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Articles 1 - 26 of 26
Full-Text Articles in Food and Drug Law
The Helicopter State: Misuse Of Parens Patriae Unconstitutionally Precludes Individual And Class Claims, Gabrielle J. Hanna
The Helicopter State: Misuse Of Parens Patriae Unconstitutionally Precludes Individual And Class Claims, Gabrielle J. Hanna
Washington Law Review
The doctrine of parens patriae allows state attorneys general to represent state citizens in aggregate litigation suits that are, in many ways, similar to class actions and mass-tort actions. Its origins, however, reflect a more modest scope. Parens patriae began as a doctrine allowing the British king to protect those without the ability to protect themselves, including wards and mentally disabled individuals. The rapid expansion of parens patriae standing in the United States may be partly to blame for the relative absence of limiting requirements or even well-developed case law governing parens patriae suits. On the one hand, class actions …
Examining Comity And The Exhaustion Doctrine In Tribal Court Civil Jurisdiction: The Cherokee Nation’S Opioid Litigation, Joëlle Klein
Examining Comity And The Exhaustion Doctrine In Tribal Court Civil Jurisdiction: The Cherokee Nation’S Opioid Litigation, Joëlle Klein
Washington Law Review
The opioid epidemic has devastated communities throughout the United States over the last two decades. Native American and Alaska Native tribes faced disproportionate impacts and suffered the long-lasting consequences that opioid addiction causes families and communities. In response, states and municipalities across the United States sued the distributors and pharmacies responsible for illegally diverting opioids. In April of 2017, the Attorney General for the Cherokee Nation, Todd Hembree, initiated a civil suit against opioid pharmaceutical distributors and retailers: CVS, Walgreens, Wal-Mart (pharmacies), and McKesson, Cardinal Health, and AmerisourceBergen (distributors). Although other tribes in the United States also brought claims against …
Commercializing Cannabis: Confronting The Challenges And Uncertainty Of Trademark And Trade Secret Protection For Cannabis-Related Businesses, John Mixon
Washington Journal of Law, Technology & Arts
Over the last couple of decades, society has become more accepting of recreational cannabis and an ever-growing number of states have passed pro-cannabis legislation. With this change, the cannabis industry has, to some extent, exploded into a booming enterprise in states that have legalized marijuana. Nonetheless, cannabis' status as a Schedule I banned substance under the Controlled Substances Act of 1970 remains unchanged. As a result, businesses in the cannabis industry face the unique challenge of having to toe the line between "legally" operating under state law and violating federal law, which trumps state law. One particular situation in which …
Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath
Emergent Regulatory Systems And Their Challenges: The Case Of Combination Medical Products, George Horvath
Washington Law Review
Where regulatory systems overlap, courts and scholars often focus on the undesirable aspects of the overlap—the ways in which systems conflict. One such context involves the regulation of prescription drugs and medical devices by the FDA’s premarket evaluation processes and by state common-law tort and products liability actions. FDA regulation and state common law are often described as separate, conflicting regulatory systems. This Article challenges that description by proposing a model in which FDA premarket evaluation and state common law function as a single regulatory system. This model brings order to the Supreme Court’s seemingly inconsistent medical products preemption cases, …
Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang
Greater Uniformity And Centralization: The Regulatory Development Of Chinese Food And Product Safety Under The Wto, Nga Kit (Christy) Tang
Washington International Law Journal
The WTO Agreements emphasize free trade, which links with diversity, deregulation, and decentralization. China, on the other hand, emphasizes uniformity and centralization, especially regarding the political control and the one-party system of “democratic dictatorship.” China’s joining the WTO, therefore, may be considered as a development that changes the regulatory structure to become more diverse, deregulated, and decentralized. This paper, however, finds the opposite. Under the WTO law, China is encouraged to move towards greater uniformity and centralization with its decentralized and non-uniform settings under the market policy. Moreover, the WTO’s uniform and centralized encouragements can be integrated into the rule-by-man …
The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan
The Surprising Reach Of Fda Regulation Of Cannabis Even After Rescheduling, Sean M. O'Connor, Erika Lietzan
Articles
As more states legalize cannabis, the push to “deschedule” it from the Controlled Substances Act is gaining momentum. At the same time, the Food and Drug Administration (FDA) recently approved the first conventional drug containing a cannabinoid derived from cannabis—cannabidiol (CBD) for two rare seizure disorders. This would all seem to bode well for proponents of full federal legalization of medical cannabis. But some traditional providers are wary of drug companies pulling medical cannabis into the regular small molecule drug development system. The FDA’s focus on precise analytical characterization and on individual active and inactive ingredients may be fundamentally inconsistent …
Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, Rebecca Sweeney
