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Articles 271 - 300 of 405
Full-Text Articles in Food and Drug Law
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher
Scholarly Works
In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
A New Governance Recipe For Food Safety Regulation, Alexia Brunet Marks
Publications
Although food safety is a significant and increasing global health concern, international economic law does not adequately address today’s global food safety needs. While most countries rely on a collection of formalized legal rules to protect food safety, these rules too often fall short. As fiscal constraints impede raising the number of border inspections, formal international commitments (treaties) frequently limit governmental efforts to raise food safety standards. Private companies, meanwhile, can readily adopt higher standards to meet consumer demands and supply chain needs, thus demonstrating more nimbleness and flexibility in adopting the highest food safety standards available. Can countries learn …
Persistent Threats To Commercial Speech, Jonathan H. Adler
Persistent Threats To Commercial Speech, Jonathan H. Adler
Faculty Publications
The current Supreme Court is very protective of speech, including commercial speech. Threats to commercial speech persist nonetheless. This article briefly examines two: the use of commercial speech restrictions as a form of rent-seeking, and compelled commercial speech. Regulation of commercial speech is sometimes used to protect established corporate interests from competitors who are less able to bear the costs of regulation, with consequences that extend beyond the economic marketplace. In the case of commercial speech, courts have also been unduly deferential to claims of a consumer “right to know” as a basis for mandated labeling and disclosure. Greater and …
Classwide Arbitration: A Method Of Resolving The "Natural" Food Label Litigations, Angelina Dalia
Classwide Arbitration: A Method Of Resolving The "Natural" Food Label Litigations, Angelina Dalia
Cardozo Journal of Conflict Resolution
This Note discusses how classwide arbitration in food labeling disputes can better serve as a resolution method for both parties. Part I will review the current legal landscape surrounding food labeling litigations and the limitations of the FDA's regulatory and enforcement power. It will analyze how the lack of regulation has led to the recent surge in food labeling class actions. Part II will introduce the general benefits and downfalls of mandatory arbitration in comparison to litigation as a means of legal remedy. Furthermore, it will describe the recent trend of incorporating mandatory arbitration clauses and class action waivers in …
Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann
Panel 1: False Advertising, Ashima Dayal, Jeffrey Greenbaum, Jen Lavie, Rebecca Tushnet, Brett Frischmann
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Introductions, Tatsuya Adachi
Introductions, Tatsuya Adachi
Cardozo Arts & Entertainment Law Journal
No abstract provided.
Compelled Commercial Speech And The Consumer "Right To Know", Jonathan H. Adler
Compelled Commercial Speech And The Consumer "Right To Know", Jonathan H. Adler
Faculty Publications
Compelled commercial speech, including mandatory labeling and the disclosure of factually true information, should not be seen as a separate category of speech under the First Amendment. Rather, compelled commercial speech should be understood as a type of commercial speech and be subject to the same level of protection as commercial speech generally. Accordingly, commercial speech compulsions, such as mandatory disclosures and labeling requirements, must be supported by a substantial government interest under the Central Hudson framework. The assertion of a consumer “right to know” does not constitute such an interest and cannot, by itself, justify compelled commercial speech within …
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah Brennan
Michigan Telecommunications & Technology Law Review
The United States spends nearly $1,000 per person annually on drugs—forty percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, intellectual property law plays a crucial and well-documented role in inhibiting access to cheaper, generic medications. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different avenue of exclusivity—trademark law. New studies suggest that pharmaceutical …
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
New Dtca Guidance — Enough To Empower Consumers?, Christopher Robertson
Faculty Scholarship
As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn't mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product's risks as well. Since it's not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a …
Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck
Side Effects: State Anti-Fraud Statutes, Off-Label Marketing, And The Solvable Challenge Of Causation, Isaac D. Buck
Cardozo Law Review
While the American public remains preoccupied with the lurching implementation of the Affordable Care Act, the regulation of pharmaceutical companies for their off-label marketing and promotion of drugs features a regulatory environment within the health industry that seems to be in wild flux. Following the Second Circuit's decision in United States v. Caronia, commentators and providers are unsure about the future of federal regulation in this area, with the FDA seeking to minimize the opinion and pharmaceutical companies celebrating its impact. Much of the understandably spirited reaction to the Caronia case has omitted a discussion of the relevant and …
Re-Tooling Marine Food Supply Resilience In A Climate Change Era: Some Needed Reforms, Robin Kundis Craig
Re-Tooling Marine Food Supply Resilience In A Climate Change Era: Some Needed Reforms, Robin Kundis Craig
Seattle University Law Review
Ocean fisheries and marine aquaculture are an important but often overlooked component of world food security. For example, of the seven billion (and counting) people on the planet, over one billion depend on fish as their primary source of protein, and fish is a primary source of protein (30 percent or more of protein consumed) in many countries around the world, including Japan, Greenland, Taiwan, Indonesia, several countries in Africa, and several South Pacific island nations. Marine fisheries and marine aquaculture have been subject to a number of stressors that can undermine world food security, including overfishing, habitat destruction, and …
Keynote Remarks: Re-Tooling Law And Legal Education For Food System Reform: Food Law And Policy In Practice, Emily M. Broad Leib
Keynote Remarks: Re-Tooling Law And Legal Education For Food System Reform: Food Law And Policy In Practice, Emily M. Broad Leib
Seattle University Law Review
Thank you for the opportunity to be with you today and to take part in this symposium on the important role law schools and lawyers can play in changing our food system. Food preferences and food choices are incredibly personal, but the way we produce and consume food, and its impacts on our environment, public health, and the safety of ourselves and others, make it a pressing societal issue as well.
