Law Commons^™

Caps On Capsules: Prescription For Lower Drug Prices In The United States, Christine Chasse

Student Scholarship

The United States is the foremost innovator of pharmaceutical therapies in the world. That innovation, however, comes at a price—literally. Americans pay more for their medications than any other country. In a country without universal healthcare, the topics of economics, human rights, and healthcare intersect at the crossroads of pharmaceutical pricing. In contrast to most other countries, the United States has no regulations on pharmaceutical price control. One major argument against government regulation is its inherent opposition to the free market system: the heart of the American economy. Further still is the argument that profit restriction would create a chilling …

The Role Of The Opioid Crisis In Elder Abuse, Kimberly I. Snow Mhsa, Jennifer Pratt, Stuart Bratesman Mpp

Disability & Aging

As the opioid crisis has deepened over the past twenty years, its effect on individuals and families, including older adults, has grown. To find out how the opioid crisis might be impacting elder abuse, neglect, and exploitation in Maine, we conducted a mixed methods analysis of 2015-2018 Maine Adult Protective Services (APS) investigations to determine: 1) Did opioid-related investigations increase over time? 2) Do investigations involving opioid misuse or abuse differ from investigations that don’t involve opioids? 3) What themes or features of cases involving opioid misuse or abuse by clients and/or perpetrators emerge from the data?

Key Findings: The …

Dispute Settlement Under The African Continental Free Trade Area Agreement: A Preliminary Assessment, Olabisi D. Akinkugbe

Articles, Book Chapters, & Popular Press

The African Continental Free Trade Area Agreement (AfCFTA) will add a new dispute settlement system to the plethora of judicial mechanisms designed to resolve trade disputes in Africa. Against the discontent of Member States and limited impact the existing highly legalized trade dispute settlement mechanisms have had on regional economic integration in Africa, this paper undertakes a preliminary assessment of the AfCFTA Dispute Settlement Mechanism (DSM). In particular, the paper situates the AfCFTA-DSM in the overall discontent and unsupportive practices of African States with highly legalized dispute settlement systems and similar WTO-Styled DSMs among other shortcomings. Notwithstanding the transplantation of …

Washington Cannabusiness: Washington’S Durational Residency Requirement Should Be Eliminated On Economic, Social, And Constitutional Grounds, Alejandro Monarrez

Seattle University Law Review SUpra

No abstract provided.

Drug Policy Reform In The Americas: A Welcome Challenge To International Law, Alvaro Santos

Georgetown Law Faculty Publications and Other Works

Drug policy in the American hemisphere is in flux. After decades whereby a prohibitionist regime reigned supreme and proposing alternatives was taboo, several countries have begun to reconsider policy, particularly in the case of marijuana. International law has been instrumental in building the legal and institutional regime of prohibition, and it has remained largely impervious to critiques of its disastrous consequences. Indeed, when it comes to drug law and policy, international law has been part of the problem. Nevertheless, countries in the Americas have begun to adopt innovative strategies that also embrace international obligations. In this essay, I examine the …

Distorted Drug Patents, Erika Lietzan

Faculty Publications

Drug patents are distorted. Unlike most other inventors, drug inventors must complete years of testing to the government’s specifications and seek government approval to commercialize their inventions. All the while, the patent term runs. When a drug inventor finally launches a medicine that embodies the invention, only a fraction of the patent life remains. And yet, conventional wisdom holds — and empirical studies show — that patent life is essential to innovation in the pharmaceutical industry, perhaps more so than any other inventive industry. Congress tried to do something about this in 1984, authorizing the Patent and Trademark Office to …

Using One Dying Regime To Save Another, Robert A. Mikos

Vanderbilt Law School Faculty Publications

Cannabis reforms are proliferating. A handful of nations have already legalized the drug for recreational purposes, and several more may soon follow suit. These national cannabis reforms are generating bottom-up pressure to liberalize the transnational legal order (TLO) for cannabis prohibition, one that involves not only international law, but also domestic law and regulatory practice. Based on a trio of international conventions, this TLO currently requires member states to limit access to marijuana, especially for non-medical or non-scientific purposes. But even as it comes under attack from below, the existing cannabis prohibition TLO may be exerting its own downward pressure …

