Regulating By Repute,
2012
Wharton School of the University of Pennsylvania
Regulating By Repute, David Zaring
Michigan Law Review
Is regulation a hopeless cause? Many thoughtful observers spend a lot of time enumerating all of the reasons why it is doomed to fail. The entire field of public choice, with impeccable logic, posits the likely corruption of every bureaucrat. And if corruption cannot explain the failure of regulation, the atrophy that comes from lack of competition-there is just one government, after all, and it does not have a profit motive-may be just as rich a vein to mine. It could also be that the legal system itself, with its myriad complexities, checks, and procedural requirements, may ossify to the …
Medicines That Kill,
2012
Sarah Lawrence College
Medicines That Kill, Lina Ahmed Abushouk
Annual Undergraduate Conference on Health and Society
The prevalence of counterfeit drugs on the African continent has been increasing at an alarming rate. “Medicines that Kill” is a research paper that attempts to analyze the factors that make African countries particularly susceptible to this global threat. Nigeria, a country that has had some of the highest rates of counterfeit drugs in the world, is the main case study for this paper. Its efforts to combat the issue are compared and contrasted with those of Tanzania and Kenya in an attempt to understand what aspects of the issue are unique to Africa and the methods that have been …
Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System,
2012
University of Michigan Law School
Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy
Michigan Law Review
In Granholm v. Heald, the Supreme Court held that states must treat instate and out-of-state alcoholic beverages equally under the dormant Commerce Clause and established a heightened standard of review for state alcohol laws. Yet in dictum the Court acknowledged that the three-tier distribution system-a regime that imposes a physical presence requirement on alcoholic beverage wholesalers and retailers-was "unquestionably legitimate." Though the system's physical presence requirement should trigger strict scrutiny, lower courts have placed special emphasis on Granholm's dictum, refusing to subject the three-tier distribution system to Granholm's heightened standard of review. This Note argues that the dictum should be …
Playing By Market Rules: Anti-Doping Policy In The European Union,
2012
Pomona College
Playing By Market Rules: Anti-Doping Policy In The European Union, Kayla Mcculley
Claremont-UC Undergraduate Research Conference on the European Union
No abstract provided.
Socio-Economic Effects Of Demolishing Squatter Settlements And Illegal Structures In Abuja Metropolis, Federal Capital Territory, Nigeria,
2012
SelectedWorks
Socio-Economic Effects Of Demolishing Squatter Settlements And Illegal Structures In Abuja Metropolis, Federal Capital Territory, Nigeria, Ishaku Iy Mallo Phd, Victor G. Obasanya
Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria
Abuja the Federal Capital Territory and study area is located between latitudes 8o25’ and 9o25’ North of the Equator and longitudes 6o45’ and 7o45’ East of the Greenwich Meridian. The study was carried out in Abuja Phase 1, and it is aimed at highlighting various socioeconomic effects of demolition of illegal structures and informal or squatter settlements on the people within the study area. Data was collected through reconnaissance survey, personal interviews with respondents, and a well laid out questionnaire. The results indicate that the demolition exercise embarked upon by the authorities in the Federal Capital Territory was a response …
Rainfall Variability And Crop Zones Classification For The Federal Capital Territory, Nigeria,
2012
SelectedWorks
Rainfall Variability And Crop Zones Classification For The Federal Capital Territory, Nigeria, Shaibu M. Hassan Phd
Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria
This study aims at analyzing agro-climatological parameters and establishing a link between some selected agro-climatological indices and sustainability of agricultural production in the Federal Capital Territory (FCT). Two sets of data, climatic and crop yield data were collected and subjected to various agro-climatological analyses. Agro-climatological analyses include the derivation of Onset, Cessation and Length of Rainy Season (LRS), Seasonality Index, Drought Index and Precipitation Periodicity Index. The statistical analyses include monthly and annual means, deviation from the mean, trend line. The result of moisture index in line with crops optimum moisture requirement was used to classify the Territory into agro-climatic …
Every High Has A Low: A Pragmatic Approach To The War On Drugs,
2012
University of Michigan Law School
Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan
University of Michigan Journal of Law Reform Caveat
One of the lasting vestiges of Richard Nixon’s presidency is the infamous “War on Drugs,” a forty-year-old effort aimed at curtailing “illicit drug consumption and transactions in America.” Although the goal behind the policy—a reduction in the rate of substance abuse—may be altruistic, the War on Drugs has dismally failed to achieve its goals and has exacerbated existing problems. Specifically, laws dealing with crack cocaine result in a “heavily disproportionate impact on black defendants;” in 2008 “blacks comprised 79.8 percent of those convicted for crack cocaine-related offenses,” whereas “whites comprised only 10.4 percent.” More generally, these laws illustrate a fundamental …
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak,
2012
University of Michigan Law School
Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson
University of Michigan Journal of Law Reform Caveat
Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused …
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both,
2012
Georgia State University College of Law
Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled
Michigan Telecommunications & Technology Law Review
Over the past decade or so, the United States has been the arena of a boisterous debate regarding the creation of a new regulatory framework for the approval of generic versions of biologics-based pharmaceutical products (also known as "biological products" and "biologics")--an important and increasingly growing class of drugs. The basic purpose of such a framework is to create a fast and less-costly route to FDA approval for biologics that would be similar or identical to already-approved biological products--typically ones that are sold on the market at monopoly rates--thereby allowing cheaper versions of such medicines to enter the market. One …
Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson,
2012
SelectedWorks
Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns
Brooke Burns
This Casebrief recognizes the current division developing among courts concerning whether PSRs have been wrongly misclassified as exempt from overtime pay since the World War II era. Despite the Second Circuit’s more recent decision in In re Novartis Wage and Hour Litigation, this Casebrief identifies the Third Circuit’s jurisprudence in Smith v. Johnson & Johnson as providing controlling guidance for practitioners navigating the current legal landscape.
Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?,
2012
Rutgers - School of Law, Newark
Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin
Keren F. Bisnauth
The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …
Polar Law And Good Governance,
2012
SelectedWorks
Polar Law And Good Governance, Prof. Elizabeth Burleson
Prof. Elizabeth Burleson
This chapter will assess the Antarctic Treaty System, ask what polar lessons can be learned regarding common pool resources, and analyze law of the sea and related measures. It will consider such substantive areas as Arctic and Antarctic natural resource management and procedural opportunities as inclusive governance structures. Enhancing good governance can occur through trust building forums that bring together stakeholders, share information, and make environmentally sound decisions regarding sustainable development.
Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012),
2012
UIC School of Law
Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012), Benjamin Liu
UIC Review of Intellectual Property Law
Countries after countries are adopting a controversial regulatory system of linking the market approval for pharmaceuticals to the status of potentially blocking patents as part of their bilateral and multilateral trade agreement package with the United States. Surprisingly, China took up pharmaceutical patent linkage in the absence of any treaty obligations and became the first country to adopt this regulatory regime outside of North America, despite the presence of a flourishing generics pharmaceutical industry and its developing country status. In fact, the Chinese regulation promised more intellectual property ("IP") protection than what even the United States FDA is capable of …
The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety,
2012
University of Maryland Francis King Carey School of Law
The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven
Journal of Health Care Law and Policy
No abstract provided.
Reconsidering The U.S. Patent System: Lessons From Generics,
2012
Vanderbilt University Law School
Reconsidering The U.S. Patent System: Lessons From Generics, Molly F.M. Chen
Vanderbilt Journal of Transnational Law
Scholars and pharmaceutical industry representatives consider the United States a worldwide leader in pharmaceutical innovation. However, the recent expansion of the international generics market has threatened the strength of the U.S. pharmaceutical industry. The pressure has led to the U.S. market's overreliance on a patentability standard that blocks generics competition without contributing substantially to the state of the art. This Note contrasts the U.S. nonobviousness standard and patent linkage regime with those of generics giants India and Israel and considers the effects of these policies on the relevant national and international generics industries. This Note proposes that the United States …
One Size Does Not Fit All,
2012
American University Washington College of Law
One Size Does Not Fit All, David Spratt
Articles in Law Reviews & Other Academic Journals
No abstract provided.
A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward,
2012
American University Washington College of Law, Washington D.C.
A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud
IP Theory
No abstract provided.
The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012),
2012
UIC School of Law
The Physician Payment Sunshine Act: An Important First Step In Mitigating Financial Conflicts Of Interest In Medical And Clinical Practice, 45 J. Marshall L. Rev. 963 (2012), Alexandros Stamatoglou
UIC Law Review
No abstract provided.
Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012),
2012
UIC School of Law
Updating The Patent System's Novelty Requirement To Promote Small-Molecule Medicinal Progress, 45 J. Marshall L. Rev. 1151 (2012), Jason Brewer
UIC Law Review
No abstract provided.
Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?,
2012
University of Nevada, Las Vegas -- William S. Boyd School of Law
Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher
Nevada Law Journal
No abstract provided.
