Food and Drug Law Commons^™

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

From Tech To Table: Moving Sustainable Proteins Beyond Marketplace Bottlenecks, Andy Fitch, Cynthia Hanawalt

Sabin Center for Climate Change Law

Climate advocates may hope to see dramatic commercial breakthroughs over the next several decades that reshape emissions-intensive components of our everyday lives, such as our dietary choices, household energy use, and transportation habits. Yet transforming these consumer sectors will require not only scientific ingenuity and entrepreneurial ambition, but also nimble competition policy to address complex market dynamics.

Sustainable food production likely necessitates substantial departure from traditional livestock-management practices. Agricultural production currently generates about one-third of global greenhouse gas emissions (“GHGs”). Animal livestock account for the largest share, while occupying roughly 40% of the Earth’s habitable land, much of which could …

When The Weeds Strike Back: Rethinking Aphis's Regulation Of Genetically Engineered Plants Post-National Family Farm Coalition V. Vilsack, Reagan Powers

Celebrating WCL Student Authors

No abstract provided.

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Probing The Prevalence Of Pharmaceutical Corruption, Marc A. Rodwin

Suffolk University Law School Faculty Works

This article reviews the history and current evidence of systematic pharmaceutical industry corruption.  It draws on studies by the OECD on international corruption; reports of the Securities and Exchange Commission; studies of the Public Citizen health Research Group of settlement agreements between federal and state authorities and pharmaceutical firm; the history of the Medicare and Medicaid Anti-Kickback Act; professional and industry codes of ethics; the literature on institutional corruption; and studies of conflicts of interest.  These sources support findings of systemic corruption since the mid-20th century. The paper also explores the relationship between classic corruption, institutional corruption and conflicts of …

Drug Scheduling As Institutional Design, Matthew B. Lawrence, David E. Pozen

Faculty Scholarship

Controlled Substances Act (CSA), U.S. drug law has simultaneously fueled mass incarceration, inhibited needed access, and enabled an opioid crisis. To make better choices, this Article argues that the CSA’s institutional design must account for three distinctive features of psychoactive drugs: the prohibition problem (drug bans tend to backfire when demand is inelastic), the pharma problem (drug companies have supercharged incentives to manipulate markets and exploit consumers), and the pluralism problem (drug policy involves irreducibly political questions that no expert discipline can answer). On their own, each of these problems calls for reform to the CSA. Taken together, they call …

Hester’S Dubious Roots And Legacy: Open Fields Doctrine Under Scrutiny, Laura K. Donohue

Georgetown Law Faculty Publications and Other Works

For over a century, open fields doctrine has shaped Fourth Amendment law, denying people the right to be secure on their own property. Its application has steadily expanded, with the result that, by some estimates, the Government can now engage in warrantless surveillance of some ninety-six percent of private land and buildings regardless of fences, postings, the distance from public roads or byways, or the use to which the property is put. An originalist approach throws the doctrine into disarray: at the time of the Founding, common law protected the curtilage, which extended to the fields, barns, storehouses, and other …

Legalizing Magic Mushrooms: A Different Set Of Laws For A Different Kind Of Drug, Edward S. Adams

Articles

This Article explores the regulation of the cannabis industry, highlighting its origins, history, and shortcomings. The Article then compares the cannabis and psilocybin industries, arguing against the replication of the cannabis regulatory structure for psilocybin. Instead, this Article will propose tailored regulatory solutions designed to address the unique characteristics of psilocybin and foster a well-regulated, safe, and effective market.

