Food and Drug Law Commons^™

Mending Invisible Wounds: The Efficacy And Legality Of Mdma-Assisted Psychotherapy In United States' Veterans Suffering With Post-Traumatic Stress Disorder, Jonathan Perry

Journal of Law and Health

Though Veteran Affairs has provided crucial life sustaining—and often lifesaving—treatments to returning soldiers, the substantial and ever-increasing rates of veteran suicides, drug addictions, and criminal behavior indicate a need for broader options in treatment. One of the most profound discoveries uncovered through MDMA-assisted psychotherapy research is MDMA’s facilitation of the alleviation of addictive behavior in subjects, and, as a result, an alleviation of addictions in general. Addiction is one of the key symptoms of post-traumatic stress disorder (PTSD) and drug abuse plays a large role in the other afflictions suffered by veterans, namely criminal activity and a high rate of …

Potholes: Dui Law In The Budding Marijuana Industry, Zack G. Goldberg

Brooklyn Law Review

The rapid legalization of marijuana across the United States has produced a number of novel legal issues. One of the most confounding issues is that presented by the marijuana-impaired driver. In jurisdictions that have legalized the use of marijuana, how high is too high to get behind the wheel? This note assesses the various marijuana DUI laws that states have implemented to combat marijuana-impaired driving. Many of these statutes have followed in the footsteps of the BAC-based standard used to combat drunk driving—using THC measurements to quantify a driver’s level of marijuana-based impairment. Unfortunately, unlike alcohol, the scientific properties of …

The New York Pharmaceutical Cost Transparency Act: How A Narrow View Of The Prescription Drug Pricing Puzzle Renders A Well-Intentioned Bill Irrational, John G. Curran

Brooklyn Law Review

Pricing prescription pharmaceuticals is a complex process that entails the consideration of a multitude of factors, not the least of which is the research and development expenditure exhausted by drug makers to gain FDA approval. While public sentiment has increasingly turned against the pharmaceutical industry due to its perceived greed as manifested in the high cost of its drugs, the intricacies of pricing such unique products is rarely discussed. A recently proposed New York state bill, the Pharmaceutical Cost Transparency Act (the NYPCTA), continues this unfortunate trend, by requiring companies to disclose the R&D costs of newly approved drugs in …

Fsma: The Future Of Food Litigation, Robert Shawn Hogue

University of Miami Inter-American Law Review

No abstract provided.

Pitfalls Of The Food Safety Modernization Act: Enhanced Regulation, Minimal Consumer Benefit, And Zero Tolerance Levels For Naturally-Occurring Trace Pathogens, Lindsey Lazopoulos Friedman, Wesley Van Camp

University of Miami Inter-American Law Review

Congress enacted the Food Safety Modernization Act (“FSMA”), to regulate the fresh produce industry in the United States and increase consumer safety when handling and consuming raw produce. But FSMA risks imposing a zero tolerance policy on raw produce, even where a naturally occurring low-level pathogen, such as listeria, is found in negligible amounts. A zero tolerance policy for all naturally-occurring pathogens does not increase consumer safety, and only serves to increase the cost of raw produce for consumers. This article begins with a summary of the modern history of FSMA, including a brief overview of how the law has …

A Trademark Holder's Hangover: Reconciling The Lanham Act With The Alcohol And Tobacco Tax And Trade Bureau's System Of Designating American Viticultural Areas, Julia Lynn Titolo

Journal of Intellectual Property Law

No abstract provided.

Why Coca-Cola's Fictional Lawsuit Against Coke Zero For Taste Infringement Is A Losing Battle, Jessica Nicole Cox

Journal of Intellectual Property Law

No abstract provided.

Traversing The Triangulum: The Intersection Of Tobacco, Legalised Marijuana And Electronic Vaporisers In Denver, Colorado, Emily Anne Mcdonald, Lucy Popova, Pamela M. Ling

Publications and Research

Objective: To explore the intersection of tobacco, legalised marijuana and electronic vaporiser use among young adults in the ‘natural laboratory’ of Colorado, the first state with legalised retail marijuana.

Methods: We conducted semistructured interviews with 32 young adults (18–26 years old) in Denver, Colorado, in 2015 to understand the beliefs and practices related to the use of tobacco, marijuana and vaporisers.