Unrealistic Expectations: The Federal Government's Unachievable Mandate For State Cannabis Regulation, Rebecca Sweeney
Washington Law Review
The states that have legalized cannabis maintain a complicated relationship with the federal government. Since the Ogden Memorandum was issued in 2009, the federal government has left regulation of cannabis to the discretion of the states. That policy has recently shifted. In 2018, former U.S. Attorney General Jeff Sessions issued a new memorandum that rescinded guidance for states about how to structure the legalization of cannabis. The federal government’s current position is now ideologically aligned with that of states like Nebraska and Oklahoma. These states chose not to legalize cannabis and instead adhere to the Controlled Substances Act’s classification of …
“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton
“High” Standards: How The Tide Of Marijuana Legalization Sweeping The Country Ignores The Hidden Risks Of Edibles, Steve Calandrillo, Katelyn Fulton
Articles
As a tide of marijuana legalization sweeps across the United States, there is a surprising lack of scrutiny as to whether the benefits of recreational marijuana outweigh the risks. Notably, marijuana edibles present special risks to the population that are not present in smoked marijuana. States that have legalized recreational marijuana are seeing an increase in edible-related calls to poison control centers and visits to emergency rooms. These negative reactions are especially prevalent in vulnerable populations such as children, persons with underlying preexisting conditions, and out-of-state marijuana novices. Unfortunately, research on edible marijuana is scant and state regulatory regimes are …
Appellations And Adaptations: Geographical Indication, Viticulture, And Climate Change, Raz Barnea
Appellations And Adaptations: Geographical Indication, Viticulture, And Climate Change, Raz Barnea
Washington International Law Journal
Fine wine as we know it is a relatively modern innovation. But French wine culture presents a mythology of a stable and venerable tradition dating back centuries. Central to this mythology is the concept of terroir: the notion that the place—both the land and the people—defines the product. In the early Twentieth Century, France adopted laws giving local producers of wine exclusive rights to name the wine for the region of its origin. These regions, called appellations, have come to stand for the type and quality of wine produced within them—Champagne and Bordeaux are two well-known examples. The appellation regime …
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Robin Jacob
Washington Journal of Law, Technology & Arts
The Future of Innovation in Medicine Conference (“Conference”) proceedings contained in this Symposium Issue are about the problem of incentivizing research into new uses for established medicines. Putting the problem into the wider context of financing pharma research generally gives an important perspective.
The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka
The Patent And Non-Patent Incentives For Research And Development Of New Uses Of Known Pharmaceuticals In Japan, Toshiko Takenaka
Washington Journal of Law, Technology & Arts
Japan is one of most innovative drug manufacturer-friendly countries because it revised its patent and drug regulation systems for providing patent and non-patent incentives for new use and treatment R&D based on its pro-patent and pro-medical science policies. This article provides an overview of the pharmaceutical industry and examines patent and non-patent incentives for drug R&D in focusing on incentives for developing new uses of and treatments for known drugs from a comparative law perspective. After discussing the difficulties in establishing infringement and in obtaining injunctions against generic drug manufacturers who infringe new use product patents, the article reviews measure …
Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann
Infringement Of Swiss-Type Second Medical Use Patent Claims In Germany—Recent Developments In Case Law, Matthias Zigann
Washington Journal of Law, Technology & Arts
Following recent regional court decisions on the infringement of second medical use patent claims, the German concept of manifest arrangement—previously believed to provide a safe harbor for generic pharmaceutical companies as long as they skinny-labeled their products—may be subject to a new interpretation. The German decisions are part of a Europe wide series of decisions on the same or similar subject matter and prove to be patent owner friendly.
Innovation In Known Drugs—The European Angle, Galit Gonen
Innovation In Known Drugs—The European Angle, Galit Gonen
Washington Journal of Law, Technology & Arts
Research into new uses for known drugs should be encouraged because the “repurposing” of known drug molecules can be a highly effective route of innovation for pharmaceutical companies. Investment in the development of these products should be rewarded. However, incentives that are designed to reward innovation must be in line with the size and value of the innovation in order to maintain a sustainable balance between incentivizing research and developing and encouraging a competitive market. In the context of encouraging innovation of new uses for known drugs, factors that facilitate access to drug development and innovation should also be considered …
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon
Future Of Innovation In Medicine: Incentives For New Medical Treatments And Global Health, Anon
Washington Journal of Law, Technology & Arts
A transcript of the symposium's proceedings.
Take Me To Your Liter: Politics, Power, And Public-Private Partnerships With The Sugar-Sweetened Beverage Industry In The Post-2015 Development Agenda, Craig W. Moscetti, Allyn L. Taylor
Take Me To Your Liter: Politics, Power, And Public-Private Partnerships With The Sugar-Sweetened Beverage Industry In The Post-2015 Development Agenda, Craig W. Moscetti, Allyn L. Taylor
Washington International Law Journal
Today, non-communicable diseases (“NCDs”) are widely recognized as a global public health crisis and a foreign policy priority. The international community was slow to identify and respond to the crisis of NCDs in the later part of the twentieth century. However, in 2011 the United Nations High Level Meeting on NCDs recognized NCDs as one of the greatest threats to health and development in the twenty-first century, and a major topic for the post-2015 development agenda. Notably, many experts, national governments, and global leaders have rallied for an inclusive, “whole-of-government” and “whole-of-society” approach, situating public-private partnerships (“PPPs”) with some of …
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Washington Law Review
This Article evaluates the free speech implications of laws requiring that GE foods be labeled and concludes that such regulations would meet all First Amendment requirements for compelled commercial speech. Part I traces the history of food labeling in the United States, the advent of genetic engineering, and the application of that technology in agriculture and the food industry. Part II evaluates the scope of commercial free speech and the appropriate test to be applied in determining whether a GE food labeling law would violate the First Amendment. Part III examines the impacts of an agricultural and food system increasingly …
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Much Ado About Something: The First Amendment And Mandatory Labeling Of Genetically Engineered Foods, Stephen Tan, Brian Epley
Washington Law Review
This Article evaluates the free speech implications of laws requiring that GE foods be labeled and concludes that such regulations would meet all First Amendment requirements for compelled commercial speech. Part I traces the history of food labeling in the United States, the advent of genetic engineering, and the application of that technology in agriculture and the food industry. Part II evaluates the scope of commercial free speech and the appropriate test to be applied in determining whether a GE food labeling law would violate the First Amendment. Part III examines the impacts of an agricultural and food system increasingly …
Repairing The Antibiotic Pipeline: Can The Gain Act Do It?, Caitlin Forsyth
Repairing The Antibiotic Pipeline: Can The Gain Act Do It?, Caitlin Forsyth
Washington Journal of Law, Technology & Arts
Antibiotic resistance, according to the World Health Organization, is one of the greatest threats to public health. To combat the problem, new antibiotics need to be developed. However, antibiotic research and development is fraught with scientific and economic problems. Recognizing these problems and the public health threat posed by antibiotic resistance, Congress passed the GAIN Act, which President Obama signed into law in June 2012. The GAIN Act (Act) incentivizes pharmaceutical companies to invest in antibiotic research and development. This Article will outline the incentives in the Act and suggest why the Act may not solve the growing antibiotic resistance …
The Perfect Pairing: Protecting U.S. Geographical Indications With A Sino-American Wine Registry, Laura Zanzig
The Perfect Pairing: Protecting U.S. Geographical Indications With A Sino-American Wine Registry, Laura Zanzig
Washington Law Review
Chinese counterfeiters have infiltrated the wine world, falsely labeling products and using fraudulent geographical indications (GIs). GIs, which function as a type of brand, are internationally protected designations of a product’s origin and characteristics. Recently, United States GIs, such as Napa or Walla Walla, have appeared on bottles of wine composed of Chinese grapes. By misappropriating U.S. brands, Chinese counterfeiters deceive and confuse consumers, disadvantage legitimate businesses, and causes health concerns. Unlike other brands, GIs protect regions, rather than individual producers. This creates a particular void: no single winery can register a GI and no single winery is harmed by …
Pressing Washington's Wine Industry Into The Twenty-First Century: Rethinking What It Means To Be A Winery, Rebecca Thompson
Pressing Washington's Wine Industry Into The Twenty-First Century: Rethinking What It Means To Be A Winery, Rebecca Thompson
Washington Law Review
Washington’s wine industry is growing, and the ways in which Washington winemakers craft and sell their product are changing. Traditional “brick and mortar” wineries coexist with so-called “virtual wineries,” which typically purchase grapes from growers and contract with other wineries or custom crush facilities to access winemaking equipment. The virtual winery is an incubator model and contributes to the rich diversity of Washington’s wine industry. Washington’s current winery licensing statute, RCW 66.24.170, does not clearly apply to virtual wineries because it links the concept of a winery with a particular physical location and fails to delineate exactly what types of …
Intellectual Property Rights And The Public Sector: Why Compulsory Licensing Of Protected Technologies Critical For Food Security Might Just Work In China, Gregory C. Ellis