Scuttling Iuu Fishing And Rewarding Sustainable Fishing: Enhancing The Effectiveness Of The Port State Measures Agreement With Trade-Related Measures, Anastasia Telesetsky
Scuttling Iuu Fishing And Rewarding Sustainable Fishing: Enhancing The Effectiveness Of The Port State Measures Agreement With Trade-Related Measures, Anastasia Telesetsky
Seattle University Law Review
Illegal, unreported, and unregulated fishing (IUU fishing) is a substantial threat to global food security and a recurring problem for global fishery managers already facing difficult baseline situations exacerbated by climate change, including warming oceans and increasing acidification. There is nothing historically new about IUU fishing; there have always been poachers who take advantage of operating in the shadows of legal commercial fishing. What is new is the extent to which marine poaching has industrialized. It is estimated that 19% of the worldwide value of marine catches are unlawful. The problem is not limited to developing states. For example, even …
The Dangerous Right To Food Choice, Samuel R. Wiseman
The Dangerous Right To Food Choice, Samuel R. Wiseman
Seattle University Law Review
Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right. The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …
Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns
Pay No Attention To That Man Behind The Curtain: Concealment, Revelation, And The Question Of Food Safety, Denis W. Stearns
Seattle University Law Review
Despite knowledge that commerce in food is a profit-driven enterprise, the public has consistently put great faith in the wholesomeness and safety of the food being purchased. To some extent, such faith is necessary, even if not always justified. In making the decision to put a bite of food in one’s own mouth, or the mouth of a friend or family member, a form of faith or trust must accompany the act of eating. For who would knowingly eat food suspected to be unsafe? But that is precisely what millions of people do every year, with a great many of …
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
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.
Dissecting The Contents Of Law Of Indonesia On Halal Product Assurance, Aal Lukmanul Hakim
Dissecting The Contents Of Law Of Indonesia On Halal Product Assurance, Aal Lukmanul Hakim
Indonesia Law Review
Indonesia with its majority Moslem population and even the biggest Moslem nation in the world has obligations to its citizens to assurance the halal products (halal) for consumption and/or used as a constitutional obligation to be enforceable and applicable. The constitutional obligation is granted in the form of legal certainty covering the halalness of all products either to those useable, consumed and/or utilized by the society. Upon the legalization and enactment of Law of the Republic of Indonesia Number 33 year 2014 regarding Halal Product Assurance is the evidence of constitutionally protection commitment. Having this Halal Product Assurance Law, the …
An Fda For Financial Innovation: Applying The Insurable Interest Doctrine To Twenty-First-Century Financial Markets, Eric A. Posner, E. Glen Weyl
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 …
Regulating Farming: Balancing Food Safety And Environmental Protection In A Cooperative Governance Regime, Margot J. Pollans
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 …
A Practitioner's Guide To Defending "Natural" Food Labeling Litigation, Lauren E. Handel
A Practitioner's Guide To Defending "Natural" Food Labeling Litigation, Lauren E. Handel
Kentucky Journal of Equine, Agriculture, & Natural Resources Law
No abstract provided.
