Food and Drug Law Commons^™

E-Cigarettes, Vaping, And Youth, Lawrence O. Gostin, Aliza Y. Glasner

Georgetown Law Faculty Publications and Other Works

E-cigarettes, a relatively new product, storming the tobacco industry are causing a massive stir among public health advocates. While e-cigarettes have the potential to serve as an effective harm reduction tool for existing smokers, they also may present an equally tempting pathway to first time smoking, particularly among youth. Many fear that e-cigarettes will revive the popular smoking culture that has taken decades to dismantle.

In April 2014, the FDA issued proposed rules to “deem” or extend its authority over tobacco products to regulate electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (hookah) tobacco, and orally ingested dissolvable tobacco products. …

Hidden Risks Of Taking Generic Drugs Over Brand Name: The Impact Of Drug Labeling Regulations On Injured Consumers And The Pharmaceutical Industry , Samantha Koopman

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

The Role And Mission Of The United States Food And Drug Administration: Regulator, Watchdog, Facilitator, Or "All Of The Above", Roseann Termini J.D., Anthony Knabb Didonato J.D.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Feeding The Racial Disparity In Disease: How Federal Agricultural Subsidies Contribute To A Racial Disparity In The Prevalence Of Diet Related Illness, Lawrence F. Dempsey

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Confusion Under The Big Tent: Analysis Of The North Carolina Court's Application Of N.C.G.S. § 90-95(H)(4) To The Possiession Of Prescription Pharmaceuticals In Pill Form Containing Opium Or Opium Derivatives In State V. Ellison, Sable K. Nelson

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Food Labeling Litigation: Exposing Gaps In The Fda's Resources And Regulatory Authority, Nicole Negowetti

Law Faculty Publications

No abstract provided.

Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley

Washington Law Review

This Article evaluates the free speech implications of laws requiring that GE foods be labeled and concludes that such regulations would meet all First Amendment requirements for compelled commercial speech. Part I traces the history of food labeling in the United States, the advent of genetic engineering, and the application of that technology in agriculture and the food industry. Part II evaluates the scope of commercial free speech and the appropriate test to be applied in determining whether a GE food labeling law would violate the First Amendment. Part III examines the impacts of an agricultural and food system increasingly …

Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley

Washington Law Review

This Article evaluates the free speech implications of laws requiring that GE foods be labeled and concludes that such regulations would meet all First Amendment requirements for compelled commercial speech. Part I traces the history of food labeling in the United States, the advent of genetic engineering, and the application of that technology in agriculture and the food industry. Part II evaluates the scope of commercial free speech and the appropriate test to be applied in determining whether a GE food labeling law would violate the First Amendment. Part III examines the impacts of an agricultural and food system increasingly …

Making Liquor Immunity Worse: Nevada's Undue Protection Of Commercial Hosts Evicting Vulnerable And Dangerous Patrons, Jeffrey W. Stempel

Nevada Law Journal

No abstract provided.

A Case Study Of The Regulations Imposed Upon Massachusetts' Prescription Monitoring Program, Meredith Rodman

Public Affairs Capstones Collection

This case study focuses on the effectiveness of the recent regulations imposed upon Massachusetts’s prescription monitoring program. Abuse and/or misuse of prescription opioids is becoming increasingly problematic within the United States and as a result many policy makers are looking for ways to combat the problem. In Massachusetts, the OxyContin and Heroin Commission was established to investigate the impact of both OxyContin and heroin on the state. The Commission delivered recommendations that eventually led the state legislature to make changes to Massachusetts’s prescription monitoring program. This study targeted five major stakeholder groups and asked a series of questions through interviews …

Christopher V. Smithkline Beecham Corporation: A Tough Pill To Swallow For Pharmaceutical Sales Representatives?, Hsuan Li

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff

Michigan Telecommunications & Technology Law Review

“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …

Managing Complex Water Resource Systems For Ecological Integrity: Evaluating Tradeoffs And Uncertainty, Richard Morrison

Publications

Water resource systems often contain numerous components that are intertwined or even contradictory, such as power production, water delivery, recreation, and environmental needs. This complexity makes it difficult to holistically assess management alternatives. In addition, hydro climatic and ecological uncertainties complicate efforts to evaluate the impacts of management scenarios. We need new tools that are able to inform managers and researchers of the tradeoffs or consequences associated with flow alternatives, while also explicitly incorporating sources of uncertainty. My research addresses this limitation using two modeling approaches: stochastic system dynamics modeling and Bayesian network modeling. I developed a stochastic system dynamics …

The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig

Publications

It is time to move past the concept of sustainability. The realities of the Anthropocene warrant this conclusion. They include unprecedented and irreversible rates of human-induced biodiversity loss, exponential increases in per-capita resource consumption, and global climate change. These factors combine to create an increasing likelihood of rapid, nonlinear, social and ecological regime changes. The recent failure of the Rio +20 provides an opportunity to collectively reexamine--and ultimately move past--the concept of sustainability as an environmental goal. We must face the impossibility of defining--let alone pursuing--a goal of "sustainability" in a world characterized by such extreme complexity, radical uncertainty and …

Shortsighted Response To Reverse Payments: How The Third Circuit May Cause Consumers To "Pay For The Delay" Of New Drug Development, Jude Steinniger

Villanova Law Review (1956 - )

This case note examines the legislation of the Hatch-Waxman Act, its purpose, and the mechanics that led to the resulting reverse payment settlements. Next it surveys the landscape of prior case law in the circuit courts, and focuses on the recent Third Circuit decision in In re K-Dur Antitrust Litigation that has rekindled the Hatch-Waxman debate. Then the note analyzes the policy concerns advanced by opposing sides of the argument and the economic fallout likely to result. Finally, it concludes with the assertion that the Supreme Court must intervene and establish the most beneficial standard of analysis for reverse payment …

The End Of Sustainability, Melinda Harm Benson, Robin Kundis Craig

Publications

No abstract provided.

Presidential Politics As A Safeguard Of Federalism: The Case Of Marijuana Legalization, David S. Schwartz

Buffalo Law Review

No abstract provided.

Let My Brewers Go! A Look At Home Brewing In The U.S., Hannah Jeppsen

Journal of Food Law & Policy

In mid-August of 2012, a group of Americans stormed the White House, demanding transparency on a subject many Americans may find surprising: beer. More specifically, Americans requested White House home brew recipes, a presidential secret until Barack Obama's administration released them on September 1, 2012. Not only does Obama enjoy a good home brew, he is also the first president to brew in the White House and even take beer on the campaign trail. However, it was the August petition that garnered home brewing national media attention.

Forging Careers In Food Law And Policy: Challenges And Opportunities For Law Schools, Allison Condra

Journal of Food Law & Policy

Food Law and Policy (FL&P) is a quickly growing field of legal practice that offers many exciting career opportunities for law students. As national awareness of food and agricultural issues increases, particularly the way laws and policies influence our food system, more law students are demanding that their law schools offer courses, internships, and clinical experiences in this field. Law schools across the country have an opportunity to satisfy this student demand, while at the same time providing students with skills and knowledge that will equip them to engage with the many complex, dynamic, and important issues related to the …

Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe

Journal of Food Law & Policy

The marketing of goods under geographical names has always been common. In addition to introducing commercial facets of wine distribution agreements, this article discusses the justifications, principles and, policies that lie behind the protection of geographical indications (GIs) for wine on an international level as well as in the Old World and, to a lesser degree, in the New World. The scope and shape of the GI system will then be scrutinized in light of its own justifications and in the light of its impact on international trade, intellectual property, and agricultural policy.