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Articles 241 - 270 of 310
Full-Text Articles in Food and Drug Law
Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole E. Negowetti
Opening The Barnyard Door: Transparency And The Resurgence Of Ag-Gag & Veggie Libel Laws, Nicole E. Negowetti
Seattle University Law Review
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 …
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 …
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 …
Ag Gag Past, Present, And Future, Justin F. Marceau
Ag Gag Past, Present, And Future, Justin F. Marceau
Seattle University Law Review
While the animal rights and food justice movements are relatively young, their political unpopularity has generated a steady onslaught of legislation designed to curtail their effectiveness. At each stage of their nascent development, these movements have confronted a new wave of criminal or civil sanctions carefully tailored to combat the previous successes the movements had achieved.
From The Lab To The Supermarket: In Vitro Meat As A Viable Alternative To Traditional Meat Production, Trae Norton
From The Lab To The Supermarket: In Vitro Meat As A Viable Alternative To Traditional Meat Production, Trae Norton
Journal of Food Law & Policy
In 1932, Winston Churchill predicted that 50 years in the future "we shall escape the absurdity of growing a whole chicken in order to eat the breast or wing by growing these parts separately under a suitable medium." Although Churchill's prediction is about 30 years off, in August of 2013, the first ever meat patty grown in vitro was consumed in London, England. With this historic scientific achievement, many are predicting that in vitro meat will be a viable solution to the problems associated with industrial meat production, such as animal cruelty, inefficient natural resource consumption, and pollution. Analysts predict …
Patent Punting: How Fda And Antitrust Courts Undermine The Hatch-Waxman Act To Avoid Dealing With Patents, Rebecca S. Eisenberg, Daniel A. Crane
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 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.
"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 …
International Trade - Possible Undermining Of U.S. Pesticide And Food Safety Laws By The Draft Text Of The Uruguay Round Of Gatt Negotiations, Beth Sanders
Georgia Journal of International & Comparative Law
No abstract provided.
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Pay-For-Delay Settlements In The Wake Of Actavis, Michael L. Fialkoff
Michigan Telecommunications & Technology Law Review
“Pay-for-delay” settlements, also known as reverse payments, arise when a generic manufacturer pursues FDA approval of a generic version of a brand-name drug. If a patent protects the brand-name drug, the generic manufacturer has the option of contesting the validity of the patent or arguing that its product does not infringe the patent covering the brand-name drug. If the generic manufacturer prevails on either of these claims, the FDA will approve its generic version for sale. Approval of a generic version of a brand-name drug reduces the profitability of the brand-name drug by forcing the brand-name manufacturer to price its …
Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe
Trademarks, Gis, And Commercial Aspects Of Wine Distribution Agreements, Sarah A. Hinchliffe
Journal of Food Law & Policy
The marketing of goods under geographical names has always been common. In addition to introducing commercial facets of wine distribution agreements, this article discusses the justifications, principles and, policies that lie behind the protection of geographical indications (GIs) for wine on an international level as well as in the Old World and, to a lesser degree, in the New World. The scope and shape of the GI system will then be scrutinized in light of its own justifications and in the light of its impact on international trade, intellectual property, and agricultural policy.
Bad Medicine: Ftc V. Actavis, Inc. And The Missed Opportunity To Resolve The Pay-For-Delay Problem, Susan Schipper
Bad Medicine: Ftc V. Actavis, Inc. And The Missed Opportunity To Resolve The Pay-For-Delay Problem, Susan Schipper
Maryland Law Review
No abstract provided.
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Actavis, The Reverse Payment Fallacy, And The Continuing Need For Regulatory Solutions, Daniel A. Crane
Articles
The Actavis decision punted more than it decided. Although narrowing the range of possible outcomes by rejecting the legal rules at the extremes and opting for a rule of reason middle ground, the opinion failed to grapple with the most challenging issues of regulatory policy raised by pharmaceutical patent settlements. In particular, it failed to clearly delineate the social costs of permitting and disallowing patent settlements, avoided grappling with the crucial issues of patent validity and infringement, and erroneously focused on “reverse payments” as a distinctive antitrust problem when equally or more anticompetitive settlements can be crafted without reverse payments. …
Rebalancing Pay-For-Delay: Why No-Authorized Generic Agreements Should Be Subject To Higher Antitrust Scrutiny, David C. Kurlander
Rebalancing Pay-For-Delay: Why No-Authorized Generic Agreements Should Be Subject To Higher Antitrust Scrutiny, David C. Kurlander
Cardozo Arts & Entertainment Law Journal
No abstract provided.
