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Articles 331 - 360 of 413
Full-Text Articles in Food and Drug Law
Teva V. Eisai: What's The Real Controversy, Grace Wang
Teva V. Eisai: What's The Real Controversy, Grace Wang
Michigan Telecommunications & Technology Law Review
This Note examines the changing role of declaratory judgment actions in challenging patents upon generic entry and evaluates alternative regulatory schemes to the FDA's current system of patent enforcement in the drug approval setting. Part I reviews the Federal Circuit's recent decisions regarding generic drug entry, focusing on how the courts justify declaratory judgments in the current system and when a "controversy" exists to create Article III jurisdiction. Part II examines the complex system of regulating generic drug entry and how attempts to stop the exploitation of loopholes have resulted in a patchwork of regulation by various parties. It challenges …
Food-Borne Ultimatum: Proposing Federal Legislation To Create Humane Living Conditions For Animals Raised For Food In Order To Improve Human Health, The, Lynn M. Boris
Journal of Law and Health
In order to reduce the large number of human health risks associated with reckless farming practices, Congress must enact federal legislation that requires humane living conditions for farm animals and declares a moratorium on the routine use of unnecessary antibiotics. Part II of this Note will briefly review traditional farming and animal husbandry practices and examine the shift to the modern practices used by producers of animal products today. Part II will also present several farming practices utilized today that are particularly dangerous to human health. Part III of this Note will explore the immense human suffering that is occurring …
Did The Mlbpa Strike Out? An Analysis Of Union Liability In Major League Baseball's Anonymous 2003 Steroid Testing, David Adelsberg
Did The Mlbpa Strike Out? An Analysis Of Union Liability In Major League Baseball's Anonymous 2003 Steroid Testing, David Adelsberg
Cardozo Arts & Entertainment Law Journal
No abstract provided.
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.
The Quest To End Hunger In Our Time: Can Political Will Catch Up With Our Core Values?, David P. Lambert
The Quest To End Hunger In Our Time: Can Political Will Catch Up With Our Core Values?, David P. Lambert
Journal of Food Law & Policy
David Lambert a nationall recognized advocate to end hunger speaks about his work and the impact it has had on Arkansas, the USA and the world.
A Bittersweet Deal For Consumers: The Unnatural Application Of Preemption To High Fructose Corn Syrup Labeling Claims, Josh Ashley
A Bittersweet Deal For Consumers: The Unnatural Application Of Preemption To High Fructose Corn Syrup Labeling Claims, Josh Ashley
Journal of Food Law & Policy
The recent rise of consumer consciousness regarding the health qualities of foods and beverages has become something akin to common knowledge. Reflecting this rise, studies reveal that labels regarding the health qualities of a food are more likely to increase sales. And among the health labels consumers prefer, labels describing the product as natural top the list. One website reports that according to a recent study, 31.3-percent of respondents thought that "100% natural" was the best description to read on a label, compared with only 14.2-percent who thought that "100% organic" was the best description. "All natural ingredients" was the …
United States Food Law Update: Health Care Reform, Preemption, Labeling Claims And Unpaid Interns: The Latest Battles In Food Law, A. Bryan Endres, Nicholas R. Johnson, Michaela N. Tarr
United States Food Law Update: Health Care Reform, Preemption, Labeling Claims And Unpaid Interns: The Latest Battles In Food Law, A. Bryan Endres, Nicholas R. Johnson, Michaela N. Tarr
Journal of Food Law & Policy
This edition of the Food Law Update explores four legal issues arising in the first half of 2010 reflective of the diverse nature of the food law specialist. As the national debate surrounding the merits of health care reform dominated the legislative agenda, this article first will discuss the food labeling rules embedded within section 4205 of the Patient Protection and Affordable Care Act of 2010. The authors then analyze the preemptive reach of the Federal Food, Drug, and Cosmetic Act and the Meat Inspection Act with respect to three separate California statutes regarding animal welfare standards, retail labels on …
Produce Exceptionalism: Examining The Leafy Greens Marketing Agreement And Its Ability To Improve Food Safety, Varun Shekhar
Produce Exceptionalism: Examining The Leafy Greens Marketing Agreement And Its Ability To Improve Food Safety, Varun Shekhar
Journal of Food Law & Policy