Medical Marijuana, Taxation, And Internal Revenue Code Section 280e, Douglas A. Kahn, Howard J. Bromberg

Articles

Congress enacted § 280E of the Internal Revenue Code in 1982 to punish businesses engaged in illegal drug trafficking, including marijuana. Section 280E denies all credits and deductions, including ordinary business expenses, from gross income of businesses illegally trafficking in a Schedule I or II controlled substance. This provision violates the principle that the tax code should foster a consistent treatment of income, regardless of source; and that the income tax is ill-used for punitive measures. Now that marijuana has been legalized in some form in at least 46 states for therapeutic purposes, this federal tax penalty transgresses principles of …

Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley

Articles

As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.

The Case For Blockchain In The Beauty Industry, Sumanpreet Kaur

Blockchain Law

Part II of this paper addresses the legal issues presented by counterfeit cosmetics and false claims, and also compares the regulatory landscape in the United States versus that of the European Union. Part III analyzes how blockchain can be used to fill in the gaps left by the lack of strong regulations in the United States and provide consumers reliable methods of authenticating the ingredients in their personal care products. Part III also explains how Cult Beauty is implementing blockchain in its business. Part IV discusses the potential hurdles and negatives of using blockchain in the beauty industry. Part V …

Sobering Up After The Seventh Inning: Alcohol And Crime Around The Ballpark, Jonathan Klick, John M. Macdonald

All Faculty Scholarship

Objectives: This study examines the impact of alcohol consumption in a Major League Baseball (MLB) stadium on area level counts of crime. The modal practice at MLB stadiums is to stop selling alcoholic beverages after the seventh inning. Baseball is not a timed game, so the duration between end of the seventh inning (last call for alcohol) and the end of the game varies considerably, providing a unique natural experiment that allows us to estimate the relationship between alcohol consumption and crime near a stadium on game days to non-game days and to areas around sports bars that fans also …

The Evolving Federal Response To State Marijuana, Robert Mikos

Vanderbilt Law School Faculty Publications

The states have launched a revolution in marijuana policy, creating a wide gap between state and federal marijuana law. While nearly every state has legalized marijuana in at least some circumstances, federal law continues to ban the substance outright. Nonetheless, the federal response to state reforms has been anything but static during this revolution. This Essay, based on my Distinguished Speaker Lecture at Delaware Law School, examines how the federal response to state marijuana reforms has evolved over time, from War, to Partial Truce, and, next (possibly) to Capitulation. It also illuminates the ways in which this shifting federal response …

Cannabis And Its Historical Role In America’S Intentional Segregation Of Race, William E. Kelley

Student Publications

One of the more dramatic shifts in attitudes towards a particular trend or culture we have seen during the turn of the century is none other than attitudes towards marijuana. The Cannabis plant, commonly known as marijuana, has been illegal in the United States for a while now. In the past ten years, we have seen an influx of states and countries relaxing their attitudes towards marijuana, and it's potential benefits. While this shift in attitude towards a relatively harmless drug is a step in the right direction, many are unaware of the sinister and racist history behind outlawing the …

How Can Pennsylvania Protect Itself From Its Own Measles Outbreak?, Megan M. Riesmeyer, Kristen Feemster

Faculty Scholarly Works

When a response to inaccurate information strives to be an informative exercise of its own, it is difficult to balance the desire to respond point by point to mischaracterized, misleading, or untrue information, with the need to simply offer a complete picture of facts. This article is a response to Abigail Wenger’s article regarding

vaccinations. To reply to each mischaracterization or inaccuracy in turn means this response loses its own informative intent and becomes simply a rebuttal. However, to ignore mischaracterizations and inaccuracies is to risk the reader’s acceptance of those points as true. Through illustrative examples in the United …

