Open Access. Powered by Scholars. Published by Universities.®
- Institution
-
- University of Maryland Francis King Carey School of Law (7)
- University of New Hampshire (7)
- Embry-Riddle Aeronautical University (5)
- Montclair State University (5)
- Selected Works (5)
-
- William & Mary Law School (4)
- Georgia State University College of Law (3)
- Saint Louis University School of Law (3)
- St. Mary's University (3)
- Bridgewater State University (2)
- City University of New York (CUNY) (2)
- Cleveland State University (2)
- Maurer School of Law: Indiana University (2)
- SelectedWorks (2)
- University of Pennsylvania Carey Law School (2)
- American University Washington College of Law (1)
- Brigham Young University (1)
- Brigham Young University Law School (1)
- Florida International University (1)
- Fordham University (1)
- Kutztown University (1)
- MaineHealth (1)
- Notre Dame Law School (1)
- Penn State Dickinson Law (1)
- Regis University (1)
- SIT Graduate Institute/SIT Study Abroad (1)
- Seattle University School of Law (1)
- Seton Hall University (1)
- UMass Global (1)
- University of California, Irvine School of Law (1)
- Keyword
-
- FDA (7)
- Drugs (5)
- Marijuana (5)
- Medical (4)
- Diamond v. Chakrabarty (3)
-
- Federal Circuit (3)
- Food and Drug Administration (3)
- Intellectual property (3)
- Myriad Genetics (3)
- Opioid (3)
- Substance abuse (3)
- America (2)
- Antibiotics (2)
- Ass'n for Molecular Pathology (2)
- BRCA 1 (2)
- BRCA 2 (2)
- Bacterial Infections (2)
- COVID-19 (2)
- Chemicals (2)
- E-cigarettes (2)
- Erlotinib (2)
- Genetic engineering (2)
- Health (2)
- Healthcare (2)
- IVCDD (2)
- IVD (2)
- Mayo Collaborative Services (2)
- Mental health (2)
- Myriad I (2)
- Myriad II (2)
- Publication Year
- Publication
-
- Journal of Health Care Law and Policy (7)
- All Faculty Scholarship (5)
- International Bulletin of Political Psychology (5)
- Law Faculty Scholarship (4)
- Department of Public Health Scholarship and Creative Works (3)
-
- Faculty Publications By Year (3)
- Department of Justice Studies Faculty Scholarship and Creative Works (2)
- Dissertations (2)
- Faculty Publications (2)
- IP Theory (2)
- Jonathan R. K. Stroud (2)
- Journal of Law and Health (2)
- Master’s Theses and Projects (2)
- Publications and Research (2)
- RISK: Health, Safety & Environment (1990-2002) (2)
- Robert Watters (2)
- St. Mary's Law Journal (2)
- Articles in Law Reviews & Other Academic Journals (1)
- BYU Law Review (1)
- CRVAW Faculty Journal Articles (1)
- DOUGLAS J HENDERSON (1)
- Dickinson Law Review (2017-Present) (1)
- English Department: Research for Change - Wicked Problems in Our World (1)
- Eric A. Kades (1)
- FIU Electronic Theses and Dissertations (1)
- Independent Study Project (ISP) Collection (1)
- Journal of Nonprofit Innovation (1)
- Luis González Vaqué (1)
- Maine Collection (1)
- Maine Medical Center (1)
- Publication Type
Articles 1 - 30 of 74
Full-Text Articles in Law
Reducing Food Scarcity: The Benefits Of Urban Farming, S.A. Claudell, Emilio Mejia
Reducing Food Scarcity: The Benefits Of Urban Farming, S.A. Claudell, Emilio Mejia
Journal of Nonprofit Innovation
Urban farming can enhance the lives of communities and help reduce food scarcity. This paper presents a conceptual prototype of an efficient urban farming community that can be scaled for a single apartment building or an entire community across all global geoeconomics regions, including densely populated cities and rural, developing towns and communities. When deployed in coordination with smart crop choices, local farm support, and efficient transportation then the result isn’t just sustainability, but also increasing fresh produce accessibility, optimizing nutritional value, eliminating the use of ‘forever chemicals’, reducing transportation costs, and fostering global environmental benefits.
