Regulation Of Encapsulated Placenta, 2019 University of Pittsburgh School of Law
Regulation Of Encapsulated Placenta, Greer Donley
Articles
The practice of placenta encapsulation is rapidly growing. It typically involves post-partum mothers consuming their placentas as pills in the months after childbirth. The perceived benefits include improved mood and energy, reduced bleeding and pain, and greater milk supply. But these effects are unproven, and consumption comes with health risks. The rise of this trend has sparked a vigorous debate in the recent medical literature, but this Article is the first to consider the legal implications of placenta encapsulation. This Article examines whether FDA should regulate encapsulated placenta, and if so, whether it should be regulated as a drug, supplement, …
The Critical Tax Project, Feminist Theory, And Rewriting Judicial Opinions, 2019 University of Pittsburgh School of Law
The Critical Tax Project, Feminist Theory, And Rewriting Judicial Opinions, Anthony C. Infanti, Bridget J. Crawford
Articles
In this essay, the authors discuss the intellectual foundations for their co-edited book, Feminist Judgments: Rewritten Tax Opinions (2017), the first in a series of subject-matter specific volumes published in the U.S. Feminist Judgments Series by Cambridge University Press. Using only the facts and precedents in existence at the time of the original opinion, the contributors to this and other feminist judgments projects around the globe seek to show how application of feminist perspectives could impact, or even change, the holding or reasoning of judicial decisions. Underlying Feminist Judgments: Rewritten Tax Opinions is the belief that the study of taxation …
The "Evergreening" Metaphor In Intellectual Property Scholarship, 2019 University of Missouri School of Law
The "Evergreening" Metaphor In Intellectual Property Scholarship, Erika Lietzan
Faculty Publications
This article is a plea for changes in the scholarly dialogue about "evergreening" by drug companies. Allegations that drug companies engage in "evergreening" are pervasive in legal scholarship, economic scholarship, medical and health policy scholarship, and policy writing, and they have prompted significant policymaking proposals. This Article was motivated by concern that the metaphor has not been fully explained and that policymaking in response might therefore be premature. It canvasses and assesses the scholarly literature-more than 300 articles discussing or mentioning "evergreening." It catalogues the definitions, the examples, and the empirical studies. Scholars use the term when describing certain actions …
Drugs' Other Side Effects, 2019 University of Colorado Law School
Drugs' Other Side Effects, Craig J. Konnoth
Publications
Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …
The Carbon Tax Vacuum And The Debate About Climate Change Impacts: Emission Taxation Of Commodity Crop Production In Food System Regulation, 2018 Food Law International
The Carbon Tax Vacuum And The Debate About Climate Change Impacts: Emission Taxation Of Commodity Crop Production In Food System Regulation, Gabriela Steier
Pace Environmental Law Review
The scientific consensus on climate change is far ahead of U.S. policy on point. In fact, the U.S. has a legal vacuum of carbon taxation while climate change continues to impact the codependence of agriculture and the environment. As this Article shows, carbon taxes follow the polluter-pays model, levying taxes on the highest greenhouse gas (“GHG”) emissions—and contributions to climate change. But this is not only unsustainable; it would also undermine agricultural production and, thus, food security. This Article describes how the law can regulate climate change contributions and promote adaptation and mitigation supported through carbon taxes in the agricultural …
Food Sustainability In The Age Of Complex, Global Supply Chains, 2018 University of Wisconsin
Food Sustainability In The Age Of Complex, Global Supply Chains, Steph Tai
Arkansas Law Review
Food production has become more complex over time. Moreover, we are producing food in an increasingly global, rather than local, manner. How can demands for sustainability be reinforced in this age of complex, global supply chains? This essay focuses on three key features of the modern food supply chain: the variety of components, the complexity of the chain itself, and diversity of “enforcement” mechanisms in food production supply chains. These features suggest that traditional governmental tools (such as command and control measures) and contractual tools (such as performance standards) may not be sufficient to ensure sustainable production methods.
Tying The Knot: An Interdisciplinary Approach To Understanding The Human Right To Adequate Nutrition, 2018 Johns Hopkins University School of Advanced International Studies
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, 2018 Rhode Island Sea Grant Law Fellow
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.
Ethical Cannabis Lawyering In California, 2018 University of the Pacific
Ethical Cannabis Lawyering In California, Francis J. Mootz Iii
St. Mary's Journal on Legal Malpractice & Ethics
Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …
Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, 2018 University of Washington School of Law
Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, Rebecca Sweeney
Washington Law Review
The states that have legalized cannabis maintain a complicated relationship with the federal government. Since the Ogden Memorandum was issued in 2009, the federal government has left regulation of cannabis to the discretion of the states. That policy has recently shifted. In 2018, former U.S. Attorney General Jeff Sessions issued a new memorandum that rescinded guidance for states about how to structure the legalization of cannabis. The federal government’s current position is now ideologically aligned with that of states like Nebraska and Oklahoma. These states chose not to legalize cannabis and instead adhere to the Controlled Substances Act’s classification of …
Sb 17 - Alcoholic Beverages, 2018 Georgia State University
Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn
Georgia State University Law Review
Georgia law previously allowed counties and municipalities to permit the sale of alcoholic beverages on Sundays from 12:30 P.M. until 11:30 P.M. This Act, deemed “the Brunch Bill,” authorizes the counties and municipalities that have affirmatively voted by referendum to sell alcoholic beverages on Sundays to sell them earlier, at 11:00 A.M., if approved by a second referendum vote. This change applies to restaurants that make at least 50% of their revenue from the sale of food and hotels, and Georgia wineries.
The Crazy Maze Of Food Labeling And Food Claims Laws, 2018 St. John's University School of Law
The Crazy Maze Of Food Labeling And Food Claims Laws, Patrick Meyer
St. John's Law Review
(Excerpt)
This Article critiques the role of the FDA in providing consumers with accurate and relevant food label information, identifies impediments in the pursuit of its mission, and offers solutions to those impediments.
Part I of this Article traces the history of U.S. food labeling and health claims laws. Current food laws and their regulation have developed over time. The first federal legislation was passed in the early 1900s. The food laws of today have certainly been influenced by past food laws, which were largely a reaction to societal events. A brief summary of the historical development of our nation’s …
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, 2018 Texas A&M University School of Law
The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan
Srividhya Ragavan
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, …
Peacebuilding Through Food Recovery, 2018 University at Albany, State University of New York
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, 2018 Brooklyn Law School
The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski
Faculty Scholarship
No abstract provided.
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, 2018 University of Illinois
The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene Mccarthy
Michigan Business & Entrepreneurial Law Review
In this Article, I argue that drug companies have created a highly profitable but dangerous business model by employing the same legal tactics as the nineteenth-century “robber barons,” the group of financiers who orchestrated corporate law’s infamous race to the bottom. Like these historical financiers, drug company executives have captured the legal apparatus and regulatory bodies that oversee them. In so doing, they have transformed the law from a system of governance into a set of enabling doctrines. The pharmaceutical industry has turned legislation intended to protect the public into a legal justification for marketing ineffective and unsafe prescription drugs. …
Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, 2018 Elisabeth Haub School of Law at Pace University
Life Cycle Costing And Food Systems: Concepts, Trends, And Challenges Of Impact Valuation, Katherine Fiedler, Steven Lord, Jason J. Czarnezki
Michigan Journal of Environmental & Administrative Law
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 …
Agricultural Investments Under International Investment Law, 2018 Columbia Law School, Columbia Center on Sustainable Development
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, 2018 Elisabeth Haub School of Law at Pace University
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, 2018 University of Missouri School of Law
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 …