Health Law and Policy Commons^™

Securing Safe Supply During Covid-19 And Beyond: Scoping Review And Knowledge Mobilization, Matthew Bonn, Natasha Touesnard, Brianna Cheng, Michael Pugliese, Emilie Comeau, Claire Bodkin, Thomas D. Brothers, Leah Genge, Matthew Herder, Candis Lepage, Ayden Scheim, Dan Werb, Sheila Wildeman

Articles, Book Chapters, & Popular Press

Background

Safe supply is defined as the legal and regulated provision of drugs with mind and/or body altering properties that have been typically accessible only through the illegal drug market. In response to the coronavirus disease 2019 (COVID-19) pandemic and related social/physical distancing measures, efforts have been made to scale up and increase access to safe supply programs in an effort to reduce overdose and other drug- and drug policy-related risks. However, it remains unclear whether these efforts taken thus far have meaningfully mitigated the barriers to safe supply experienced by People Who Use Drugs (PWUD), both during and beyond …

Neither “Post-War” Nor Post-Pregnancy Paranoia: How America’S War On Drugs Continues To Perpetuate Disparate Incarceration Outcomes For Pregnant, Substance-Involved Offenders, Becca S. Zimmerman

Pitzer Senior Theses

This thesis investigates the unique interactions between pregnancy, substance involvement, and race as they relate to the War on Drugs and the hyper-incarceration of women. Using ordinary least square regression analyses and data from the Bureau of Justice Statistics’ 2016 Survey of Prison Inmates, I examine if (and how) pregnancy status, drug use, race, and their interactions influence two length of incarceration outcomes: sentence length and amount of time spent in jail between arrest and imprisonment. The results collectively indicate that pregnancy decreases length of incarceration outcomes for those offenders who are not substance-involved but not evenhandedly -- benefitting white …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

The Fda’S Power Over Non-Therapeutic Uses Of Drugs And Devices, Patricia J. Zettler

Washington and Lee Law Review

Although we often—and rightly—think of the U.S. Food and Drug Administration (FDA) as regulating important therapies for patients, the agency also can regulate non-therapeutic uses of drugs and devices. The Federal Food, Drug, and Cosmetic Act defines drugs and devices as including not only products intended to address disease but also those intended to affect the structure or function of the body, such as cognitive enhancements, wrinkle removers, and recreational drugs. Indeed, if these broad definitions were read literally, many everyday consumer products—such as winter jackets intended to keep wearers’ warm—may be drugs or devices. Accordingly, Congress, courts, and the …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

Encouraging Interagency Collaboration: Learning From Covid-19, Rachel Sachs

Scholarship@WashULaw

In the health innovation context, federal regulatory authority is sharply fragmented among different agencies. The National Institutes of Health, Food and Drug Administration, Centers for Medicare and Medicaid Services, and other agencies all share responsibilities in the development and dissemination of new healthcare technologies. Scholars have previously written about the importance of interagency collaboration both in the healthcare area and more generally, and about strategies for encouraging collaborative efforts to promote various policy goals. Under these accounts, a failure to collaborate between federal agencies may be unfortunate, but it does not typically result in or exacerbate a crisis. In the …

Recent Trends In Medicaid Spending And Use Of Drugs With Us Food And Drug Administration Accelerated Approval, Rachel Sachs, Kyle A. Gavulic, Julie M. Donohue, Stacie B. Dusestzina

Scholarship@WashULaw

State Medicaid programs have reported concerns about rising drug prices and spending, particularly regarding drugs entering the market through the accelerated approval program under the US Food and Drug Administration (FDA). The accelerated approval program enables the FDA to approve drugs on the basis of unverified surrogate end points, meaning that clinical benefits for these products are uncertain at the time of approval. However, state Medicaid programs are legally required to cover these drugs. Little is known about the set of products with accelerated approval over time, their use among Medicaid beneficiaries, or the magnitude of their financial influence on …

The Rhetorical Transformations And Policy Failures Of Prescription Drug Pricing Reform Under The Trump Administration, Rachel Sachs

