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Food and Drug Law Commons

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Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman 2018 Washington and Lee University School of Law

Reconciling The Lanham Act And The Fdca: A Comment On Chris Hurley’S Note, Christopher B. Seaman

Washington and Lee Law Review

No abstract provided.


The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly 2018 University of Cincinnati College of Medicine

The Formulary Fix Buries Fritz & Harvey: Drug Promotion Escapes Its Past Constraints, James T. O'Reilly

Washington and Lee Law Review

No abstract provided.


The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg 2018 Brooklyn Law School

The “Deeming Rule”: The Fda’S Destruction Of The Vaping Industry, Lauren H. Greenberg

Brooklyn Law Review

The FDA has recently passed sweeping regulations, which classifies and then regulates electronic cigarettes as “tobacco products” in the same manner as traditional cigarettes. Though the agency reasons that unknowing adults and children may easily turn to e-cigarettes without fully understanding the potential health effects, there is a lack of conclusive evidence in this field to justify such a comprehensive regulatory scheme. Through the far-reaching “Deeming Rule,” e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market. The channels by which the FDA proposes manufacturers and retailers gain permission from ...


Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines 2018 University of Nevada, Las Vegas -- William S. Boyd School of Law

Dying For A Solution: The Regulation Of Medical Devices Falls Short In The 21st Century Cures Act, Marilyn Uzdavines

Nevada Law Journal

No abstract provided.


Delaying Competition: How Sound Public Policy And Rigorous Antitrust Scrutiny Can Be Applied To Controversial Patent Settlements, 17 J. Marshall Rev. Intell. Prop. L. 655 (2018), Sam Hensel 2018 John Marshall Law School

Delaying Competition: How Sound Public Policy And Rigorous Antitrust Scrutiny Can Be Applied To Controversial Patent Settlements, 17 J. Marshall Rev. Intell. Prop. L. 655 (2018), Sam Hensel

The John Marshall Review of Intellectual Property Law

The rising costs of prescription drugs are a growing concern for many Americans. The restraint of trade for pharmaceutical drugs is a cause of rising costs for consumers, as companies seek to push potential competitors out of the market to maintain profits. This unlawful restraint of trade will be discussed in this comment. Specifically, this comment will focus on "Pay for Delay" agreements, mostly between generic versus brand name pharmaceutical manufacturers. The proliferation of these agreements only leads to an unsustainable market that discourages innovation and advancement, and promotes fraud, as invalid patents are used as leverage to prevent generics ...


Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen 2018 University of Michigan Law School

Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen

Articles

In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article ...


Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown 2018 Elisabeth Haub School of Law at Pace University

Beyond Corporate Form: A Response To Dan Depasquale, Surbhi Sarang, And Natalie Bump Vena’S Forging Food Justice Through Cooperatives In New York City, Jonathan Brown

Pace Law Faculty Publications

In their article, Forging Food Justice Through Cooperatives in New York City, Dan DePasquale, Surbhi Sarang, and Natalie Bump Vena (the “Authors”) argue that consumer-owned and worker-owned cooperatives hold promise as a means for advancing policy objectives associated with “food justice,” namely building community wealth and power and providing more affordable access to healthy food in low-income and minority communities. Looking to examples of legislation and policies in other jurisdictions, they advocate for a wide range of policies to promote the viability of cooperatives in New York City, including reforms to cooperative corporation laws and strategies for better allocating funding ...


The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan 2018 Texas A&M University School of Law

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication


Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim 2018 Georgia State University College of Law

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s ...


The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid 2017 University of Miami Law School

The Epipen Problem: Analyzing Unethical Drug Price Increases And The Need For Greater Government Regulation, Talal Rashid

University of Miami Business Law Review

In recent years, some pharmaceutical companies have started increasing the price of their existing drugs to exorbitant levels. Often, these drugs are medically necessary for patients, who are left to take on the high costs of the medicine. One recent example is Mylan, who raised the price of the EpiPen by four hundred percent, solely for the profit of its own company and to the detriment of consumers who rely on the EpiPen. Similar patterns of drug price increases have occurred in the past and will likely happen again in the future. This Comment will seek to identify the common ...


The Constitutionality Of Restrictions On Recreational Cannabis Advertising: Balancing Public Health And Freedom Of Expression, Melanie L. McPhail 2017 The University of Western Ontairo

The Constitutionality Of Restrictions On Recreational Cannabis Advertising: Balancing Public Health And Freedom Of Expression, Melanie L. Mcphail

Electronic Thesis and Dissertation Repository

On April 20, 2016, Health Minister Jane Philpott announced that legislation legalizing recreational marijuana would be introduced in Spring 2017, with the goal of keeping marijuana out of the hands of children and profit out of the hands of criminals. Bill C-45, An Act Respecting Cannabis passed the second reading in the House of Commons, and contains restrictions on advertising cannabis, with a few exceptions. Advertising is recognized as a protected form of expression under the Charter of Rights and Freedoms, so if the government infringes on this right, they must be able to prove that it is justified in ...


Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney II, Katherine E. Legel 2017 Marquette University Law School

Current Navigation Points In Drug Diversion Law: Hidden Rocks In Shallow, Murky, Drug-Infested Waters, John J. Mulrooney Ii, Katherine E. Legel

Marquette Law Review

None


Stopping Illegal Fishing And Seafood Fraudsters: The Presidential Task Force’S Plan On Tackling Iuu Fishing And Seafood Fraud, Thomas Lampert 2017 Boston College Law School

Stopping Illegal Fishing And Seafood Fraudsters: The Presidential Task Force’S Plan On Tackling Iuu Fishing And Seafood Fraud, Thomas Lampert

Boston College Law Review

Worldwide seafood markets have a major problem: too often, the seafood listed on the menu is of a different species than what is served. This phenomenon—known as seafood fraud—and the related practice of illegal, unreported, and unregulated fishing threatens the sustainability of our oceans, poses health risks to consumers, and forces consumers to pay a high price for a cheap product. Previous domestic and international efforts to combat this issue have failed for a number of reasons, including the international nature of the industry, a byzantine supply chain, the large number of entities responsible for combatting the issue ...


Impacts Of The Food Safety Modernization Act On On-Farm Food Safety Practices For Small And Sustainable Produce Growers, Aaron Adalja, Erik Lichtenberg 2017 Cornell University School of Hotel Administration

Impacts Of The Food Safety Modernization Act On On-Farm Food Safety Practices For Small And Sustainable Produce Growers, Aaron Adalja, Erik Lichtenberg

Aaron Adalja

We use data from a national survey of fruit and vegetable growers to examine the current prevalence and cost burden of food safety practices required in the proposed Produce Rule implementing the Food Safety Modernization Act. In particular, we analyze the influence of farm size and farming practices on the probability of adopting food safety measures that would be required by the Produce Rule; and we analyze how the costs of using those food safety practices vary by farm size and farm practices. Majorities of our respondents currently employ most of the food safety practices that would be required under ...


Adoption And Coexistence Of Ge, Conventional Non-Ge, And Organic Crops, Aaron Adalja, Catherine Greene, James Hanson, Robert Ebel, Michael Barron 2017 Cornell University School of Hotel Administration

Adoption And Coexistence Of Ge, Conventional Non-Ge, And Organic Crops, Aaron Adalja, Catherine Greene, James Hanson, Robert Ebel, Michael Barron

Aaron Adalja

The adoption of genetically engineered (GE) crop varieties by U.S. farmers is widespread for major crops—94 percent of planted acres for soybeans, and 88 percent for corn in 2012 (USDA-NASS 2012). The potential exists for GE crop production to impose costs on organic and conventional non-GE production via unintended presence of GE material along the supply chain through: • Contamination of seed stock • Accidental cross-pollination • Accidental co-mingling during planting, harvesting, handling, and storing of crops (Bullock and Desquilbet 2002). Maintaining the integrity of GE-differentiated product markets relies on segregation protocols such as: • Hybrid selection and seed purity testing • Physical ...


Small Sustainability Supply: How Small Business And Lean Manufacturing Can Change Supply Chains, Carlos Lopez 2017 American University Washington College of Law

Small Sustainability Supply: How Small Business And Lean Manufacturing Can Change Supply Chains, Carlos Lopez

Sustainable Development Law & Policy

No abstract provided.


Benefitting From Sustainable Development, Victoria Frappaolo 2017 American University Washington College of Law

Benefitting From Sustainable Development, Victoria Frappaolo

Sustainable Development Law & Policy

No abstract provided.


Batteries Included: Incentivizing Energy Storage, Lindsay Breslau, Michael Croweak, Alan Witt 2017 American University Washington College of Law

Batteries Included: Incentivizing Energy Storage, Lindsay Breslau, Michael Croweak, Alan Witt

Sustainable Development Law & Policy

Distributed Energy Storage (“DES”) technologies that allow households and businesses to store substantial amounts of electricity on site are rapidly advancing and could soon have dramatic impacts on the nation’s electricity generation, transmission, and distribution markets. These technologies could provide numerous benefits, including enhanced energy security, grid stability, and greater support for renewable generation technologies, but several obstacles are slowing their adoption throughout the country. Among these obstacles are stubbornly high manufacturing costs and the potential impacts of DES development on utilities and the traditional energy regulatory framework. Fortunately, policymakers in California, New York, Hawaii, and some other states ...


Appraising The Role Of The Ifc And Its Independent Accountability Mechanism: Community Experiences In Haiti’S Mining Sector, Kate Nancy Taylor 2017 American University Washington College of Law

Appraising The Role Of The Ifc And Its Independent Accountability Mechanism: Community Experiences In Haiti’S Mining Sector, Kate Nancy Taylor

Sustainable Development Law & Policy

No abstract provided.


Green Is Good: How Green Bonds Cultivated Into Wall Street’S Environmental Paradox, Luke Trompeter 2017 American University Washington College of Law

Green Is Good: How Green Bonds Cultivated Into Wall Street’S Environmental Paradox, Luke Trompeter

Sustainable Development Law & Policy

When the European Investment Bank issued the first green bond in 2007, few imagined this debt instrument would attract mainstream investors. Designed to finance projects ranging from climate change prevention to clean transportation development, green bonds were geared for socially responsible investors concerned with our planet’s sustainability. However, by 2015, green bonds were issued by major corporations like Apple and municipalities like New York City at a record $40 billion. Major players on Wall Street have taken notice and look to cash in on the rapidly growing green bond market. With this new influx of investment and the bonds ...


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