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2018

Food and Drug Law

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Full-Text Articles in Law

Tying The Knot: An Interdisciplinary Approach To Understanding The Human Right To Adequate Nutrition, Jessica Fanzo, Kaitlin Y. Cordes, Elizabeth F. Fox, Anna Bulman Dec 2018

Tying The Knot: An Interdisciplinary Approach To Understanding The Human Right To Adequate Nutrition, Jessica Fanzo, Kaitlin Y. Cordes, Elizabeth F. Fox, Anna Bulman

Columbia Center on Sustainable Investment Staff Publications

Malnutrition is alarmingly prevalent, affecting one in three people worldwide. In this Article, we argue that a key reason the global community has been unsuccessful in combating malnutrition is a lack of clarity outside the field of nutrition regarding the true meaning of “nutrition.” In particular, this has limited the effectiveness of international human rights law as a mechanism for addressing malnutrition.

In this interdisciplinary Article, which draws from both the legal and nutrition fields, we unpack the meaning of nutrition and demonstrate that a standalone right to adequate nutrition does indeed exist in international human rights law as a …


Selling Fish To Restaurants And The Public: A Fisher's Guide, Marine Affairs Institute, Roger Williams University School Of Law, Brynae Riggins Dec 2018

Selling Fish To Restaurants And The Public: A Fisher's Guide, Marine Affairs Institute, Roger Williams University School Of Law, Brynae Riggins

Sea Grant Law Fellow Publications

No abstract provided.


Peacebuilding Through Food Recovery, Angela Hackstadt Nov 2018

Peacebuilding Through Food Recovery, Angela Hackstadt

University Libraries Faculty Scholarship

The United States wastes approximately 133 billion pounds of food annually while 15 million American households are food insecure. Current and proposed U.S. legislation attempts to encourage food recovery efforts to address both of these problems by incentivizing donation of surplus foods by businesses to charitable organizations, yet legislation has failed to deliver. Food insecure individuals who use food banks or other safety net programs are often required to provide personal information and are subject to scrutiny in the process of acquiring food. Information can be leveraged in different ways to stigmatize or marginalize those in need. This presentation discusses …


The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski Oct 2018

The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski

Faculty Scholarship

No abstract provided.


Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger Oct 2018

Agricultural Investments Under International Investment Law, Jesse Coleman, Sarah Brewin, Thierry Berger

Columbia Center on Sustainable Investment Staff Publications

International investment law, based primarily on international investment treaties, plays an important role in the governance of investment in agriculture, forestry, and fishing. The obligations established by these treaties, and enforced by means of investor–state arbitration, can present challenges for policy-makers and others seeking to ensure that investments are sustainable, including by affecting the ways in which the costs and benefits of investments are distributed among different actors.

CCSI partnered with the International Institute for Environment and Development (IIED) and the International Institute for Sustainable Development (IISD) to produce a briefing note on agricultural investments under international investment law. The …


Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Jason J. Czarnezki Oct 2018

Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Our global food systems create pervasive environmental, social, and health impacts. Impact valuation is an emerging concept that aims to quantify all environmental, social, and health costs of food systems in an attempt to make the true cost of food more transparent. It also is designed to facilitate the transformation of global food systems. The concept of impact valuation is emerging at the same time as, and partly as a response to, calls for the development of legal mechanisms to address environmental, social, and health concerns. Information has long been understood both as a necessary precursor for regulation and as …


Paper Promises For Drug Innovation, Erika Lietzan Oct 2018

Paper Promises For Drug Innovation, Erika Lietzan

Faculty Publications

Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …


Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs Sep 2018

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.