Imagine Doris, who is …
Cultivating Health, Not Wealth In The United States' Healthcare System: Comprehensive Revisions For The Orphan Drug Act Of 1983, Kayla Smith
Regis University Student Publications (comprehensive collection)
This thesis explores the way in which the Orphan Drug Act of 1983, originally instituted in response to a lack of treatments for rare diseases in the United States of America, has failed to achieve its initial objectives in the 40 years since its implementation. In evaluating various successful examples of government subsidization programs designed to intervene in private industry, this thesis composes the criterion required for funding-based legislation which maximize market outcomes while minimizing tax-payer burden. An analysis of the synthetic organic chemistry industry – and a case study into the production of a particular orphan treatment for a …
The Politics Of The Self: Psychedelic Assemblages, Psilocybin, And Subjectivity In The Anthropocene, Joshua Falcon
The Politics Of The Self: Psychedelic Assemblages, Psilocybin, And Subjectivity In The Anthropocene, Joshua Falcon
FIU Electronic Theses and Dissertations
This dissertation examines how psychedelic substances become drawn into particular sociohistorical and political arrangements, and how psychedelic experiences with psilocybin ‘magic mushrooms’ are used as tools of subjectivation. Guided by literatures in philosophy, critical theory, and the social sciences that focus on subjectivity, assemblage theory, and critical posthumanism, I argue that psychedelics are drawn into variegated assemblages, each of which conceptualizes the nature of psychedelics in highly specific ways that reflect implicit conceptions of the world and the self. In developing the concept of psychedelic assemblages, this research provides a window onto the politics of the self in the Anthropocene. …
Rural Pregnant Women’S Experiences With Substance Use Disorder: A Qualitative Study, Cami Weber
Rural Pregnant Women’S Experiences With Substance Use Disorder: A Qualitative Study, Cami Weber
Dissertations
Rural pregnant women with substance use disorder (SUD) are an understudied vulnerable population that often experiences poor pregnancy outcomes (Higgins et al., 2019; Jumah, 2016; Kramlich et al., 2018; Shaw et al., 2015). Despite the high prevalence and high burden associated with SUD, rural women are less likely than non-pregnant women to seek addiction treatment and complete an outpatient treatment program during pregnancy (Shaw et al., 2015). This study aimed to give voice to rural Missouri women with SUD. The research questions explored the life experiences and motivations for seeking treatment using a qualitative, descriptive research design with grounded theory …
Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci
Seattle Journal of Technology, Environmental & Innovation Law
The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …
Police Officers' Perceptions Of The Law Enforcement Narcan Program And The Effectiveness In Fighting The Opioid Epidemic, James Russo
Seton Hall University Dissertations and Theses (ETDs)
Abstract
The purpose of this study was to investigate how police officers perceived the N.J. Narcan policy and standards in saving lives and deterring opioid use. This study also examined the impact of the law enforcement Narcan program in reducing the opioid overdose death rate. Participant interviews will be conducted, and thematic coding will be utilized to capture the dominant themes associated with the police officers’ perceptions of the N.J. Narcan policy and standards in reducing the opioid overdose death rate. Fifteen police officers will participate in the study, and their anonymity will be maintained to elicit transparent responses. This …
To What Extent Are Appropriate Resources Provided To Veterans With Mental Illness To Prevent Contact With The Criminal Justice System?, Riley Christine Doyle
To What Extent Are Appropriate Resources Provided To Veterans With Mental Illness To Prevent Contact With The Criminal Justice System?, Riley Christine Doyle
Master’s Theses and Projects
United States military veterans are a special population of men and women that have willingly sacrificed their lives to serve their country. They are perceived to be patriotic, honorable, strong, and disciplined people. Unfortunately, veterans are not exempt from committing criminal acts that land them in the criminal justice system. In fact, veterans are highly susceptible to developing mental illnesses and substance use disorders which can ultimately lead to criminal behavior. The purpose of this study was to examine to what extent available resources are provided to veterans to help them prevent contact with the criminal justice system. This study …
Corruption In Capsules: How It Is Legal For Companies To Put Harmful Ingredients In Vitamins And Dietary Supplements, Emily Leggiero
Corruption In Capsules: How It Is Legal For Companies To Put Harmful Ingredients In Vitamins And Dietary Supplements, Emily Leggiero
English Department: Research for Change - Wicked Problems in Our World
The vitamin and supplement industry has increased exponentially in profits as well as potential products on the market since the turn of the century. However, these products are not regulated, nor do they undergo any premarket clinical research or testing. Public health is compromised by vitamins and supplements that are available for American consumption that is disproportionately unregulated to their chemically similar counterparts. This wicked problem is facilitated through the combination of historical legislative definitions that has since been distorted for corrupt administrative gain through the allotment of corporate expenditures. Company disbursements are made to the same policymakers that create …
Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman
Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman
All Faculty Scholarship
We find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.
