Food and Drug Law Commons^™

The Impact Of Cannabis Access Laws On Opioid Prescribing, W. Kip Viscusi, Benjamin J. Mcmichael, R. Lawrence Van Horn

Vanderbilt Law School Faculty Publications

While recent research has shown that cannabis access laws can reduce the use of prescription opioids, the effect of these laws on opioid use is not well understood for all dimensions of use and for the general United States population. Analyzing a dataset of over 1.5 billion individual opioid prescriptions between 2011 and 2018, which were aggregated to the individual provider-year level, we find that recreational and medical cannabis access laws reduce the number of morphine milligram equivalents prescribed each year by 11.8 and 4.2 percent, respectively. These laws also reduce the total days’ supply of opioids prescribed, the total …

Marijuana Law Reform In 2020 And Beyond: Where We Are And Where We’Re Going, Sam Kamin

Seattle University Law Review

With another presidential election now looming on the horizon, both political parties and both sides of the marijuana law reform debate are once again preparing for the possibility of a seismic change in how marijuana is regulated in the United States. In this Article, I lay out the state of marijuana law and policy in the United States today with an eye toward that uncertain future. I describe the differential treatment of marijuana under state and federal law and the tensions this causes for those seeking to take advantage of marijuana law reform in the states. I analyze recent changes …

A Commitment To The Whole Athlete: Embracing The Role Of Cannabinoids In Collegiate Athletics, Kelli Rodriguez Currie

Seattle University Law Review

Cannabinoids can be a highly effective way for athletes to combat various kinds of pain associated with intense training. Derivatives of cannabis, such as marijuana, have been used for centuries as a form of pain relief. Part I of this Article discusses how cannabinoids are used in sports medicine. Part II discusses the different approaches to marijuana and cannabidiol use across sports leagues. Part III highlights the inconsistencies between the NCAA’s approach to testing for substance abuse and its investment in student-athletes’ well-being. Part IV discusses how the NCAA must focus on student-athlete health. Finally, Part V concludes that the …

Tiptoeing Through The Landmines: The Evolution Of States’ Legal Ethics Authority Regarding Representing Cannabis Clients, Karen E. Boxx

Seattle University Law Review

Despite the continued federal classification of cannabis as an illegal drug, states have legalized the possession, use, production, and sale of cannabis. In order to do so, the states have created complex regulatory schemes to control and monitor the cannabis industry and satisfy the federal government concerns, such as use by minors and organized crime involvement. First, this Article presents the ethical dilemma of cannabis lawyering. Second, this Article describes the history, evolution, and current status of the various states’ pronouncements on a lawyer’s ethical duties with respect to the business and use of cannabis that may be legal under …

Say “No” To Discrimination, “Yes” To Accommodation: Why States Should Prohibit Discrimination Of Workers Who Use Cannabis For Medical Purposes, Anne Marie Lofaso, Lakyn D. Cecil

Seattle University Law Review

This Article addresses the question of how the law should treat medical cannabis in the employment context. Using Colorado as a primary example, we argue that states such as Colorado should amend their constitutions and legislate to provide employment protections for employees who are registered medical cannabis cardholders or registered caregivers.

Part I briefly traces the legal regulation of cannabis from an unregulated medicine known as cannabis to a highly regulated illicit substance known as marijuana under the Controlled Substances Act. Our travail through this history reveals, unsurprisingly, an increasing demonization of cannabis throughout the twentieth century. That socio-legal demonization …

In Memory Of Professor James E. Bond, Janet Ainsworth

Seattle University Law Review

Janet Ainsworth, Professor of Law at Seattle University School of Law: In Memory of Professor James E. Bond.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

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 …

Global Implementation Of Soda Taxes: Is There A Better Solution For Combatting Obesity?, Lauren Cedeno

Brooklyn Journal of International Law

As incidences of overweight and obese populations continue to increase around the world, countries are looking for ways to decrease the prevalence of this epidemic. Soda and SSB taxes have increased in prevalence as countries seek to address the health problems associated with consumption of soda and other sugary beverages. This Note explores the implementation of these taxes in Mexico, Europe, and the United States. In analyzing these taxes, this Note seeks to gain a greater understanding of whether these taxes have impacted overweight and obesity rates in the countries and municipalities that have enacted them. This Note argues that …

