Food and Drug Law Commons^™

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, and …

Retroviral Protease (Rvp) Ddi2 Is A Viable Alternative For Full-Length (Fl) Ddi2, Ethan Chi

Undergraduate Research Symposium Lightning Talks

Proteasome inhibitors are drugs used to treat multiple myeloma. Currently, three are approved by the FDA.

Ministerial Decision On The Trips Agreement (Wto), Ana Santos Rutschman

Faculty Publications

No abstract provided.

Examining Comity And The Exhaustion Doctrine In Tribal Court Civil Jurisdiction: The Cherokee Nation’S Opioid Litigation, Joëlle Klein

Washington Law Review

The opioid epidemic has devastated communities throughout the United States over the last two decades. Native American and Alaska Native tribes faced disproportionate impacts and suffered the long-lasting consequences that opioid addiction causes families and communities. In response, states and municipalities across the United States sued the distributors and pharmacies responsible for illegally diverting opioids. In April of 2017, the Attorney General for the Cherokee Nation, Todd Hembree, initiated a civil suit against opioid pharmaceutical distributors and retailers: CVS, Walgreens, Wal-Mart (pharmacies), and McKesson, Cardinal Health, and AmerisourceBergen (distributors). Although other tribes in the United States also brought claims against …

A Uniform Approach To Farm Animal Welfare Laws: Thought For Our Food Instead Of Food For Our Thought, Channing Burd

Journal of Food Law & Policy

We have all seen the commercials and know “Happy Cows Come from California,” but there is a larger issue hidden inside the phrase. Why should not all farm animals be happy, regardless of which state they were raised in? Why are only the cows in California happy, but not the chickens and the hogs as well? Farm animal welfare in the United States needs regulatory overhaul, and we needed it decades ago. This article will illustrate why regulatory overhaul is needed. First, we will examine how a new system of laws, which are part of a uniform code enacted by …

The Cow Has Left The Barn: Updating Standards Of Identity To Reflect Consumer Understanding Of Plant-Based Foods, Nicholas G. Miller

Journal of Food Law & Policy

Have you ever seen “tofurkey” at the supermarket and thought it was a rare, delicious cousin of the turkey? The animal based food industries, led by milk and meat producers, are claiming that the reasonable consumer might. On the other hand, the plant based food substitutes are appearing on supermarket shelves with increasingly bold names for their products that tap into our familiarity with animal-based foods, using names like “Beyond Meat.” Where do we draw the line on what plant based food can be called? And who should draw that line? This paper examines the debate surrounding the labeling of …

The Cost Of Compassion: Why State Ballot Initiatives Complicate Farm Animal Welfare And Overlook The True Problems In Modern Agriculture, Seth Victor

Journal of Food Law & Policy

Farm animal welfare is a concern for many Americans, both among those who value a higher standard of care for the animals’ own sake, and those concerned with food safety. Industrial agriculture has become the dominant form of animal production to satiate a daunting demand for meat, eggs, and dairy products. Industrial animal-raising facilities, also known as concentrated animal feeding operations (“CAFOs”), prioritize volume and efficiency and are a key factor in keeping consumer prices low. CAFOs are highly specialized and excel at production by minimizing inputs, maximizing confined animals, and externalizing environmental costs. This production method comes at the …

Federal Food Safety Framework: Where Does Seaweed Fit In?, Catherine M. Janasie

Journal of Food Law & Policy

When one mentions seaweed as food, what do you think of? The dried nori used to wrap your sushi roll or perhaps the seaweed salad on the side? In fact, seaweed has many uses, including as both a food source in its own right and as a food additive. While the seaweed market has been dominated by East Asian countries, seaweed is cultivated in about 50 countries, and the U.S. seaweed industry is steadily growing. The global seaweed industry is currently worth about $6 billion annually. Food products for human consumption account for about 85% of this value.

Do States Prefer Alcohol Over Marijuana? A Look At Labeling Regulatory Differences Between The Alcohol And Edibles Industries, Mckinley H. Groves

Journal of Food Law & Policy

In the children’s book "Through the Looking Glass and What Alice Found There", Alice interacts with Humpty Dumpty. During their conversation, Humpty notes that he, alone, can decide the meaning of words. Even Alice, at the young age of seven, casts doubt on this idea. Definitions of words and phrases play an important role in human interactions and even more so when the words and phrases defined are within a statute. In the United States, Congress and state legislatures play the role of Humpty Dumpty by coming up with meanings of important words and phrases found in the laws they …

Following The Framework: Intentional Genomic Alterations In Animals, Sarah Copper

Journal of Food Law & Policy

Intentional genomic alterations in animals or genetically engineered animals have existed in their modern form since the 1980s. However, the introduction of these animals into our food supply has been a more recent development. The federal government has taken steps in an attempt to regulate these products in a streamlined and efficient manner but has faced criticism in their approach. While the Food and Drug Administration (“FDA”) is currently responsible for the regulation of intentional genomic alterations (“IGAs”) in animals, there is significant effort behind transferring that oversight to the United States Department of Agriculture (“USDA”). However, in the meantime, …

Corrupt Or Charitable? Patient Assistance Programs And The Case For Narrowing The Breadth Of The Federal Anti-Kickback Statute, Isaac Strauss

Cardozo Law Review

No abstract provided.