While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new …
Homicide And Drug Trafficking In Impoverished Communities In Brazil, Elenice De Souza De Souza Oliveira, Braulio Figueiredo Alves Da Silva, Flavio Luiz Sapori, Gabriela Gomes Cardoso
Homicide And Drug Trafficking In Impoverished Communities In Brazil, Elenice De Souza De Souza Oliveira, Braulio Figueiredo Alves Da Silva, Flavio Luiz Sapori, Gabriela Gomes Cardoso
Department of Justice Studies Faculty Scholarship and Creative Works
Many studies demonstrate that homicides are heavily concentrated in impoverished neighborhoods, but not all socially disadvantaged neighborhoods are hotbeds of violence. Conducted in Belo Horizonte, Brazil, this study hypothesizes that the association between high rates of homicide and impoverished areas is influenced by the emergence of a specific type of street drug-dealing common to favelas (slums). The study applies econometric techniques to police data on homicides and drug arrests from 2008 to 2011, as well as 2010 Census data, to test its hypothesis. The findings provide insight into the development of crime prevention policies in areas of high social vulnerability.
21 In The 21st—An Evaluation Of The Tobacco Regulation Trend, Casey Kellum
21 In The 21st—An Evaluation Of The Tobacco Regulation Trend, Casey Kellum
St. Mary's Law Journal
Tobacco regulation persists as a controversial issue both legally and politically in the United States. Throughout American history, states rely on local legislation to provide adequate protection to consumers of tobacco products, as “Big Tobacco” targets consumers for its addictive product. One of the most recent amendments in this arena is the state by state decision to raise the minimum legal sales age for tobacco to twenty-one.
Despite rigorous regulation of tobacco products in the United States, however, tobacco remains the leading cause of preventable deaths in the country. These “Tobacco 21” ordinances come at a critical time when the …
Laws Restricting Access To Abortion Services And Infant Mortality Risk In The United States, Roman Pabayo, Amy Ehntholt, Daniel M. Cook, Megan Reynolds, Peter Muennig, Sze Yan Liu
Laws Restricting Access To Abortion Services And Infant Mortality Risk In The United States, Roman Pabayo, Amy Ehntholt, Daniel M. Cook, Megan Reynolds, Peter Muennig, Sze Yan Liu
Department of Public Health Scholarship and Creative Works
Objectives: Since the US Supreme Court′s 1973 Roe v. Wade decision legalizing abortion, states have enacted laws restricting access to abortion services. Previous studies suggest that restricting access to abortion is a risk factor for adverse maternal and infant health. The objective of this investigation is to study the relationship between the type and the number of state-level restrictive abortion laws and infant mortality risk. Methods: We used data on 11,972,629 infants and mothers from the US Cohort Linked Birth/Infant Death Data Files 2008–2010. State-level abortion laws included Medicaid funding restrictions, mandatory parental involvement, mandatory counseling, mandatory waiting period, and …
Drug Courts And The Following Of The Federal Guidelines, Charles James Souza
Drug Courts And The Following Of The Federal Guidelines, Charles James Souza
Master’s Theses and Projects
During the 1980’s, drug offense were running high within the United States. The court system along with the police and other fields were forced to form other methods of dealing with offenders who have a substance abuse problem. In 1989, the first drug court in the United States was formed in the state if Florida. The idea was to create a therapeutic method to help those who are committing non-violent criminal acts due to their addiction. The goal of drug court was to get offenders the treatment they needed so they would not resort to criminal activity. Drug court personal …
Mhpaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi
Mhpaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi
Dickinson Law Review (2017-Present)
No abstract provided.
