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Food and Drug Law

2011

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Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp Dec 2011

Mergers, Market Dominance And The Lundbeck Case, Herbert J. Hovenkamp

All Faculty Scholarship

In Lundbeck the Eighth Circuit affirmed a district court’s judgment that a merger involving the only two drugs approved for treating a serious heart condition in infants was lawful. Although the drugs treated the same condition they were not bioequivalents. The Eighth Circuit approved the district court’s conclusion that they had not been shown to be in the same relevant market.

Most mergers that are subject to challenge under the antitrust laws occur in markets that exhibit some degree of product differentiation. The Lundbeck case illustrates some of the problems that can arise when courts apply ideas derived from models …


The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth Nov 2011

The Transatlantic Gmo Dispute Against The European Communities: Some Preliminary Thoughts, David A. Wirth

David A. Wirth

Any day now, a World Trade Organization panel is expected to rule in a dispute between the U.S. and the EU concerning market access for genetically-engineered foods and crops. This piece, written before the release of the WTO panel's report, analyzes novel systemic issues concerning the impact of WTO law on regulatory design, at both the national and international levels, that are raised by this dispute. These include (1) the application of WTO disciplines to regulatory schemes that require prior governmental approval to protect the environment and public health from newly-introduced products and substances; (2) the role of precaution as …


Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González Oct 2011

Food Justice As Interracial Justice: Urban Farmers, Community Organizations And The Role Of Government In Oakland, California, Christopher J. Curran, Marc-Tizoc González

University of Miami Inter-American Law Review

No abstract provided.


Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr Oct 2011

Unanswered Questions Of A Minority People In International Law: A Comparative Study Between Southern Cameroons & South Sudan, Bernard Sama Mr

Bernard Sama

The month July of 2011 marked the birth of another nation in the World. The distressful journey of a minority people under the watchful eyes of the international community finally paid off with a new nation called the South Sudan . As I watched the South Sudanese celebrate independence on 9 July 2011, I was filled with joy as though they have finally landed. On a promising note, I read the UN Secretary General Ban Ki-moon saying “[t]ogether, we welcome the Republic of South Sudan to the community of nations. Together, we affirm our commitment to helping it meet its …


Revisiting The Original Tea Party: The History Of Regulating Food Consumption In America, Alison Peck Oct 2011

Revisiting The Original Tea Party: The History Of Regulating Food Consumption In America, Alison Peck

Law Faculty Scholarship

In response to concerns over rising obesity rates, state and federal policymakers have introduced laws that seek to internalize the public health costs of consuming unhealthy foods. These laws range from taxes on sugared beverages to mandatory nutritional information disclosures and beyond. Vocal opponents to such laws, including many Tea Party members, characterize such laws as government overreaching into the private sphere. That opposition often evokes Revolutionary images and ideology, with references to the Boston Tea Party, the Founding Fathers, and the framing of the Constitution. This article challenges the symbolism used by these opponents by examining the pre-Revolutionary non-importation …


The Kingpin Act Vs. California's Compassionate Use Act: The Dubious Battle Between State And Federal Drug Laws, Sumeet H. Chugani, Xingjian Zhao Sep 2011

The Kingpin Act Vs. California's Compassionate Use Act: The Dubious Battle Between State And Federal Drug Laws, Sumeet H. Chugani, Xingjian Zhao

University of the District of Columbia Law Review

No abstract provided.


The Politics Of Exclusion In California's Marijuana Reform Movement, Brooke Mascagni Sep 2011

The Politics Of Exclusion In California's Marijuana Reform Movement, Brooke Mascagni

University of the District of Columbia Law Review

No abstract provided.


A Decade After Drug Decriminalization: What Can The United States Learn From The Portuguese Model?, Jordan Blair Woods Sep 2011

A Decade After Drug Decriminalization: What Can The United States Learn From The Portuguese Model?, Jordan Blair Woods

University of the District of Columbia Law Review

No abstract provided.


Rise Of The Pills, Ken Lammers Jr. Sep 2011

Rise Of The Pills, Ken Lammers Jr.

University of the District of Columbia Law Review

No abstract provided.


Again And Again We Suffer: The Poor And The Endurance Of The "War On Drugs", Brian Gilmore Sep 2011

Again And Again We Suffer: The Poor And The Endurance Of The "War On Drugs", Brian Gilmore

University of the District of Columbia Law Review

No abstract provided.


