Law Commons^™

Comments On The World Bank’S Draft Guidance Note For Borrowers Ess5: Land Acquisition, Restrictions On Land Use And Involuntary Resettlement, Columbia Center On Sustainable Investment

Columbia Center on Sustainable Investment Staff Publications

In December 2017, CCSI sent comments to the World Bank regarding its Draft Guidance Note for Borrowers ESS5: Land Acquisition, Restrictions on Land Use and Involuntary Resettlement.

CCSI’s overarching comments on the Guidance Note were that:

• Its description of affected persons and their rights contradicts and undermines international consensus on land governance supported by the Bank
• It fails to provide any guidance on when involuntary resettlement should be considered unavoidable or how Borrowers can prioritize project designs that actually minimize displacement or other harms
• It fails to put rights-holders (or “affected stakeholders”) at the center of solutions
• Its discussion of …

"Fowl" Practice Of Humane Labeling: Proposed Amendments To Federal Standards Governing Chicken Welfare And Poultry Labeling Practices, Latravia Smith

Alumni Works

Chickens raised specifically for meat production are the world’s most intensively farmed land animals. Yet, the existing legal frameworks that regulate the production and labeling of poultry products in the United States allow poultry producers to mistreat chickens, falsely distinguish poultry products, and defraud conscious consumers. This article proposes unique opportunities to improve poultry welfare in the United States’ agricultural industry and offers methods to ensure the accurate labeling of poultry products.

Newsroom: Logan Quoted In Bloomberg News On Opiod Litigation 08-16-2017, Jef Feeley, Jared S. Hopkins

Life of the Law School (1993- )

No abstract provided.

Beyond The War: The Evolving Nature Of The U.S. Approach To Drugs, Don Stemen

Criminal Justice & Criminology: Faculty Publications & Other Works

Over the last forty years, perhaps no issue has affected the United States’s criminal justice system as profoundly as has drug policy. Since President Nixon declared drug abuse “America’s public enemy number one,”1 concerns about the manufacture, distribution, and possession of drugs have remained at the fore of criminal justice policy discussions.2 President Reagan’s subsequent pronouncement of drugs as “an especially vicious virus of crime” set a course for national drug policy that emphasized enforcement and punishment over treatment to “win the war on drugs.”3 Throughout the 1980s, increasing public concern about the effects of drug abuse4 further pressured policymakers …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Engaging Health Insurers In The War On Prescription Painkillers, Valarie K. Blake

Law Faculty Scholarship

No abstract provided.

Illegal Marijuana Cultivation On Public Lands: Our Federalism On A Very Bad Trip, Hope M. Babcock

Georgetown Law Faculty Publications and Other Works

Fueled by increasing demand for marijuana, illegal cultivation of the drug on public lands is causing massive environmental harm. The federal government lacks the resources to wage what would be a difficult and costly campaign to eradicate these illegal grow sites and instead focuses its limited resources on enforcing the federal marijuana ban. Marijuana decriminalization might allow legally grown marijuana to squeeze out its illegal counterpart, but the political likelihood of decriminalization is low. The key is reducing demand for the illegal drug by changing public buying preferences. However, doing this depends on an available legal alternative. This Article discusses …

Eating Is Not Political Action, Joshua Ulan Galperin, Graham Downey, D. Lee Miller

Elisabeth Haub School of Law Faculty Publications

Food and environment are cultural stalwarts. Picture the red barn and solitary farmer toiling over fruited plains; or purple mountains majesty reflected in pristine waters. Agriculture and environment are core, distinct, American mythologies that we know are more intertwined than our stories reveal.

To create policy at the interface of such centrally important and overlapping American ideals, there are two options. Passive governance fosters markets in which participants make individual choices that aggregate into inadvertent collective action. In contrast, assertive governance allows the public, mediated through elected officials, to enact intentional, goal oriented policy.

American mythologies of food and environment …

Beyond Zero-Sum Environmentalism, Jessica Owley, Shalanda Baker, Robin Kundis Craig, John Dernbach, Keith Hirokawa, Sarah Krakoff, Melissa Powers, Shannon Roesler,, Jonathan Rosenbloom, J. B. Ruhl, Jim Salzman, Inara Scott, David Takacs

Articles

Environmental law and environmental protection are often portrayed as requiring trade offs: "jobs versus environment," "markets versus regulation," "enforcement versus incentives." In the summer of 2016, members of the Environmental Law Collaborative gathered to consider how environmentalism and environmental regulation can advance beyond this framing to include new constituents and offer new pathways to tackle the many significant challenges ahead. Months later, the initial activities of the Trump Administration highlighted the use of zero-sum rhetoric, with the appointment of government officials and the issuance of executive orders that indeed seem to view environmental issues as in a zero-sum relationship with …

