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Articles 1 - 26 of 26
Full-Text Articles in Law
Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff
Medical Evidence In Cases Of Intrauterine Drug And Alcohol Exposure , Judith Larsen, Robert M. Horowitz, Ira J. Chasnoff
Pepperdine Law Review
No abstract provided.
Vaccines And The Law, Michael Sanzo Ph.D.
Vaccines And The Law, Michael Sanzo Ph.D.
Pepperdine Law Review
The last twenty years have seen a sea-change in the area of proving causation in the toxic tort setting, with courts demanding stronger, scientifically tested evidence. At the same time, a closely related debate has been raging about separating cause from coincidence under the National Childhood Vaccine Injury Act compensation program for injuries that might have been the result of vaccinations. The Vaccine Act created a no-fault compensation fund financed by a tax on childhood vaccines to address harms resulting from those vaccines. Unfortunately, Congress gave little direction with regard to the level of causal certainty that would be required …
The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano
The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano
Pepperdine Law Review
No abstract provided.
The Gray Zone In The Power Of Local Municipalities: Where Zoning Authority Clashes With State Law, Skye L. Daley
The Gray Zone In The Power Of Local Municipalities: Where Zoning Authority Clashes With State Law, Skye L. Daley
The Journal of Business, Entrepreneurship & the Law
This article will explore the oft-overlooked area of police powers granted to local municipalities by the California Constitution through the lens of marijuana dispensaries. These dispensaries, and the obstacles they face, provide the perfect vantage point from which to survey the current status of zoning power in California. This article will consider the extent and limits of what is known as the “police powers” of local municipalities: the power of cities, towns and counties to regulate, restrict, and proscribe the way in which land can be utilized within its borders. If local municipalities are the creation of the state--indeed, an …
Pressing Washington's Wine Industry Into The Twenty-First Century: Rethinking What It Means To Be A Winery, Rebecca Thompson
Pressing Washington's Wine Industry Into The Twenty-First Century: Rethinking What It Means To Be A Winery, Rebecca Thompson
Washington Law Review
Washington’s wine industry is growing, and the ways in which Washington winemakers craft and sell their product are changing. Traditional “brick and mortar” wineries coexist with so-called “virtual wineries,” which typically purchase grapes from growers and contract with other wineries or custom crush facilities to access winemaking equipment. The virtual winery is an incubator model and contributes to the rich diversity of Washington’s wine industry. Washington’s current winery licensing statute, RCW 66.24.170, does not clearly apply to virtual wineries because it links the concept of a winery with a particular physical location and fails to delineate exactly what types of …
Leveraging The Dialectical Theory In Case Study Analysis: Genzyme's Ethical Dilemma, Andrei Duta
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, …
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
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.
Always Ask For A Brand-Name Drug: Trying To Untangle The Holding In Pliva V. Mensing, Elizabeth M. Lafayette
Always Ask For A Brand-Name Drug: Trying To Untangle The Holding In Pliva V. Mensing, Elizabeth M. Lafayette
West Virginia Law Review
No abstract provided.
Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel
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 …
Regulating By Repute, David Zaring
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 …
Discarding The North Dakota Dictum: An Argument For Strict Scrutiny Of The Three-Tier Distribution System, Amy Murphy
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, Kayla Mcculley
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.
Every High Has A Low: A Pragmatic Approach To The War On Drugs, Mark Garibyan
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, Colleen Nicholson
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, Yaniv Heled
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 …
The Inherent Uncertainty Of Risk Assessment: How Pesticide Residue Tolerances Fall Short On Safety, Matthew Standeven
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, Molly F.M. Chen
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 …
A Thousand Tiny Pieces: The Federal Circuit’S Fractured Myriad Ruling, Lessons To Be Learned, And The Way Forward, Jonathan R. K. Stroud
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), Alexandros Stamatoglou
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), Jason Brewer
UIC Law Review
No abstract provided.
Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher
Food Choice And Fundamental Rights: A Piece Of Cake Or Pie In The Sky?, Kammi L. Rencher
Nevada Law Journal
No abstract provided.
Time To Cut The Fat: The Case For Government Anti-Obesity Legislation , Stephen A. Mcguinness
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 constitute unjustified …
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.
Beyond Nuremberg: A Critique Of Informed Consent In Third World Human Subject Research , Jacob Schuman
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 …
The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon
The Biologics Price Competition And Innovation Act Of 2009: Legislative Imprudence, Patent Devaluation, And The False Start Of A Multi-Billion Dollar Industry, Brian F. Mcmahon
Kentucky 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
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 …