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Food and Drug Law Commons

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Provigil: A Commentary, Daniel A. Crane 2011 University of Michigan Law School

Provigil: A Commentary, Daniel A. Crane

Articles

Michael Carrier's case study on Provigil' offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. These settlements purported to allow generic entry before the expiration of the patent period, but, according to Carrier, the promise of early entry was negated by the second prong of Cephalon's anticompetitive strategy. During the time that ...


Enough Rope: Why United States V. White Plume Was Wrong On Hemp And Treaty Rights, And What It Could Cost The Federal Government, Lori Murphy 2011 University of Oklahoma College of Law

Enough Rope: Why United States V. White Plume Was Wrong On Hemp And Treaty Rights, And What It Could Cost The Federal Government, Lori Murphy

American Indian Law Review

No abstract provided.


Small, Slow, And Local, Mary Jane Angelo 2011 University of Florida Levin College of Law

Small, Slow, And Local, Mary Jane Angelo

UF Law Faculty Publications

The United States is in the middle of a significant cultural shift. Until very recently, United States citizens and policy-makers were willing to accept, or at least tolerate, what has become our food status quo--a highly subsidized, centralized, industrial food system that is environmentally harmful and unsustainable and encourages unhealthy eating habits. Many citizens and policy-makers are now demanding that we re-evaluate our entire agricultural system from farm to table and look for ways to develop a new food paradigm that is environmentally sound, sustainable, socially equitable, and that makes healthy whole foods available to all.

During the summer of ...


What’S Wrong With Race-Based Medicine?, Dorothy E. Roberts 2011 University of Pennsylvania

What’S Wrong With Race-Based Medicine?, Dorothy E. Roberts

Faculty Scholarship

This article is based on the 2010 Dienard Memorial Lecture on Law and Medicine at University of Minnesota and part of a larger book project, Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-first Century (The New Press, 2011). In June 2005, the Food and Drug Administration approved the first pharmaceutical indicated for a specific race. Its racial label elicited three types of criticism – scientific, commercial, and political. I discuss the first two controversies en route to what I consider the main problem with race-based medicine – its political implications. By claiming that race, a political grouping ...


Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe 2011 University of Florida Levin College of Law

Patents, Genetically Modified Foods, And Ip Overreaching, Elizabeth A. Rowe

UF Law Faculty Publications

Genetically engineered plants and animals have become and will continue to constitute a large part of the food we consume. The United States is the world's largest producer of genetically modified foods, making American consumers the most exposed population to these products. Agricultural biotechnology patents spur and support innovation. Accordingly, patent law is one of the main contributors to this phenomenon that has changed not only the kinds of food we eat, but the nature of the agri-business industry that produces these foods. This Article takes on an area of concern involving the patenting of food that has remained ...


Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel 2011 Touro College

Did The Fda Properly Assess The Safety Of Olestra As A Food Additive?, Leah Lebel

The Science Journal of the Lander College of Arts and Sciences

The following is an excerpt of the introduction to this article: Olestra, a fat-substitute comprised of sucrose that has been esterified with fatty acids (Blume 1995), has been the subject of much controversy ever since its creation. Olestra is not absorbed (Mattson and Nolen 1972) because it cannot be hydrolyzed by pancreatic lipases (Mattson and Volpenhein 1972) or taken up across the enterocyte microvillus membrane (Freston et al. 1997), and thus, cannot be utilized for energy. Olestra has physical and organoleptic properties similar to those of traditional triglycerides (Jandacek and Webb 1978) and is emulsified together with triglyceride (Freston et ...


Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax 2011 California Western School of Law

Protecting Scientific Integrity: The Commercial Speech Doctrine Applied To Industry Publications, Joanna K. Sax

Faculty Scholarship

Pharmaceutical companies face increasing pressure to bring new treatments to market in order to survive. The economic reality of survival and profits may distort a company’s decision-making process regarding full disclosure on a particular new drug.

Part II of this article analyzes the publication tactics employed by some members of the pharmaceutical industry (hereinafter “industry”) and explains how some of the publications promote misleading information. Part III proposes policy recommendations to require accurate dissemination of the results of clinical trials in order to protect scientific integrity and the public welfare. Part IV of this article addresses whether industry publications ...