Breaking Free From Insanity: A White-Collar Crime Approach To Drug War Policy, Brian Harrison Sep 2011

Breaking Free From Insanity: A White-Collar Crime Approach To Drug War Policy, Brian Harrison

University of the District of Columbia Law Review

Preventing crime should be a top priority for law enforcement. A victim of crime would readily agree that never having been a victim at all is preferable to suffering at the hands of a criminal. Even if the criminal is later caught and punished, a victim remains a victim. Despite this simple truth, current drug policy does not place a top priority preventing the laundering of drug-tainted money. As a result, the United States remains a victim in the War on Drugs.' As will be discussed, the crime of money laundering can be prevented in many instances by prosecuting banks …


What Would It Look Like If We Cared About Narcotics Trafficking? An Argument To Attack Narcotics Capital Rather Than Labor, Mark Osler Sep 2011

What Would It Look Like If We Cared About Narcotics Trafficking? An Argument To Attack Narcotics Capital Rather Than Labor, Mark Osler

University of the District of Columbia Law Review

Law enforcement actions should be judged by a simple measure: are they solving a problem? After all, we Americans loathe the loss of freedom and the spending of tax dollars, and we should never take away citizens' freedom and money unless there actually is a problem being solved. Illegal narcotics are a problem, but we aren't solving it. Narcotics trafficking and use lead to violence, undermine productivity,' and rip apart the social fabric of families and communities. Despite much attention to these issues, drug use in this country continues at high levels, even among children.2 We have failed, and it …


Pliva V. Mensing And Its Implications, Brian Wolfman, Dena Feldman Sep 2011

Pliva V. Mensing And Its Implications, Brian Wolfman, Dena Feldman

Georgetown Law Faculty Publications and Other Works

The U.S. Supreme Court ruling in PLIVA Inc. v. Mensing will immunize generic drug manufacturers facing failure-to-warn claims from state-law liability, and may also have implications for preemption jurisprudence more generally, says attorney Brian Wolfman and co-author Dena Feldman in this BNA Insight. The authors analyze the ruling, and offer their views on the questions that PLIVA raises about the ongoing vitality of the presumption against preemption, the standard for determining ‘‘impossibility’’ preemption, and the propriety of deference to an agency’s views on preemption.


Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang Sep 2011

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …


Are Food Subsidies Making Our Kids Fat? Tensions Between The Healthy Hunger-Free Kids Act And The Farm Bill, Melissa D. Mortazavi Sep 2011

Are Food Subsidies Making Our Kids Fat? Tensions Between The Healthy Hunger-Free Kids Act And The Farm Bill, Melissa D. Mortazavi

Washington and Lee Law Review

On December 15, 2010, President Obama signed the Healthy Hunger- Free Kids Act of 2010 (HHFKA)1 into law. It was hailed as a bipartisan success and a significant reform of childhood nutrition policy. Indeed, on its surface the law appears to make a significant shift away from the food paradigm of the past. However, upon closer examination, it fails to unwind the tangled connections between domestic eating habits and longstanding farm subsidies. This Article breaks new ground in several ways: First, it is one of the first essays in the emerging and underexplored field of food law, a crosssection of …


Assessment Of Organic And Inorganic Phosphorus In Soils Derived From Cretaceous Sediments And Basement Complex Soils Of Guinea Savannah Of Kogi State, North Central Nigeria, Sunday I. Amhakhian, H H. Isitekhale, Charles I. Oyewole Aug 2011

Assessment Of Organic And Inorganic Phosphorus In Soils Derived From Cretaceous Sediments And Basement Complex Soils Of Guinea Savannah Of Kogi State, North Central Nigeria, Sunday I. Amhakhian, H H. Isitekhale, Charles I. Oyewole

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

A pot experiment was carried out using 20 surface soils (0-15cm depth) in 2008 to assess soil organic phosphorus and some fraction of inorganic phosphorus in other to know their availability in the soils of the studied area and also work have not been done in this areas in respect to organic and in-organic phosphorus. The experiment was conducted using 20 soils 10 from each geological formation (Cretaceous sediments and Basement complex soils), respectively. The mean organic phosphorus of 63.51 mgkg 1 soil was obtained for Cretaceous sediment soils and 158.54 mgkg 1 soil for the basement complex soils respectively. …


Development Of Functional Indices Of Facility Occurrence Towards The Distribution Of Social Services In Lagos Island Nigeria., Augustus O. Atubi Aug 2011

Development Of Functional Indices Of Facility Occurrence Towards The Distribution Of Social Services In Lagos Island Nigeria., Augustus O. Atubi

