Food and Drug Law Commons^™

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 …

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 …

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 …

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 …

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 …

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

Introducing Biosimilar Competition For Cell And Gene Therapy Products, Brian Canter, Sabine Sussman, Stephen Colvill, Nitzan Arad, Elizabeth Staton, Arti Rai

Faculty Scholarship

This article provides an early analysis of the potential for creating future biosimilar competition for cell and gene therapies (CGTs) to lower prices and improve patient access, building on a unique set of interviews with relevant experts. Our discussion addressed regulatory, manufacturing, intellectual property, and market size challenges. Due to CGTs’ complexity, meeting the regulatory requirement of ‘high similarity with no clinically meaningful differences’ will be difficult. Gene therapies are likely better candidates for biosimilar development than cell therapies. Biosimilarity should be met when gene therapy biosimilars contain the same genetic sequence as a reference product, and the variability in …

Vaccine Development, The China Dilemma, And International Regulatory Challenges, Peter K. Yu

Faculty Scholarship

This article examines the role played by China in the development of international regulatory standards at the intersection of intellectual prop- erty, international trade, and public health. It begins by briefly discussing the role China has played in the global health arena during the COVID-19 pandemic. The article then highlights the difficulty in determining how best to engage with the country in the development of new international regula- tory standards. It shows that the preferred method of engagement will likely depend on one’s perspective on China’s potential contributions and hin- drances: a perspective that focuses on global competition—in the economic, …

Hydra: Lessons From The World's Largest Darknet Market, Priyanka Goonetilleke, Alex Knorre, Artem Kuriksha

Faculty Scholarship

Research Summary

We present a comprehensive description of Hydra, the largest darknet marketplace in the world until its shutdown in April 2022. We document the main features of Hydra such as dead-drop delivery, feedback and reputation system, escrow, and dispute resolution. Using data scraped from the platform, we quantitatively examine the scale and the structure of the marketplace. We find that it has been highly competitive, geographically covering at least 69% of the Russian population and trading a wide variety of drugs, while also allowing the wholesale trade of drugs and precursors. The dead-drop delivery system used on Hydra was …

Fishing And Fisheries Under International Water Law: A Dialogue Between Professor Gabriel Eckstein And Professor Paul Stanton Kibel, Gabriel Eckstein, Paul Stanton Kibel

Faculty Scholarship

On April 10 and 11, 2023, the Center on Urban Environmental Law (CUEL) at Golden Gate University School of Law hosted a two-day webinar on International Law Aspects of Fisheries and Hydropower in Europe. To open the webinar, Professor Gabriel Eckstein (of Texas A&M University School of Law) and Professor Paul Stanton Kibel (of Golden Gate University School of Law) participated in a keynote dialogue titled Fishing and Fisheries under International Water Law. What follows is a transcription of this dialogue between Professor Eckstein and Professor Kibel.

Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

Patient Access In Fourteen High-Income Countries To New Antibacterials Approved By The Fda, Ema, Pmda, Or Health Canada, 2010-2020, Kevin Outterson, Ebiowei S. F. Orubu, John Rex, Christine Årdal, Muhammad H. Zaman

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020. This goal was achieved in terms of the number of drug approvals, but actual patient access requires commercial launches in many countries, which itself requires sustainable commercial markets. Prior work has described limited access to new antibacterials in low- and middle-income countries (LMICs), in part due to the inability of many to afford these drugs. This study examines patient access for new antibacterials in the G7 and 7 other high-income countries in Europe, to better understand other barriers to patient access to effective antibacterial therapy.

The Legal Role In Building Sustainable Public Health (Symposium Transcript), Joanna K. Sax

Faculty Scholarship

The article presents a discussion of food as a public health issue, beginning with why science matters and utilizing science to solve food as a public health issue, especially as it relates to sustainability and climate change. Consumer misperceptions of the risk created by new scientific technologies (e.g., GMOs), or even older scientific technologies, may thwart use of such technologies to solve sustainability problems. The talk addresses why consumers might inappropriately assign risk to certain scientific applications and ways that we might want to think about resolving that issue or closing the divide between consumer misperception of risk and evidence-based …

Where's The Beef? Meat Shortages, Farmer Needs, And Long-Term Recovery Policies In A Pandemic Era, Kim Vu-Dinh

Faculty Scholarship

COVID-19 not only affected every hospital bed in the nation--if not the world; it also affected nearly every dinner table in America and beyond. Supply chain disruptions caused by the pandemic highlighted deep-seated problems with how we get our meat, and how difficult we make it for American farmers to sell to the family next door. Within a few months of the first reported case in the US, hundreds of workers from just two meat-processing plants on American shores became infected with COVID-19, and imports from around the world came to a standstill as factories and shipping companies were forced …

Marketing Authorization At The Fda: Paradigms And Alternatives, Adam I. Muchmore

Faculty Scholarship

In many critical industries, the Food and Drug Administration’s (FDA’s) marketing authorization decisions determine the range of products available in the United States. Because of the broad scope of the FDA’s marketing authorization responsibilities, the existing scholarship focuses on individual product categories, or small groups of product categories, regulated by the agency. This Article identifies how the existing literature has overlooked important connections between the FDA’s different marketing authorization programs. These connections suggest both explanations for existing programs and strategies for potential reforms.