Room To Grow: A Comparative Analysis Of Cannabis Regulation Models In Europe, Amanda H. Cronin
Room To Grow: A Comparative Analysis Of Cannabis Regulation Models In Europe, Amanda H. Cronin
Independent Study Project (ISP) Collection
Debilitated by years of economic instability, the Spanish economy has not fully rebounded to its once strong place in the European market. And now, in the aftermath of a devastating pandemic, the nation will be searching for new sources of wealth. The lucrative market potential of controlled cannabis in medicinal and recreational settings is an attractive industry gaining popularity across Europe. This paper explores the various policy models and legal systems in Portugal, Germany, and the Netherlands. Combining a variety of sources, I seek to ascertain the best plan for Spain. Ultimately, analysis shows that a multi-pronged approach is the …
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman
All Faculty Scholarship
This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space. The Essay provides a short case study on CEPI, a large-scale public-private partnership dedicated exclusively to funding research on vaccines for infectious diseases. In exploring how the interaction between intellectual property rules and practices affect vaccine innovation, the Essay offers illustrations from …
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman
All Faculty Scholarship
Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …
Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser
Combatting The Opioid Epidemic In Texas By Holding Big Pharma Manufacturers Liable, Katherine Spiser
St. Mary's Law Journal
Abstract forthcoming
Preserving A Precious Resource: Rationalizing The Use Of Antibiotics, Eric Kades
Preserving A Precious Resource: Rationalizing The Use Of Antibiotics, Eric Kades
Eric A. Kades
No abstract provided.
The Strange Career Of The Transnational Legal Order Of Cannabis Prohibition, Ely Aaronson
The Strange Career Of The Transnational Legal Order Of Cannabis Prohibition, Ely Aaronson
UC Irvine Journal of International, Transnational, and Comparative Law
There is a crack in everything — that’s how the light gets in
Leonard Cohen, Anthem
In an era often characterized as one of growing convergence of the laws
governing criminal activities in different countries, the issue-area of cannabis
policy undergoes processes of fragmentation and polarization. Some countries
continue to criminalize all forms of medical and recreational uses of
cannabis. Others have sought to “separate the market” for cannabis from
that of other drugs by decriminalizing the possession of small amounts of
marijuana, authorizing its use for medical purposes, and establishing
administrative measures for taxing and regulating the commercial sale …
Leveraging Pharma To Lower Premiums: Medical Loss Ratio Regulation In The Pharmaceutical Industry, Cami R. Schiel
Leveraging Pharma To Lower Premiums: Medical Loss Ratio Regulation In The Pharmaceutical Industry, Cami R. Schiel
BYU Law Review
Many recognize escalating drug prices as a significant dilemma related to America’s rising healthcare costs. Yet few can agree on what to do about them. Unaffordable drug prices are a result of many complex forces. One theory to address this problem is to reduce all government intervention and let normal market forces act as they usually do to bring the goods’ prices down to consumer-friendly ranges. However, the prescription drug market is not, and perhaps never can be, a normal market. Reasons for this include (1) a lack of price transparency, (2) information and control asymmetries between patients and physicians, …
Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender
Radical Social Ecology As Deep Pragmatism: A Call To The Abolition Of Systemic Dissonance And The Minimization Of Entropic Chaos, Arielle Brender
Student Theses 2015-Present
This paper aims to shed light on the dissonance caused by the superimposition of Dominant Human Systems on Natural Systems. I highlight the synthetic nature of Dominant Human Systems as egoic and linguistic phenomenon manufactured by a mere portion of the human population, which renders them inherently oppressive unto peoples and landscapes whose wisdom were barred from the design process. In pursuing a radical pragmatic approach to mending the simultaneous oppression and destruction of the human being and the earth, I highlight the necessity of minimizing entropic chaos caused by excess energy expenditure, an essential feature of systems that aim …
The Predictors Of Juvenile Recidivism: Testimonies Of Adult Students 18 Years And Older Exiting From Alternative Education, La Toshia Palmer
The Predictors Of Juvenile Recidivism: Testimonies Of Adult Students 18 Years And Older Exiting From Alternative Education, La Toshia Palmer
Dissertations
Purpose: The purpose of this descriptive, qualitative study was to identify and describe the importance of the predictors of juvenile recidivism and the effectiveness of efforts to prevent/avoid juvenile recidivism as perceived by previously detained, arrested, convicted, and/or incarcerated adult students 18 years of age and older exiting from alternative education in Northern California. A second purpose was to explore the types of support provided by alternative schools and the perceived importance of the support to avoid recidivism according to adult students 18 years of age and older exiting from alternative education.
