Law Commons^™

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Michael J. Malinowski

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Repairing The Antibiotic Pipeline: Can The Gain Act Do It?, Caitlin Forsyth

Washington Journal of Law, Technology & Arts

Antibiotic resistance, according to the World Health Organization, is one of the greatest threats to public health. To combat the problem, new antibiotics need to be developed. However, antibiotic research and development is fraught with scientific and economic problems. Recognizing these problems and the public health threat posed by antibiotic resistance, Congress passed the GAIN Act, which President Obama signed into law in June 2012. The GAIN Act (Act) incentivizes pharmaceutical companies to invest in antibiotic research and development. This Article will outline the incentives in the Act and suggest why the Act may not solve the growing antibiotic resistance …

What's In A Name?: Geographical Indicators, Legal Protection, And The Vulnerability Of Zinfandel, Stephen M. Jurca

Indiana Journal of Global Legal Studies

This note explores the issues countries face when one party allegedly takes unfair economic advantage of foreign competitors in an increasingly global market by broadly interpreting international product labeling laws in its favor. The United States' widespread use of the term "champagne" in its domestic sparkling wine industry is just one example of how "genericide"-the process by which a popular brand name becomes so commonly used that the term is no longer protected by intellectual property law-negatively affects trade relations and hampers economic growth. This note focuses on the dangers of genericide in the marketplace, most specifically, the international wine …

Food Court, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

This article, focusing on produce and grain, discusses the environmental and climate change impacts of food production, processing, packaging, and distribution, which ultimately contribute to both economic and social costs. The article addresses environmental energy costs in the food supply. Figure 1 shows, for example, the significant amount of energy used in various aspects of food production, transportation, and processing.

Much of this article's focus will be on commodity crops. Along with wheat and rice, corn and soybeans constitute the world's most popular planted and consumed crops. The United States is the leading producer of corn, growing nearly 40 percent …

Application Of Responsive Regulation In The Food Safety Regulations Of Bangladesh, Abu Noman M. Atahar Ali

Abu Noman Mohammad Atahar Ali

Application of responsive regulation in the food safety regulations of Bangladesh - Abstract Bangladesh, a developing country of the South Asian region, has been suffering from rampant food adulteration for the last few decades. Recent studies revealed that numerous deaths along with countless physical illnesses are occurring as the consequences of this ongoing food adulteration. Several attempts have been made through to change the food safety regulations [FSR] of Bangladesh to combat this alarming issue. Unfortunately, the situation has hardly been changed. Rather it is getting worse day by day. However, Bangladesh has never changed the regulatory enforcement philosophy of …

The Perfect Pairing: Protecting U.S. Geographical Indications With A Sino-American Wine Registry, Laura Zanzig

Washington Law Review

Chinese counterfeiters have infiltrated the wine world, falsely labeling products and using fraudulent geographical indications (GIs). GIs, which function as a type of brand, are internationally protected designations of a product’s origin and characteristics. Recently, United States GIs, such as Napa or Walla Walla, have appeared on bottles of wine composed of Chinese grapes. By misappropriating U.S. brands, Chinese counterfeiters deceive and confuse consumers, disadvantage legitimate businesses, and causes health concerns. Unlike other brands, GIs protect regions, rather than individual producers. This creates a particular void: no single winery can register a GI and no single winery is harmed by …

Waging War On Specialty Pharmaceutical Tiering In Pharmacy Benefit Design, Chad I. Brooker

Chad I Brooker

Specialty drugs represent a growing concern for both health insurance issuers and beneficiaries given their exceedingly high (and growing) costs—representing almost half of all drug spend by 2017. Payers have sought to reduce their specialty drug spend by sharing more of the cost of these drugs with the beneficiaries who depend on them through the creation of specialty drug tiers. This has forced some patients to choose between forgoing other needs to pay for their medications or not take them at all. While several states have sought to outlaw the use of specialty drug tiers or limit pharmaceutical OOP cost-sharing, …

