Food and Drug Law Commons^™

Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs

Articles

Throughout the United States, escalating drug prices are putting immense pressure on state budgets. Several states are looking for ways to push back. Last year, Massachusetts asked the Trump administration for a waiver that would, among other things, allow its Medicaid program to decline to cover costly drugs for which there is limited or inadequate evidence of clinical efficacy. By credibly threatening to exclude such drugs from coverage, Massachusetts hoped to extract price concessions and constrain the fastest-growing part of its Medicaid budget.

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.