Methodology: This qualitative, descriptive research design identified …
The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa
The Biologics Price Competition And Innovation Act: Is A Generic Market For Biologics Attainable?, Kasey E. Koballa
William & Mary Business Law Review
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated approval pathway for biological therapeutic products shown to be biosimilar to an FDA-approved biological reference product. The BPCIA purported to reduce the price of biologics while promoting innovation. In two recent cases, the Federal Circuit interpreted a key provision of the BPCIA requiring an applicant to provide the reference product sponsor with notice 180 days before marketing the product. The Federal Circuit’s interpretation extends the exclusivity period already provided for the reference product sponsor, deterring innovation and price reduction. Thus, the Supreme Court granted certiorari in one …
Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim
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 approval …
Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman
Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman
Maine Medical Center
There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.
After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …
Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen
Analysis Of The Proposed Tpp-Related Patent Linkage System In Taiwan, Ping-Hsun Chen
Journal of Law and Health
The Trans-Pacific Partnership (TPP) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’s patent linkage system allows a pioneer drug company to register patents claiming (a) a material, (b) a combination or formula, or (c) pharmaceutical use. The …
Circling The Drain: Regulating Nutrient Pollution From Agricultural Sources, William Gutermuth
Circling The Drain: Regulating Nutrient Pollution From Agricultural Sources, William Gutermuth
Journal of Law and Health
The 2014 Toledo, Ohio tap water ban has, at least temporarily, put a spotlight on United States water supplies. Consequently, many Americans have begun to take a closer look at the quality of the fresh water bodies being used to supply tap water to their homes. Therefore, this Note analyzes the problems currently threatening the lakes, rivers, and other surface waters that are the source of fresh drinking water for huge populations in the United States. Part II examines the problem of nutrient pollution and explains the harmful effects it has on human health. Part III provides an overview of …
Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn
Do Desperate Times Really Call For Desperate Measures? The Ethical Dilemma Behind The Regulation And Use Of Experimental Drugs, Lauren Kuehn
Notre Dame Journal of International & Comparative Law
This Note will argue that, unlike what many patients believe, the U.S. Food and Drug Administration (FDA) plays an invaluable and imperative role in seeking the efficacy and safety of new treatment options and drugs. The balance of interests between those who are terminally ill, who wish to see increased access to unapproved medicines; the general public, who has an interest in preserving the drug approval process; and the FDA, who has been mandated by law to safeguard the safety of the general public, creates a tension that will continue to go unresolved. Thus, the patients who continue to advocate …
Marijuana Regulation And Federalism, John M. Greabe
Marijuana Regulation And Federalism, John M. Greabe
Law Faculty Scholarship
[Excerpt] "Federal law makes the cultivation and use of marijuana illegal for all purposes. Yet, over the past two decades, 28 states plus the District of Columbia have legalized marijuana for medicinal purposes, and eight states plus the District of Columbia have legalized it for recreational purposes. Marijuana regulation thus provides a useful and timely example for exploring the ways in which the distribution of power between the federal government and the states can facilitate policy change."