It Is Not About The Drugs: A Comparative And Contextual Analysis Of Singapore And European Approach To Drug Issues, Rathna N. Korman Sep 2018

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 2, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

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 5, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

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 4, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

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 …


Taxing & Zapping Marijuana: Blockchain Compliance In The Trump Administration Part 1, Richard Thompson Ainsworth, Brendan Magauran Aug 2018

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 …


Drug Approval In A Learning Health System, W. Nicholson Price Jul 2018

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 Jul 2018

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, …


Nurturing A More Just And Sustainable Food System: The First Year Of Pace Law's Food And Beverage Law Clinic, Jonathan Brown Jul 2018

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 …


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

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

Law Library Newsletters/Blog

No abstract provided.


Cheers To Central Hudson: How Traditional Intermediate Scrutiny Helps Keep Independent Craft Beer Viable, Daniel J. Croxall May 2018

Cheers To Central Hudson: How Traditional Intermediate Scrutiny Helps Keep Independent Craft Beer Viable, Daniel J. Croxall

NULR Online

Independent craft breweries contributed approximately $68 billion to the national economy last year. However, an arcane regulatory scheme governs the alcohol industry in general and the craft beer industry specifically, posing both obstacles and benefits to independent craft brewers. This Essay examines regulations that arguably infringe on free speech: namely, commercial speech regulations that prohibit alcohol manufacturers from purchasing advertising space from retailers. Such regulations were enacted to prohibit undue influence and anticompetitive behavior stemming from vertical and horizontal integration in the alcohol market. Although these regulations are necessary to prevent global corporate brewers from dominating the craft beer market …


No Farms No Food? A Response To Baylen Linnekin, Joshua Ulan Galperin May 2018

No Farms No Food? A Response To Baylen Linnekin, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

You have likely seen the bumper sticker, bold white text on a green background, reading “No Farms No Food.” The sticker is a product of, and in fact a tagline for, the American Farmland Trust. On the one hand, the point is obvious: As American Farmland Trust puts it, “[e]very meal on our plates [c]ontains ingredients grown on a farm. We all need farms to survive.” On the other hand, what seems like a plain statement on its face, “no farms no food,” is not so simple. Farms produce affordable food, they produce vast quantities of food, they produce healthy …


Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan May 2018

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …


Food Localization: Empowering Community Food Systems Through The Farm Bill, Joshua Ulan Galperin, Brian Fink, Alexandra Schluntz Apr 2018

Food Localization: Empowering Community Food Systems Through The Farm Bill, Joshua Ulan Galperin, Brian Fink, Alexandra Schluntz

Elisabeth Haub School of Law Faculty Publications

Our intent in this Article is not to delineate foods that are local or not local, nor is it to lionize one agricultural production method over another. Rather, we hope to build on the literature that for many decades has documented how local communities have emerged as influential actors on the American food system through establishing control over local supply chains often alongside national and global supply chains. We begin with Part I, which explores how some food-system scholars have conceptualized these democratic changes occurring. We look to Thomas Lyson’s concept of civic agriculture, which attempts to move corporation-oriented communities …


The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan Mar 2018

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication


Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax Jan 2018

Administrative Guidance And Genetically Modified Food, Edward L. Rubin, Joanna K. Sax

Faculty Scholarship

One of the most controversial issues in administrative law, the use of guidance, is exemplified by the regulation of one of the most controversial areas in modern society: genetically modified (GM) food. The appropriate use of guidance versus notice and comment rulemaking is a much-debated issue in administrative law. While agency officials generally assert that they are using guidance to express an agency’s thoughts about how to comply with a specific statutory provision or agency rule, the practical consequence is that the regulated party will hesitate to disobey, even if it believes that the guidance goes beyond the requirements of …


What Motivates Legislators To Act: Problem Definition & The Opioid Epidemic, A Case Study, Taleed El-Sabawi Jan 2018

What Motivates Legislators To Act: Problem Definition & The Opioid Epidemic, A Case Study, Taleed El-Sabawi