The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff 2011 Duke Law School

The Case For Legal Regulation Of Physicians’ Off-Label Prescribing, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

No abstract provided.


Food-Borne Ultimatum: Proposing Federal Legislation To Create Humane Living Conditions For Animals Raised For Food In Order To Improve Human Health, The, Lynn M. Boris 2011 Cleveland State University

Food-Borne Ultimatum: Proposing Federal Legislation To Create Humane Living Conditions For Animals Raised For Food In Order To Improve Human Health, The, Lynn M. Boris

Journal of Law and Health

In order to reduce the large number of human health risks associated with reckless farming practices, Congress must enact federal legislation that requires humane living conditions for farm animals and declares a moratorium on the routine use of unnecessary antibiotics. Part II of this Note will briefly review traditional farming and animal husbandry practices and examine the shift to the modern practices used by producers of animal products today. Part II will also present several farming practices utilized today that are particularly dangerous to human health. Part III of this Note will explore the immense human suffering that is occurring ...


The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison 2011 John Marshall Law School

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

The John Marshall Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of ...


Blood Transfusions, Jehovah’S Witnesses, And The American Patients’ Rights Movement, Charles Baron 2010 Boston College Law School

Blood Transfusions, Jehovah’S Witnesses, And The American Patients’ Rights Movement, Charles Baron

Charles H. Baron

The litigation to protect Jehovah’s Witnesses from unwanted blood transfusions, which their theology considers a violation of the biblical prohibition against drinking blood, has produced important changes in both the right to refuse treatment and in the preferred treatment methods of all patients. This article traces the evolution of the rights of competent medical patients in the United States to refuse medical treatment. It also discusses the impact this litigation has had on the medical community’s realization that blood transfusions were neither as safe nor as medically necessary as medical culture posited.


An Assessment Of Socio-Economic Impact Of Waste Scavenging As A Means Of Poverty Alleviation In Gwagwalada, Abuja., John Magaji, Samuel Dakyes 2010 University of Abuja

An Assessment Of Socio-Economic Impact Of Waste Scavenging As A Means Of Poverty Alleviation In Gwagwalada, Abuja., John Magaji, Samuel Dakyes

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

Waste scavengers are usually perceived as being among the poor, and scavenging is considered a marginal activity. They tend to have low incomes, but can obtained decent earning when they are not exploited by middlemen. This study was conducted in Gwagwalada town with the aim of assessing the socio-economic impact of scavenging on the people. A structured questionnaire was constructed to capture the demographic characteristics of the scavengers, their experiences, types of items scavenged, the economic gains and the challenges being faced. The target pollution is waste scavengers and a random sampling technique was adopted in selecting the respondents for ...


An Approach To Building The Case For Nutrition Policies To Limit Trans-Fat Intake – A Singapore Case Study., Andy Tan 2010 University of Pennsylvania

An Approach To Building The Case For Nutrition Policies To Limit Trans-Fat Intake – A Singapore Case Study., Andy Tan

Andy SL Tan

Objective. At present, Singapore health authorities are deliberating nutrition labeling and regulations to reduce trans-fat in the food supply. This paper reviews the case for enacting nutrition policies to reduce population trans-fat intake in Singapore. It further proposes a decision-making framework that may inform other jurisdictions in assessing the merits of nutrition policies.

Review framework. This case study reviews the necessity of interventions to reduce trans-fat intake, appropriateness of a policy-based approach, and feasibility of trans-fat policies in the Singapore context. Evidence is drawn from national health reports, measures of stakeholder support, resources for implementing these policies, and results from ...


Biased Advice, Christopher Robertson 2010 University of Arizona

Biased Advice, Christopher Robertson

Christopher T. Robertson

The modern capitalist society, characterized by decentralized decision making and increasingly sophisticated products and services, turns on relationships of epistemic reliance, where laypersons depend upon advisors to guide their most important decisions. Yet many of those advisors lack real expertise and may be biased by conflicting interests. In such situations, laypersons are likely to make suboptimal decisions that sometimes aggregate into systematic failures, from soaring health care costs to market crashes. Regulators can attempt to manage the symptoms and worst abuses, but the fundamental problem of biased advice will remain. There are many potential policy solutions, from outright bans on ...


