Food and Drug Law Commons^™

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

The Public Health Turn In Reproductive Rights, Rachel Rebouché

Washington and Lee Law Review

Over the last decade, public health research has demonstrated the short-term, long-term, and cumulative costs of delayed or denied abortion care. These costs are imposed on people who share common characteristics: abortion patients are predominantly low income and disproportionately people of color. Public health evidence, by establishing how law contributes to the scarcity of services and thereby entrenches health disparities, has vividly highlighted the connections between abortion access, race, and income. The contemporary attention to abortion law’s relationship to inequality is no accident: researchers, lawyers, and advocates have built an infrastructure for generating credible empirical studies of abortion restrictions’ effects. …

Blood In The Water: Why The First Step Act Of 2018 Fails Those Sentenced Under The Maritime Drug Law Enforcement Act, Lauren R. Robertson

Washington and Lee Law Review

For some, the open ocean is prison. The Maritime Drug Law Enforcement Act (MDLEA) prohibits individuals from knowingly or intentionally distributing a controlled substance or possessing it with the intent to distribute. Empowered by the MDLEA, the United States Coast Guard arrests and detains foreign nationals hundreds of miles outside of U.S. territorial waters. After months shackled to Coast Guard ships, these individuals face the harsh reality of American mandatory minimum drug sentencing, judged by the kilograms of drugs on their vessels. But the MDLEA conflates kilograms with culpability. More often than not, those sentenced are fishermen-turned-smugglers due to financial …

Alternative Solutions For Government Intervention In Climate Crisis Markets: Price Gouging And The Pandemic Egg Market Case Study, S. Byron Frazelle

William & Mary Environmental Law and Policy Review

The cost of a thing is the amount of what I will call life which is required to be exchanged for it, immediately or in the long run.

The incredible, edible egg.

Fires in California, hurricanes along the Gulf, a worldwide pandemic—it is evident that the year 2020 was defined by great crises, most of which were direct results of or exacerbated by climate change. The effects of these crises on broader American society, in particular that of the COVID-19 pandemic, are just beginning to be realized. Nearly every aspect of American life has been impacted by the pandemic and …

Intellectual Property Exhaustion And Parallel Imports Of Pharmaceuticals: A Comparative And Critical Review, Irene Calboli

Faculty Scholarship

This Chapter addresses the topic of intellectual property (IP) exhaustion in the context of the parallel trade of pharmaceuticals. These imports, which are controversial in general, are more complex with respect to pharmaceuticals, which require additional marketing and import authorizations. Nevertheless, individual countries remain free to accept these imports under the flexibility of Article 6 of the Agreement on Trade Related Aspects to Intellectual Property Rights (TRIPS Agreement). This Chapter reviews several national approaches—in developed, developing, and least developed countries (LDCs)—from the perspective of the exhaustion of patent rights as well as other IP rights. Through this review, it highlights …

Estate Planning For Cannabis Business Owners: An Introduction, Bridget J. Crawford, Jonathan G. Blattmachr

Elisabeth Haub School of Law Faculty Publications

As more states legalize cannabis sales, estate planners may increasingly be called upon to advise clients with interests in cannabis-related businesses. This essay seeks to assist estate planners in two ways. First, it aims to raise general awareness of cannabis business owners' unique concerns. Second, the essay provides an overview of some of the fundamental issues about which cannabis business owners are likely to seek estate planning advice: business formation matters, wealth transfers, the ability of trusts to own cannabis-related businesses, and gift, estate, and income tax considerations.

In most states that permit legal cannabis sales, there is limited (or …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

The Fight Over Frankenmeat: The Fda As The Proper Agency To Regulate Cell-Based “Clean Meat”, Zoe A. Bernstein

Brooklyn Law Review

In recent years, concern over the environmental, animal welfare, and human costs of animal agriculture has spurred an increased demand for nonanimal sourced protein. This has led to significant innovation in food technology. As part of this trend, food scientists have developed a process for in-vitro cultivation of meat cells to produce protein that is biologically and nutritionally identical to meat from traditionally raised and slaughtered animal sources, but that involves neither animal agriculture nor animal slaughter. This lab-grown “clean meat” represents a new era in food technology and is already having an effect on the existing meat industry. In …