"Pay-For-Delay" Settlements Post-Actavis: Why Mediation Can Tackle The "Unreasonable" Antitrust Settlements, Sheena Ching
"Pay-For-Delay" Settlements Post-Actavis: Why Mediation Can Tackle The "Unreasonable" Antitrust Settlements, Sheena Ching
Cardozo Journal of Conflict Resolution
This Note discusses the benefits that mediation can have on the reverse payment settlement and antitrust debate, and how it can satisfy the "rule of reason" requirement post-Actavis. Accordingly, Section II discusses the legislative history and policy of the Hatch-Waxman Act. It elaborates on the pioneer drug development process and how the combination of legislation and the inherent nature of drug development resulted in "pay-for-delay" settlements. Section III discusses majority and dissenting opinions in the landmark Supreme Court case FTC v. Actavis as well as the circuit split decisions that led up to the Court's ultimate ruling and …
Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin
Who's Swallowing The "Bitter Pill"?: Reforming Write-Offs In The State Of Washington, Lauren M. Martin
Seattle University Law Review
Washington’s application of the collateral source rule permits recovery for medical expenses that were never incurred and have no relationship to their market value. This application is set forth in Hayes v. Wieber Enterprises, Inc., where the plaintiff sued a restaurant for injuries she sustained from falling down the restaurant’s basement stairs. Why should the collateral source rule compel the defendant in Hayes to pay the original amount billed, $5,800, when the physician accepted $3,300 as payment in full? Is not $3,300 the reasonable or market value of the medical services provided to the plaintiff? This Comment discusses whether Washington …
The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley
The Jurisprudence Of Nature: The Importance Of Defining What Is "Natural", Jill M. Fraley
Catholic University Law Review
Informal regulations defining nature, natural, and organic have proliferated across diverse fields of law from patents to agriculture, from taxation to gemstones. The unwritten jurisprudence of defining nature is primarily a story of the struggle to isolate mankind’s manipulations and interventions, creating a man-nature dichotomy that frustrates more than it explicates. This failure to define nature continues with the Supreme Court’s recent Myriad decision, which struggles to define the law of nature exception to patentability, highlighting the challenge of measuring levels of human intervention and manipulation. Our dichotomous definitions do not generate neat, binary answers, but rather complicated scales of …
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Seattle University Law Review
Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …
A Proposed Reconciliation Of Stakeholder Interests In The Ge Soybean Industry And Role Of Earth Jurisprudence Principles, Kristen N. King Jaiven
A Proposed Reconciliation Of Stakeholder Interests In The Ge Soybean Industry And Role Of Earth Jurisprudence Principles, Kristen N. King Jaiven
Florida A & M University Law Review
The historical art of seed saving ensured farmers would have enough quality seeds for the following season. Traditional and indigenous farmers mastered seed saving techniques, saving the healthiest and strongest seeds to ensure preservation of seed diversity and adequate crop yields. To provide adequate protection and meet maximum sustainability for all interested parties, it is essential that laws governing the soybean industry consider the soybean as a stakeholder.
The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan
The Prohibition Of Moonshine: A Consumer Protection Analysis Of Raw Milk In Interstate Commerce, Whitney R. Morgan
West Virginia Law Review
No abstract provided.
Health And Welfare Preempted: How National Meat Association V. Harris Undermines Federalism, Food Safety, And Animal Protection, Marya Torrez
Journal of Food Law & Policy
In 2008, the Humane Society of the United States (HSUS) released an undercover video filmed at the Hallmark Meat Packing Company and Westland Meat Company (Hallmark/Westland) in Chino, California. "The footage depicted nonambulatory cows being kicked, dragged, electrocuted, jammed with forklifts and sprayed in the nostrils with water to simulate drowning - in an effort to get them to stand up and walk to their slaughter." At least five inspectors from the U.S. Department of Agriculture (USDA) - the federal agency tasked with ensuring that food safety and animal welfare guidelines are followed - were present at the time. The …
Depicting The Graphic Truth: The Heated Controversy Over Cigarette Warning Labels And The Boundaries Of First Amendment Protection, Brian Fedele
Cardozo Public Law, Policy & Ethics Journal
No abstract provided.
Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann
Dietary Supplement Labeling: Cognitive Biases, Market Manipulation & Consumer Choice, Michael Mccann
Law Faculty Scholarship
There exists increasing concern that the Dietary Supplements Health and Education Act (DSHEA) has proven ineffective. Much of the concern regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Namely, while pharmaceutical drugs must undergo years of costly pre-market testing, most supplements, like foods, can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration (FDA) remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as supplements tend to be most perceived for their apparent medicinal qualities. This philosophy of waiting for a …
Greenwashing And Self-Declared Seafood Ecolabels, Jason J. Czarnezki
Greenwashing And Self-Declared Seafood Ecolabels, Jason J. Czarnezki
Elisabeth Haub School of Law Faculty Publications
The credibility and veracity of an environmental claim depends on a high degree of transparency, clarity, and trust. Businesses that utilize ecolabels to market the environmental performance of their seafood products often turn to third-party certifications to minimize the potential for greenwashing and provide a level of verification and independence. Others rely on a riskier approach by developing their own self-declared or first-party ecolabels. Seafood retailers and suppliers considering the creation and use of an ecolabel, certification, or seal to be used in the marketing of seafood products should ensure compliance with applicable Food and Drug Administration and United States …