Scholarship@WashULaw

Throughout his four years in office, President Trump made prescription drug pricing a focus of his policy agenda. President Trump not only used strong language to criticize the pharmaceutical industry and its practices but also introduced ambitious reform policies that had previously lacked acceptance among Republican policy makers. President Trump appears to have been successful in developing a new populist form of rhetoric that Republicans can use in support of novel drug pricing reforms such as the ones his administration considered. From a policy perspective, however, the Trump administration failed to implement any of their more ambitious reform ideas. This …

The Search For Answers: Overcoming Chaos And Inconsistency In Addressing The Opiod Crisis, John Kip Cornwell

Mitchell Hamline Law Review

No abstract provided.

Vaccination Equity By Design, Olatunde C.A. Johnson, Kristen Underhill

Faculty Scholarship

This Essay examines how states’ initial COVID-19 vaccine-distribution strategies tended to disadvantage populations of color, including Black, Latinx, and Native American communities. These dynamics resonate with “inverse equity” effects of other public-health innovations. We argue for a federal regulatory framework to reduce inequity-forcing effects during initial vaccine rollout.

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Lewis & Clark Law Review

This Article examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high school students. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to 3.6 million youth.

This Article reviews the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by allowing …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

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 Double-Edged Sword Of Medical Patents: How Monopolies On Healthcare Products Disparately Impact Certain American Populations, Sarah Mcgraw

The University of Cincinnati Intellectual Property and Computer Law Journal

No abstract provided.

Litigating An Epidemic: California Plaintiffs In The National Opioid Litigation, Samantha T. Pannier

Loyola of Los Angeles Law Review

Can litigation solve a public health epidemic? The opioid epidemic has cost California 24,885 lives, $4.3 billion, and counting. As a result, over 500 California cities, counties, and sovereign Indian tribes are engaged in civil litigation against over twenty different opioid manufacturers, distributors, and pharmacies for their role in creating and profiting from an epidemic of addiction. Cases brought by California plaintiffs account for about 20 percent of all ongoing opioid litigation nationally. This Note situates the claims of three California plaintiffs— the State, the County of Mariposa, and the City of Los Angeles—within the context of the ongoing national …

Shifting The Burden On Pay-For-Delay Challenges: Analyzing Ab 824’S Effects On Reverse Payment Settlements And Drug Costs, Kevin Wallentine

Loyola of Los Angeles Law Review

Antitrust scholars and agencies have recognized the anticompetitive impact of reverse payment settlements—in which branded and generic drug companies settle patent disputes, typically by delaying the entry of generics into the market. Despite clear competition concerns, these settlements are typically subject to a rule of reason analysis that puts the burden on enforcers and plaintiffs to prove their anticompetitive harms. Recent California legislation—AB 824—shifts the burden to the settling drug companies to prove their arrangement is not anticompetitive. AB 824 presents an opportunity for advocates of lower drug costs but still faces hurdles and shortfalls. This Note examines the efficacy …

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 …

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 …

Oklahoma V. Purdue Pharma: Public Nuisance In Your Medicine Cabinet, Justin Kaufman

Cardozo Law Review

No abstract provided.

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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 …

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.

Something To Celebrate?: Demoting Dairy In Canada's National Food Guide, Maneesha Deckha

Journal of Food Law & Policy

In early 2019, the Canadian Government released the much-anticipated new Canada Food Guide. It is a food guide that de-emphasizes dairy products and promotes plant-based eating. Notably, in the new version, milk and milk products are de-listed as one of the previously four essential food groups. On the surface, it seems that the federal government is promoting veganism and helping to bring about a friendlier future for animals and humans harmed by being producers and consumers of dairy, as the new Guide may seriously contract the currently robust Canadian dairy industry and its powerful lobby. On closer inspection, the messaging …

States, Localities And Public Health, David Gartner

West Virginia Law Review

No abstract provided.

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 …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Dickinson Law Review (2017-Present)

No abstract provided.