Pharmaceutical Drug Pricing: The Internet As A Solution For This Health Issue Turned Financial Issue, Thomas P. Kelly

Brooklyn Journal of Corporate, Financial & Commercial Law

Over the course of five decades, American annual expenditure on pharmaceutical drugs has increased by more than $350 billion. This drastic increase has led many patients to struggle to afford their necessary, and potentially life-saving, medications. Today’s high pharmaceutical prices are largely due to the fact that name-brand drug manufacturers have few restrictions on how much they can charge for their products. Additionally, name-brand manufacturers are able to monopolize the manufacture of their drugs because patent laws prevent other manufacturers from using the formula of these drugs for two decades. To combat these high prices, this Note proposes a partnership …

Green Means Go: Tribes Rush To Regulate Cannabis In Indian Country, Julie Kim, Jessica Roberts

American Indian Law Journal

During the Obama administration, the United States Department of Justice (DOJ) issued a series of memos stating that the federal government would not interfere with state laws legalizing cannabis. The United States Attorney General later expressly extended this policy to Indian Country. As a result, tribes began debating potential advantages and disadvantages of participating in the cannabis market. Then, in January 2018, the DOJ rescinded the memos and publicly recommitted itself to prosecuting the possession, cultivation, and distribution of marijuana. Consequently, tribes should approach “The Green Rush” as an exercise of their sovereignty; when a tribe decides to legalize or …

A New Age Of Evolution: Protecting The Consumer’S Moral And Legal Right To Know Through The Clear And Transparent Labeling Of All Genetically Modified Foods, Halie M. Evans

Journal of Law and Health

The United States government, until recently, did not require the labeling of genetically modified organisms (GMOs). On July 29, 2016, President Barack Obama signed into law the National Bioengineered Food Disclosure Standard (NBFDS). This law directs the United States Department of Agriculture (USDA) to create regulations that require manufacturers to disclose certain bioengineered products on food labels. On December 20, 2018, the USDA released the final regulations for the NBFDS, which requires food manufactures, importers, and certain retailers to ensure bioengineered foods are appropriately disclosed. The final regulations include provisions that will leave the majority of GMO derived foods unlabeled. …

Updating The Building Code To Include Indoor Farming Operations, Clint Simpson

Journal of Food Law & Policy

Urban agricultural production has grown to be a critical tool in the battles for food security and sustainability. A common regulatory barrier to urban agricultural operations big and small has been ambiguity in land-use laws. Local governments are increasingly friendly toward community gardens, small greenhouse farming operations, farmers markets, and the like. Many have sought to lift regulatory restrictions and provide clarity in the law. However, while these efforts benefit a multitude of local food production efforts, they do little to address the regulatory ambiguities faced by commercial-scale, indoor farming operations, especially vertical farms. Particularly concerning to indoor vertical farms …

Contents, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Editorial Board, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Addiction-Informed Immigration Reform, Rebecca Sharpless

Articles

Immigration law fails to align with the contemporary understanding of substance addiction as a medical condition. The Immigration and Nationality Act regards noncitizens who suffer from drug or alcohol substance use disorder as immoral and undesirable. Addiction is a ground of exclusion and deportation and can prevent the finding of "good moral character" needed for certain immigration applications. Substance use disorder can lead to criminal behavior that lands noncitizens, including lawful permanent residents, in removal proceedings with no defense. The time has come for immigration law to catch up to today's understanding of addiction. The damage done by failing to …

Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath

Washington Law Review

Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap—the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, …

Journal Of Food Law & Policy - Fall 2019, Journal Editors

Journal of Food Law & Policy

No abstract provided.

