Law Commons^™

Sanitation: Reducing The Administrative State’S Control Over Public Health, Lauren R. Roth

Scholarly Works

On April 18, 2022, in Health Freedom Defense Fund, Inc. v. Biden, United States District Judge Kathryn Kimball Mizelle vacated the mask mandate issued by the Centers for Disease Control and Prevention. Following a framework laid out in other decisions restricting CDC actions in response to COVID-19, the court found that the agency lacked statutory authority to protect the public from the virus by requiring mask wearing during travel and at transit hubs because Congress did not intend such a broad grant of power. Countering decades of public health jurisprudence, the federal district court failed to defer to experts and …

The Nih-Moderna Vaccine: Public Science, Private Profit, And Lessons For The Future, Christopher J. Morten

Faculty Scholarship

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

The President’S Remedy–What The Hydroxychloroquine Story Teaches Us About The Need To Limit Off-Lable Prescribing Powers, Jennifer Bard

Catholic University Law Review

When the history of the first year of the United States Government’s response to the COVID-19 virus is written, there is likely to be mention of the still unexplained vehemence with which then president Donald J. Trump made use of his access to social media to promote seldom used anti-malaria drug, hydroxychloroquine, for both the prevention and treatment of COVID-19 despite the active growing opposition of most of the world’s scientists, including his own government scientists. While the use of drugs developed and approved by the FDA for different purposes to combat new diseases, off-label prescribing, is legal in the …

Health Choice Or Health Coercion? The Osha Emergency Temporary Standard Covid-19 Vaccination Mandates: Ax Or Vax, Savannah Snyder

Helm's School of Government Conference - American Revival: Citizenship & Virtue

No abstract provided.

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 …

Beyond Compulsory Licensing: Pfizer Shares Its Covid-19 Medicines With The Patent Pool, Chenglin Liu

Faculty Articles

On March 15, 2022, the United States, European Union, India, and South Africa reached an agreement on the waiver of intellectual property rights (IP rights) for COVID-19 vaccines. The waiver agreement has rekindled the debate on the balance between IP rights protection and equitable access to medicines during a public health crisis. India, South Africa, and other developing countries maintain that a waiver was the only way to make vaccines affordable and accessible. Leading pharmaceutical companies argue that the waiver will stifle innovation and make lifesaving medicines less accessible. Both sides have seemingly overlooked Pfizer's voluntary agreement with the Medicines …

Safeguarding The Public: Why Workers’ Rights Education Should Be Required Learning For Nurses, Esperanza N. Sanchez

Touro Law Review

Nurses are integral to the delivery of quality health care in this country. They set aside their own needs and fears to provide care and other social services to people across a multitude of settings, taking on the burdens and stresses of others. However, our profit-driven health care system incentivizes employers to maximize productivity at reduced costs by asking nurses to do more with less. Nurses are expected to endure harsh working conditions, proven to be harmful to the nurses’ health and well-being, despite evidence showing that poor working conditions can lead to poor patient outcomes.

There are numerous worker …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

Applying The Health Justice Framework To Address Health And Health Care Inequities Experienced By People With Disabilities During And After Covid-19, Robyn M. Powell

Washington Law Review

The COVID-19 pandemic has been especially devastating for people with disabilities, as well as other socially marginalized communities. Indeed, an emerging body of scholarship has revealed that people with disabilities are experiencing striking disparities. In particular, scholars have shined a light on state and hospital triage policies that allow hospitals to ration critical health care and resources, such as ventilators, for people with disabilities if resources become limited and they cannot treat all patients during the pandemic. These injustices deserve extensive consideration from policymakers, legal professionals, and scholars.

Elucidating how the inequities that people with disabilities experience during the COVID-19 …

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Prisons, Nursing Homes, And Medicaid: A Covid-19 Case Study In Health Injustice, Mary Crossley

Articles

The unevenly distributed pain and suffering from the COVID-19 pandemic present a remarkable case study. Considering why the coronavirus has devastated some groups more than others offers a concrete example of abstract concepts like “structural discrimination” and “institutional racism,” an example measured in lives lost, families shattered, and unremitting anxiety. This essay highlights the experiences of Black people and disabled people, and how societal choices have caused them to experience the brunt of the pandemic. It focuses on prisons and nursing homes—institutions that emerged as COVID-19 hotspots –and on the Medicaid program.

Black and disabled people are disproportionately represented in …

Euthanasia Of The Coronavirus - Covid-19, Sheila P. Davis

Journal of Health Ethics

At the time of this editorial, COVID-19, aka the Novel Coronavirus, has wrecked havoc and left in its path of destruction, death, unemployment, the instability of nation’s economies, misery, uncertainty, despair, and a fear regarding what the new tomorrow will look like. And, perhaps more importantly, the question of who will be here tomorrow lingers. Now classified as a pandemic, this virus has resulted in over 1,381,014 cases worldwide with 78,269 deaths to date. Presently, Louisiana and Detroit are emerging as the next hot spots behind New York as the fastest rate of increase for COVID-19 cases in the world. …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …