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


Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn 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.


Ethical Cannabis Lawyering In California, Francis J. Mootz III 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 ...


The Uneasy Case For Patent Law, Rachel E. Sachs 2018 Washington University in St. Louis School of Law

The Uneasy Case For Patent Law, Rachel E. Sachs

Michigan Law Review

A central tenet of patent law scholarship holds that if any scientific field truly needs patents to stimulate progress, it is pharmaceuticals. Patents are thought to be critical in encouraging pharmaceutical companies to develop and commercialize new therapies, due to the high costs of researching diseases, developing treatments, and bringing drugs through the complex, expensive approval process. Scholars and policymakers often point to patent law’s apparent success in the pharmaceutical industry to justify broader calls for more expansive patent rights.

This Article challenges this conventional wisdom about the centrality of patents to drug development by presenting a case study ...


The (Re)Newed Barrier To Access To Medication: Data Exclusivity, Srividhya Ragavan 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 ...


The Pharma Barons: Corporate Law's Dangerous New Race To The Bottom In The Pharmaceutical Industry, Eugene McCarthy 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 ...


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


Reversal Of Fortune: Moving Pharmaceuticals From Over-The-Counter To Prescription Status?, Lars Noah 2018 Villanova University Charles Widger School of Law

Reversal Of Fortune: Moving Pharmaceuticals From Over-The-Counter To Prescription Status?, Lars Noah

Villanova Law Review

No abstract provided.


The Demise Of Drug Design Litigation Death By Federal Preemption, Aaron Twerski 2018 Brooklyn Law School

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

Faculty Scholarship

No abstract provided.


Swimming Upstream: The Need To Resolve Inconsistency In The Fda's Fishy Regulatory Scheme, Kelsie Kelly 2018 Brooklyn Law School

Swimming Upstream: The Need To Resolve Inconsistency In The Fda's Fishy Regulatory Scheme, Kelsie Kelly

Journal of Law and Policy

The citizens of the United States rely on the federal government to maintain the safety of their food through effective regulation. As the technology used to develop food has advanced, the outermost limits of the current regulatory framework are being tested. The result has been a circuitous and ineffective attempt to regulate transgenic organisms, intended for human consumption, using multiple agencies and a patchwork of laws. The ability to incorporate DNA from nearly any organism into the genome of another provides immense potential for innovative new food products, but may also allow for unintended health and environmental consequences. Proper regulation ...


Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams 2018 University of Michigan Law School

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid ...


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

Pace 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 ...


Preventing Drug-Related Deaths At Music Festivals: Why The "Rave" Act Should Be Amended To Provide An Exception For Harm Reduction Services, Robin Mohr 2018 Chicago-Kent College of Law

Preventing Drug-Related Deaths At Music Festivals: Why The "Rave" Act Should Be Amended To Provide An Exception For Harm Reduction Services, Robin Mohr

Chicago-Kent Law Review

No abstract provided.


Limiting State Flexibility In Drug Pricing, Nicholas Bagley, Rachel E. Sachs 2018 University of Michigan Law School

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 2018 Seattle University School of Law

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 ...


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

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

Research Collection 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 ...


Commentary On The Investigation: The April 20, 2001 Peruvian Shootdown Accident, Editor 2018 Embry-Riddle Aeronautical University

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


The Overdose/Homicide Epidemic, Valena E. Beety 2018 West Virginia University College of Law

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 ...


Drug Approval In A Learning Health System, W. Nicholson Price 2018 University of Michigan Law School

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 ...


Dying To Be Fresh And Clean? Toxicants In Personal Care Products, The Impact On Cancer Risk, And Epigenetic Damage, Katherine Drabiak 2018 University of South Florida, College of Public Health

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 ...


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