Food and Drug Law Commons^™

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, …

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.

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 …

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 …

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 …

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 …

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, Muhammad H. Zaman, John Rex, Christine Ardal

Faculty Scholarship

In 2010, the Infectious Diseases Society of America called for 10 new antibiotics by 2020 [1]. 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 [2]. 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 …

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

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.

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 …

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 …

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 …

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 …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski

Faculty Scholarship

No abstract provided.

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 4, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fourth of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on retail-level frauds. It proposes a limited purpose crypto currency. At the retail level the MJ Freeway or METRC software essentially functions as a marijuana-industry-specific point of sale (POS) system. It is common in retail for different industry sectors (restaurants, hotels, convenience stores, or gasoline stations) to have market-specific POS systems that are molded to fit the unique characteristics of …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 2, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

Legalization of marijuana burdens the States with the responsibility of (a) monitoring the physical flows of marijuana through the supply chain (making sure the marijuana does not enter inter-state commerce; making sure it stays out of the hands of minors, etc.), and (b) monitoring the fiscal flows (making sure the proceeds of marijuana production do not end up in criminal hands).

The type of controls favored by the states are track and trace (TAT), or seed-to-sale (STS) systems. These systems are reasonably complex, as well as technology-intensive. Nevertheless, there are questions about whether they are adequate to the enforcement needs. …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 5, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

This is the fifth part of a five-part series dealing with the rescission by U.S. Attorney General Jeff Sessions of the Obama-era policy that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases.

This article focuses on the back-end leakage in the state’s obligation to control both the physical flows of legalized marijuana, as well as the related fiscal flows (the proceeds of legalized marijuana sales). These flows intersect dramatically in retail-level frauds.

There are very few new proposals on how to solve the physical flow problems with consumer re-sales into the black market. Traditional …

Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 1, Richard Thompson Ainsworth, Brendan Magauran

Faculty Scholarship

On January 4, 2018, the Trump Administration through Attorney General Sessions rescinded an Obama-era policy1 that discouraged federal prosecutors from bringing charges in all but the most serious marijuana cases under the federal Controlled Substances Act,2 as well as under the Bank Secrecy Act.3 Federal law is at odds with state law in the majority of states on the legalization and subsequent state taxation of marijuana.4 Twenty-eight states and the District of Columbia have at least partially legalized marijuana. Eight of these states have legalized both medicinal and recreational use.5 With limited exceptions, legalized sales of marijuana are taxed.

We …

The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan

Faculty Scholarship

This Article is set in the background of the consequences of the WTO’s prescriptions on patenting of life-saving medications which has largely contributed to the morphing of patents o n life-saving medication into a luxury. Remarkably, there has been a transformation of the role of patents in the context of pharmaceutical innovation into a strategic business tool leading to a larger interest in creation and sustenance of regulatory rights. The biggest global development in this area is an increased effort to strengthen exclusivity using regulatory protections for all chemicals, and even, biologics, involved in all stages of drug development. Consequently, …

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

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 …

Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax

Faculty Scholarship

One of the most controversial issues in administrative law, the use of guidance, is exemplified by the regulation of one of the most controversial areas in modern society: genetically modified (GM) food. The appropriate use of guidance versus notice and comment rulemaking is a much-debated issue in administrative law. While agency officials generally assert that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of …

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. …