Regulating Milk: Women And Cows In France, Mathilde Cohen

Faculty Articles and Papers

Animal milk, most commonly cow’s milk, is one of the most heavily regulated commodities in both France and the United States. With the increasing popularity of breastfeeding and the possibility of pumping, freezing, and storing breast milk, a cottage industry has emerged for people wishing to buy, sell, or donate milk produced by humans. Yet the legal landscape for human milk remains inchoate, prompting public health officials and medical professionals to call for tighter regulation. Animal and human milk are typically viewed as two distinct substances with little in common beyond a name. In contrast, this Article highlights the analogies …

Pueblo Indian Water Rights: Charting The Unknown, Richard W. Hughes

Publications

This article examines the so-far-unsuccessful efforts to judicially define and quantify the water rights appurtenant to the core land holdings of the 19 New Mexico Pueblos, many of whose lands straddle the Rio Grande. It explains that the Tenth Circuit Court of Appeals has squarely held that Pueblo water rights are governed by federal, not state law, and are prior to those of any non-Indian appropriator, but also that the Tenth Circuit acknowledged that it could not say how those rights should be characterized. Part I of the article examines the course of the cases that have sought to achieve …

Shooting Stars And Dancing Fish: A Walk To The World We Want, Tony Oposa

Environmental Law Program Publications @ Haub Law

From the foreword by Durwood Zaelke, President, Institute for Governance & Sustainable Development, Washington, DC.

“Since the beginning of time, human knowledge and culture have been passed down through stories. Short stories, songs, prayers, poems, even paintings can stick in your mind forever. These have always been the most powerful ways we learn and remember.

Tony is not only one of the world’s greatest lawyers, he is also one of the world’s greatest storytellers.

This book, in which he generously shares his experiences, his scars, and most importantly his humanity, is Tony’s gift to generations to come.

But he does …

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Notice And Standing In The Fourth Amendment: Searches Of Personal Data, Jennifer Daskal

Articles in Law Reviews & Other Academic Journals

In at least two recent cases, courts have rejected service providers' capacity to raise Fourth Amendment claims on behalf of their customers. These holdings rely on longstanding Supreme Court doctrine establishing a general rule against third parties asserting the Fourth Amendment rights of others. However, there is a key difference between these two recent cases and those cases on which the doctrine rests. The relevant Supreme Court doctrine stems from situations in which someone could take action to raise the Fourth Amendment claim, even if the particular thirdparty litigant could not. In the situations presented by the recent cases, by …

Eating For The Environment: The Potential Of Dietary Guidelines To Achieve Better Human And Environmental Health Outcomes, Margaret Sova Mccabe

Law Faculty Scholarship

Agriculture and food production contribute significantly to greenhouse gas emissions and environmental pollution. Shifting human dietary patterns has the potential to reduce such environmental harms while also promoting human health. Government policy, in the form of the United States Dietary Guidelines (USDG), recommends what Americans should eat and could play an important role in shifting the food system to one that is more sustainable. However, the USDG are an overlooked aspect of U.S. food policy. While many countries have moved to synthesize environmental goals with dietary guidance, the United States has taken the opposite approach. In 2015, despite recommendations from …

What Is The Purpose Of The Orphan Drug Act?, Matthew Herder

Articles, Book Chapters, & Popular Press

The Orphan Drug Act (ODA) [1], first enacted in the United States in 1983, was set up to encourage the development of drugs for rare diseases. At that time, drug therapies for such diseases were rarely developed. Three decades later, a growing proportion of industry research and development (R&D) [2] and regulatory drug approvals [3] target diseases affecting fewer than 200,000 persons in the United States, the prevalence-based threshold of rare disease under the ODA.

In a new article published in PLOS Medicine, Aaron Kesselheim and colleagues document an embedded trend: within the …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

Tax Treatment Of A Marijuana Business, Douglas A. Kahn, Howard Bromberg

Articles

Currently, twenty-eight states and the District of Columbia allow the use of marijuana for medical purposes and permit the conduct of a business marketing of marijuana for that purpose. Eight of those states and the District of Columbia permit the recreational use of marijuana. There is reason to believe that more states will decriminalize the marketing of marijuana. However, marijuana is listed in Schedule 1 of the federal Controlled Substances Act of 1970 (CSA) which makes it illegal under federal law to manufacture or distribute marijuana even when it is legal to do so under local state law. In a …

Risky Business? The Trump Administration And The State-Licensed Marijuana Industry, Robert A. Mikos