Isolated food safety crises are not uncommon occurrences in the United States. Indeed, the history of public scares indicates a pattern of deficiencies in the safety of the American food supply. In the early 20th century, the public learned of the squalid conditions of meatpacking facilities through muckraking publications such as Upton Sinclair's The Jungle. In the 1980s, a 60 Minutes report documented research finding carcinogenic properties of a widespread pesticide, traces of which were commonly found in apple-based products. In the 1990s, widespread media reports of beef tainted with E. coli led to both product recalls unprecedented in scope …
Reconsidering Federalism And The Farm: Toward Including Local, State And Regional Voices In America's Food System, Margaret Sova Mccabe
Reconsidering Federalism And The Farm: Toward Including Local, State And Regional Voices In America's Food System, Margaret Sova Mccabe
Journal of Food Law & Policy
Why is the relationship between our food system and federalism important to American law and health? It is important simply because federal law controls the American food system. This essay considers how federal law came to structure our food system, and suggests that though food is an essential part of our national economy, the dominating role of the federal government alienates citizens from their food system. It does so by characterizing food as a primarily economic issue, rather than one that has ethical, health, and cultural components. However, state and local governments have much to offer in terms of broadening …
Splitting Scales: Conflicting National And Regional Attempts To Manage Commercial Aquaculture In The Exclusive Economic Zone, Brandee Ketchum
Splitting Scales: Conflicting National And Regional Attempts To Manage Commercial Aquaculture In The Exclusive Economic Zone, Brandee Ketchum
Journal of Food Law & Policy
Like other environmental resources subject to public use, various interest groups struggle over joint management of scarce fisheries resources. Further, differing goals for resource management, such as financial goals versus conservation goals, frequently pit regional groups against one another. In some cases, regional interests may conflict with overall national interests. As goes the water and the air, so go the fish.
Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza
Are You Covered? The Need For Improvement In Insurance Coverage For Autism Spectrum Disorder, 44 J. Marshall L. Rev. 291 (2010), Marissa Mazza
UIC Law Review
No abstract provided.
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
It Is Time: Why The Fda Should Start Disclosing Drug Trial Data, Mustafa Ünlü
Michigan Telecommunications & Technology Law Review
Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping …
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Misplaced Fears In The Legislative Battle Over Affordable Biotech Drugs, David E. Adelman, Christopher M. Holman
Faculty Works
Much like tort reform, the debate over recently enacted legislation on biotech drugs — and particularly regulatory supplements to patent protection — has taken on a significance that dwarfs its impact on prescription drug expenditures. Under the Health Care Reform legislation, Congress enacted two major reforms: First, creation of an abbreviated Food and Drug Administration (FDA) approval process for follow-on biologics (FOBs), which are the analogues of generics for biotech drugs. Second, establishment of a twelve-year “data exclusivity” period in which clinical testing data collected by brand-name innovators cannot be used by producers of FOBs to satisfy FDA testing requirements. …
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 developments in Canadian food law and policy in 2009. This update primarily analyzes 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. In 2009, regulatory and policy developments continue to be dominated by the 2008 Listeriosis outbreak in ready-to-eat, deli meats. Other noted activities include Canada's ongoing efforts to minimize the effects of infectious diseases related to meat production, Canada's request for a WTO panel to consider the effects of American Country of Origin Labelling, and an initiative …
European Union Food Law Update, Emilie H. Leibovitch
European Union Food Law Update, Emilie H. Leibovitch
Journal of Food Law & Policy
In June 2009, citizens of the European Union elected a new European Parliament. Some Members of the European Parliament (MEPs) were reelected while some were not. The majority party is the EPP, the Group of the European People's Party, and the Group of the Progressive Alliance of Socialists & Democrats has the second majority of the seats. The elections were still governed by the Treaty of Nice, since up until very recently, the future of the Treaty of Lisbon was still uncertain. The Treaty of Lisbon was up until now rejected by a few Member States, who, by their reluctance …
United States Food Law Update: Food Allergy Labels, Reaching Organic Equivalence, Misbranding Litigation And Regulatory Takings, A. Bryan Endres, Michaela N. Tarr
United States Food Law Update: Food Allergy Labels, Reaching Organic Equivalence, Misbranding Litigation And Regulatory Takings, A. Bryan Endres, Michaela N. Tarr