Food For Thought: Intellectual Property Protection For Recipes And Food Designs, Kurt M. Saunders, Valerie Flugge

Duke Law & Technology Review

As any chef will tell you, cooking and food preparation is a creative, sometimes innovative, endeavor. Much thought and time is invested in selecting ingredients, developing the process for preparing the dish, and designing an interesting or appealing look and feel for a food item. If this is true, then it should come as no surprise that recipes, food designs, and other culinary creations can be protected by various forms of intellectual property, namely: trade secrets, design and utility patents, trade dress, but usually not copyright. This article considers how intellectual property law has been applied to protect recipes and …

Fixing The Business Of Food: Aligning Food Company Practices With The Sdgs, Sustainable Development Solutions Network, Columbia Center On Sustainable Investment, Sanda Chiara Lab, Barilla Center For Food And Nutrition

Columbia Center on Sustainable Investment Staff Publications

The food sector confronts significant sustainable development challenges. It both contributes to, and suffers from, environmental degradation, especially human-induced climate change and deforestation. Although it can provide farming communities with livelihoods and incomes, it also can fuel land grabs that undermine community rights and wellbeing. The sector feeds the growing global population, but also contributes to the epidemics of obesity and metabolic diseases, while chronic malnutrition has continued to worsen in the years since adoption of the Sustainable Development Goals (SDGs).

In light of these challenges and opportunities, a number of frameworks, guidance documents, and standards have aimed to create …

Medical Device Artificial Intelligence: The New Tort Frontier, Charlotte A. Tschider

BYU Law Review

The medical device industry and new technology start-ups have dramatically increased investment in artificial intelligence (AI) applications, including diagnostic tools and AI-enabled devices. These technologies have been positioned to reduce climbing health costs while simultaneously improving health outcomes. Technologies like AI-enabled surgical robots, AI-enabled insulin pumps, and cancer detection applications hold tremendous promise, yet without appropriate oversight, they will likely pose major safety issues. While preventative safety measures may reduce risk to patients using these technologies, effective regulatory-tort regimes also permit recovery when preventative solutions are insufficient.

The Food and Drug Administration (FDA), the administrative agency responsible for overseeing the …

Mitigating The Effects Of Intellectual Property Colonialism On Budding Cannabis Markets, Hughie Kellner

Indiana Journal of Global Legal Studies

Globalization has reduced barriers to trade, communication, and understanding, opening opportunities that extend far beyond national borders. However, in this bounty of opportunity lie obligations, and often those obligations tie a nation's hands when trying to deal with a problem that arises. One obligation nations face is upholding the United Nations' (UN) decision to prevent the illicit use of cannabis. Another is supporting and following the World Trade Organization's (WTO) near elimination of barriers for companies to bring patent and trademark protection with them into any country they do business with. In a modern globalized economy, if a nation fails …

Marijuana-Related Crime In Oregon Following Legalization Of Recreational Use, Ana Alicia Soto

Dissertations and Theses

In this decade we are seeing the legalization of recreational marijuana occurring across the nation, with new legislation being passed every year. This necessitates research into what works within the regulatory framework of states where MJ has been legalized. This study sets out to look at Oregon's implementation of recreational marijuana and its impact on marijuana-related offenses. Using NIBRS, we examine marijuana-related offenses across 13 counties with crime data from 41 agencies in Oregon from pre-legalization to post-legalization (2010 to 2019). This study uses elements of legalization, licenses, and production to analyze the association between these aspects and offenses that …

"Not For Human Consumption": Prison Food's Absent Regulatory Regime, Amanda Chan, Anna Nathanson

William & Mary Bill of Rights Journal

Prison food is poor quality. The regulations which govern prison food are subpar and unenforceable by prisoners, due in large part to Sandin v. Conner and the Prison Litigation Reform Act. This Article aims to draw attention to the dire food conditions in prisons, explain the lax federal administrative law that permits these conditions, highlight the role of Sandin v. Conner and the Prison Litigation Reform Act in curtailing prisoners’ rights, and criticize the role of the private entity American Correctional Association in enabling mass neglect of prison food. The authors recommend that the Prison Litigation Reform Act be repealed, …

Making Executioners Out Of Pharmacists: Why South Carolina Should Not Adopt A Lethal Injection Secrecy Statute, Elizabeth T. French

South Carolina Law Review

No abstract provided.