The Forgotten Half Of Food System Reform: Using Food And Agricultural Law To Foster Healthy Food Production, Emily Broad Leib
The Forgotten Half Of Food System Reform: Using Food And Agricultural Law To Foster Healthy Food Production, Emily Broad Leib
Journal of Food Law & Policy
America is facing widespread problems with its food system, including environmental harms due to externalities from industrial farms; the increasing amount of "food _miles" traveled by the products that make up our daily meals; and the growing size and complexity of recent outbreaks of foodborne illnesses. Indeed, the entire system that covers the life cycle of food, through production, processing, distribution, consumption, and food waste management, is in crisis. One of the most disturbing of these well-documented problems with the industrial food system is the increase in rates of obesity and diet-related illnesses. Obesity rates in the U.S. have more …
United States Food Law Update: Shrouded By Election-Year Politics, State Initiatives And Private Lawsuits Fill In The Gaps Created By Congressional And Agency Ossification, A. Bryan Endres, Lisa R. Schlessinger, Rachel Armstrong
United States Food Law Update: Shrouded By Election-Year Politics, State Initiatives And Private Lawsuits Fill In The Gaps Created By Congressional And Agency Ossification, A. Bryan Endres, Lisa R. Schlessinger, Rachel Armstrong
Journal of Food Law & Policy
Observers of food law in the 2012 presidential election year witnessed a dramatic slowing of federal initiatives-perhaps arising from a desire by both Congress and the administration to avoid upsetting critical constituent groups during a year seemingly dominated by campaigns and endless talking points. For example, Congress failed to take action on a unique compromise between what some had considered mortal enemies-the Humane Society of the United States and United Egg Producers-that would implement a federal animal welfare standard for laying hens in return for abandoning ballot measures in various states. Similarly, the FDA waited until the early days of …
In Re K-Dur Antitrust Litigation: The Third Circuit's Controversial Pay-For-Delay Antitrust Decision Splits With Other Circuit Courts, Carl W. Hittinger, Lesli C. Esposito
In Re K-Dur Antitrust Litigation: The Third Circuit's Controversial Pay-For-Delay Antitrust Decision Splits With Other Circuit Courts, Carl W. Hittinger, Lesli C. Esposito
Villanova Law Review (1956 - )
No abstract provided.
Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes
Front-Of-Package Nutrition Claims: Trustworthy Facts Or Deceptive Marketing? Closing The Loopholes In Labeling, Kathryn E. Hayes
Cardozo Journal of Equal Rights & Social Justice
The note argues that front-of-package (FOP) labeling on children's food products is insufficient and often misleading, failing to meet basic nutritional standards. It advocates for the adoption of uniform, science-based labeling standards developed by an objective body like the Institute of Medicine (IOM) to help parents make healthier choices. The analysis highlights the limitations of self-regulation by manufacturers and the need for stronger governmental oversight to address deceptive practices and improve public health outcomes.
Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo
Pay-To-Play: The Impact Of Group Purchasing Organizations On Drug Shortages, Christian Deroo
American University Business Law Review
No abstract provided.
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
A New Prescription To Balance Secrecy And Disclosure In Drug-Approval Processes, Gerrit M. Beckhaus
University of Michigan Journal of Law Reform
To obtain approval to market a drug, a manufacturer must disclose significant amounts of research data to the government agency that oversees the approval process. The data often include information that could help advance scientific progress, and are therefore of great value. But current laws in both the United States and Europe give secrecy great weight. This Article proposes an obligatory sealed-bid auction of the sensitive information based on the experience with similar auctions in mergers and acquisitions, to balance manufacturers' interest in secrecy and the public interest in disclosure.
Cornography: Perverse Incentives And The United States Corn Subsidy, Anthony Kammer
Cornography: Perverse Incentives And The United States Corn Subsidy, Anthony Kammer
Journal of Food Law & Policy
Among the most important functions we have afforded to the U.S. Congress is the power to reshape social and economic incentive structures through legislation. Proceeding from the enumerated powers under the Constitution and using a complex toolbox of legislative and regulatory innovations, the federal legislature has enormous power to transform the types of behavior that people will perceive as self-interested throughout our economy and thus how those same people are likely to act. Congress can, among other things, create new forms of criminal and civil liability, establish entitlement systems, subsidize industries, encourage behavior through the tax code, regulate interactions among …
Put A Cork In It: The Use Of H.R. 161 To End Direct Wine Shipping Throughout The States Once And For All, Victoria H. Jones
Put A Cork In It: The Use Of H.R. 161 To End Direct Wine Shipping Throughout The States Once And For All, Victoria H. Jones
Journal of Food Law & Policy
Due to Congress' recent agenda, oenophiles throughout the country are up in arms about the possible threat to their beloved wine. Wine lovers and other alcohol enthusiasts face the very real fear that access to their favorite products may soon be heavily restricted. This is in large part attributed to the fact that House Resolution 1161 would effectively change the ways in which states regulate alcohol shipment. The possible implications of this bill range from the forced shutdown of many wineries and distilleries due to lack of funding, to the smaller effects of regulation such as the inability of customers …
European Union Food Law Update, Emilie Majster
European Union Food Law Update, Emilie Majster
Journal of Food Law & Policy
Nutrition is increasingly important in both the European Union (EU) and in global food-related policy making. Governments, which up until recently have focused on regulating food products based on a food safety perspective, are now turning to regulate from a nutritional aspect.