The Article sets forth a two-level framework for analyzing the FDA’s marketing authorization role. At the first …

Genetically Engineered Food, Food Security, And Climate Change, Joanna K. Sax

Faculty Scholarship

Malnutrition is the leading cause of death and disease worldwide. Climate change is an existential crisis. We need to feed people and address the role of agriculture in climate change – at the same time. This is problematic, as agriculture inherently creates issues that contributes to climate change. Utilizing science, through genetically engineered crops, is one way to close the harm gap between food security and climate change. This essay addresses the controversial issue of genetically engineered crops with the complicated issues of food security and climate change by analyzing three main issues: (1) how the science of genetically engineered …

Environmental Law, Disrupted By Covid-19, Rebecca Bratspies, Vanessa Casado-Pérez, Robin Kundis Craig, Lissa Griffin, Keith Hirokawa, Sarah Krakoff, Katrina Kuh, Jessica Owley, Melissa Powers, Shannon Roesler, Jonathan Rosenbloom, J.B. Ruhl, Erin Ryan, David Takacs

Faculty Scholarship

As we were in the final phases of editing a book on disruption in environmental law, a pandemic swept across the world disrupting daily life and the functioning of society to an extent unprecedented in living memory. The novel coronavirus known as COVID-19 was identified in China in late 2019 and by late February 2020, it had spread to every continent except Antarctica; as of April, 2021, the World Health Organization (WHO) estimated that over 148 million people had been infected worldwide with over 3 million deaths. Scientists and public health experts have raced to understand the virus—how is it …

Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli

Faculty Scholarship

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspects to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights …

American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears And What To Do About It, Connor Burns, Jay D. Wexler

Faculty Scholarship

Why can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism, by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years, has once again arisen with a new …

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

Drugs, Patents, And Well-Being, Christopher Buccafusco, Jonathan S. Masur

Faculty Scholarship

The ultimate end of patent law should be to spur innovations that improve human welfare-innovations that make people better off. But firms will only invest resources in developing patentable inventions that will allow them to make money-that is, inventions that people will want to use and buy. This can gravely distort the types of incentives that firms face and the types of inventions they pursue. Nowhere is this truer than in the pharmaceutical field There is by now substantial evidence that treatments for diseases that primarily afflict poorer people-including the citizens of developing nations-are dramatically underproduced, compared with drugs that …

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Faculty Scholarship

No abstract provided.

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …

Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox

Faculty Scholarship

This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …

The Enhanced Danger Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

The COVID-19 pandemic represents a major challenge to both technologically advanced and resource-poor countries. There are currently no effective treatments for severe disease other than supportive care and advanced life support measures, including the use of mechanical ventilators. With the urgency and necessity bred from desperation, there have been many calls to utilize unproven therapies, such as hydroxychloroquine, for which little evidence of efficacy exists. We have previously argued that such off-label use, while legal, is problematic (and even dangerous) and have suggested several regulatory remedies that could protect patients and advance their interests while preserving the reasonable authority of …

Animal Agriculture Liability For Climatic Nuisance: A Path Forward For Climate Change Litigation?, Daniel E. Walters

Faculty Scholarship

Despite possessing statutory authority to regulate at least some contributing causes of climate change, environmental regulators in the United States have recently found themselves tied up in political gridlock. In response, advocates are turning from the regulatory track to a common law liability track, bringing public nuisance suits against fossil fuel producers and electric utilities. However, most of these public nuisance suits have met a common fate: they have been held to be displaced by the comprehensive regulatory framework for controlling greenhouse gas emissions contained in the Clean Air Act. As long as there is even the possibility of regulatory …

Rohrabacher-Blumenauer Amendment, Case Law And The Department Of Justice: Who Prevails In The Medical Marijuana Legalization Debate?, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

Drug Prices, Dying Patients, And The Pharmaceutical Marketplace: A New Conditional Approval Pathway For Critical Unmet Medical Needs, Robert A. Bohrer

Faculty Scholarship

Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear often: first, the very high prices of new drugs, particularly the "specialty" drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both issues, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs, and for insurance companies and the government …