Vanderbilt Law School Faculty Publications

While it is clear that the new attorney general opposes state marijuana reforms, it is less clear what he will or even could do to block those reforms or to curb the industry that has flourished under them. The popularity of reforms, limits on federal resources, and legal doctrines like the anticommandeering rule all limit the DOJ’s ability to shut down the state-licensed marijuana industry. While Jeff Sessions may never embrace reforms, he may choose to pursue other tactics, like anti-marijuana media campaigns, to curb the use of marijuana and the harms caused thereby. Only time will tell, of course, …

The Uncharted Waters Of Competition And Innovation In Biological Medicines, Erika Lietzan

Faculty Publications

In 2010, Congress fundamentally changed how federal law encourages the discovery and development of certain new medicines and for the first time authorized less expensive “duplicates” of these medicines to be approved and compete in the marketplace. The medicines at issue are biological medicines, generally made from, or grown in, living systems. Many of the world’s most important and most expensive medicines for serious and life–threatening diseases are biological medicines.

We have a profound interest in understanding and evaluating the impact of this legislation on innovation and competition. Scholars and courts considering this question may be tempted to reason from, …

Pharmaceutical M&A Activity: Effects On Prices, Innovation, And Competition, Barak D. Richman, Will Mitchell, Elena Vidal, Kevin Schulman

Faculty Scholarship

The rise of blockbuster pharmaceutical acquisitions has prompted fears that unprecedented market concentration will weaken competition. Two of the most prominent concerns focus on the upstream and downstream ends of the pharmaceutical industry: (1) the concern that these mergers will concentrate the market for discovery and will therefore lead to fewer discoveries; and (2) the concern that merging large marketing, sales, and distribution forces will strengthen the hands of select pharmaceutical manufacturers and weaken downstream competition. Having considered potential dynamic effects in the industry and conducted a series of preliminary interviews with knowledgeable observers, though, this Article argues that neither …

Value Hypocrisy And Policy Sincerity: A Food Law Case Study, Joshua Ulan Galperin

Elisabeth Haub School of Law Faculty Publications

t is tempting to say that in 2017 there is a unique problem of hypocrisy in politics, where words and behaviors are so often in opposition. In fact, hypocrisy is nothing new. A robust legal and psychological literature on the importance of procedural justice demonstrates a longstanding concern with developing more just governing processes. One of the important features of this scholarship is that it does not focus only on the consequences of policymaking, in which behaviors, but not words, are relevant. Instead, it respects the intrinsic importance of fair process, lending credence not only to votes but also to …

Farming And Eating, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

This essay argues that the “us versus them” rhetoric that dominates food and agriculture policy today drives a wedge between farmers and food consumers. Together, farmers and food consumers could form a powerful coalition to challenge the true obstacle to sustainable and equitable food production: concentration of market and political power elsewhere along the food chain.

Value Hypocrisy And Policy Sincerity: A Food Law Case Study, Joshua Galperin

Articles

It is tempting to say that in 2017 there is a unique problem of hypocrisy in politics, where words and behaviors are so often in opposition. In fact, hypocrisy is nothing new. A robust legal and psychological literature on the importance of procedural justice demonstrates a longstanding concern with developing more just governing processes. One of the important features of this scholarship is that it does not focus only on the consequences of policymaking, in which behaviors, but not words, are relevant. Instead, it respects the intrinsic importance of fair process, lending credence not only to votes but also to …

The Gmo/Ge Debate, Joanna K. Sax

Faculty Scholarship

The scientific community and the public sphere are having different debates about the application of genetic engineering to improve our food supply. Many that are deeply steeped in the science view genetically engineered food as a more precise way to accomplish what we have been doing for centuries, which is genetically modifying our food supply. Some members of the public view genetically engineered food with skepticism especially as it relates to health, safety and the environment. A disconnect between the scientific consensus and public perception is not a new phenomenon. This Article attempts to bridge this gap by explaining what …

Fda-Required Tobacco Product Inserts & Onserts – And The First Amendment, Eric N. Lindblom, Micah L. Berman, James F. Thrasher

O'Neill Institute Papers

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted …

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Risk And Regulatory Calibration: Wto Compliance Review Of The U.S. Dolphin-Safe Tuna Labeling Regime, Cary Coglianese, André Sapir

All Faculty Scholarship

In a series of recent disputes arising under the TBT Agreement, the Appellate Body has interpreted Article 2.1 to provide that discriminatory and trade-distortive regulation could be permissible if based upon a “legitimate regulatory distinction.” In its recent compliance decision in the US-Tuna II dispute, the AB reaffirmed its view that regulatory distinctions embedded in the U.S. dolphin-safe tuna labeling regime were not legitimate because they were not sufficiently calibrated to the risks to dolphins associated with different tuna fishing conditions. This paper analyzes the AB’s application of the notion of risk-based regulation in the US-Tuna II dispute and finds …