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Where Are Your Drugs Really Made And Who Is Regulating It?, Floyd Trillis III 2012 Cleveland State University

Where Are Your Drugs Really Made And Who Is Regulating It?, Floyd Trillis Iii

In the Balance

No abstract provided.


Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway 2012 University of Georgia School of Law

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to ...


Breakfast And Lunch Participation In Massachusetts Schools, Center for Social Policy, University of Massachusetts Boston, Massachusetts Budget and Policy Center, Massachusetts Law Reform Institute, Eos Foundation 2012 University of Massachusetts Boston

Breakfast And Lunch Participation In Massachusetts Schools, Center For Social Policy, University Of Massachusetts Boston, Massachusetts Budget And Policy Center, Massachusetts Law Reform Institute, Eos Foundation

Center for Social Policy Publications

The Center for Social Policy at the University of Massachusetts Boston (CSP), the Massachusetts Budget and Policy Center (MassBudget), and the Massachusetts Law Reform Institute (MLRI), with support from the Eos Foundation, established a research team to examine school food and related programs in Massachusetts.

While the team developed an overview of all federally funded food programs in Massachusetts, the focus of our work was on school meal programs and several aspects of the Supplemental Nutritional Assistance Program (SNAP). The full project is composed of several individual pieces of research and analysis, most of which were primarily undertaken by one ...


Canada's Marihuana Medical Access Regulations: Up In Smoke, Carolynn Conron 2012 The University of Western Ontario

Canada's Marihuana Medical Access Regulations: Up In Smoke, Carolynn Conron

Electronic Thesis and Dissertation Repository

The Supreme Court of Canada has interpreted the constitutional principles entrenched in the Canadian Charter of Rights and Freedoms to mean that everyone in Canada has a constitutional right to access necessary medical treatment without fear of criminal sanction. The latest research suggests cannabis (marihuana) provides a unique medicinal benefit that, for some individuals, is necessary. The federal criminal prohibition of cannabis deprives many individuals of a potentially beneficial medicine and stigmatizes them with a criminal record.

Without a valid medical cannabis access system, the criminal prohibition is invalid. The current Marihuana Medical Access Regulations were recently struck down. Parliament ...


Leveraging The Dialectical Theory In Case Study Analysis: Genzyme's Ethical Dilemma, Andrei Duta 2012 Pepperdine University

Leveraging The Dialectical Theory In Case Study Analysis: Genzyme's Ethical Dilemma, Andrei Duta

The Journal of Business, Entrepreneurship & the Law

This paper provides the theoretical framework for a case study that I share with students in my courses. The dialectical theory is used to analyze ethical conundrums pertaining to Genzyme, a successful bio-tech corporation based in Boston, Massachusetts that manufactures treatments for serious diseases such as kidney problems, immune diseases, and cancer. We discuss questions such as: is Genzyme acting unethically when averaging extremely high profit margins on drugs for rare diseases? Is the company taking advantage of the lack of pharmaceutical choices that patients have when addressing their ailments? The dialectical theory provides the framework and vocabulary for discussing ...


Would State-Mandated Labels For Biotech Foods Violate World Trade Agreements?, Drew Kershen 2012 University of Oklahoma College of Law

Would State-Mandated Labels For Biotech Foods Violate World Trade Agreements?, Drew Kershen

Drew L. Kershen

No abstract provided.


A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus 2012 University of Michigan Law School

A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus

University of Michigan Journal of Law Reform

To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.


Enhancing Food Safety: The Role Of The Food And Drug Administration, Lewis Grossman 2012 American University Washington College of Law

Enhancing Food Safety: The Role Of The Food And Drug Administration, Lewis Grossman

Lewis A. Grossman

Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and ...


Caremark's Irrelevance, Mercer E. Bullard 2012 University of Mississippi

Caremark's Irrelevance, Mercer E. Bullard

Mercer E Bullard

In re Caremark Int’l Inc. Derivative Litig. is commonly held out as the iconic corporate law case on liability for a failure of legal compliance, but the true source of corporate law as to legal compliance is the higher standard established by other sources of law. The expected cost of liability, both criminal and civil, for violations of federal healthcare regulations, for example, is a far stronger determinant of corporate compliance systems than potential liability under Caremark. Other areas of industry-specific regulation, such as for financial services, telecommunications and energy, similarly play a greater role than state corporate law ...