American Edibles: How Cannabis Regulatory Policy Rehashes Prohibitionist Fears And What To Do About It, Connor Burns, Jay D. Wexler

Faculty Scholarship

Why can’t we buy a cannabis muffin with our morning coffee? For much of the past century, the answer was simple: cannabis was illegal. Now, however, with more and more states legalizing cannabis for adult use, the answer is far less clear. Even in those states that have legalized cannabis, the simple action of buying and eating edibles at the same location has somehow remained a pipe dream despite consumer demand. Digging a little deeper, we can see how contemporary alarmism, by rehashing the same prohibitionist rhetoric demonizing cannabis for over eighty years, has once again arisen with a new …

When Claims About Lollipops Are Best Kept Under Wraps: Can The Fda Regulate Off-Label Speech?, Emily Moss

Minnesota Journal of Law, Science & Technology

No abstract provided.

Mandatory Sars-Cov-2 Vaccinations In K-12 Schools, Colleges/Universities, And Businesses, Lawrence O. Gostin, Jana Shaw, Daniel A. Salmon

Georgetown Law Faculty Publications and Other Works

The Centers for Disease Control and Prevention (CDC) recently issued guidance that fully vaccinated individuals can safely remove masks and end social distancing in most indoor settings. Educational facilities and businesses are faced with whether and how to differentiate between vaccinated and unvaccinated individuals, including requiring proof of vaccination. Mandatory vaccination has historically served as a tool to reach and sustain high immunization coverage and to prevent transmission in K-12 schools, colleges/universities, and health care facilities. Vaccine mandates could extend to workers and customers in businesses to ensure safer environments. This Viewpoint examines the epidemiologic, public health, and legal considerations …

Researching Marijuana Law, Seth Quidachay-Swan

Law Librarian Scholarship

This article provides a brief overview of the current legal framework governing the regulation of marijuana at the federal and state levels in the United States. It also provides an overview of the state of Michigan’s current regulatory framework and resources for attorneys interested in learning more about marijuana regulation.

Climate Change, Competition & Conflict Along The River Nile: The Great Ethiopian Renaissance Dam & Shifting Customary International Water Law, Salma Shitia

Fordham Environmental Law Review

Decade-long negotiations between the Arab Republic of Egypt and the Federal Democratic Republic of Ethiopia surround the decision to build the hydroelectric power plant along the River Nile. For much of Ethiopia, the Grand Ethiopian Renaissance Dam represents a beacon of prosperity. For countless Egyptians, the structure embodies a potential catastrophe. Grounded in threats of displacement for Egyptian agricultural communities, some have compared the Grand Ethiopian Renaissance Dam crisis to disasters culminating in mass migration.

This battle for natural resource access has intensified as climate change exacerbates the region’s dire conditions. Specifically, exhaustible resource allocation amid climate change indicates that …

A Paper Tiger? Prosecutorial Regulators In China’S Civil Environmental Public Interest Litigations, Chunyan Ding, Huina Xiao

Fordham Environmental Law Review

In July 2015, China’s national legislature brought in prosecutor-led civil environmental public interest litigation (“EPIL”) for thirteen selected provincial areas of the country. After a two-year legal experiment, this prosecutor-led civil EPIL system was then established nationwide in July 2017. Yet, can it be said that prosecutorial regulators in China are in fact a paper tiger? Drawing upon content analysis of the 655 prosecutor-led civil EPILs and in-depth interviews with twelve frontline prosecutors and judges, this article examines the dynamics of regulatory practice and the motivation of the Chinese prosecutorial organs to engage in environmental regulation through litigation. Based upon …

The Yoga Analogy: Scaling-Up The U.S.’S Renewable Energy Sector Mindfully With New Technologies, Evolving Standards, Public Buy-In, Data Sharing, And Innovation Clusters, Kimberly E. Diamond

Fordham Environmental Law Review

This paper focuses on innovative renewable energy devices, exploring how scientifically-based industry standards that continuously evolve with engineering design technology, the public’s buy-in and feeling of connectedness with groundbreaking devices, and innovation clusters that accelerate device development through data sharing and public-private partnerships can all help advance the U.S.’s domestic renewable energy industry.