Canadian Food Law Update, Patricia L. Farnese
Canadian Food Law Update, Patricia L. Farnese
Journal of Food Law & Policy
Provided below is an overview of the developments in Canadian food law and policy in 2011. This update considers the regulatory and policy developments and litigation activities by the federal government. This focus reflects the significance of federal activities in the food policy realm.
United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson
United States Food Law Update: Moving Toward A More Balanced Food Regulatory Regime, A. Bryan Endres, Nicholas R. Johnson
Journal of Food Law & Policy
For decades, the federal government has played a significant role in promoting healthy eating. In the early 1900s, the United States Department of Agriculture (USDA) promoted a foundational diet of milk, proteins, fruits and vegetables, and grains. Most Americans are at least somewhat familiar, although perhaps confused, with the more nuanced healthy eating recommendations contained in the food pyramid - first employed in 1992. And virtually every American has experienced the federally supported school lunch program. In the first half of 2011, these two iconic programs underwent significant change as part of a stepped-up effort to improve the health of …
The Tragedy Of The Horse, American Icon, Tim Opitz
The Tragedy Of The Horse, American Icon, Tim Opitz
Journal of Food Law & Policy
Whether a prohibition on slaughter improves the welfare of the American horse population is the focus of this article. At the time it was written, winter of 2010-2011, a confluence of Federal and State legislative action had ended domestic slaughter. These actions are detailed in the body of this article. Since 2007, the legal status of horse slaughter remained static. Just as Sir Isaac Newton's first law of motion explained, an object at rest tends to stay at rest. Legislative inertia is the perspective from which this article was originally written. However, Newton's first law also stated that the object …
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Pharmaceutical Patent Litigation Settlements: Balancing Patent & Antitrust Policy Through Institutional Choice, Timothy A. Cook
Michigan Telecommunications & Technology Law Review
Should a branded pharmaceutical company be allowed to pay a generic competitor to stay out of the market for a drug? Antitrust policy implies that such a deal should be prohibited, but the answer becomes less clear when the transaction is packaged as a patent-litigation settlement. Since Congress passed the Hatch-Waxman Act, which encourages generic manufacturers to challenge pharmaceutical patent validity, settlements of this kind have been on the rise. Congress, the Department of Justice, and the Federal Trade Commission have condemned these agreements as anticompetitive and costly to American consumers, but none of these bodies has been able to …
Provigil: A Commentary, Daniel A. Crane
Provigil: A Commentary, Daniel A. Crane
Articles
Michael Carrier's case study on Provigil' offers new support for the view that Big Pharma is to blame for stymieing competition, retarding innovation, and inflating prices in the drug industry. Carrier argues that Cephalon was able to thwart generic entry by a combination of anticompetitive strategies. It entered into a reverse payment settlement agreement with generics seeking to enter the market. These settlements purported to allow generic entry before the expiration of the patent period, but, according to Carrier, the promise of early entry was negated by the second prong of Cephalon's anticompetitive strategy. During the time that it had …
Cheaters Shouldn't Prosper And Consumers Shouldn't Suffer: The Need For Government Enforcement Against Economic Adulteration Of 100% Pomegranate Juice And Other Imported Food Products, Michael T. Roberts
Journal of Food Law & Policy
In the modern global food system - marked by the trade flow of a variety of food products and ingredients from multiple locations in the world - economically motivated adulteration has emerged as a growing menace that threatens the health and wellbeing of consumers, the economic livelihoods of honest purveyors of food in the global marketplace, and the integrity and viability of national food regulatory systems. Economic adulteration is a form of cheating that includes the padding, diluting, and substituting of food product. Although this cheating is rooted in past food systems, the new paradigm for economic adulteration - a …
European Union Food Law Update, Emilie H. Leibovitch
European Union Food Law Update, Emilie H. Leibovitch
Journal of Food Law & Policy
This EU Food Law Update will focus on the recent developments in the areas of genetically modified organisms, novel foods, feed safety, transmissible spongiform encephalopathy, salmonella and food borne diseases, food additives, organic farming, food contact materials, and labeling.