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 …

Regulating Medicines In A Globalized World With Increased Recognition And Reliance Among Regulators: A National Academies Report, Lawrence O. Gostin, Alastair J. Wood, Patricia A. Cuff

Georgetown Law Faculty Publications and Other Works

Research and development of pharmaceuticals are now complex global endeavors, with drug companies operating worldwide using global supply chains. Pharmaceutical companies source their products from many countries, conduct trials in multiple sites, and market essential drugs and vaccines globally. Yet oversight of drug safety and effectiveness is primarily the responsibility of national regulators of variable capacities. National agencies often undertake product reviews without recognizing that similar reviews are occurring elsewhere, sometimes simultaneously. The result is duplication and redundancy, which benefits neither national nor global public health. Supported by the US Food and Drug Administration (FDA), the National Academies of Sciences, …

The Cost Of Novelty, Will Nicholson Price Ii

Articles

Patent law tries to spur the development of new and better innova­tive technology. But it focuses much more on “new” than “better”—and it turns out that “new” carries real social costs. I argue that patent law promotes innovation that diverges from existing technology, either a little (what I call “differentiating innovation”) or a lot (“exploring innova­tion”), at the expense of innovation that tells us more about existing technology (“deepening innovation”). Patent law’s focus on newness is unsurprising, and fits within a well-told narrative of innovative diversity accompanied by market selection of the best technologies. Unfortunately, innovative diversity brings not only …

The Doctrine Of Wilful Blindness In Drug Offences: Adili Chibuike Ejike V Public Prosecutor [2019] 2 Slr 254, Rennie Whang

Research Collection Yong Pung How School Of Law

In Adili Chibuike Ejike v Public Prosecutor [2019] 2 SLR 254, the Court of Appeal clarified the operation of the wilful blindness doctrine in the context of knowing possession for drug offences. In particular, it affirmed wilful blindness as a doctrine of substantive rather than evidential law, which applies as a limited extension to the legal requirement of actual knowledge. The court then articulated a three-part test for the finding of wilful blindness in relation to knowledge as an ingredient of possession. However, it left open the content of the doctrine as applied to the element of knowledge in drug …

Why The Dea & Not The Fda? Revisiting The Regulation Of Potentially Addictive Substances, Taleed El-Sabawi

Faculty Publications

In addressing the opioid overdose crisis, Congress has explicitly questioned its historic reliance on a criminal justice approach to problem drug use and has instead adopted a more health-oriented approach. Despite Congress' rhetoric, the DEA, a criminal justice agency, continues to retain the power to make key decisions on the classification of potentially-addictive substances, thereby affecting their manufacture, distribution, and overall availability. While the DEA is statutorily required to defer to the Food and Drug Administration (“FDA”), a public health agency, at junctions of the decision-making process, the current “split enforcement” scheme laid out in the statutes has not actualized …

(Almost) No Bad Drugs: Near-Total Products Liability Immunity For Pharmaceuticals Explained, Anita Bernstein

Faculty Scholarship

No abstract provided.

The Budding Hemp Industry: The Effect Of Texas House Bill 1325 On Employment Drug Policies, Meina Heydari

Student Scholarship

Contemporary attitudes toward cannabis use in the United States have shifted from War on Drugsera prohibition toward decriminalization over the past two decades. As states that do not seek to decriminalize marijuana nonetheless enact legislation legalizing CBD, policy tensions arise. In 2019, Texas joined the ranks of states that legalized hemp and hemp-derived products with the passage of House Bill 1325. In light of this legislation, this Article discusses the implications of legalized cannabidiol (CBD) on employment drug policies in Texas. The benefits of CBD legalization must be weighed against the practical implications to effectively balance policies that aim to …

Revisiting Cook V. Food And Drug Administration: A Lens For Analyzing The Current State Of Fda Enforcement And Assurance Of Product Quality – Increased Oversight Or Not Enough?, Catherine Gould

Upper Level Writing Requirement Research Papers

No abstract provided.