The Ethics Of Industry-Funded Speakers’ Bureaus—How They Disseminate Innovation And Could Corrupt Medicine, Jennifer E. Miller, Christopher Robertson

Faculty Scholarship

It is often said that a business without marketing is dead. But when a medical product is marketed irresponsibly, it is patients who may pay with their lives. In this context, Wieberdink et al¹ examine participation in industry-sponsored speakers’ bureaus by academic clinical faculty, conceptualizing the practice as a form of conflicted and irresponsible pharmaceutical marketing. Reviewing 129 US allopathic medical school conflict-of-interest (COI) policies, they found that less than 40% prohibit industry speakers’ bureau participation outright, while 19% impose conditional restrictions, such as requiring that faculty retain control over presentation content. Wieberdink et al¹ advocate for a …

Agricultural Biotechnology In The Courts: Judicial Opinions And Commentary, Drew L. Kershen

Faculty Articles

Seven jurisdictions from around the world have issued judicial opinions that address fundamental issues about the governance and regulatory systems of agricultural biotechnology. This article summarizes these legal proceedings and describes their impact upon agricultural biotechnology. The article then provides a commentary and critique of the legal proceedings and resulting judicial opinions.

Redressing The Harm Of Accelerated Approval, Laura Karas

Articles

The accelerated approval pathway of the United States Food and Drug Administration (FDA) enables drugs to come to market more quickly than would be possible under a traditional FDA approval pathway. Accelerated approval is based upon the agency's determination that changes in a surrogate or intermediate clinical endpoint are "reasonably likely" to predict a clinical benefit meaningful for patients. In essence, the pathway affords sick patients earlier access to potentially beneficial drugs while trials to confirm clinical benefit continue. Accelerated approval has been likened to a social compromise in which promising drugs enter the market sooner in exchange for a …

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

Meat, The Future: The Role Of Regulators In The Lab-Grown Revolution, Joseph B. Davault, Michael S. Sinha

All Faculty Scholarship

The United States is one of the largest consumers of meat globally. The production of meat contributes substantially to climate change due to the levels of greenhouse gasses emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Traditional meat production is another major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks associated with meat production have typically focused on reducing meat consumption, alternatives to meat, …

Brief Of 11 Narcolepsy Patients, Public Interest Orgnizations, Medical Professionals, And Professors Of Law As Amici Curiae In Support Of Defendants-Appellees, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are patients, organizations, medical professionals, and legal scholars who share a common interest in advancing the law toward better patient health and welfare. New, clinically superior drug products for treating rare diseases and conditions tremendously benefit patients and society, because those products offer choice, competition, and improved patient care. In filing this brief, amici hope to make this Court aware of the broad real-world implications of this case, both for narcolepsy patients and for the public interest generally. Generation Patient is a nonprofit organization that represents young adults with chronic and rare conditions across the United States. Created …

Brief Of 12 Narcolepsy Patients, Public Interest Organizations, Medical Professionals, And Professors Of Law And Medicine As Amici Curiae In Support Of Defendants-Appellees (Amended To Add Further Signatories), Charles Duan

Amicus Briefs & Court Filings

A prior copy of this brief was filed, inadvertently omitting one signatory. This brief has accordingly been amended to correct the error, reflected in the Certificate as to parties and the Appendix.

Brief Of 30 Scholars Of Law, Economics, And Medicine As Amici Curiae In Support Of The Petition, Charles Duan

Amicus Briefs & Court Filings

Amici curiae are scholars of law, economics, and medicine, listed in the Appendix. Their interest is in the proper development of patent law in ways that best promote the interests of innovation access and the public interest.

Race, The Academy, And The Constitution Of The War On Drugs, Jeffrey Bellin, Bennett Capers

Vanderbilt Law School Faculty Publications

The war on drugs is widely viewed as a policy failure. Despite massive government intrusions on personal liberty, drug addiction, overdoses, and drug-related violence have only in- creased since the war was declared in 1971. David Pozen's new book, The Constitution of the War on Drugs, reveals a constitutional failure as well. Pozen chronicles a host of constitutional arguments that American litigants deployed to protect a "right" to use drugs with surprising, if fleeting, suc- cess. Pozen asks what might have been, exploring why the courts backtracked and effectively re- moved the Constitution as a meaningful obstacle to drug prohibitions. …

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

The Big Cost Of Small Farms, Tammi S. Etheridge

Scholarly Articles

Americans love meat. We celebrate our independence with steaks on the grill, we enjoy our favorite pastime with hot dogs, and we give thanks with turkey. Our love of meat is so ingrained in our culture that, historically, small increases in meat prices have driven the populace to riot. Today, meat prices are rising. Simultaneously, the largest meat processors and packagers are seeing record profits. Consumers, in turn, are outraged. Their emotions are being fueled by politicians who blame rising profits on a pandemic of greed and collusion and then argue that rigid antitrust enforcement is the only solution.