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

Proper coordination of transport and public facilities provision is vital to any balanced regional development strategy. The central aim of this study, therefore, is to find out what the relationship is between access to the transport network and the provision of functional indices of facility occurrence towards the distribution of social services in Lagos Island, Nigeria. In particular it seeks to find out areas that have below or above average level of facility occurrences relative to the level of accessibility. However, a pair wise correlation matrix of the eleven (11) variables employed in the index construction was carried out. The …


Creating A More Efficient And Effective Food Safety System In Memphis And Shelby County, Harvard Law School Mississippi Delta Project Aug 2011

Creating A More Efficient And Effective Food Safety System In Memphis And Shelby County, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

The taste of a fresh-picked peach on a warm summer day is one of life’s simple joys. A store-bought peach can never truly replicate the experience. But in Memphis, getting that peach from the farmer’s tree into the customer’s hand is not as simple as one would assume. The fruit cannot be simply picked from the tree and then sold from the back of a produce truck. Instead, someone wanting to sell these fruits from his truck must obtain a permit and conform to outdated rules, such as the requirement for the truck to remain in motion at all times …


Urban Climate And Challenges Of Tropical Cities, B E. Omogbai Jul 2011

Urban Climate And Challenges Of Tropical Cities, B E. Omogbai

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

This study examines the nature of urban climate, features and the challenges on the developing tropical cities in the 21st century. It argues that the use of principles of urban climate would help in providing comfortable living conditions and problem immune working environments for the inhabitants of tropical cities. The findings reveal that owing to poor environmental planning, inadequate geotechnical landscape surveys prior to the development of urban infrastructures, and non-adherence to the principles of urban climate, challenges of landscape degradation, excessive flooding of the built infrastructures, heat-island effects, and collapse of buildings have emerged. Suggested measures to avert these …


Drugs In Sport: A Study Of The Origins, Rights And Outcomes, Annette Greenhow Jul 2011

Drugs In Sport: A Study Of The Origins, Rights And Outcomes, Annette Greenhow

Annette Greenhow

Extract: This paper will examine the origins of the use of drugs in sport, dating back to ancient times through to modern evidence in the broader context of recreational and performance enhancing drug use. It will also consider the rights of the athlete involved in an anti-doping offence and examine whether the protection of the legitimate interests of the sport is still sufficient to justify the imposition of the strict liability principles applicable today. One perspective that requires further examination is whether the ‘one rule fits all’ approach to the application of the sanctions under the WADA Code is reasonable …


Detecting Changes In Landuse/Cover Of Umuahia, South-Eastern Nigeria Using Remote Sensing And Gis Techniques, Fanan Ujoh, Olarewaju Oluseyi Ifatimehin, Adams Ndalai Baba Jul 2011

Detecting Changes In Landuse/Cover Of Umuahia, South-Eastern Nigeria Using Remote Sensing And Gis Techniques, Fanan Ujoh, Olarewaju Oluseyi Ifatimehin, Adams Ndalai Baba

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

Since 1991 when it became the capital city of Abia State, Umuahia has undergone tremendous transformation in its land use and land cover due to rapid urbanization. The main materials employed for this study are a land use map (1991) and Landsat ETM+satellite image (2007) of the study area. These, combined with field survey/checks, were brought into a GIS environment using ILWIS 3.2 Academic image classification software to map the land use/land cover and to estimate the rate of urban expansion and loss of rural land at the peri-urban fringes of Umuahia between 1991 and 2007. The study revealed significant …


International Drug Trafficking: A Global Problem With A Domestic Solution, Matthew S. Jenner Jul 2011

International Drug Trafficking: A Global Problem With A Domestic Solution, Matthew S. Jenner

Indiana Journal of Global Legal Studies

Forty years ago, the world declared war on drugs. Today, after decades of failing to adequately control drug consumption, an even graver problem has emerged: violent drug traffickers have taken the industry hostage and will stop at nothing to preserve their power. Governments have instituted dozens of programs to dismantle the illicit drug industry, but they have seen only marginal success. One strategy, however, has yet to be fully tested: universal legalization. Universal legalization of all drugs would attack the illicit drug market head-on, destroying the profit incentive for drug traffickers and placing control of the industry in the hands …


Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart Jul 2011

Food And Drug Administration Regulation Of Food Safety, Lawrence O. Gostin, Katie F. Stewart

Georgetown Law Faculty Publications and Other Works

Food-borne illness remains a major public health challenge in the United States, causing an estimated 48 million illness episodes and 3000 deaths annually. The FDA Food Safety Modernization Act (FSMA), enacted in 2011, gives the Food and Drug Administration (FDA) new tools to regulate food safety. The act emphasizes prevention, enhanced recall authority, and oversight of imported food.

