Water Governance Challenges In New Mexico's Middle Rio Grande Valley: A Resilience Assessment,
2014
University of New Mexico
Water Governance Challenges In New Mexico's Middle Rio Grande Valley: A Resilience Assessment, Melina Harm Benson, Dagmar Llewellyn, Ryan Morrison, Mark Stone
Publications
No abstract provided.
Jump In Before It's Too Late: Protecting And Increasing Streamflows In New Mexico,
2014
University of New Mexico
Jump In Before It's Too Late: Protecting And Increasing Streamflows In New Mexico, Sharon Wirth
Publications
Freshwater ecosystems need adequate streamflow to supply clean water for humans and maintain healthy habitat for wildlife. Over-appropriation, overuse, climate change, and drought plague New Mexico's rivers, taxing many rivers beyond sustainability. Despite the myriad of problems caused by little or no water in our rivers, policies and procedures to protect and increase streamflows in New Mexico are limited. While most Western states have made demonstrable progress in alleviating various legal and technical barriers to protecting and increasing streamflows, New Mexico has made only limited, recent progress towards solutions for our drying rivers. This article takes a critical look at …
Developing The Law Of The River: The Integration Of Law And Policy Into Hydrologic And Socio-Economic Modeling Efforts In The Willamette River Basin,
2014
University of New Mexico
Developing The Law Of The River: The Integration Of Law And Policy Into Hydrologic And Socio-Economic Modeling Efforts In The Willamette River Basin, Adell Louise Amos
Publications
A legal and policy infrastructure -- referred to as a "law of the river" -- exists for every river basin in the U.S. an can be as important as natural processes in terms of managing the future of the resource. Because of the way that water law and policy have evolved in the U.S., this infrastructure involves a matrix of state and federal law that governs the choices that policymakers, end users, and agencies make. This "law of the river" provides the context in which decisions are made and not made. It also draws the boundaries within which decision makers …
Fraud In The Market,
2014
Florida State University College of Law
The Hang-Up With Hamburg: How Center For Food Safety V. Hamburg Will Alter The Food Industry,
2014
University of Maryland Francis King Carey School of Law
The Hang-Up With Hamburg: How Center For Food Safety V. Hamburg Will Alter The Food Industry, Joella Roland
Journal of Business & Technology Law
No abstract provided.
Hatch-Waxman’S Safe-Harbor Provision For Pharmaceutical Development: A Free Ride For Patent Infringers?, 13 J. Marshall Rev. Intell. Prop. L. 445 (2014),
2014
UIC School of Law
Hatch-Waxman’S Safe-Harbor Provision For Pharmaceutical Development: A Free Ride For Patent Infringers?, 13 J. Marshall Rev. Intell. Prop. L. 445 (2014), Kate Y. Jung
UIC Review of Intellectual Property Law
The Safe-Harbor provision of the Hatch-Waxman Act allows generic drug manufacturers to use a patented invention during pre-market testing of generic drugs. However, the U.S. Court of Appeals for the Federal Circuit’s recent interpretation of the Safe-Harbor provision in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. created controversy when it extended the Safe-Harbor exemption to post-FDA approval. This extension was done in an unprecedented manner and would “allow almost all activity by pharmaceutical companies to constitute ‘submission’ and therefore justify a free license to trespass.” The U.S. Supreme Court has yet to settle this matter, and courts are now faced …
Food Choice: Should The Government Be At The Head Of The Table?,
2014
University of Oklahoma College of Law
Food Choice: Should The Government Be At The Head Of The Table?, Emily Semands
Oklahoma Law Review
No abstract provided.
Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A),
2014
Cleveland State University
Excluding Patentability Of Therapeutic Methods, Including Methods Using Pharmaceuticals, For The Treatment Of Humans Under Trade Related Aspects Of Intellectual Property Rights Article 27(3)(A), Michael Henry Davis
Law Faculty Articles and Essays
The Agreement on Trade Related Aspects of Intellectual Property Rights ("TRIPS"), the General Agreement on Tariffs and Trade ("GATT"), and the World Trade Organization ("WTO") debacle has radically altered the traditional ability of nations to adopt whatever patent regime seems appropriate to them. Instead, TRIPS requires all member nations, even those which never thought it appropriate to grant such state monopolies, to afford patent protection to areas which had never been granted before-most dramatically in the area of health related innovations and, most expensively, pharmaceuticals. Until TRIPS, most -- or at least a number approaching half -- countries simply did …
Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings,
2014
Indiana University Maurer School of Law
Targeted Drug Donations: A Necessary Evil In Need Of A Global Harness And A Possible Cure For Trips Shortcomings, Gabriella Tzeneva
Indiana Journal of Global Legal Studies
This Note explores the economic and social factors that drive multinational pharmaceutical companies to donate drugs to developing countries and evaluates the effectiveness of such donations in combating medicine shortages. The Note poses that such donations provide necessary economic incentives to drug companies and help curb high medical prices in developed nations while being an essential tool for ameliorating intellectual property requirements imposed by TRIPS. The Note proposes two solutions to further incorporate donations in access to medicine relief efforts and advocates increased international cooperation in the practice.
