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Food and Drug Law Commons

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The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck 2012 Georgetown University Law Center

The Difficult Case Of Direct-To-Consumer Drug Advertising, David C. Vladeck

David C. Vladeck

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies ...


A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck 2012 University of California San Francisco School of Medicine

A Critical Examination Of The Fda’S Efforts To Preempt Failure-To-Warn Claims, David A. Kessler, David C. Vladeck

David C. Vladeck

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate ...


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.


Bioethics And Law In The United States: A Legal Process Perspective, Charles H. Baron 2012 Boston College Law School

Bioethics And Law In The United States: A Legal Process Perspective, Charles H. Baron

Charles H. Baron

An analytical exposition of the law regarding a patient's "right to die" as it has developed in the United States over the last 30 years provides an exemplar overview of the variety of legal mechanisms that American legal institutions can and do bring to bear to deal with the challenges posed by new developments in medicine and the biosciences. Opposing "pro-life" and "pro-choice" ideological and political forces have been channeled through the federal and state legislative, judicial, and executive branches, where the various legal actors have developed legal principles that so far provide patients with a right to refuse ...


Socio-Economic Effects Of Demolishing Squatter Settlements And Illegal Structures In Abuja Metropolis, Federal Capital Territory, Nigeria, Ishaku Mallo, Victor Obasanya 2012 Selected Works

Socio-Economic Effects Of Demolishing Squatter Settlements And Illegal Structures In Abuja Metropolis, Federal Capital Territory, Nigeria, Ishaku Mallo, Victor 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 ...


“Inherently Bad, And Bad Only”: A History Of State-Level Regulation Of Cigarettes And Smoking In The United States Since The 1880s. Volume 1: An In-Depth National Study Embedding Ultra-Thick Description Of A Representative State (Iowa), Marc Linder 2012 University of Iowa College of Law

“Inherently Bad, And Bad Only”: A History Of State-Level Regulation Of Cigarettes And Smoking In The United States Since The 1880s. Volume 1: An In-Depth National Study Embedding Ultra-Thick Description Of A Representative State (Iowa), Marc Linder

University of Iowa Faculty Books

This book lays out empirical and methodological underpinnings for studying the early period of anti-cigarette legislation in the United States by overcoming the lack of primary source-based historical scholarship. Constantly repeating wildly erroneous claims at second, third, and more remote hand, anti-smoking academics and pro-tobacco apologists have fundamentally distorted history, on the one hand by dismissing the early anti-cigarette movement as merely religiously and morally motivated and the legislation it secured as unenforced exercises bereft of historical relevance, and, on the other by absurdly magnifying its achievements. Reconstruction of the national scope of the real course of the passage and ...


Rainfall Variability And Crop Zones Classification For The Federal Capital Territory, Nigeria, Shaibu M. Hassan PhD 2012 Selected Works

Rainfall Variability And Crop Zones Classification For The Federal Capital Territory, Nigeria, Shaibu M. Hassan Phd

Confluence Journal of 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 ...


Disease-Branding And Drug-Mongering: Could Pharmaceutical Industry Promotional Practices Result In Tort Liability?, Jason S. Cetel 2012 Seton Hall Law

Disease-Branding And Drug-Mongering: Could Pharmaceutical Industry Promotional Practices Result In Tort Liability?, Jason S. Cetel

Law School Student Scholarship

No abstract provided.


Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns 2012 Villanova University Charles Widger School of Law

Prescription For Change: Third Circuit Diagnoses Pharmaceutical Sales Representatives As Exempt From Overtime Pay In Smith V. Johnson & Johnson, Brooke Burns

Villanova Law Review

The article presents information on the pharmaceutical companies manufacturing brand-name drugs and the issues related to pharmaceutical sales representative (PSR). The intensive sales training program, the exempt from overtime pay based on the U.S. Fair Labor Standards Act and the economic justice and security of low income group are discussed. The court decision of Smith v. Johnson & Johnson, white-collar exemptions and employee misclassification are also discussed.


Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher 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.


Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012), Benjamin Liu 2012 John Marshall Law School

Fighting Poison With Poison? The Chinese Experience With Pharmaceutical Patent Linkage, 11 J. Marshall Rev. Intell. Prop. L. 623 (2012), Benjamin Liu

The John Marshall 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 ...


Compounding Reform: Reconsidering The Draft Safe Drug Compounding Act Of 2007 In Light Of The Ongoing Fungal Meningitis Outbreak, Colleen Nicholson 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 ...


Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan 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 ...


Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled 2012 Georgia State University College of Law

Patents V. Statutory Exclusivities In Biological Pharmaceuticals - Do We Really Need Both, Yaniv Heled

Michigan Telecommunications and 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 ...


A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud 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.


Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. McGuinness 2012 Cleveland State University

Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness

Journal of Law and Health

This Article examines—and ultimately rejects—this anti-paternalism argument against government anti-obesity policies. It argues that government intervention in the food industry for the purpose of stemming the American obesity epidemic is justified and survives paternalistic objections to the contrary. This Article begins by briefly outlining the nature, severity, and causes of the obesity epidemic. It considers what can be done about the problem, finding that only government intervention is capable of effectively combating the crisis. It also outlines several types of potentially successful government anti-obesity strategies. Finally, it considers the primary topic of this Article: whether government anti-obesity policies ...


Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman 2012 Cleveland State University

Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman

Journal of Law and Health

This Article discusses the history of informed consent, critically analyzes this principle, and suggests an alternative approach to informed consent. Part II explores the concept of informed consent, including its philosophical bases, its implementation through FDA regulations, and current proposals on how to protect the principle in drug testing conducted abroad. Part III performs a critical analysis of the principle of informed consent; first providing an empirical examination of the realities of Third World human subject research, and then questioning both the coherence of an abstract “right” to informed consent, as well as the possibility of truly autonomous “consent” to ...


Debating The Cause Of Health Disparities: Implications For Bioethics And Racial Equality, Dorothy E. Roberts 2012 University of Pennsylvania Law School

Debating The Cause Of Health Disparities: Implications For Bioethics And Racial Equality, Dorothy E. Roberts

Faculty Scholarship

No abstract provided.


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