Food and Drug Law Commons^™

Carrots And Sticks: Safer Fresh Produce In The United States Through British Style Supermarket Co-Regulation, Victoria Tokar

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

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

Publications

No abstract provided.

Marijuana Localism, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have wrested control of marijuana policy from the federal government, but they risk losing some of their newfound power to another player: local governments. Hundreds of local communities are now seeking to establish their own marijuana policies, from legalization to prohibition and a variety of idiosyncratic regulatory schemes in between. These local efforts raise one of the most important and unresolved questions surrounding marijuana law and policy: What authority, if any, should states give local governments to regulate marijuana? This Article provides some guidance on this question. It starts by identifying two competing considerations that help determine whether …

Scouting For Approval: Lessons On Medical Device Regulation In An Era Of Crowdfunding From Scanadu’S “Scout”, Colleen Smith

Student Award Winning Papers

This Article will argue that medical device companies should be able to utilize crowdfunding to raise the necessary capital to develop a product. However, because of the risks medical devices pose, any solution that allows medical device companies to employ crowdfunding should ensure the continuing commitment to consumer safety that is at the core of FDA regulation. This Article uses the Scanadu Scout as an example and a staring point for evaluating the use of crowdfunding in the medical device industry. This Article explains how and why Scanadu broke the law when it moved the Scout, an “adulterated or misbranded” …

An Fda For Financial Innovation: Applying The Insurable Interest Doctrine To Twenty-First-Century Financial Markets, Eric A. Posner, E. Glen Weyl

Northwestern University Law Review

The financial crisis of 2008 was caused in part by speculative investment in complex derivatives. In enacting the Dodd–Frank Act, Congress sought to address the problem of speculative investment, but it merely transferred that authority to various agencies, which have not yet found a solution. We propose that when firms invent new financial products, they be forbidden to sell them until they receive approval from a government agency designed along the lines of the FDA, which screens pharmaceutical innovations. The agency would approve financial products if they satisfy a test for social utility that focuses on whether the product will …

Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole Negowetti

Law Faculty Publications

Over the past several decades, as the agricultural system became increasingly industrialized and the steps from farm to plate multiplied, consumers became farther removed from the sources of their food. Until recently, most consumers in America were content to eat their processed, cheap, and filling foods without giving a second thought to how these foods were produced. The tides are changing. Increasingly, consumers are calling for more transparency in the food system. Repulsed by images of animal cruelty and shocked by unsavory food production practices, consumers want the food industry’s veil lifted and are demanding changes in food production. The …

The Executioners‘ Dilemmas, Eric Berger

Nebraska College of Law: Faculty Publications

When people learn that I study lethal injection, they are usual-ly curious to know more (or at least they are polite enough to ask questions). Interestingly, the question that arises most often—from lawyers, law students, and laypeople—is why states behave as they do. In the wake of botched executions and ample evidence of lethal injection‘s dangers, why do states fail to address their execution procedures‘ systemic risks? Similarly, why do states so vigorously resist requests to disclose their execution procedures‘ details? This symposium essay takes a stab at answering these ques-tions. In the interest of full disclosure, I should admit …

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.