Food and Drug Law Commons^™

Putting A Gag On Farm Whistleblowers: The Right To Lie And The Right To Remain Silent Confront State Agricultural Protectionism, Rita-Marie Cain Reid, Amber L. Kingery

Journal of Food Law & Policy

Whistleblowers play an important role in filling gaps in government food safety systems. Unfortunately, several dominant food-producing states have pursued legislative initiatives that punish farm whistleblowers and silence investigative tactics. First, this research describes various state legislative initiatives that curb criticism of agriculture. The work analyzes the federal food safety system and how these protections limiting agricultural criticism contravene that food safety net. Further, the research analyzes the free speech concerns in the newest protectionist laws. The analysis recommends strategies and future research to improve agriculture safety and protect free speech in an evolving food safety landscape.

Spring 2015 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Optimizing Reservoir Operations To Adapt To 21st Century Expectations Of Climate And Social Change In The Willamette River Basin, Oregon, Kathleen M. Moore

Publications

Reservoir systems in the western US are managed to serve two main competing purposes: to reduce flooding during the winter and spring, and to provide water supply for multiple uses during the summer. Because the storage capacity of a reservoir cannot be used for both flood damage reduction and water storage at the same time, these two uses are traded off as the reservoir fills during the transition from the wet to the dry season. Climate change, population growth, and development in the western US may exacerbate dry season water scarcity and increase winter flood risk, creating a need to …

Sprung From Night Into The Sun: An Examination Of Colorado's Marijuana Regulatory Framework Since Legalization, Robert T. Hoban, Raushanah A. Patterson

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

The Implementation Of The Food Safety Modernization Act And The Strength Of The Sustainable Agriculture Movement, Samuel R. Wiseman

Scholarly Publications

In the wake of growing public concerns over salmonella outbreaks and other highly publicized food safety issues, Congress passed the FDA Food Safety Modernization Act in 2011, which placed more stringent standards on food growing and packaging operations. In negotiations preceding the Act's passage, farmers of local, sustainable food argued that these rules would unduly burden local agricultural operations or, at the extreme, drive them out of business by creating overly burdensome rules. These objections culminated in the addition of the Tester-Hagan Amendment to the Food Safety Modernization Act, which created certain exemptions for small farms. Proposed Food and Drug …

Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane

Michigan Telecommunications & Technology Law Review

Under the Hatch-Waxman Act, patent law and FDA regulation work together to determine the timing of generic entry in the market for drugs. But FDA has sought to avoid any responsibility for reading patents, insisting that its role in administering the patent provisions of the Hatch-Waxman Act is purely ministerial. This gap in regulatory oversight has allowed innovators to use irrelevant patents to defer generic competition. Meanwhile, patent litigation has set the stage for anticompetitive settlements rather than adjudication of the patent issues in the courts. As these settlements have provoked antitrust litigation, antitrust courts have proven no more willing …

The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan

West Virginia Law Review

No abstract provided.

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.

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.

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

Publications

No abstract provided.

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 …

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

Journal Articles

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 …

Spring 2014 Utton Center Newsletter, Utton Center, University Of New Mexico - School Of Law

Publications

No abstract provided.

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

The Inclusion Of Pregnant Women In Clinical Research, Barbara A. Noah

Faculty Scholarship

In the past three decades, there has been unprecedented growth in medical research utilizing human subjects, with much promise for new treatments that extend life, improve quality of life, and prevent disease and disability. Safe prescribing of drug therapies requires that researchers design clinical trials to test products for the benefit of all persons who are likely to utilize them, not just a limited population. For this reason, it is essential that clinical trials include women, pregnant women, children, and racial minorities, as appropriate, because these populations sometimes exhibit different patterns of response or adverse reactions.

Despite some significant progress …

A New Framework For Assessing Clinical Data Transparency Initiatives, Erika Lietzan

Faculty Publications

Biopharmaceutical companies submit vast amounts of clinical data and analysis to support approval of their medicines, expecting the information to be kept confidential, as has been the practice of regulators around the world for decades. Over the last ten years, however, pressure has been mounting for regulators or industry to release this information. Legal scholars have generally taken the view that no relevant doctrines or bodies of law preclude the release of this material and that public policy considerations compel its release. This article argues that the scholarship to date has overlooked key considerations: the special issues presented by operation …

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.

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 …

When Truth Cannot Be Presumed: The Regulation Of Drug Promotion Under An Expanding First Amendment, Christopher Robertson

Faculty Scholarship

The Food, Drug, and Cosmetic Act (FDCA) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off-label” uses, and often do so. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches.

This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark court of appeals decision holding that the First Amendment precludes …

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, 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 …

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.

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

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 …

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

Publications

No abstract provided.

The U.S. Department Of Agriculture As A Public Health Agency? A "Health In All Policies" Case Study, Lindsay F. Wiley

Journal of Food Law & Policy

The "war on obesity" is now well into its second decade. What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.

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.