Faculty Publications

This article explores why federal legislators may have been motivated to treat the current opioid crisis as a health issue, when past drug problems have been treated as a criminal justice issue. Using theories from political science, policy studies and sociology, this article summarizes leading theories of legislative behavior and applies them to the current opioid crisis, in an effort to better understand what motivates legislators to enact legislation to solve pressing social problems in a way that reframes the problem. Part II of this article provides an overview of the Comprehensive Addiction and Recovery Act, its significance, and how …


Localism, Labels And Animal Welfare, Samuel R. Wiseman Jan 2018

Localism, Labels And Animal Welfare, Samuel R. Wiseman

Scholarly Publications

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanelyraised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …


Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd Jan 2018

Consolidation And Innovation In The Pharmaceutical Industry: The Role Of Mergers And Acquisitions In The Current Innovation Ecosystem, Joanna Shepherd

Faculty Articles

Recent changes in the pharmaceutical industry have spurred an unprecedented wave of mergers and acquisitions. Some researchers and agencies have questioned whether pharmaceutical consolidation could impede drug innovation. However, as I explain in this Article, these concerns are largely based on an outdated understanding of the drug innovation ecosystem. Whereas a few decades ago almost all drug discovery took place inside traditional pharmaceutical companies, today most drug innovation is externally-sourced from biotech companies and smaller firms. Internal R&D is no longer the primary source, or even an important source, of drug innovation. As a result, analyses that focus on the …


Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler Jan 2018

Food Federalism: States, Local Governments, And The Fight For Food Sovereignty, Sarah B. Schindler

Faculty Publications

Recently, a number of states have sought to withdraw or restrain local power. In this Article, which is part of the “Re-Thinking State Relevance” symposium hosted by the Ohio State Law Journal, I write about a state taking the opposite approach, and attempting to affirmatively endow its local governments with additional powers. The state is Maine, and the context is control over local food production and sales. This Article begins by addressing the emergence of the sustainable local foods movement broadly, and reasons for the growth of this movement. It then focuses more pointedly on the food sovereignty movement, considering …


Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown Jan 2018

Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown

Elisabeth Haub School of Law Faculty Publications

In their article, Forging Food Justice Through Cooperatives in New York City, Dan DePasquale, Surbhi Sarang, and Natalie Bump Vena (the “Authors”) argue that consumer-owned and worker-owned cooperatives hold promise as a means for advancing policy objectives associated with “food justice,” namely building community wealth and power and providing more affordable access to healthy food in low-income and minority communities. Looking to examples of legislation and policies in other jurisdictions, they advocate for a wide range of policies to promote the viability of cooperatives in New York City, including reforms to cooperative corporation laws and strategies for better allocating funding …


Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd Jan 2018

Gender, Race & The Inadequate Regulation Of Cosmetics, Marie C. Boyd

Faculty Publications

Scholars and other commentators have identified failures in the regulation of cosmetics-which depends heavily on voluntary industry self- regulation-and called for more stringent regulation of these products. Yet these calls have largely neglected an important dimension of the problem: the current laissez-faire approach to the regulation of cosmetics disproportionally places women, and particularly women who are members of other excluded groups, at risk. This Article examines federal cosmetics law and regulation through a feminist lens. It argues that cosmetics law and regulation have lagged behind that of the other major product categories regulated by the Food and Drug Administration under …


The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan Jan 2018

The History And Political Economy Of The Hatch-Waxman Amendments, Erika Lietzan

Faculty Publications

Reform of the Hatch–Waxman generic drug framework is in the air. Scholars, consumer advocacy groups, regulated industry, and policymakers are engaged in heated debate about perceived shortcomings in the scheme, flaws, and unexpected loopholes. Changes in how the U.S. Food and Drug Administration (FDA) implements the law, as well as changes to the law itself, are under serious consideration. These policymaking discussions take place against a backdrop of shared assumptions about the origins and nature of the original Hatch–Waxman legislation — assumptions that this Article claims are wrong. Convention wisdom holds that the Hatch–Waxman legislation was a delicate compromise privately …