Food and Drug Law Commons^™

A Prescription For Biopharmaceutical Patents: A Cure For Inter Partes Review Ailments, Alex A. Jurisch

Seattle University Law Review

The patent system in the United States was forever changed with the introduction of the Leahy-Smith America Invents Act (AIA) in September of 2011. The AIA brought sweeping changes to American patent law in order to align the U.S. with much of the rest of the world by changing the invention priority from a “first to invent” to a “first to file” system. The first section of this note will provide a brief overview of the substance of inter partes reviews and some of the most critical negatives that have become apparent since 2013. The second section of this Note …

It Is Not About The Drugs: A Comparative And Contextual Analysis Of Singapore And European Approach To Drug Issues, Rathna N. Korman

Research Collection Yong Pung How School Of Law

This article aims to establish that Singapore’s drug policy and approach though not in tandem, is consistent with the elements espoused in the harm reduction approach advocated by the Global Commission on drug policies. The Commission takes the position that drug control nationally has to be aligned with the sustainable development goals agenda approved by the member states in 2015. It has recommended abolishing death penalty for all drug related offences, decriminalizing drug possession and cultivation for personal consumption, implementing non-penal sanctions for all low level drug offenders, and exploring non-penal regulatory models following decriminalization. There is a paradigm shift …

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 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 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 …

Commentary On The Investigation: The April 20, 2001 Peruvian Shootdown Accident, Ibpp Editor

International Bulletin of Political Psychology

This article critiques an investigative report officially intended (1) to establish the facts and circumstances contributing to the April 20, 2001 interdiction of a United States (US) missionary floatplane and the death of two US citizens and (2) to make recommendations to minimize another such accident. The report was issued by the US Department of State Bureau for International Narcotics and Law Enforcement Affairs.

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 Overdose/Homicide Epidemic, Valena E. Beety

Georgia State University Law Review

This Article explores the lack of regulation of coroners, concerns within the forensic science community on the reliability of coroner determinations, and ultimately, how elected laypeople serving as coroners may influence the rise in drug-induced homicide prosecutions in the midst of the opioid epidemic.

This Article proposes that the manner of death determination contributes to overdoses being differently prosecuted; that coroners in rural counties are more likely to determine the manner of death for an illicit substance overdose is homicide; and that coroners are provided with insufficient training on interacting with the criminal justice system, particularly on overdose deaths. Death …

Administering Health Innovation, Rachel E. Sachs

Cardozo Law Review

Scholars and policymakers have recently begun to focus on the role federal agencies charged with health-related missions can play in the development of innovative health technologies and promotion of access to those technologies. Appreciating the expertise of agencies like the National Institutes of Health, Food and Drug Administration, and Centers for Medicare and Medicaid Services has expanded the range of tools contemplated by scholars who had previously focused largely on the United States Patent and Trademark Office.

Yet much of this attention has so far focused on the capacities of single agencies, acting alone. This Article expands the existing scholarly …

Drug Approval In A Learning Health System, W. Nicholson Price

Articles

The current system of FDA approval seems to make few happy. Some argue FDA approves drugs too slowly; others too quickly. Many agree that FDA—and the health system generally—should gather information after drugs are approved to learn how well they work and how safe they are. This is hard to do. FDA has its own surveillance systems, but those systems face substantial limitations in practical use. Drug companies can also conduct their own studies, but have little incentive to do so, and often fail to fulfil study commitments made to FDA. Proposals to improve this dynamic often suggest gathering more …

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, …

Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak

Pace Environmental Law Review

The FDA does not conduct pre-market review of chemicals contained in cosmetics—which encompasses not only makeup but also numerous personal care products including shampoo, lotion, perfume, aftershave, and shaving cream. Every day, consumers use cosmetic products that contain a variety of synthetic ingredients, none of which the FDA has approved for safety but each of which are being ingested, absorbed, and inhaled into our bodies and accumulating in our tissue. Many of these products contain endocrine disrupting chemicals (“EDCs”), which emerging research links to an increased risk of cancer as well as immune and neurological dysfunction. This Article examines how …