Journal of Food Law & Policy
The start of 2009 found the nation transitioning to a new presidential administration, speculating on the impact new appointees to the executive branch may have on regulatory priorities and monitoring a bill' making its way through Congress that seeks a substantial overhaul of the food regulatory system. This version of the Food Law Update will analyze two major developments in food allergy labeling: finalization of rules requiring the labeling of Cochineal extract/ carmine and an analysis of the proposed "gluten-free" product labels. The update next discusses the execution of an equivalency agreement between the United States and Canada with respect …
Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier
Unsettling Drug Patent Settlements: A Framework For Presumptive Illegality, Michael A. Carrier
Michigan Law Review
A tidal wave of high drug prices has recently crashed across the U.S. economy. One of the primary culprits has been the increase in agreements by which brand-name drug manufacturers and generic firms have settled patent litigation. The framework for such agreements has been the Hatch-Waxman Act, which Congress enacted in 1984. One of the Act's goals was to provide incentives for generics to challenge brand-name patents. But brand firms have recently paid generics millions of dollars to drop their lawsuits and refrain from entering the market. These reverse-payment settlements threaten significant harm. Courts nonetheless have recently blessed them, explaining …
Publicity, Pressure, And Environmental Legislation: The Untold Story Of Availability Campaigns, Molly J. Walker Wilson, Megan P. Fuchs
Publicity, Pressure, And Environmental Legislation: The Untold Story Of Availability Campaigns, Molly J. Walker Wilson, Megan P. Fuchs
Cardozo Law Review
The availability heuristic - a cognitive rule of thumb whereby events that are easily brought to mind are judged to be more likely - is employed by decision-makers on a daily basis. Availability campaigns occur when individuals and groups strategically exploit this cognitive tendency in order to generate publicity for a particular issue, creating pressure to effect legislative change. This paper is the first to argue that environmental availability campaigns are more beneficial than they are harmful. Because they result in pressure on Congress, these campaigns serve as a catalyst for the enactment of critical new legislative initiatives. Specifically, these …
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Does Misery Love Company - Evidence From Pharmaceutical Markets Before And After The Orphan Drug Act, Frank R. Lichtenberg, Joel Waldfogel
Michigan Telecommunications & Technology Law Review
The possibility that small populations would see few medications developed for their conditions has [...] led the U.S. Congress to pass the 1983 Orphan Drug Act ("ODA"), giving firms special incentives to develop drugs for diseases afflicting fewer than 200,000 persons per year.[...][U]under the Act, drug makers receive seven years of exclusive marketing upon FDA approval of newly-developed drugs qualifying as "orphan drugs"--i.e., drugs for disorders affecting fewer than 200,000 persons.[...]Together, [the] provisions (a) increase the effective market size; and (b) reduce fixed (sunk) costs. In doing so, the Act provides a natural experiment for measuring the impact of increased …
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Pdufa And Initial U.S. Drug Launches, Mary K. Olson
Michigan Telecommunications & Technology Law Review
In the 1970s and 1980s, many pharmaceutical firms launched new drugs abroad prior to gaining U.S. approval. Consequently, U.S. patients often faced delays in accessing important new medicines. High regulatory barriers to entry, such as a stringent regulation and a lengthy drug review process, contributed to this problem. This Article examines the impact of the Prescription Drug User Fee Act (PDUFA), and subsequent increases in the speed of FDA review, on the likelihood of initial U.S. drug launches. These factors are hypothesized to lower regulatory barriers to entry in the U.S. pharmaceutical market. The results show that increased drug review …
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Why Fdca Section 505(U) Should Not Concern Us Greatly, Kyle Faget
Michigan Telecommunications & Technology Law Review
Among the many amendments found in the Food and Drug Administration Amendment Act of 2007 (FDAAA) is a provision at the end of the act, Section 505(u), which grants chiral switches five years of market exclusivity under certain circumstances. Prior to Congressional enactment of the FDAAA, the Food and Drug Administration (FDA) refused to award new chemical entity (NCE) status to enantiomers of previously approved racemic mixtures. The FDA defines a new chemical entity ("NCE") as a drug that contains no active moiety that has been approved by the FDA in any other application submitted under Section 505(b) of the …