Prosecutorial Discretion Revisited, Siyuan CHEN 2012 Singapore Management University

Prosecutorial Discretion Revisited, Siyuan Chen

Siyuan CHEN

Quek Hock Lye is the latest of three very recent Court of Appeal decisions that addresses the constitutional challenge against the exercise of prosecutorial discretion in the context of the Misuse of Drugs Act (the other two decisions being Ramalingam Ravinthran v Attorney General and Yong Vui Kong v Public Prosecutor). In Quek Hock Lye, the appellant Q was convicted of participating in a criminal conspiracy with W and S to traffic in not less than 62.14 grams of diamorphine (thus attracting the mandatory death penalty). Before Q’s trial began, W had pleaded guilty to a separate charge ...


Food Fight: A Case Study Of The Community Food Security Coalition’S Campaign For A Fair Farm Bill, Marni Salmon 2012 SIT Graduate Institute

Food Fight: A Case Study Of The Community Food Security Coalition’S Campaign For A Fair Farm Bill, Marni Salmon

Capstone Collection

The farm bill is an all-encompassing piece of legislation that is reauthorized approximately every five years and establishes federal policy for everything from farm subsidies and crop insurance to energy, conservation, food stamps and school lunches. The current law expires at the end of September 2012. Reauthorization of the farm bill represents the single largest opportunity to reform the policies that shape food systems in the United States. The Community Food Security Coalition (CFSC) is campaigning to improve access to healthy food by increasing links with family farmers and to strengthen local and regional food systems. This case study traces ...


Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel 2012 Kennesaw State University

Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel

Georgia Journal of Public Policy

Discussions about public policy relating to alcohol cause a polarizing reaction to many people in this country, particularly in the South. The state of Georgia, for example, has a long history of policies regulating alcohol which reflects its membership as part of the “Bible Belt” where Sunday is regarded as a holy day and therefore alcohol cannot and should not be purchased on this day. Given that the impetus of alcohol control policy has generally widened the availability of alcohol since the Prohibition, the moral concerns of voters regarding alcohol regulation have been superseded in the public debate with safety ...


Dynamics Of Land Use/Land Cover Changes And Its Implication On Food Security In Anyigba, North Central, Nigeria, Tokula E. Arome, Sunday P. Ejaro (PhD) 2012 SelectedWorks

Dynamics Of Land Use/Land Cover Changes And Its Implication On Food Security In Anyigba, North Central, Nigeria, Tokula E. Arome, Sunday P. Ejaro (Phd)

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

This study assessed land use/land cover changes and its effect on Agricultural land in Anyigba. The objectives were to identify and delineate different land use / land cover categories, assess the rate of change that occurred and examine the impact of land use/land cover change on food security using satellite remote sensing data collected at three different years (1987 Land sat TM, 2001 Land Sat TM and 2011 Land Sat ETM). The study utilized GIS software such as Idrisi Andes academic and ArcGIS 9.3. The study area covers approximately 31.8km2, and four major land use/cover classes ...


Constitutionalizing An Enforceable Right To Food: A Tool For Combating Hunger, Michael J. McDermott 2012 Boston College Law School

Constitutionalizing An Enforceable Right To Food: A Tool For Combating Hunger, Michael J. Mcdermott

Boston College International and Comparative Law Review

Although international treaties recognize a right to food, few nations have established a domestic, legally enforceable right to food. A justiciable national right to food can provide a basis for legal redress, national food policies, and state aid programs. India, South Africa, and Brazil pro-vide insight and lessons that can be applied to other nations, like Mexico, to identify effective means for creating a national right to food. This Note compares effective national right to food efforts and identifies essential elements underlying a justiciable national right to food. By evaluating the development of a right to food within in the ...


An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans 2012 Boston College Law School

An Uncertain Risk And An Uncertain Future: Assessing The Legal Implications Of Mercury Amalgram Fillings., Mary Ann Chirba-Martin, Carolyn M. Welshhans

Mary Ann Chirba

Trying to buy a mercury thermometer at the local pharmacy these days will result in a deluge of information regarding the risks of mercury and the proper disposal protocol for mercury thermometers as hazardous waste. Yet, inquiring about the risks of placing mercury in one’s mouth, in the form of a dental filling, is likely to meet with resounding assurances of safety from the dental profession. While such comforting disclaimers are meant to ease patient concerns, many continue to worry about the safety of dental mercury. This article will begin by describing the many safety concerns that surround the ...


Regulating By Repute, David Zaring 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, Lina Ahmed Abushouk 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, Amy Murphy 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 ...


Playing By Market Rules: Anti-Doping Policy In The European Union, Kayla McCulley 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.


The Dialogue Between Biomedicine And Law In An “Intraamerican Transnational Perspective”, Charles H. Baron 2012 Boston College Law School

The Dialogue Between Biomedicine And Law In An “Intraamerican Transnational Perspective”, Charles H. Baron

Charles H. Baron

No abstract provided.


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