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation,
2014
University of Richmond
Vape Away: Why A Minimalist Regulatory Structure Is The Best Option For Fda E-Cigarette Regulation, Nick Dantonio
Law Student Publications
This comment argues that the FDA should regulate ecigarettes, but in doing so, it should take a minimalist approach to regulation. Instead of continuing its attempts to regulate tobacco products under the drug and device provisions of the Federal Food, Drug, and Cosmetic Act ("FDCA"), an incredibly stringent statute, the FDA should focus its efforts under the Tobacco Control Act ("TCA"), which is tailored specifically to regulate tobacco products. While the FDA has extensive regulatory options under the TCA, much of this authority should not be applied to ecigarettes. Part II will provide background information on ecigarettes generally as well …
Implementing The Food Safety Modernization Act: An Examination Of The Inequitable Impact Of The Proposed Preventive Controls And Produce Safety Rules,
2014
University of Kentucky
Implementing The Food Safety Modernization Act: An Examination Of The Inequitable Impact Of The Proposed Preventive Controls And Produce Safety Rules, Ben Metzger
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
Private Parties And The Ffdca: How Creative Litigants Have Circumvented Section 310 And Undermined The Nlea’S Express Preemption Amendments,
2014
The Catholic University of America, Columbus School of Law
Private Parties And The Ffdca: How Creative Litigants Have Circumvented Section 310 And Undermined The Nlea’S Express Preemption Amendments, Joe Dages
Catholic University Law Review
No abstract provided.
23andme, The Food And Drug Administration, And The Future Of Genetic Testing,
2014
New York Law School
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
Other Publications
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.
The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs ,
2014
Cleveland State University
The Highs Of Tomorrow: Why New Laws And Policies Are Needed To Meet The Unique Challenges Of Synthetic Drugs , Joseph A. Cohen
Journal of Law and Health
This article reviews the federal government’s attempts to control the influx of synthetic drugs, particularly synthetic cannabinoids and cathinones, into the U.S. recreational drug market since 2008. It offers three recommendations targeted at Congress, the DEA, and the Department of State on ways to prevent and control synthetic drug use in America: (1) Congress should grant the DEA a new “immediate scheduling” authority; (2) the DEA should improve information sharing with states; and (3) the Department of State and the DEA should prioritize the development of a global early warning system.
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates,
2014
University of Richmond
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
Law Student Publications
This article explores whether a graphic warning is possible or preferable in the government's fight against tobacco. Part II outlines a brief history of tobacco regulation in the United States. Part III turns to the Family Smoking Prevention and Tobacco Control Act (FSPTCA) and the FDA's initial rulemaking process. Part IV outlines the doctrine of commercial free speech, and Part V discusses why the Rule faced insurmountable challenges under this jurisprudence. Part VI explores how the FDA may overcome these hurdles in its future rulemaking, while Part VII discusses alternative methods through which the government can pursue its anti-tobacco agenda …
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions,
2014
University of Michigan Law School
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Articles
The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …
The International War Against Doping: Limiting The Collateral Damage From Strict Liability,
2014
Vanderbilt University Law School
The International War Against Doping: Limiting The Collateral Damage From Strict Liability, Thomas W. Cox
Vanderbilt Journal of Transnational Law
The World Anti-Doping Agency (WADA) and the World Anti-Doping Code are largely considered the model for an effective and well-coordinated antidoping regime. This model has allowed numerous sports and various countries to secure the same rules for domestic and international athletes. Within this regime, strict liability for prohibited substances stands as the "cornerstone." Strict liability has allowed antidoping officials to prosecute doping violations through an effective testing regime. However, this principle occasionally implicates innocent athletes with no intention of performance enhancement. This Note proposes that WADA modify its criteria for including substances on the Prohibited List and suspend strict liability …
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates,
2014
University of Richmond School of Law
Lighting A Fire Under Free Speech: The Fda's Graphic Attempts To Reduce Smoking Rates, Ashley Peterson
University of Richmond Law Review
No abstract provided.
Examining The § 271(E)(1) Safe Harbor Of The Hatch-Waxman Act: A Legislative Proposal Granting Mandatory Post-Marketing Exceptions,
2014
Benjamin N. Cardozo School of Law
Examining The § 271(E)(1) Safe Harbor Of The Hatch-Waxman Act: A Legislative Proposal Granting Mandatory Post-Marketing Exceptions, Jessica Chao
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Fair Or Foul? Major League Baseball's Use Of A Tortious Interference Lawsuit As A Means Of Investigation,
2014
Benjamin N. Cardozo School of Law
Fair Or Foul? Major League Baseball's Use Of A Tortious Interference Lawsuit As A Means Of Investigation, Michael S. Beck
Cardozo Arts & Entertainment Law Journal
No abstract provided.