Executive Summary On Ensuring Economic Viability And Sustainability Of Coffee Production, Jeffrey D. Sachs, Kaitlin Y. Cordes, James Rising, Perrine Toledano, Nicolas Maennling

Columbia Center on Sustainable Investment Staff Publications

Coffee, the world’s favorite beverage, provides livelihoods for at least 60 million people across dozens of countries. Yet this beloved drink is experiencing a sustainability crisis. A sustained decline in world coffee prices has squeezed coffee producers, and thrown a tremendous number of producers below the global extreme poverty line of US$1.90 per day. This briefing note presents our research into sustainability within the coffee sector, including the results of our analytical and empirical modeling, and provides several recommendations.

The Burden On Society From Eleventh-Hour "Citizen Petitions" Filed To Slow Generic Drugs, Feldman Robin

Maryland Law Review Online

No abstract provided.

Three Framing Of "Faster" At The Fda And The Federal Right To Try, Jordan Paradise

Faculty Publications & Other Works

In May 2018, Congress passed the controversial Right to Try (“RTT”) Act, creating a process for terminally ill patients to request access to investigational drugs. The federal RTT Act is not the first legal mechanism that fosters quicker access to investigational drugs. This new right to try is distinct from existing pathways created by law, regulation or federal administrative agency policy. Various mechanisms facilitated by the U.S. Food and Drug Administration (“FDA”) are significantly more substantial and important in the context of “faster” access to therapeutic products. These mechanisms lie along a spectrum of product development spanning investigational new drug …

Fda Publicity And Enforcement In The Covid-19 Era, Jordan Paradise, Elise Fester

Faculty Publications & Other Works

No abstract provided.

Our Federalism On Drugs, Jonathan Adler

Faculty Publications

Over the past decade, voters and legislatures have moved to legalize the possession of marijuana under state law. Some have limited these reforms to the medicinal use of marijuana, while others have not. Despite these reforms marijuana remains illegal under federal law. Although the Justice Department has not sought to preempt or displace state-level reforms, the federal prohibition casts a long shadow across state-level legalization efforts. This federal-state conflict presents multiple important and challenging policy questions that often get overlooked in policy debates over whether to legalize marijuana for medical or recreational purposes. Yet in a “compound republic” like the …

Mphaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Faculty Publications

Federal parity laws, and their state equivalents, have been shown to increase access to substance use disorder (SUD) treatment, by decreasing the cost of SUD treatment borne by the insured, and has resulted in little increase in health plan costs. Despite these improvements, the effects of parity on access to SUD treatment have been lower than expected. Recent reports suggest that states have varied in their enforcement parity, failures which may explain why persons surveyed still report having inadequate insurance coverage for SUD treatment despite the parity legislation. While other articles have offered suggestions for improving parity, most have lumped …

Geographical Indications Of Origin, Economic Development, And Cultural Heritage: Good Match Or Mismatch?, Irene Calboli

Faculty Scholarship

In this article, I propose that geographical indications (GIs) carry important economic benefits. First, GIs are essential instruments to facilitate investments in high-quality products and niche markets, and promote local trade and development. Second, GIs offer an additional layer of information for consumers about the geographical origin and quality of the products they identify, in turn reducing the information asymmetries between producers and consumers. Third, because of this information function, GIs can assist in rewarding or holding producers accountable for their products based on the additional information they convey to the market. Yet, GIs can also protect culture-related interests and …

The U.S. Posture On Global Access To Medication & The Case For Change, Michael Palmedo, Srividhya Ragavan

Faculty Scholarship

The year 2020 marks the 25th anniversary of including intellectual property rights within the larger agenda of trade. While the marriage between trade and intellectual property was always uncomfortable, COVID-19 exposed the flaws, failures and the inadequacy of the trade agenda to harmonise intellectual property rights, particularly for patents in pharmaceuticals. Typically, the United States through its questionable United States Trade Representative (USTR) process exposed the vulnerabilities of the intellectual property systems of the rest of the world. COVID-19 exposed the manner in which the so-called ‘superior’ intellectual property regime of the US left the country with a weak health-care …