School Of Law Faculty And Professional Staff, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Science And Risk Analysis In Cptpp/Sps-Plus: Role Model Or Unbearable Burden?, Kuei-Jung Ni

Journal of Food Law & Policy

Trade in food and agricultural products accounts for a major part of global trade, and the trade continues to alert domestic consumers to the risks associated with modern food processing and production methods. The Trans-Pacific Partnership Agreement (TPP), now rebranded as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), represents a new model of mega-regional trade pacts posed to set higher standards for promoting and streamlining trade liberalization. Because of concerns with national food safety regulations that could constitute forms of non-tariff barriers, the CPTPP, in contrast to the World Trade Organization (WTO), stipulates further rules on parties’ sanitary …

The Marketing Of Self-Care And Alternative Therapies In The U.S. In 2019: How Industry Stakeholders Appeal To Consumers’ Perceptions Of Novel Food Products And Additives, Melanie Marie Glover

Journal of Food Law & Policy

This article examines the current marketing techniques of food products and additives in the growing self-care industry in print and digital formats. It assesses how well consumers understand such advertising tactics, and what the industry and federal government agencies are doing (or not doing) to help consumers be mindful and savvy about their purchase choices. The discussion further showcases hot-topic food products and additives including CBD, Kratom, and plant-based meat as examples of both regulatory risk and opportunity. Lastly, the article advocates a collaborative effort among federal government agencies (FDA, FTC, USDA, etc.), industry stakeholders, and the public to help …

Going Hemp Wild: Understanding The Challenges And Opportunities For Fda Regulation Of Cbd In Food Products, Hannah Catt

Journal of Food Law & Policy

After the passage of the 2018 Farm Bill, champions of hemp began to tout opportunities for farmers and businesses involved with the crop. The industry has rallied around one of hemp’s major byproducts, cannabidiol, or CBD. However, the demand for CBD has left the Food and Drug Administration (“FDA”) playing catch-up. This article explains what CBD is, how it is derived, current FDA-approved uses, and a current path forward for the FDA in creating guidance for industry and consumers.

Agricultural Exceptionalism And Industrial Animal Food Production: Exploring The Human Rights Nexus, Charlotte E. Blattner, Odile Ammann

Journal of Food Law & Policy

The host of negative effects of animal agriculture on the immediate environment, workers, and local communities are well-documented, yet little is known about the global repercussions of animal agriculture, especially on human rights guarantees. This contribution attempts to begin filling this soaring gap. It examines the nexus between industrial animal agriculture (with a focus on concentrated animal feeding operations (CAFOs)) on the one hand, and specific international human rights violations on the other hand. Our emphasis is on the role of government in producing these violations, rather than on the agribusiness itself. Laws originally designed to govern small family farms—so-called …

Time For Change: Stepping Up The Fda's Regulation Of Dietary Supplements To Promote Consumer Safety And Awareness, George Kennett

Journal of Law and Health

People are often looking for that quick fix when it comes to their health. With dietary supplements so readily available on the market, the public assume that they have been through rigorous testing. Dietary supplements are not tested as much as consumers believe. The Food and Drug Administration (FDA) does not initiate the same type of testing and analysis for supplements as it does for food, drink and medication. Given that people are now choosing supplemental meal replacements and the like, as opposed to whole foods, regulations drastically need to be stepped up in an effort to emphasise public safety. …

Puff Puff Pass The Legislation: A Comparison Of E-Cigarette Regulations Across Borders, Rachel E. Zarrabi

Journal of the National Association of Administrative Law Judiciary

This comment explores the types of legislation, approaches to regulating e-cigarettes, and analyzes whether the FDA’s campaign and current regulations are effective. So far, it appears that the United States is ahead of the game with its new, aggressive proposal for regulating e-cigarettes. The FDA is standing against the companies and products that target youthful consumers. Most countries acknowledge the gaps in current scientific research regarding the long-term health risks of vaping, and some are waiting to take a legislative stance until it is clearer which side of the health line e-cigarettes fall. Section II of this comment discusses the …

Beauty Shouldn’T Cause Pain: A Makeover Proposal For The Fda’S Cosmetics Regulation, Lauren Jacobs

Journal of the National Association of Administrative Law Judiciary

The American cosmetics industry is not required by the Food and Drug Administration (FDA) to conduct pre-market safety assessments of cosmetics. The FDA only reviews personal care products when people voluntarily report problems. Further, companies continue to test animals for cosmetics, despite the FDA’s recommendation that manufacturers seek more humane and accurate testing. Although the FDA does not require animal testing for product safety or premarket approval, the United States is one of the largest users of laboratory animals for product testing. There are two pending pieces of legislation, which if passed would be the first acts of cosmetic regulation …