Food and Drug Law Commons^™

Burning Questions: Changing Legal Narratives On Cannabis In Indian Country, Robin M. Rotman, Sam J. Carter

Faculty Publications

In the not-so-distant past, thoughts of Cannabis legalization in the United States were radical. In the present day, the narratives around Cannabis are changing. The term “present day” affixes this Article to early 2023, a snapshot in time. To understand the current legal narratives surrounding Cannabis, and what they might become in the future, it is important to examine the history of Cannabis law and policy in United States. This Article begins by discussing Cannabis regulation in the United States, from the rise of federal regulation to the gradual deregulation by states with tacit federal consent. The Article then examines …

Solutions Still Searching For A Problem: A Call For Relevant Data To Support "Evergreening" Allegations, Erika Lietzan, Kristina M. L. Acri

Faculty Publications

For years pharmaceutical policymaking discussions have been revolving around allegations of supposed “evergreening” by pharmaceutical companies, and policymakers have considered a range of significant policy reforms — including to antitrust law and drug regulatory law — to address this purported problem. This paper evaluates empirical data offered to substantiate “evergreening” and explains that these data — though mostly accurate — do not support proposed policy changes.

The “evergreening” claim is that by securing additional patents and FDA-related exclusivities after approval of their new drugs, brand drug companies enjoy a period of exclusivity in the market that is longer than the …

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.

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 …

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 …

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 …

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 …

The Arkansas Ll.M. Program: Forty Years Of Leadership, Susan A. Schneider

Journal of Food Law & Policy

The University of Arkansas School of Law has been a leader in agricultural law education for over forty years through its innovative LL.M. Program in Agricultural and Food Law. This essay memorializes the history of this signature Program and charts its progress through the decades as agricultural law issues evolved and the discipline expanded.

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 …

"Serving Time And It's No Longer A Crime: An Analysis Of The Proposed Cannabis Administration And Opportunity Act, Its Potential Effects At The Federal And State Level, And A Guide For Practical Application By Local Government", R. Allyce Bailey

University of the District of Columbia Law Review

There has been much recent discussion surrounding cannabis use with some researchers supporting the use of medical marijuana, some investors relishing in the recently booming cannabis and CBD industry, and some states decriminalizing marijuana and even harsh controlled substances. As it appears, at least some public opinion is changing regarding marijuana, but the law has not effectively caught up to that change. Bias in the criminal justice system has led to the over-policing of, higher conviction rates, and harsher sentences for minorities. Thus, the decriminalization of marijuana alone does not remedy the grave disproportionate negative effects on populations of color …

Race And Regulation Podcast Episode 6 - Race, Social Inequalities, And Clinical Drug Trials, Jill A. Fisher

Penn Program on Regulation Podcasts

As mandated by the U.S. Food and Drug Administration, clinical trials for new pharmaceuticals enroll healthy people as paid research participants to test for drug safety and tolerability. But the social injustices from these trials are too often overlooked. Drawing on her award-winning book, Adverse Events, Jill Fisher of UNC-Chapel Hill’s Center for Bioethics explains how clinical drug trials attract disproportionate participation by racial and ethnic minorities who then disproportionately assume risks of participating in these trials, often just to stay financially afloat.

Using Insurance To Regulate Food Safety: Field Notes From The Food Produce Sector, Timothy D. Lytton

New Mexico Law Review

Foodborne illness is a public health problem of pandemic proportions. In the United States alone, contaminated food sickens an estimated 48 million consumers annually, causing 128,000 hospitalizations and 3,000 deaths. Nowhere is this crisis more acute than in the fresh produce sector, where microbial contamination in growing fields and packing houses has been responsible for many of the nation’s largest and deadliest outbreaks.

This Article examines emerging efforts by private insurance companies to regulate food safety on farms that grow fresh produce.

Previous studies of using insurance to regulate food safety rely on economic theories that yield competing conclusions. Optimists …

A Helper For Patenting The “Unpredictable”: Artificial Intelligence, Shuang Liu

Minnesota Journal of Law, Science & Technology

No abstract provided.

The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard

Catholic University Law Review

When the history of the first year of the United States Government’s response to the COVID-19 virus is written, there is likely to be mention of the still unexplained vehemence with which then president Donald J. Trump made use of his access to social media to promote seldom used anti-malaria drug, hydroxychloroquine, for both the prevention and treatment of COVID-19 despite the active growing opposition of most of the world’s scientists, including his own government scientists. While the use of drugs developed and approved by the FDA for different purposes to combat new diseases, off-label prescribing, is legal in the …

Legalization Without Disruption: Why Congress Should Let States Restrict Interstate Commerce In Marijuana, Scott Bloomberg, Robert A. Mikos

Pepperdine Law Review

Over the past twenty-five years, states have developed elaborate regulatory systems to govern lawful marijuana markets. In designing these systems, states have assumed that the Dormant Commerce Clause (“DCC”) does not apply; Congress, after all, has banned all commerce in marijuana. However, the states’ reprieve from the doctrine may soon come to an end. Congress is on the verge of legalizing marijuana federally, and once it does, it will unleash the DCC, with dire consequences for the states and the markets they now regulate. This Article serves as a wake-up call. It provides the most extensive analysis to date of …