Food and Drug Law Commons^™

Scale Economies, Scale Externalities: Hog Farming And The Changing American Agricultural Industry, Shi-Ling Hsu

Scholarly Publications

American agriculture is inexorably concentrating into the hands of a small number of large conglomerates. Expanding farms pursuing scale economies would normally have to abide by a system of environmental and other laws that would, in theory, require farms to account for negative externalities. If those laws were observed and enforced, they would help strike a balance between the greater profitability and the larger externalities of scaling up. But these laws are not widely observed nor rigorously enforced, which upsets this balance and gives large-scale farms a cost advantage while insulating them from corresponding responsibilities.

Perhaps nowhere in agriculture is …

Effectively Regulating E-Cigarettes And Their Advertising—And The First Amendment, Eric N. Lindblom

O'Neill Institute Papers

If tobacco smoking did not exist in the United States, there would be no reason, from a public health perspective, to allow addictive, nicotine-containing e-cigarettes to be marketed and sold. Because e-cigarette use, by itself, is neither beneficial nor benign to users and nonusers, the only public health justification for allowing e-cigarettes in the existing U.S. market would be if doing so would not sustain or increase existing smoking levels but would help smokers quit completely or provide addicted smokers a less harmful way to obtain the nicotine they crave. Yet e-cigarettes are now pervasive in the U.S. market, being …

Should All Drugs Be Patentable?: A Comparative Perspective, Cynthia M. Ho

Vanderbilt Journal of Entertainment & Technology Law

Although there has been substantial discussion of the proper scope of patentable subject matter in recent years, drugs have been overlooked. This Article begins to address that gap with a comparative perspective. In particular, this Article considers what is permissible under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), as well as how India and Canada have utilized TRIPS flexibilities in different ways to properly reward developers of valuable new drugs, while also considering the social harm of higher prices beyond an initial patent term on drugs.

This Article brings valuable insight into this area at a critical …

High Times: Is The Federal Legalization Of Marijuana Next? What The Food And Drug Administration Could Learn From Its Existing Regulations, Christopher B. Erly

American University Journal of Gender, Social Policy & the Law

This student comment examines the efficacy of marijuana being regulated by the Food and Drug Administration. The author discusses and applies potential FDA regulatory models that could be used to regulate marijuana. The comment concludes marijuana could be easily regulated under the current Food and Drug Administration regulatory scheme and suggests that marijuana should be regulated in a manner akin to tobacco rather than as a drug.

The Little “Black” Pill: Dressing Unlikely Murderers For Defense Success, 48 J. Marshall L. Rev. 933 (2015), Cassandra Wich

UIC Law Review

No abstract provided.

Doping In Cycling: Incentivizing The Reporting Of Uci Anti-Doping Rules Violations Through Organizational Oversight And Accountability, 49 J. Marshall L. Rev. 625 (2015), Tom Laser

UIC Law Review

No abstract provided.

Legal Preparedness And Ebola Vaccines, Sam F. Halabi, John T. Monahan

Faculty Publications

On Dec 9, 2014, US Secretary of Health and Human Services Sylvia Burwell issued a declaration under the US Public Readiness and Emergency Preparedness Act to provide immunity from legal claims in the USA related to manufacturing, testing, development, distribution, and administration of three candidate Ebola vaccines except in instances of willful misconduct. Although progress in combating Ebola in west Africa has shifted public attention away from vaccine development and deployment, we should not forget that the management of legal liabilities related to vaccines has been an important subject of discussion between national governments, international organizations, vaccine manufacturers, and other …

Sharing The Burden Of Ebola Vaccine Related Adverse Events, Sam F. Halabi, John Monahan

Faculty Publications

Based upon past experience with other vaccines, the proposed administration of Ebola vaccines (once testing has been completed) will inevitably result in at least some adverse events that will give rise to legal liabilities of only crudely estimable magnitude at this time. Manufacturers, beneficiary governments (e.g., Guinea, Liberia, Sierra Leone), supporting governments (e.g. U.S., U.K.), individuals suffering adverse events, and populations benefiting from widespread vaccination against the Ebola virus all have a shared interest in recognizing, understanding, and managing potential liability as effectively as possible within the framework of a global public health response. There are multiple options available to …