This …

Abundance And Other Food Fixations, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

Although most people in the United States no longer devote the majority of their time to food production, processing, and distribution, food remains a daily fixation. This Article explores three driving food fixations--abundance, thinness, and health--and situates each against an inverse fear--scarcity, fatness, and illness, respectively. Mapping these threats onto U.S. food policy, this Article examines, among other policy arenas, food waste policy, nutrition and health claim labeling law, and food additive regulations. Across food policy, these fixations feed what this Article calls the “politics of abundance.” This politics helps to insulate the food industry from deeper systemic reform aimed …

Reflections And Gratitude: The Journal Of Food Law & Policy From A Twenty-Year Perspective, Margie Alsbrook

Articles

Twenty years after the Journal of Food Law & Policy published its first issue, I find myself looking back with deep gratitude for the people who helped create it, for the students who sustained it, and for the community that continues to make it thrive. What began as an untested idea has grown into a respected publication and a cornerstone of a still-growing field. This essay is both a reflection on that journey and a heartfelt thank-you to everyone who made it possible.

Psychedelic Medicine Exceptionalism, Mason Marks, I. Glenn Cohen

Scholarly Publications

Research on psychedelic medicines is experiencing a revival. Some clinicians, scientists, and ethicists believe that psychedelics are so different from other treatments that they warrant special consideration in how they are researched, regulated, commercialized, and administered. Others argue that psychedelic medicines show clinical potential, but they should be treated like other medical interventions. In other words, identical standards should apply. This article analyzes whether psychedelic medicines warrant special consideration from a regulatory and ethical perspective.

Birthdate Phaseout, Katharine B. Silbaugh

Faculty Scholarship

This article explores the Nicotine Free Generation (NFG) policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: Prohibition, or a legal age-gate, such as 21 for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco, and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the 21 …

An Integrated Approach Can Improve China’S Food Additives Security, Qian Li, Jingru Hou, Jennifer S. Stevenson, Cihui Liu

Faculty Articles

In China, the development of food additives remains a critical challenge in food additives security research. We discuss an integrated approach that can improve China’s food additives security, including technical management, standards implementation, and punitive damages regime. Through this integration, we identify that technical management, standards implementation, and punitive damages regime are each complementary to each other. Technical management helps reduce the inherent risks of food additives beforehand. Standards implementation helps prevent and control risks of food additives use halfway. Punitive damages regime helps relieve secondary risks arising from food additives use. Crucially, this integration enhances the suitability of food …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

Customary Corruption, Ani B. Satz, Liza Vertinsky

Faculty Articles

For over a hundred years, it has been well-accepted among tort scholars that physicians—as one of the legally recognized professions— determine their own customary practices. Within tort law, and medical malpractice more specifically, customary practice establishes whether physicians breach or uphold the required standard of care toward their patients. The results of our hand-coded examination of decided cases and statutes show a more complex picture. While some states have endeavored to shift the standard away from professional custom, it continues to play a critical, and in many cases a determinative, role in establishing physician liability in most states.

Using illustrative …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Transitioning To Regenerative Agriculture: One "Net-Zero" Pledge At A Time, Alexia Brunet Marks

Publications

As climate change intensifies, food sector multinational companies (MNCs), like Nestlé; Mars, Inc.; Unilever; PepsiCo; and Danone, face increasing pressure to reach net-zero by 2050, whereby they would reduce and ultimately eliminate carbon dioxide emissions from their supply chains by 2050. Carbon dioxide emissions are a major business liability, decreasing a firm’s value an average of $212,000 for every one thousand metric tons produced. As companies seek to align their pledges with regional, national, and subnational climate goals, they are legally required to comply with a growing number of disclosure rules for foods entering the United States and the European …