The FSMA brings the FDA’s food safety regulation in line with core tenets of public health by focusing on preventing outbreaks, rather than reacting to them, and differentiating between foods and food producers based on the degree of risk they pose. The …


Gender Participation In The Management Of Tricycle Transport For Youth Empowerment And Sustainable Development In Kano State, Nigeria, Nuratu Muhammed Jun 2011

Gender Participation In The Management Of Tricycle Transport For Youth Empowerment And Sustainable Development In Kano State, Nigeria, Nuratu Muhammed

Confluence Journal Environmental Studies (CJES), Kogi State University, Nigeria

The research examined gender participation in the management of tricycle for youth empowerment and sustainable development in Kano state, Nigeria. Stratified random sampling technique was used to select samples of drivers(150), passengers (150) and owners/managers the female tricycle owners fell under this category and they numbered(65).All together a total of 365 samples were selected for the study. Data obtained from the primary data was analyzed using simple statistical techniques and chi square test to ascertain whether there was any significant differences in some of the variables tested. The results of the analysis revealed that the main difference was found in …


Drinking Motives Of College Students At A Hbcu In Oklahoma, Yasmeen Shumate May 2011

Drinking Motives Of College Students At A Hbcu In Oklahoma, Yasmeen Shumate

McCabe Thesis Collection

The use of alcohol can be found throughout colleges across the nation (O'Malley and Johnston, 2002). Whether the college is a 2 year institution or a 4 year institution, private of public, there have been multiple studies conducted over alcohol use in various settings. College students consistently report higher levels of alcohol use than their non-college counterparts (O'Malley and Johnston, 2002). In addition, specific demographic characteristics, such as gender, ethnicity, and age, have been studied in relation to college drinking. It's been proven that college men are found to drink more than college females (Humara and Sherman, 2004). Non- White …


Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang Apr 2011

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …


Community Growth And Land Use, Susan Kelly Apr 2011

Community Growth And Land Use, Susan Kelly

Publications

No abstract provided.


Breaking Patents, Daniel R. Cahoy Apr 2011

Breaking Patents, Daniel R. Cahoy

Michigan Journal of International Law

In the 1970s and 1980s, the Boeing aircraft company worked to address the rising cost of jet fuel by inventing lighter metal alloys for use in aerospace materials. Among its discoveries was a method of producing aluminum-lithium alloys with high "fracture toughness," and in 1989, Boeing received a patent for the process. Five years later, another aerospace company working as a National Aeronautics and Space Administration (NASA) contractor, Lockheed Martin, was attempting to solve a similar problem related to materials used in the space shuttle. Lighter materials were necessary for future shuttle missions to transport components of the International Space …


The Analyses Of State And Federal Medical Marijuana Laws And How They Apply To Employment, Lizaveta Sergeev Apr 2011

The Analyses Of State And Federal Medical Marijuana Laws And How They Apply To Employment, Lizaveta Sergeev

UNLV Theses, Dissertations, Professional Papers, and Capstones

The purpose of this study is to analyze and discuss the current discrepancies in the legal system as it applies to medical marijuana in the employment sector. The laws regarding the legalization of medical marijuana are relatively new and have many constraints when applied to employment. On the federal level, medical marijuana remains illegal. Many states have passed some form of legislation legalizing medical marijuana. Unfortunately, only two states have laws that protect users from being discriminated in employment. This leaves employers and employees uncertain about what actions to take when dealing with medical marijuana in the employment sector.


Drug Policy In Context: Rhetoric And Practice In The United States And The United Kingdom, Richard C. Boldt Mar 2011

Drug Policy In Context: Rhetoric And Practice In The United States And The United Kingdom, Richard C. Boldt

Richard C. Boldt

The history of narcotics use and drug control in the U.S. before passage of the Harrison Act in 1914 is similar in important respects to that in the U.K. during the same period. Although the two countries’ paths diverged significantly over the ensuing decades, there has been a convergence of sorts in recent years. In the United States, the trend lines have moved from an active “war on drugs” in which criminal enforcement and punishment have been the primary rhetorical and practical instruments of policy to an evolving approach, at least at the federal level, characterized by a somewhat more …