Fda Approval Of Drugs And Devices: Preemption Of State Laws For “Parallel” Tort Claims, Marcia Boumil

Journal of Health Care Law and Policy

The U.S. Supreme Court’s important ruling in Mutual Pharmaceutical Co., Inc. v. Bartlett concerns whether the Food and Drug Administration’s (“FDA”) approval of a generic drug insulates the drug manufacturer from liability under state tort laws from claims of injury due to an alleged “design defect.” The Court previously ruled that FDA approval does not preempt state law claims based upon failure-to-warn, at least with respect to brand name products. In contrast, the Court previously ruled that the federal regulatory process leading to FDA approval of generic equivalents of brand drugs—and designation of the drug label—does preempt state law as …

New York City Rules! Regulatory Models For Environmental And Public Health, Jason J. Czarnezki

Elisabeth Haub School of Law Faculty Publications

Scholars have become increasingly interested in facilitating improvement in environmental and public health at the local level. Over the last few years, former New York City Mayor Michael Bloomberg and the New York City Council have proposed and adopted numerous environmental and public health initiatives, providing a useful case study for analyzing the development and success (or failure) of various regulatory tools, and offering larger lessons about regulation that can be extrapolated to other substantive areas. This Article, first, seeks to categorize and evaluate these “New York Rules,” creating a new taxonomy to understand different types of regulation. These “New …

Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans

Elisabeth Haub School of Law Faculty Publications

After providing a brief overview of regulation in each area, Part I of this Article identifies three types of discordance between produce safety and environmental protection on farms. First, because of limited resources, farmers will have to choose between implementing food safety practices and implementing environmental practices. Second, indirect trade-offs between the two regulatory goals result in damaging collateral consequences for the environment. Food safety regulation may exacerbate a range of existing environmental harms. Third, there is at least one direct clash that may make compliance with food safety law incompatible with participation in certain environmental programs. Part I also …

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 …

Michigan Craft Beer Legislation, Kincaid C. Brown

Law Librarian Scholarship

Michigan is currently in the midst of a craft beer boom. The Michigan Brewers Guild’s member list includes more than 150 breweries and brewpubs brewing craft beer. Michigan’s craft beer industry is boosting the state’s economy. According to an analysis by the Brewers Association customized by the Michigan Brewers Guild, the craft beer industry is directly responsible for more than 5,000 Michigan jobs and contributes more than $277 million to the state’s economy and more than $144 million in wages.

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.

The Lanham Act's Wonderful Complement To The Fdca: Pom Wonderful V.Coca-Cola Enhances Protection Against Misleading Labeling Through Integrated Regulation, Jennifer Thurswell Radis

Loyola University Chicago Law Journal

POM Wonderful sued Coca-Cola under the Lanham Act claiming that it suffered losses due to the misleading label on Coca-Cola’s Minute Maid brand’s Pomegranate Blueberry juice blend. Reversing the Ninth Circuit’s decision in June 2014, the Supreme Court found that POM’s claim was not precluded even though the label was regulated by the FDCA. In fact, the Court acknowledged the complementary nature of private enforcement with FDA regulation, as it did in Wyeth v. Levine in 2009. This Article submits that POM exemplifies the Court’s willingness to strengthen the Lanham Act’s protections against misleading labeling, as it did the same …

From Silicon Valley To The Kitchen Table: Innovative Online Agriculture & Food Start-Ups And The Law, Matthew A. Forcum

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

A Practitioner's Guide To Defending "Natural" Food Labeling Litigation, Lauren E. Handel

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Mad Cow Disease: Is There An App For That?, Sara Gonzalez-Rothi Kronenthal

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

The Aged Distilled Spirits Competitiveness Act: Increasing Kentucky's Economic Output While Leveling The Playing Field For Kentucky Distilleries, Drake Staples

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Taking "The War On Drugs" To The Fields: The Importance Of Agriculture In Reforming International Law On The Illegal Drug Market, Terra Rivera

Kentucky Journal of Equine, Agriculture, & Natural Resources Law

No abstract provided.

