Law Commons^™

The World Trade Organization Dispute Over Genetically Modified Organisms: The Precautionary Principle Meets International Trade Law, David A. Wirth

David A. Wirth

“Precaution” is increasingly accepted as a basis for governmental policy in the areas of public health and environment on both the domestic and international levels. A precautionary perspective counsels action to avert danger or threats in situations of scientific uncertainty or incomplete information. Precautionary approaches find expression in internationally harmonized formulations as non-binding exhortations, binding treaties, and meta-level principles. Precaution is a particular challenge to free trade agreements, whose purpose is to eliminate unjustified barriers to trade. In that context, precaution as a justification for a challenged governmental measure may appear to be nothing more than a pretext for protectionism. …

The Unbearable Whiteness Of Milk: Food Oppression And The Usda, Andrea Freeman

UC Irvine Law Review

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Maryland Law Review Online

No abstract provided.

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Brand Name Or Generic? A Case Note On Caraco Pharmaceutical Laboratories V. Novo Nordisck , Michael Vincent Ruocco

Journal of the National Association of Administrative Law Judiciary

No abstract provided.

The 1988 U.N. Convention Against Illicit Traffic In Narcotic Drugs And Psychotropic Substances - A Ten Year Perspective: Is International Cooperation Merely Illusory?, Jimmy Gurule

Jimmy Gurule

On the ten-year anniversary of the adoption of the 1988 U.N. Drug Convention, this Article analyzes whether signatory- parties have complied with the duties and obligations imposed thereunder, and, in particular, whether the Convention has enhanced international cooperation in narcotics enforcement. Part I of this Article examines the legal obligations and duties imposed under the 1988 U.N. Drug Convention, with special emphasis on the provisions aimed at criminalizing money laundering and at forfeiture of illicit drug proceeds and instrumentalities of narcotics trafficking. Additionally, Part I examines the requirement that parties afford one another the "widest measure of mutual legal assistance …

The Grapes Of Wrath: Encouraging Fruitful Collaborations Between Local Governments And Farm Wineries In The Commonwealth, Philip Carter Strother, Andrew E. Tarney

University of Richmond Law Review

No abstract provided.

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 …

Joe M Stell Ombudsman Program - Taos Settlement Technical Work, Peggy Barroll

Publications

No abstract provided.

Seeing Through The Murky Vial: Does The Fda Have The Authority To Stop Compounding Pharmacies From Pirate Manufacturing?, Michael Snow

Vanderbilt Law Review

In late 2012 and early 2013, tainted steroid shots from the New England Compounding Center ("NECC") caused fifty-five deaths and 745 cases of fungal meningitis in twenty states.' On October 1, 2012, the Food and Drug Administration ("FDA") inspected NECC and found vials of steroids filled with enough floating contamination to be visible to the human eye. These NECC steroid shots were distributed primarily to treat back pain, but the patients who received them were injected with foreign matter containing the deadly fungi Exserohilum rostratum or Aspergillus fumigatus. The earliest reported death from fungal meningitis caused by NECC was seventy-eight-year-old …

Eating Invaders: Managing Biological Invasions With Fork And Knife?, Joshua Ulan Galperin, Sara Kuebbing

Elisabeth Haub School of Law Faculty Publications

As the public, academy, government, and private sector all turn increased attention to food systems, new ideas constantly emerge for healthy, sustainable, and just innovations in growing, marketing, and eating food. “Invasivory” — eating invasive species — is one such idea. Biological invasions occur when humans transport an organism from its ecosystem of origin into a new ecosystem and that organism adapts to its new location, spreading widely from the site of introduction. Invasive species can cause significant ecological, economic, and public health damage. Crops, homes, and native species are all at risk. “Invasivores,” as the proponents of invasivory are …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

Farm To Institution, Harvard Law School Food Law And Policy Clinic, Harvard Law School Mississippi Delta Project

Delta Directions: Publications

In a state with rich agricultural resources and a long farming tradition, why are Mississippi’s institutions serving fruits and vegetables mostly shipped from other states and countries? Connecting Mississippi growers with institutions within the state offers a promising way to increase fruit and vegetable consumption while improving the economic viability of local farms. This step-by-step guide aims to help growers in Mississippi start to sell locally grown foods to be served in meals at institutions around the state, such as hospitals, schools, prisons, and state and local government agencies.

Groundwater Challenges In Spain: Lessons From The Western Mancha Aquifer, Pedro Martinez-Santos

Publications

No abstract provided.

Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky

West Virginia Law Review

The legal status of medical marijuana in the United States is something of a paradox. On one hand, the federal government has placed a ban on the drug with no exceptions. On the other hand, forty percent of states have legal- ized its cultivation, distribution, and consumption for medical purposes. As such, medical marijuana activity is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented, nebulous zone of legality in which an activity is both legal and illegal, what …

Pharmaceutical Efficacy: The Illusory Legal Standard , Jonathan J. Darrow

Washington and Lee Law Review

The very long and expensive process of new drug research and development might suggest to observers that the efficacy standard for drugs is elevated and substantial, but this is not the case. Under the U.S. Federal Food, Drug, and Co smetic Act, new drug approval merely requires that there be “substantial evidence that the drug will have the effect it purports or is represented to have.” While the evidence of effectiveness must therefore be substantial, the efficacy attested to by that evidence need not surpass any particular threshold (other than zero), thus allowing drugs with de minimis efficacy to be …

A Decade’S Quest For Safer Drugs: Congressional Committee Green Lights Regulation Of Drug Supply Chains And Compounding Manufacturers, Mary Ann Chirba, Alice Noble

Mary Ann Chirba

On May 22. 2013, the Senate Health, Education, Labor and Pensions (HELP) Committee unanimously approved S.959, “The Pharmaceutical Compounding Quality and Accountability Act,” and S.957, “The Drug Supply and Security Act,” (now incorporated into S. 959 as an amendment). Congressional efforts to enact comprehensive legislation to improve drug safety and secure the nation’s drug supply chain have lingered for over a decade. The lack of federal uniformity has allowed a patchwork of state legislation to emerge, attracting the less scrupulous to those states with the lowest security. The issue finally gained traction among HELP Committee members when 55 people died …

Blood Transfusions, Jehovah’S Witnesses, And The American Patients’ Rights Movement, Charles H. Baron

Charles H. Baron

The litigation to protect Jehovah’s Witnesses from unwanted blood transfusions, which their theology considers a violation of the biblical prohibition against drinking blood, has produced important changes in both the right to refuse treatment and in the preferred treatment methods of all patients. This article traces the evolution of the rights of competent medical patients in the United States to refuse medical treatment. It also discusses the impact this litigation has had on the medical community’s realization that blood transfusions were neither as safe nor as medically necessary as medical culture posited.

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 …

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.