When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller
When And How To Defer To The Fda: Learning From Michigan's Regulatory Compliance Defense, Jason C. Miller
Michigan Telecommunications & Technology Law Review
Michigan's regulatory compliance defense properly recognizes that an FDA-approved drug carrying an FDA-approved label should not be considered defective. However, the statute's absolute immunity provides no compensation for injured parties in any circumstance, including situations where the FDA process has failed. Nevertheless, it is possible to treat the FDA's approval as significant without eliminating the possibility of all state actions against drug makers by providing a litigation back-up through state attorneys general ("AGs"). This Note examines the question of FDA approval in state tort actions in Part I, discusses Michigan's answer to that question in Part II, and offers a …
Eatin' Good? Not In This Neighborhood: A Legal Analysis Of Disparities In Food Availability And Quality At Chain Supermarkets In Poverty-Stricken Areas, Nareissa Smith
Michigan Journal of Race and Law
Many Americans-especially the poor-face severe hurdles in their attempts to secure the most basic of human needs-food. One reason for this struggle is the tendency of chain supermarkets to provide a limited selection of goods and a lower quality of goods to patrons in less affluent neighborhoods. Healthier items such as soy milks, fresh fish, and lean meats are not present in these stores, and the produce that is present is typically well past the peak of freshness. Yet, if the same patron were to go to another supermarket owned by the same chain--but located in a wealthier neighborhood-she would …
The Role Of Litigation In Combating Obesity Among Poor Urban Minority Youth: A Critical Analysis Of Pelman V. Mcdonald's Corp., Ashley B. Antler
The Role Of Litigation In Combating Obesity Among Poor Urban Minority Youth: A Critical Analysis Of Pelman V. Mcdonald's Corp., Ashley B. Antler
Cardozo Journal of Equal Rights & Social Justice
The note argues that litigation, particularly when focused on low-income urban minority youth, could serve as a strategic tool to address childhood obesity by reframing the issue and catalyzing policy and industry change. It critiques the Pelman v. McDonald's Corp. lawsuit for failing to address the socioeconomic and racial disparities underlying obesity rates, thereby missing an opportunity to advance meaningful solutions. The analysis suggests that public health litigation, when strategically framed, can complement broader advocacy efforts and push for environmental changes to combat the obesity epidemic.
Crises, Congress, And Cognitive Biases: A Critical Examination Of Food And Drug Legislation In The United States, Sharon B. Jacobs
Crises, Congress, And Cognitive Biases: A Critical Examination Of Food And Drug Legislation In The United States, Sharon B. Jacobs
Publications
No abstract provided.
Steroid Regulation In Professional Sports: Sarbanes-Oxley As A Guide, Sarah R. Heisler
Steroid Regulation In Professional Sports: Sarbanes-Oxley As A Guide, Sarah R. Heisler
Cardozo Arts & Entertainment Law Journal
No abstract provided.
The Sentencing Commission Takes On Crack, Again, David Yellen
The Sentencing Commission Takes On Crack, Again, David Yellen
Articles
We may be entering a new era of drug sentencing policy. For the first time, an effort by the United States Sentencing Commission to reduce the disparity in treatment between crack and powder cocaine offenders by somewhat reducing crack sentences has succeeded. Decisions of the United States Supreme Court, culminating most recently in Kimbrough v. United States and Gall v. United States, have clarified and expanded the flexibility federal judges have in sentencing under the post- United States v. Booker advisory sentencing guidelines. Political leaders have begun to accept the need for relaxation of at least some of the …
There Ain't No Such Thing As A Free Lunch: A Look At State Gift Disclosure Laws And The Effect On Pharmaceutical Company Marketing, 41 J. Marshall L. Rev. 563 (2008), Scott Velasquez
UIC Law Review
No abstract provided.
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
The Moral Hazard Problem With Privatization Of Public Enforcement: The Case Of Pharmaceutical Fraud, Dayna Bowen Matthew
University of Michigan Journal of Law Reform
This Article takes a law and economics approach to exploring some of the costs that arise when governments rely on private enforcement to accomplish the goals of public law. The analysis focuses on qui tam enforcement under the Civil False Claims Act, because a remarkable body of empirical data demonstrates the expansive role private qui tam relators are playing in enforcing Medicare and Medicaid fraud and abuse laws. The Article further focuses on the application of these laws to the pharmaceutical industry. This focus is enlightening because the Government, as well as private enforcers, have recently targeted this industry so …