Part I analyzes challenges inherent to scaling- up novel renewable energy technologies while simultaneously developing the industry standards regulating them. Part II uses the Block Island Wind Farm, an offshore wind demonstration project, and Pavegen’s globally-deployed arrays of piezoelectric smart flooring tiles as examples illustrating the importance …

Environmental Racism: Using Environmental Planning To Lift People Out Of Poverty, And Re-Shape The Effects Of Climate Change & Pollution In Communities Of Color,, William C.C. Kemp-Neal

Fordham Environmental Law Review

In the mid-1900s the United States began to see a rise in concern for environmental awareness issues. In the early days the movement focused on things like clean air, water and pollution but by the 1970s-1990s many prominent environmental awareness groups began to form focused on the idea that in order to avert climate change the principal goal needed to be to reduce global greenhouse gas emissions. In 1987 a report was released called Toxic Waste and Race, which outlined an intimate link between the placement of environmental hazardous waste sites in communities of color, and greater instances of polluted …

Beyond Equity: Shared Natural Resources And Human Rights, Criminal Law, And The Use Of Force, Eian Katz

Fordham Environmental Law Review

Transboundary resource disputes are often analyzed by reference to two nebulous and conflicting principles that have emerged in international environmental law: “equitable and reasonable utilization” and “no significant harm.” Frequently overlooked in this context is the potential value of other canons of international law—especially human rights law, criminal law, and the rules governing the use of force—in adding definition to the muddled contours of these foundational precepts. This Article therefore undertakes an assessment of sovereign rights and obligations regarding shared natural resources which arise from these other bodies of law. In doing so, it offers new lenses through which to …

Squaring The Cercla: Superfund And The Superfund Task Force, Manny Marcos

Fordham Environmental Law Review

The Superfund Task Force recently released its final report on the implementation of its recommendations for improving the Superfund program. The Task Force was given five goals for improving the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (“CERCLA’s”), implementation. These goals are to expedite cleanup and remediation, re-invigorate responsible party cleanup and reuse, encourage foreign investment, promote redevelopment and community revitalization, and engage with partners and stakeholders. While the Task Force’s recommendations have improved CERCLA’s implementation, many of CERCLA’s structural flaws remain intact. Specifically, CERCLA still has a severe shortage of funding, an unfair liability scheme, perverse incentives, …

Fair Lending For Cannabis Banking Justice, Benjamin T. Seymour

University of Michigan Journal of Law Reform Caveat

This Comment offers a fair lending solution to promote racial equity in cannabis banking reform: amend the Equal Credit Opportunity Act to ensure individuals previously arrested, charged, or convicted for selling, cultivating, or possessing marijuana will not therefore be precluded from loans to start legal cannabis businesses. Given disparities in the criminal enforcement of marijuana laws, this amendment would provide racial justice benefits, while also encouraging entrepreneurship. As a market-based social justice effort, this amendment offers a bipartisan approach to one of the most vexing and contentious issues in marijuana banking reform.

Part II of this Comment briefly surveys the …

Covid-19: A Crisis And An Opportunity To Improve The Emergency Use Authorization Process, Daniel Walsh

Minnesota Journal of Law, Science & Technology

No abstract provided.

Is It Really Safe To Provide Banking Services To Marijuana-Related Businesses? The Marijuana Banking Dilemma, Caitlin Steiner

Et Cetera

As more and more states begin to legalize marijuana, marijuana-related businesses such as dispensaries are cropping up all over the United States. Like most other legitimate businesses, marijuana-related businesses need a safe place to keep their money. However, unlike most other legitimate businesses, marijuana-related businesses often cannot find banks that are willing to do business with them. This is because banks are heavily governed and regulated by federal law, and marijuana is still illegal on a federal level—even where states have legalized its use. Although federal guidance on the subject has been issued, many legal “gray areas” continue to exist, …

Don't You Know That You're Toxic? Cercla Section 113(H) Challenges, Sovereign Immunity, And Perfluoroalkyl Substances In Pennsylvania Drinking Water In Giovanni V. Navy, Stephanie J. Oppenheim

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Zoning For Public Health: Why A National Land Use Scheme Is Essential To Sustainable Food Production, Victor J. Absil

Villanova Environmental Law Journal (1991 - )

No abstract provided.