Intellectual Property Rights And The Public Sector: Why Compulsory Licensing Of Protected Technologies Critical For Food Security Might Just Work In China, Gregory C. Ellis
Washington International Law Journal
The majority of people in the developed world have the luxury of never having to address food shortages and malnutrition. In developing countries, however, ensuring food security presents greater challenges. Agricultural biotechnology has the potential to alleviate many of the food crises occurring in developing countries. Unlike private sector corporations, public sector entities are creating genetically modified (“GM”) crops to ensure food security. However, the intellectual property rights (“IPRs”) to the many technologies required to create a single GM crop are often fragmented across the private and public sectors. Fragmentation of IPRs creates a “patent thicket” that increases the challenges …
Genetically Modified Crops In The Philippines: Can Existing Biosafety Regulations Adequately Protect The Environment?, Christina L. Richmond
Genetically Modified Crops In The Philippines: Can Existing Biosafety Regulations Adequately Protect The Environment?, Christina L. Richmond
Washington International Law Journal
Global concern persists about the use of genetically modified crops (“GM crops”). This concern originates from the divergent perspectives of nations with a stake in either the production or consumption of GM crops. Proponents of GM crops in developing countries claim that the crops could increase food supply by improving plant resistance to pesticides, thereby alleviating the need for farmers to purchase chemicals that are frequently expensive or unavailable. However, many organizations and countries are hesitant or outright opposed to GM crops, particularly regarding their potentially undesirable ecological and agricultural consequences. As one of the first Asian nations to approve …
A Precautionary Tale: The International Trade Implications Of Regulating Genetically Modified Foods In Australia And New Zealand, Denise M. Lietz
A Precautionary Tale: The International Trade Implications Of Regulating Genetically Modified Foods In Australia And New Zealand, Denise M. Lietz
Washington International Law Journal
The current international debate surrounding the development of genetically modified ("GM") foods centers around the selection of appropriate regulations to control the new technology's potential food safety risks. Australia and New Zealand have used a precautionary approach to develop their regulatory system for GM foods—a system that will soon include a stringent labeling requirement for all foods containing GM ingredients. The United States, on the other hand, has rejected the precautionary approach to regulating GM foods and does not require mandatory labeling of most GM foods. These differing national regulations may lead to restrictions on the importation of many U.S. …
Mitigating Alcohol Health Hazards Through Health Warning Labels And Public Education, Elizabeth L. Kruger
Mitigating Alcohol Health Hazards Through Health Warning Labels And Public Education, Elizabeth L. Kruger
Washington Law Review
Alcohol is the most commonly abused drug in America today; yet, there has been no serious national effort to warn or educate the American public about the non-obvious dangers of its consumption. Courts refuse to impose liability on alcoholic beverage manufacturers for injuries arising out of their failure to warn consumers of the dangers of alcoholic beverages. They reason that the risks of alcohol consumption are widely known among the consuming public. Yet, Americans are actually less aware of the dangers of alcohol consumption than of the risks of smoking. This problem may be solved in several ways. A first …
Mitigating Alcohol Health Hazards Through Health Warning Labels And Public Education, Elizabeth L. Kruger
Mitigating Alcohol Health Hazards Through Health Warning Labels And Public Education, Elizabeth L. Kruger
Washington Law Review
Alcohol is the most commonly abused drug in America today; yet, there has been no serious national effort to warn or educate the American public about the non-obvious dangers of its consumption. Courts refuse to impose liability on alcoholic beverage manufacturers for injuries arising out of their failure to warn consumers of the dangers of alcoholic beverages. They reason that the risks of alcohol consumption are widely known among the consuming public. Yet, Americans are actually less aware of the dangers of alcohol consumption than of the risks of smoking. This problem may be solved in several ways. A first …
Ensuring The Credibility Of United States Food Aid: Proposals For Insulating The Food Security Wheat Reserve From Economic Influences, Ann Marie Neugebauer
Ensuring The Credibility Of United States Food Aid: Proposals For Insulating The Food Security Wheat Reserve From Economic Influences, Ann Marie Neugebauer
Washington Law Review
This Comment proposes and evaluates two amendments to the legislation governing the emergency reserve that would help insulate the reserve from the market. Insulation can be accomplished by creating and protecting certain contract rights of the farmer/vendor against the United States government. The farmer could enforce those rights if the government released the reserve for purposes other than urgent humanitarian food aid. The Appendix contains proposed legislation which creates and protects such remedies. These proposals should contribute positively to public policy debate over methods of ensuring world food security. However, this Comment considers only the legal viability, not the political …