. Centers for Disease Control and Food and Drug Administration to some important aspects …

"Just Ice" For Bourbon: The Need For Gis In International Protection Of America's Beloved Spirit, Haley Scott

Indiana Journal of Global Legal Studies

The term "bourbon" has become increasingly popular in markets all over the globe. The popularity of the bourbon trend has been exploited for both labelling liquors and describing nonalcoholic products. Bourbon has several separate definitions, usually differing on the issue of the geographical scope of the spirit's production. The bourbon liquor industry has experienced periods of significant downturn followed by periods of explosive revival, motivated mainly by foreign interest, from countries such as Japan, in the product In the 1970s, Japanese interest in whisky and US bourbon facilitated a resurgence of the then-struggling US bourbon industry. In 2018, production of …

Cannabis Derivatives And Trademark Registration: The Case Of Delta-8-Thc, W. Michael Schuster

Indiana Law Journal

The legal environment surrounding the cannabis industry is ambiguous and constantly changing. While cannabis is prohibited under federal law, a 2018 statute legalized a variant of the cannabis plant (“hemp”) that is low in its most common intoxicating agents. Recognizing this, entrepreneurs began to process hemp to extract and sell chemicals contained therein. Included in this trend is the extraction of Delta-8 Tetrahydrocannabinol (Δ8-THC)—a psychoactive drug with an increasing market presence in states where most cannabis (e.g., “marijuana”) is illegal.

As competition in the Δ8-THC field emerged, firms sought to distinguish their wares through brand recognition and federal trademark registration. …

Mitigating The Effects Of Intellectual Property Colonialism On Budding Cannabis Markets, Hughie Kellner

Indiana Journal of Global Legal Studies

Globalization has reduced barriers to trade, communication, and understanding, opening opportunities that extend far beyond national borders. However, in this bounty of opportunity lie obligations, and often those obligations tie a nation's hands when trying to deal with a problem that arises. One obligation nations face is upholding the United Nations' (UN) decision to prevent the illicit use of cannabis. Another is supporting and following the World Trade Organization's (WTO) near elimination of barriers for companies to bring patent and trademark protection with them into any country they do business with. In a modern globalized economy, if a nation fails …

Putting Paper To Pen: Generation Juul's Case For Harm Reduction, Liz Emanuel

Indiana Law Journal

Part I of this Note soberly explores and delineates the perceived and real threats of vaping for America’s youth, concluding with an analysis of the socioeconomic and developmental health effects of nicotine addiction. Part II delves into the federal government’s response to e-cigarettes as well as the powers and limitations of federal regulation under the Food and Drug Administration’s (FDA) “Deeming Rule” and the potential effectiveness of an increase in the national tobacco purchase age or a federal ban on flavored vaping products. Part III discusses the realistic benefits of taking a harm reduction approach to youth vaping in the …

A Corporate Duty To Rescue: Biopharmaceutical Companies And Access To Medications, Rebecca E. Wolitz

Indiana Law Journal

Controversies regarding the pricing of biopharmaceutical products are pervasive. Patients must choose between treatment and rent, prescriptions go unfilled, and health systems are forced to restrict access to life-saving medications— all because of cost. Though there is often consensus that these issues are problematic, there is disagreement as to what are appropriate solutions and who has responsibility to bring about those solutions. Most efforts to address biopharmaceutical pricing concerns focus on governmental regulation. This Article has a different focus. It provides a legal and normative analysis of a form of corporate self-regulation that could help address access and pricing concerns—a …

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

Indiana Law Journal

Is more information always better? First Amendment commercial speech jurisprudence takes this as a given. However, when information is only available from a self-interested and marketing-savvy pharmaceutical company, more information may simply lead to more misinformation. Notably, doctors are also misled. This can result in public health harms when companies are promoting unapproved uses of prescription drugs that the Food and Drug Administration (FDA) has approved for other purposes—commonly referred to as “off-label” uses. Contrary to judicial presumptions, as well as the presumptions of some doctors and scholars, doctors are not sophisticated enough to always discern what is true versus …

Opioid Policing, Barbara Fedders

Indiana Law Journal

This Article identifies and explores a new, local law enforcement approach to alleged drug offenders. Initially limited to a few police departments, but now expanding rapidly across the country, this innovation takes one of two primary forms. The first is a diversion program through which officers refer alleged offenders to community-based social services rather than initiate criminal proceedings. The second form offers legal amnesty as well as priority access to drug detoxification programs to users who voluntarily relinquish illicit drugs. Because the upsurge in addiction to —and death from—opioids has spurred this innovation, I refer to it as “opioid policing.” …

Pharmaceutical Federalism, Patricia J. Zettler

Indiana Law Journal

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013, Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Wiggle Room: Problems And Virtues Of The Inwood Standard, Rian C. Dawson