Results: We found ambiguity about whether the phrase ‘to smoke’ refers to the use of tobacco or marijuana products. Smoking marijuana blunts (emptied cigarillo or tobacco wrap filled with marijuana) was common, but few interpreted this as tobacco use. …

Price Controls Through The Back Door: The Parallel Importation Of Pharmaceuticals, A. Bryan Baer

Journal of Intellectual Property Law

No abstract provided.

Medical Cannabis: Miracle Or Myth?, Blair Henry, Arnav Agarwal, Edward Chow, Hatim A. Omar, Joav Merrick

Pediatrics Faculty Publications

No abstract provided.

Rethinking Body Property, Kara W. Swanson

Florida State University Law Review

Body products, including blood, gametes, and kidneys, are a routine part of contemporary medicine. They are also controversial. There is a strong preference for donated gifts, based on an intuition that gifts are pure, altruistic, and healthy, and that purchased products (commodities) are tainted, exploitative, and dangerous. Law and policy reflect this dichotomy, preventing market exchanges either by declaring body products non-property or banning sales by the supplying body. Yet with growing scarcity leading to injustice in the allocation and harvesting of body products, calls to allow sales have been increasing, motivating proposals to increase supplies by compensating bone marrow …

Ebola, Experimental Medicine, Economics, And Ethics: An Evaluation Of International Disease Outbreak Law, Sara L. Dominey

Georgia Journal of International & Comparative Law

No abstract provided.

Memory And Punishment, O. Carter Snead

O. Carter Snead

This article is the first scholarly exploration of the implications of neurobiological memory modification for criminal law. Its point of entry is the fertile context of criminal punishment, in which memory plays a crucial role. Specifically, this article will argue that there is a deep relationship between memory and the foundational principles justifying how punishment should be distributed, including retributive justice, deterrence, incapacitation, rehabilitation, moral education, and restorative justice. For all such theoretical justifications, the questions of who and how much to punish are inextricably intertwined with how a crime is remembered - by the offender, by the sentencing authority, …

Newsroom: Horwitz On Marijuana Legalization 7/15/2016, John S. Kiernan, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

The Current Scientific And Legal Status Of Alternative Methods To The Ld50 Test For Botulinum Neurotoxin Potency Testing, Sarah Adler, Gerd Bicker, Hans Bigalke, Christopher Bishop, Jörg Blümel, Dirk Dressler, Joan Fitzgerald, Frank Gessler, Heide Heuschen, Birgit Kegel, Andreas Luch, Catherine Milne, Andrew Pickett, Heidemarie Ratsch, Irmela Ruhdel, Dorothea Sesardic, Martin Stephens, Gerhard Stiens, Peter D. Thornton, René Thürmer, Martin Vey, Horst Spielmann, Barbara Grune, Manfred Liebsch

Martin Stephens, PhD

No abstract provided.

Litigating Medical Device Premarket Classification Decisions For Small Businesses: Have The Courts Given The Fda Too Much Deference? The Case For Taking The Focus Off Of Efficacy, Stephanie P. Fekete

Catholic University Law Review

The manufacturing of innovative medical devices is important for the continued success and growth of the U.S. health care system and economy. The medical device industry is almost exclusively comprised of small businesses. The U.S. Food and Drug Administration (FDA) regulates the medical device industry and employs a rigorous approval process to determine when products may enter the market. While the FDA’s goal is to authorize the sale of innovative devices that are safe for patient use, device manufacturers argue that the process to obtain FDA approval is unnecessarily expensive, burdensome, and has systemic problems. As a result of the …

International Fisheries Regulation, John P. Rivers

Georgia Journal of International & Comparative Law

No abstract provided.

Decline Of Dosage Regimen Patents In Light Of Emerging Next-Generation Dna Sequencing Technology And Possible Strategic Responses, Na An

Minnesota Journal of Law, Science & Technology

No abstract provided.

3d-Printed Food, Jasper L. Tran

Minnesota Journal of Law, Science & Technology

No abstract provided.

The Negative Effects Of Cumulative Abortion Regulations: Why The 5th Circuit Was Wrong In Upholding Regulations On Medication Abortions (Planned Parenthood Of Greater Texas Surgical Health Services V. Abbott), Benjamin A. Hooper

University of Cincinnati Law Review

No abstract provided.