Requirements Of A Valid Islamic Marriage Vis-À-Vis Requirements Of A Valid Customary Marriage In Nigeria, olanike odewale 2010 Lead City University, Ibadan

Requirements Of A Valid Islamic Marriage Vis-À-Vis Requirements Of A Valid Customary Marriage In Nigeria, Olanike Odewale

olanike sekinat odewale mrs

Marriage is a universal institution which is recognized and respected all over the world. As a social institution, marriage is founded on and governed by the social and religious norms of the society. Consequently, the sanctity of marriage is a well accepted principle in the world community .

Marriage could either be monogamous or polygamous in nature. A monogamous marriage has bee described as ‘…the voluntary union for life of one man and one woman to the exclusion of all others’ . A polygamous marriage on the other hand can be defined as a voluntary union for life of one man with ...


Adaptive Responses To Flooding Incidents In Ilorin, Kwara State, Nigeria, Habiba Jimoh, Kayode Iroye 2010 University of Ilorin

Adaptive Responses To Flooding Incidents In Ilorin, Kwara State, Nigeria, Habiba Jimoh, Kayode Iroye

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

Incidents of floods which are mainly caused by changes in landuse is fast becoming a city life experience in Ilorin as in most urban centres in Nigeria causing untold hardships and sometimes loss of lives. This extreme hydro-meteorological event is also being exacerbated by climate change which thus calls for adaptive response by residents towards reducing its risks, hence this study. Data used were generated from direct field measurements and questionnaire administration. Descriptive statistics and cross tabulations were used in analyzing the data. Results obtained indicate that most respondents use a wide range of non-structural adaptive response to flood. The ...


Validity, Construction, And Application Of Family Smoking Prevention And Tobacco Control Act (Fsptca), Pub. L. 111-31, 123 Stat. 1776 (2009), Daniel Klein 2010 Selected Works

Validity, Construction, And Application Of Family Smoking Prevention And Tobacco Control Act (Fsptca), Pub. L. 111-31, 123 Stat. 1776 (2009), Daniel Klein

Daniel A. Klein

No abstract provided.


The Rise Of U.S. Food Sustainability Litigation, Stephanie Tai 2010 University of Wisconsin Law School

The Rise Of U.S. Food Sustainability Litigation, Stephanie Tai

Stephanie Tai

This article provides one of the first critical looks at the interface between the values of the sustainable food movement and its rising use of litigation. In particular, it focuses on two growing areas of food sustainability litigation: challenges to CAFOs and challenges to the use of genetically modified organisms (GMOs) in the food system. These areas were chosen because they involve growing sectors of U.S. agriculture over which members of the sustainable food movement have raised significant concerns.

The article begins by describing the sustainable food movement, including how the movement fits in with factors that sociologists use ...


Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson 2010 Selected Works

Innovation Cooperation: Energy Biosciences And Law, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

This Article analyzes the development and dissemination of environmentally sound technologies that can address climate change. Climate change poses catastrophic health and security risks on a global scale. Universities, individual innovators, private firms, civil society, governments, and the United Nations can unite in the common goal to address climate change. This Article recommends means by which legal, scientific, engineering, and a host of other public and private actors can bring environmentally sound innovation into widespread use to achieve sustainable development. In particular, universities can facilitate this collaboration by fostering global innovation and diffusion networks.


Water, Climate, And Energy Security, Prof. Elizabeth Burleson 2010 Selected Works

Water, Climate, And Energy Security, Prof. Elizabeth Burleson

Prof. Elizabeth Burleson

Civil society participation can facilitate sound energy, climate, and water governance. This article analyzes the dynamics of transnational decision-making. Part II discusses sound energy strategy in light of a shrinking water-resources base due to climate change. Part III considers how public participation in international decision-making can sustain trust in governments and strengthen the legitimacy of legal decisions. Part IV concludes that process and outcome are both integral to addressing water, climate, and energy challenges.


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