Nurturing A More Just And Sustainable Food System: The First Year Of Pace Law's Food And Beverage Law Clinic, Jonathan Brown

Elisabeth Haub School of Law Faculty Publications

This article looks back at the Clinic's first year and explores lessons learned in putting the theory behind the Clinic's model into practice. Launching the Clinic required a leap of faith. Was there in fact a client demand for its services? Was there sufficient interest from law students in the intersection of transactional law and food systems? Was the scope of legal matters too broad? Was the client focus too narrow? The early returns from the first year have given us valuable insights and experience from which to draw. First, this article discusses the unmet legal need the Clinic seeks …

The Gm Food Debate: An Evaluation Of The National Bioengineered Food Disclosure Standard And Recommendations For The United States Based On Food Justice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

The Gm Food Debate: An Evaluation Of The Nationalbioengineered Food Disclosure Standard Andrecommendations For The United States Based On Foodjustice, Courtnee Grego

Seattle University Law Review

This Note aims to identify the food justice issues caused by the National Bioengineered Food Disclosure Standard (NBFDS) and make recommendations for the United States to minimize these concerns. The NBFDS requires the United States Department of Agriculture (USDA) to draft regulations establishing a mandatory disclosure standard for GM food and ultimately, will require a disclosure on the package of any GM food sold in the United States. Part I of the Note provides an overview of the genetically modified (GM) food debate. Part II reviews the NBFDS. Part III explains the food justice implications of GM food production. Part …

Law Library Blog (June 2018): Legal Beagle's Blog Archive, Roger Williams University School Of Law

Law Library Newsletters/Blog

No abstract provided.

Passing The Baton: The Effect Of The International Olympic Committee's Weak Anti-Doping Laws In Dealing With The 2016 Russian Olympic Team, Saroja Cuffey

Brooklyn Journal of International Law

Following the investigation of a Russian state-sponsored doping ploy prior to the Olympic Games in Rio 2016; the International Olympic Committee (IOC) decided against a blanket ban of the Russian Olympic team. Instead; it allowed athletes’ individual international federations to decide whether Russian athletes could compete. In following the various anti-doping laws in place; the IOC sought to protect and give justice to clean athletes around the world. This Note argues that they did not achieve this result; due to the anti-doping laws in place and the actors applying these laws. It suggests that there should be a universal anti-doping …

Regulatory Response To E-Cigarettes, Morgan Johnson

Georgia Journal of International & Comparative Law

No abstract provided.

Comment: Containerization Of Contraband: Battling Drug Smuggling At The Fourth Busiest Container Handling Facility In The United States, Adam Smith

Georgia Journal of International & Comparative Law

No abstract provided.

A Surging Drug Epidemic: Time For Congress To Enact A Mandate On Insurance Companies And Rehabilitation Facilities For Opioid And Opiate Addiction, Alanna Guy

Journal of Law and Health

This Note begins with a discussion of both the national opioid problem as well as the specific epidemic in Ohio as an example of how it has grown within all of the states. Part II discusses the differences between prescription opioids and opiates, how they can be obtained, what effects they have on the human body, and why the government has an interest in this growing problem. Next, this Note explains how and why there was an increase in access and addiction to prescription opioid pain medication. Following this explanation, the steps the government has taken to try to rectify …

Journal Of Food Law & Policy - Spring 2018, Journal Editors

Journal of Food Law & Policy

No abstract provided.