Getting A Handle On Growler Laws, Adam Star

Seattle University Law Review

This Note will begin with a brief general history of growlers in the United States and the benefits they provide to consumers, retailers, and small craft brewers. Part II will provide an overview of national alcohol distribution regulation and how the present growler law exists within this larger framework. To complete the necessary background information, Part III will provide context to the competitive landscape by way of an examination of the craft beer industry’s explosive growth. The substantive portion of the Note will follow in Part IV, beginning with an outline of the various key types of growler restrictions such …

It’S Time For The Fda To Define ‘Natural’, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

The authors discusses the FDA 's recent call for comments on a definition of the term natural as it applies to food.

The Patented Medicines (Notice Of Compliance) Regulations: An Examination Of The Decision Making Patterns In These Cases At The Supreme Court Of Canada, Jason D. Newman

Electronic Thesis and Dissertation Repository

Abstract

Generic drug approval cases involving Canada’s Patented Medicines (Notice of Compliance) Regulations are adjudicated at the Federal Court through the judicial review process. The European Union alleges that this abbreviated process is unfair to litigants who hold patents on medicines, since it does not encompass all of the features of a trial, nor is it an actual suit for patent infringement. In addition, the process has unequal appeal rights for the patent holder and the patent challenger, where the generic challenger can appeal a decision at Federal Court, but the patent holder cannot.

When examining the pattern of decision …

The Insufficiency Of The Law Surrounding Food Allergies, Aimee Nienstadt

Pace Law Review

This paper proceeds in five parts. First, I will give an overview of food allergies. The second section will discuss legal protections at the federal level, including the ADA and other specific federal laws that are aimed at food allergies. The third section will discuss legal protections at the state level, including state laws directed at school districts and state laws directed at restaurants. The fourth section will discuss actions by the private/non-profit sector. The final section of my paper will discuss further necessary legislative changes for people with food allergies.

Recent Developments And Future Prospects Of The Common Market, Michael Waelbroeck

Georgia Journal of International & Comparative Law

No abstract provided.

Newsroom: Horwitz On Legalizing Marijuana 04-10-2016, Andrew Horwitz, Peter Kilmartin

Life of the Law School (1993- )

No abstract provided.

When Tuna Still Isn’T Always Tuna: Federal Food Safety Regulatory Regime Continues To Inadequately Address Seafood Fraud, Stephen Wagner

Ocean and Coastal Law Journal

In 2012 alone, Americans consumed approximately 4.5 billion pounds of seafood, over 90% of which was imported. Simply put, Americans eat a lot of seafood, with upwards of 500 different species available to satiate the demand. Consequently, imported and domestic seafood in the United States is a thriving 80.2 billion dollar market, with certain highly desired species of fish fetching steep prices.

One fundamental assumption of the consumer-driven market is that the label on the seafood correctly identifies the species of seafood, thereby, among other things, justifying the market price. It is increasingly clear, however, that this assumption is often …

Food Patents: The Unintended Consequences, Jay Dratler Jr.

Akron Intellectual Property Journal

This short paper explores the unintended consequences of this strong economic incentive. The underlying assumptions of patent law and its economic incentive are that innovation is good, and newer is better. But is that always so? Science and history suggest maybe not, for some very fundamental reasons. And there are reasons to believe that the risks of unintended consequences of innovation in food may be more hazardous than those in other fields of innovation.

Promoting Healthcare Innovation On The Demand Side, Rebecca S. Eisenberg, W. Nicholson Price

Law & Economics Working Papers

Innovation policy often focuses on the incentives of firms that sell new products. But optimal use of healthcare products also requires good information about the likely effects of products in different patients, and it is hard to provide the right incentives for producers to develop and disclose information that could limit future sales. Regulation partially fills this gap by requiring sellers to conduct clinical trials and report adverse events. But it is inherently problematic to rely on producers to supply negative information about their own products. Healthcare payers, however, can profit from avoiding inappropriate use of costly technologies. Recent technological …

Give And Take-Back: Pharmaceutical Manufacturers Required To Dispose Of Drugs At Local Level, Allie Craver

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.