Responsive Regulation And Application Of Grading Systems In The Food Safety Regulatory Regimes Of Developing Countries, Abu Noman M. Atahar Ali

Abu Noman Mohammad Atahar Ali

The traditional tit-for-tat philosophy in the food safety regulatory regime in most developing countries has been proven ineffective in most cases. Rather, starting with persuasion, advice, and then escalating to more severe punishments for the continuing non-compliance as suggested in the responsive regulation by Ayres and Braithwaite has been proved more effective in the food safety regulatory regime of some jurisdictions. Responsive regulation aims to increase responsibility among corporations. So, if a corporation shows responsibility, it should be rewarded, and if a corporation shows irresponsibility, it should be reprimanded (if necessary). There is no logic in seeing and treating every …

Fair Or Foul: When Does Media Accusation Of Performance Enhancing Drug Use Become Tortious?, Richard T. Ward Iii

Pace Intellectual Property, Sports & Entertainment Law Forum

The Steroids Era in baseball refers to the recent period in the MLB where many players and trainers have been found guilty or been implicated in the use of performance enhancing drugs which leads to sharp increases in player talent. The stigma associated with PED use, and also any other form of cheating, has proven to be a fast track to shame in the world of Major League Baseball. This article addresses the current state of defamation law in New York and the Federal Courts by analyzing the recent statement made by Skip Bayless concerning use of Performance Enhancing Drugs …

Drug Induced Insanity And Unconsciousness - A Clarification Of California Law, Jerome Bleiweis

Pepperdine Law Review

No abstract provided.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

A Prescription Warning, Carlton Lee Harpst

Pepperdine Law Review

No abstract provided.

Fda And The Rise Of The Empowered Consumer, Lewis Grossman

Articles in Law Reviews & Other Academic Journals

This Article traces the still-evolving view of consumers of FDA-regulated products as capable, rational, and rights-bearing decision makers. It also examines the corresponding diminution of FDA’s role as a paternalistic gatekeeper collaborating with medical and scientific experts to prevent products and manufacturer-provided information from reaching the public. Compared with their 1960s counterparts, today’s consumers of food and drugs have far greater freedom to make unmediated choices among a wider variety of products, guided by a relative deluge of labeling and advertising information. Moreover, food and drug regulation, once the exclusive domain of bureaucrats and experts, has become a focus of …

My Paper Makes Ssrn Top Ten List, Gabriela Steier

Gabriela Steier

My paper, "THE WTO'S BLIND SPOT: DISPUTE RESOLUTION IN THE INTERNATIONAL FOOD INDUSTRY", was recently listed on SSRN's Top Ten download list for: Food Law & Policy eJournal, PSN: Politics of the WTO (Topic), PSN: Politics of the WTO (Topic), SRPN: Agribusiness (Topic), SRPN: Biotechnology (Topic), SRPN: Politics of Food (Topic) and SRPN: World Trade Organisation (Topic).

Advancing An Adaptive Standard Of Strict Scrutiny For Content-Based Commercial Speech Regulation, Nat Stern, Mark Joseph Stern

Scholarly Publications

No abstract provided.

Food Defense Among Meat Processing And Food Service Establishments In Kentucky, Morgan Webb-Yeates

Masters Theses & Specialist Projects

Agroterrorism is the deliberate introduction of a plant or animal disease with the
goal of causing fear, economic instability, illness, or death. After the 2002 terrorist
attacks on the World Trade Center, the security of the food supply is of increasing
concern to the United States. A major incidence of agroterrorism or food tampering would have far reaching impacts on the economy and public health. The first objective of this project was to determine knowledge and concern of agroterrorism in meat processing facilities in Kentucky, and to determine knowledge and concern of food tampering and food defense in food service …

Who We Are: Incarcerated Students And The New Prison Literature, 1995-2010, Reilly Hannah N. Lorastein

Honors Projects

This project focuses on American prison writings from the late 1990s to the 2000s. Much has been written about American prison intellectuals such as Malcolm X, George Jackson, Eldridge Cleaver, and Angela Davis, who wrote as active participants in black and brown freedom movements in the United States. However the new prison literature that has emerged over the past two decades through higher education programs within prisons has received little to no attention. This study provides a more nuanced view of the steadily growing silent population in the United States through close readings of Openline, an inter-disciplinary journal featuring …

Drugs And Alcohol In The Workplace , Venable, Baetjer & Howard, Esqs.