Independent Drug Testing To Ensure Drug Safety And Efficacy, Marc A. Rodwin

Journal of Health Care Law and Policy

This Article explores a proposal that would preclude biased drug testing by removing all drug sponsor influence on the design and conduct of clinical trials for new drug applications (“NDAs”), a reform that would address the root of institutional corruption. Recently advocated by leading scholars, the idea has a long history, yet was neglected for over half a century due to pharmaceutical industry opposition.

Cool Story: Country Of Origin Labeling And The First Amendment, Rebecca Tushnet

Georgetown Law Faculty Publications and Other Works

Country of origin labeling (COOL) requirements have long been part of government regulation of commerce. While one might ordinarily think of mandatory COOL as part of trade policy--or even as a means of encouraging individual citizens to engage in country-specific buying that would be disallowed as protectionism if carried out by their governments -- the most robust legal challenges to mandatory COOL now come from the First Amendment, not from free trade principles. This reliance on free speech claims offers a stark example of the charismatic force of the First Amendment. Objections having little to do with free speech at …

Why Healthy Behavior Is The Hard Choice, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Our society is structured to encourage unhealthy diets and physically inactive lifestyles, which are key risk factors for chronic diseases including diabetes, heart diseases, and cancers. We are bombarded with advertisements for hyperprocessed foods laden with saturated fat, salt, sugar, and refined carbohydrates, “low-fat” foods often contain high amounts of sugar and salt, and parks and recreation spaces are often inaccessible or unsafe.

Four simple ideas - taxes on unhealthy products, product reformulation, improving the informational environment, and increasing healthy food accessibility - could make healthy behaviors the “default” choice for most consumers. First, taxes on unhealthy products, such as …

The Codex Alimentarius Commission, Corporate Influence, And International Trade: A Perspective On Fda's Global Role, Sam F. Halabi

Faculty Publications

Section 305 of the FDA Food Safety Modernization Act specifically calls for FDA to develop recommendations on whether and how to harmonize requirements under the Codex Alimentarius Commission (“Codex”), an international organization charged with developing food standards, guidelines, codes of practice and “other recommendations to ensure fair practices in food trade and protect[ion of] the health of consumers.” FDA’s International Food Safety Capacity-Building Plan is largely supportive and deferential to Codex, concluding that “the use of Codex standards helps assure a safe global food supply.” To be sure, Codex’s stated mission and policies should create and facilitate adoption of universal …

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 …

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 …

Tort As Democracy: Lessons From The Food Wars, Melissa Mortazavi

Faculty Articles

This Article develops alternative emerging theories regarding the function of tort in American civil society. Often, scholars and policymakers evaluate the tort system in terms of compensation, loss allocation, and risk management. This focus overlooks an important modern function of tort; in the context of the modern administrative state, tort is a vital player in the democratic deliberative process. Tort suits bring forth new ideas, force fact-finding, and increase communication amongst public and private institutional actors to develop sound and legitimate law and policy. Perhaps nowhere is this more obvious today than with the current boom of food litigation. Lawsuits …

The Not So "Sweet Surprise": Lawsuits Blaming Big Sugar For Obesity-Related Health Conditions Face An Uphill Battle, Catherine Srithong Wicker

Journal of Law and Health

Because obesity and its associated health problems have been largely attributed to poor self-control, laziness, and various other personal failings, society has been unwilling to assign blame to food manufacturers for their role in contributing to this problem. But, as consumers are becoming more aware of the significantly harmful effect that poor diets can have on a person’s heath, the scales may be tipping in favor of bringing “Big Food” to court. Food manufacturers, however, are not exactly vulnerable. Armed with precedent disputing the causal link between consumption of fast food and adverse health effects, judicially-created barriers to admitting epidemiologic …

Food Policy And Cognitive Bias, Paul F. Campos

Publications

No abstract provided.

Ending Drunk Driving With A Flash Of Light, Andrew Sullivan

Law Student Publications

Among the methods used to combat drunk driving is mandating a person convicted of driving under the influence/driving while intoxicated install an ignition interlock device (“IID”) in his/her vehicle as a condition of restoring his/her driving privileges.This comment argues that the National Highway Traffic Safety Administration (“NHTSA”) has the authority to issue such a regulation; it need only be presented with a workable opportunity to do so. The present state of IID technology is a poor candidate to make this hypothetical regulation workable, but advances in Near Infrared (“near-IR”) Spectroscopy will provide the technology necessary to make a discussion of …