Insuring A Future For Small Farms, Mary Beth Miller, D. Lee Miller

Journal of Food Law & Policy

Congress created Whole Farm Revenue Protection (WFRP) in the 2014 Farm Bill to provide small, diversified, and organic operations with an insurance product tailored to their unique needs. The program stands out from other federal crop insurance programs with its blend of features that, inter alia, incentivize risk management through crop/animal diversification, increase premium subsidies for beginning producers, allow organic price elections, and recognize on-farm processing expenses. For the farmers who use it, WFRP provides more than peace of mind in the face of unpredictable weather and prices. It provides a revenue guarantee that opens up critical financing channels otherwise …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Proactive Policies: Building The Farm Bill Of The Futurethrough New Collaborations And Perspectives, Jennifer Zwagerman

Journal of Food Law & Policy

The Farm Bill highlights both one of the great divides in our political process, as well as one of the most beneficial partnerships in politics. Historically, partnerships between rural and urban have been key to successful passage of the Farm Bill. However, calls to divide nutrition support and agricultural support programs continue, and there are increasingly diverse viewpoints regarding agricultural programs. To build the Farm Bill of the future, one that is comprehensive and addresses the needs of not just producers, but ultimately everyone impacted by this Bill, there needs to be a broader coalition of partnerships and voices involved …

Contents, 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.

A Farm Bill To Help Farmers Weather Climate Change, Peter H. Lehner, Nathan A. Rosenberg

Journal of Food Law & Policy

The Farm Bill has an enormous impact on climate change. Greenhouse gas emissions from agriculture account for almost 10 percent of total U.S. emissions and up to a quarter of all emissions globally. The Farm Bill encourages the use of carbon-intensive agricultural practices and products responsible for these emissions, but nonetheless offers several opportunities to quickly expand carbon sequestration, making it a critical piece of climate legislation. This essay will examine the climate impact of the Farm Bill, focusing on the commodity, conservation, and crop insurance programs. It then proposes politically feasible changes to these programs aimed at minimizing agricultural …

Building Indian Country’S Future Through Food, Agriculture, Infrastructure, And Economic Development In The 2018 Farm Bill, Janie Simms Hipp, Colby D. Duren, Erin Parker

Journal of Food Law & Policy

With the potential of approximately $1 trillion in spending over 10 years in rural America, the U.S. Department of Agriculture (USDA) programs authorized by the Farm Bill have the ability to build and support thriving economies in rural America. Nowhere is this potential greater, or needed, than in rural Tribal communities. This paper will examine why the unique circumstances of Tribal governments, individual Native American food producers, and Tribal citizens necessitate changes in several USDA programs to serve Indian Country. Further, it will review several policy changes in various titles of the next Farm Bill reauthorization that will help empower …

Cooperation Or Compromise? Understanding The Farm Billas Omnibus Legislation, Margaret Sova Mccabe

Journal of Food Law & Policy

The Farm Bill (the Bill) is the principal driver of U.S. food law and policy. Its substance spans the food system including commodities, conservation, trade, nutrition, credit, rural development, forestry, and energy. These substantive titles command much scholarly analysis yet there is comparatively little review of the law-making process that yields the Bill. Given increased focus on Congress’s ability to use its legislative powers effectively, this essay questions whether the Bill’s traditional treatment as omnibus legislation leads to beneficial coherence or too much compromise in food system policy. Interestingly, disparate stakeholders prioritize maintaining the Bill as omnibus legislation. Some scholars …

The Snap Sugar-Sweetened Beverage Debate: Restricting Purchases To Improve Health Outcomes Of Low-Income Americans, Nicole E. Negowetti

Journal of Food Law & Policy

The Supplemental Nutrition Assistance Program (SNAP) is a highly effective government program that reduces poverty and improves food security for millions of our country’s most vulnerable families. Amid threats of budget cuts to this critical program in the 2018 Farm Bill, advocates representing various interests have banded together in support of this vital program. However, the issue of restricting the purchase of sugar-sweetened beverages (SSB) with SNAP benefits has divided anti-hunger and public health advocates. While public health and medical officials support the idea of restrictions on junk food, arguing that SNAP should improve health and nutrition, not contribute to …