The Helicopter State: Misuse Of Parens Patriae Unconstitutionally Precludes Individual And Class Claims, Gabrielle J. Hanna

Washington Law Review

The doctrine of parens patriae allows state attorneys general to represent state citizens in aggregate litigation suits that are, in many ways, similar to class actions and mass-tort actions. Its origins, however, reflect a more modest scope. Parens patriae began as a doctrine allowing the British king to protect those without the ability to protect themselves, including wards and mentally disabled individuals. The rapid expansion of parens patriae standing in the United States may be partly to blame for the relative absence of limiting requirements or even well-developed case law governing parens patriae suits. On the one hand, class actions …

Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler

University of Michigan Journal of Law Reform

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or …

Overqualified And Underrepresented: Gender Inequality In Pharmaceutical Patent Law, S. Sean Tu, Paul R. Gugliuzza, Amy Semet

BYU Law Review

Pharmaceutical patents represent some of the most valuable intellectual property assets in the world: they can be worth billions of dollars if courts uphold their validity and find them infringed. But, if invalidated, generic drug manufacturers can get to market earlier, generating billions of dollars of revenue for themselves and creating enormous savings for consumers. Accordingly, drug patents are the product of careful, high-cost prosecution and are associated with high-stakes, bet-the-company litigation.

But women lawyers are noticeably absent from pharmaceutical patent practice. This article reports an original empirical study finding that women comprise only one-third of the top pharmaceutical patent …

Executive Capture Of Agency Decisionmaking, Allison M. Whelan

Vanderbilt Law Review

The scientific credibility of the administrative state is under siege in the United States, risking distressful public health harms and even deaths. This Article addresses one component of this attack-—executive interference in agency scientific decisionmaking. It offers a new conceptual framework, “internalagency capture,” and policy prescription for addressing excessive overreach and interference by the executive branch in the scientific decisionmaking of federal agencies. The Article’s critiques and analysis toggle a timeline that reflects recent history and that urges forward-thinking approaches to respond to executive overreach in agency scientific decisionmaking. Taking the Trump Administration and other presidencies as test cases, it …

Cannabis Law, Lisa Moran Mcmurdo, Steven D. Forbes, Stewart R. Pollock, Christian F. Tucker

University of Richmond Law Review

On July 1, 2021, Virginia became the sixteenth state to permit recreational use of cannabis. As of 2022, thirty-nine states have legalized the medical use of cannabis, and nineteen states and the District of Columbia have legalized the adult use of cannabis for recreational purposes. “A CBS News/YouGov poll released in April 2022 found that two-thirds of Americans want recreational [cannabis] use to be legalized under federal law and in their own state.” This Article summarizes the history of cannabis regulation and examines the current legal landscape in Virginia governing the possession, cultivation, manufacturing, and sale of cannabis.

High Time For Change: The Legalization Of Marijuana And Its Impact On Warrantless Roadside Motor Vehicle Searches, Molly E. O'Connell

Washington and Lee Law Review Online

The proliferation of marijuana legalization has changed the relationship between driving and marijuana use. While impaired driving remains illegal, marijuana use that does not result in impairment is not a bar to operating a motor vehicle. Scientists have yet to find a reliable way for law enforcement officers to make this distinction. In the marijuana impairment context, there is not a scientifically proven equivalent to the Blood Alcohol Content standard nor are there reliable roadside assessments. This scientific and technological void has problematic consequences for marijuana users that get behind the wheel and find themselves suspected of impaired driving. Without …

Confronting State Violence: Lessons From India's Farmer Protests, Smita Narula

Elisabeth Haub School of Law Faculty Publications

In December 2021, following a year of sustained mass protests, farmers in India forced the repeal of three controversial Farm Laws that attempted to deregulate India’s agricultural sector in service of corporate interests. Farmers feared that the laws would dismantle price supports for key crops, jeopardize their livelihoods, and facilitate a corporate takeover of India’s agrarian economy. This Article situates India’s historic farmer protests in the context of the country’s longstanding agrarian crisis and the corporate capture of agriculture worldwide. I argue that the protests arose in response not only to the Farm Laws, but also to decades of state-sponsored …

Novel Food Ingredients: Food Safety Law, Animal Testing, And Consumer Perspectives, Taimie Bryant

Marquette Law Review

In recent years, some major food companies have publicly stated that they will no longer test their product ingredients on animals. Yet despite the availability of more reliably predictive non-animal toxicity tests, some companies continue testing novel food ingredients on animals. This Article uses the lens of a particular innovative plant-based food company’s decision to test a novel food ingredient on animals as a means of considering more generally whether any food producer has rational legal reasons for testing on animals. The Article explores FDA requirements, consumer food safety litigation, and judicial evaluation of animal test data, all of which …

"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 …