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Book Reviews, David J. Agatstein

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Environmental Regulation And The Doctrine Of Scientific Uncertainty: A Case Study Of The Epa's Cancellation Of 2, 4, 5-T, Wendy Wagner

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Utica Packing Co. V. Block, 781 F.2d 71 (6th Cir. 1986), David J. Agatstein

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Stemming The Global Trade In Falsified And Substandard Medicines, Lawrence O. Gostin, Gillian J. Buckley, Patrick W. Kelley

Georgetown Law Faculty Publications and Other Works

Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and the problem is far more common and serious in low- and middle-income countries with weak drug regulatory systems. An Institute of Medicine consensus committee report identified the causes and possible solutions to the problem of falsified and substandard drugs around the world.

The vocabulary people use to discuss the problem is itself a concern. The word counterfeit is often used innocuously to …

Harmony With Nature And Genetically Modified Seeds: A Contradictory Concept In The United States And Brazil?, Heather Leibowitz

Pace Environmental Law Review

Looking at the differing regulatory frameworks for genetically modified organisms (GMOs) in the United States and Brazil, this Article will help demonstrate how a lack of scientifically objective standards has allowed regulatory agencies to circumvent environmentally protective and sustainable policies. Additionally, this analysis will help illuminate what corrective steps can be taken.

Jurisdiction Of The Food And Drug Administration To Regulate Tobacco Products Under The Food, Drug, And Cosmetic Act: Food And Drug Administration V. Brown & Williamson Tobacco Corporation Et Al., Alison J. Lezak

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

Emerging Partially Effective Vaccines: Ethical And Policy Considerations, Vincent Y. Ling J.D., M.S.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Taxing Food And Beverage Products: A Public Health Perspective And A New Strategy For Prevention, Jennifer L. Pomeranz

University of Michigan Journal of Law Reform

The power to tax and spend is considered a primary government power, and the use thereof is associated with great public health achievements. The greatest public health challenge at present stems from the increase in obesity and chronic diseases due to poor nutrition. Several taxation strategies have emerged in the health and economic literature to raise revenue, deter consumption, and address food prices and obesity directly. These proposals include taxing obese individuals, taxing problematic food products, and instituting a tax based on certain food components. This article weighs each proposal's value and disadvantages and concludes by proposing a new tax …

Rescuing Access To Patented Essential Medicines: Pharmaceutical Companies As Tortfeasors Under The Prevented Rescue Tort Theory, Richard Cameron Gower

Richard Cameron Gower

Despite some difficulties, state tort law can be argued to create a unique exception to patent law. Specifically, the prevented rescue doctrine suggests that charities and others can circumvent patents on certain critical medications when such actions are necessary to save individuals from death or serious harm. Although this Article finds that the prevented rescue tort doctrines is preempted by federal patent law, all hope is not lost. A federal substantive due process claim may be brought that uses the common law to demonstrate a fundamental right that has long been protected by our Nation’s legal traditions. Moreover, this Article …

A Failure To Consider: Why Lawmakers Create Risk By Ignoring Trade Obligations, David R. Kocan Professor

David R. Kocan Professor

The U.S. Congress frequently passes laws facially unrelated to trade that significantly impact U.S. trade relations. These impacts are often harmful, significant, and long-lasting. Despite this fact, these bills rarely receive adequate consideration of how they will impact trade. Without this consideration, Congress cannot properly conduct a cost-benefit analysis necessary to pass effective laws. To remedy this problem, the U.S. Trade Representative should evaluate U.S. domestic law to determine whether it is consistent with international trade obligations. Moreover, the U.S. Congress committee structure should be amended so that laws that might impact trade are considered within that light. In the …