Indiana Law Journal

This Note investigates the origins of Inwood that led to the slim opinion with wide influence. It argues that the very vagueness for which scholars and practitioners have decried Inwood is the case's greatest virtue: Inwood provides a flexible standard that has allowed the common law to evolve and address new business models. Part I discusses the origins of contributory infringement in intellectual property. Part II investigates the Inwood case and the climate of trademark law at the time Inwood was litigated. It also dissects the majority opinion and Justice White's concurrance. Part III examines the Inwood standard's evolution at …

Intractable Delay And The Need To Amend The Petition Provisions Of The Fdca, Diana R. H. Winters

Indiana Law Journal

Private party oversight has proven to be ineffective at countering inaction by the Food and Drug Administration (FDA). Inaction when regulation is warranted can put the public at continued and increasing risk of harm, but the failure of private enforcement to compel action reverberates beyond this harm to the interests of individuals. It also diminishes the transparency of agency decision making, lessens the opportunity for public participation, and reduces the interaction between the institutions that oversee agencies. Moreover, the benefits afforded to the administrative process by judicial review are weakened.

This Article analyzes two examples of FDA inertia and compares …

Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings, Gabriella Tzeneva

Indiana Journal of Global Legal Studies

This Note explores the economic and social factors that drive multinational pharmaceutical companies to donate drugs to developing countries and evaluates the effectiveness of such donations in combating medicine shortages. The Note poses that such donations provide necessary economic incentives to drug companies and help curb high medical prices in developed nations while being an essential tool for ameliorating intellectual property requirements imposed by TRIPS. The Note proposes two solutions to further incorporate donations in access to medicine relief efforts and advocates increased international cooperation in the practice.

What's In A Name?: Geographical Indicators, Legal Protection, And The Vulnerability Of Zinfandel, Stephen M. Jurca

Indiana Journal of Global Legal Studies

This note explores the issues countries face when one party allegedly takes unfair economic advantage of foreign competitors in an increasingly global market by broadly interpreting international product labeling laws in its favor. The United States' widespread use of the term "champagne" in its domestic sparkling wine industry is just one example of how "genericide"-the process by which a popular brand name becomes so commonly used that the term is no longer protected by intellectual property law-negatively affects trade relations and hampers economic growth. This note focuses on the dangers of genericide in the marketplace, most specifically, the international wine …

Review, Risk, Legality And Damages, Paul Craig

Articles by Maurer Faculty

No abstract provided.

A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud

IP Theory

No abstract provided.

International Drug Trafficking: A Global Problem With A Domestic Solution, Matthew S. Jenner

Indiana Journal of Global Legal Studies

Forty years ago, the world declared war on drugs. Today, after decades of failing to adequately control drug consumption, an even graver problem has emerged: violent drug traffickers have taken the industry hostage and will stop at nothing to preserve their power. Governments have instituted dozens of programs to dismantle the illicit drug industry, but they have seen only marginal success. One strategy, however, has yet to be fully tested: universal legalization. Universal legalization of all drugs would attack the illicit drug market head-on, destroying the profit incentive for drug traffickers and placing control of the industry in the hands …

Liberty Lost: The Moral Case For Marijuana Law Reform, Eric Blumenson, Eva Nilsen

Indiana Law Journal

Marijuana policy analyses typically focus on the relative costs and benefits of present policy and its feasible alternatives. This Essay addresses a prior, threshold issue: whether marijuana criminal laws abridge fundamental individual rights, and if so, whether there are grounds that justify doing so. Over 700, 000 people are arrested annually for simple marijuana possession, a small but significant proportion of the 100 million Americans who have committed the same crime. In this Essay, we present a civil libertarian case for repealing marijuana possession laws. We put forward two arguments corresponding to the two distinct liberty concerns implicated by laws …

Midwestern Juvenile Drug Courts: Analysis & Recommendations, Nicole A. Kozdron

Indiana Law Journal

No abstract provided.

Fighting Baseball Doping In Latin America: A Critical Analysis Of Major League Baseball's Drug Prevention And Treatment Program In The Dominican Republic And Venezuela, David P. Fidler, Arturo J. Marcano Guevara

Articles by Maurer Faculty

No abstract provided.

Law Meets Food: Breakfast At Hilary's, Fedwa Malti-Douglas

Indiana Law Journal

Symposium on "Law, Morality, and Popular Culture in the Public Sphere" at the Indiana University School of Law-Bloomington, April 6, 2001.

Introduction: Syncopated Sustainable Development (Sustainable Development, Agriculture, And The Challenge Of Genetically Modified Organisms Symposium), John S. Applegate, Alfred C. Aman

Indiana Journal of Global Legal Studies

No abstract provided.

Sustainable Agriculture, Patent Rights, And Plant Innovation, Mark D. Janis

Indiana Journal of Global Legal Studies

No abstract provided.