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Unpatenting Product Hops, Michael S. Sinha

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On July 9, 2021, President Joseph R. Biden signed Executive Order 14036 (“Promoting Competition in the American Economy”), which directed the U.S. Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to collaborate on new approaches to increasing competition and lowering prices in the pharmaceutical marketplace. In response, the USPTO outlined several new initiatives, among them an intent to improve the robustness and reliability of issued patents.

A major impetus for the Executive Order was the pervasive nature of pharmaceutical product hopping, which occurs when manufacturers introduce new follow-on versions of lucrative pharmaceutical products to the …

Reproductive Rights And Medico-Legal Education Post-Dobbs: A Fireside Chat, Michael S. Sinha, Anna Krotinger, Maya A. Phan, Louise P. King

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The Supreme Court’s 2022 decision in Dobbs v. Jackson Women’s Health Organization was a pivotal moment that reshaped the landscape of abortion policy and delivery of abortion care in the United States. To create a space for critical reflection on the implications of Dobbs for the teaching and learning of abortion care in both medical and legal education, the authors engage in a dialogue highlighting the varied perspectives of professionals and professionals-in-training in both the medical and legal professions. As new attacks on reproductive autonomy continue at both state and federal levels, we foreshadow a tumultuous landscape for abortion policy …

Ai Renaissance: Pharmaceuticals And Diagnostic Medicine, Ty J. Feeney, Michael S. Sinha

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The explosive growth of Artificial Intelligence (AI) in the modern era has led to significant advancements in the world of medicine. In drug discovery, AI technology is used to classify proteins as drug targets or non-targets for specific diseases, more accurately interpret and describe pharmacology in a quantitative fashion, and predict protein structures based on only a protein sequence for input. AI methods are used in drug development to generate predictive models for drug screening purposes, refine and modify candidate structures of drugs to optimize compounds, and predict a drug’s physiochemical properties, bioactivity, and toxicity. For medical devices, the advancement …

Public Health Product Hops, Michael S. Sinha

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Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

The Psychology Of Science Denialism And Lessons For Public Health Authorities, Brenna Moreno, Molly J. Walker Wilson

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As it wreaked tragedy on the world, the outbreak of COVID-19 helped expose a pandemic of a different kind, one steeped in distrust and contrarianism. This movement, termed science denialism, has been lurking and undermining public health efforts for decades. Specifically, it is “the employment of rhetorical arguments to give the appearance of legitimate debate where there is none, an approach that has the ultimate goal of rejecting a proposition on which a scientific consensus exists.” Unlike skepticism, which is “doubt as to the truth of something” and works to progress both science and society, denialism is characterized by individuals’ …

Pandemic Federalism, Cary Coglianese

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Legislators, agency officials, and the public have a lot to learn from the United States’ experience in responding to the COVID-19 pandemic. If policymakers take seriously their responsibility to identify past mistakes, and then act now to prepare for future viral outbreaks, the nation can do better in the next crisis. One needed change will take the form of clarifying the essential role for the national government and its leadership in responding to pandemics. The United States needs to create a structure for a pandemic federalism that temporarily but responsively allows for a reconfiguration of public health authority, such that …

What Covid-19 Laid Bare: Adventures In Workers’ Compensation Causation, Michael C. Duff

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This essay performs a close analysis of workers’ compensation coverage of COVID-19 and arrives at the conclusion that it should not be “impossible” to prove in a legal sense that an employee’s COVID-19 was caused by work. Scientific proof is not the same as legal proof: workers’ compensation law has never required that claims must be supported by irrefutable scientific proof of workplace causation. Yet repeatedly one heard this suggestion during public discussion on workers’ compensation coverage of employees.

Still, there is good evidence that even when workers’ compensation undisputedly covers work-related disease employers seldom pay benefits (and states do …

Lessons Learned: Strengthening Medicaid To Address Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

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COVID-19 has disproportionately harmed low-income people, especially Black and Latino populations, seniors, and people with disabilities. Medicaid plays an essential role in providing coverage and access to care for these populations. As COVID-19 disrupted employment, earnings, and insurance coverage, Medicaid enrollment increased, in part because Congress offered states increased Medicaid funding in return for maintaining eligibility and enrollment for the duration of the public health emergency (PHE). At the same time, many states expanded eligibility and streamlined enrollment to assure that people could secure and keep coverage. Such policies resulted in more than 5.3 million more Americans having Medicaid coverage …

Property And Intellectual Property In Vaccine Markets, Ana Santos Rutschman

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As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that [h]appy families are all alike; every unhappy family is unhappy in its own way.¹ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy's principle² in the field of biopharmaceutical innovation.

The Intellectual Property Of Covid-19, Ana Santos Rutschman

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The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, …

Is There A Cure For Vaccine Nationalism?, Ana Santos Rutschman

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“[V]accine nationalism . . . should serve as a reality check for the status of global health cooperation in the twenty-first century.”

Protecting The Rights And Wellbeing Of People With Disabilities During The Covid-19 Pandemic, Elizabeth Pendo

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The COVID-19 pandemic has exposed and exacerbated significant inequities experienced by people with disabilities. It has also emphasized the value of legal protections against discrimination based on disability. The Americans with Disabilities Act was enacted 30 years ago to eliminate discrimination against people with disabilities and ensure equal opportunity across major areas of American life (ADA, 2008). Together with an earlier law, the Rehabilitation Act of 1973 Rehabilitation Act, 2012), this landmark civil rights law impacts a broad range of issues raised by the COVID-19 pandemic and protects a large and growing number of Americans. This Chapter focuses on application …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

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Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Gaps In Worker Protections That Increase Essential Workers’ Exposure To Covid-19, Ruqaiijah Yearby

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States and localities designated more than 55 million Americans as essential workers. Essential workers not only comprise those employed by the health care and food and agriculture industry, but also include teachers, grocery store workers, transit and airline workers, mail and delivery workers, energy sector and utility workers, and domestic workers (Petition for Emergency, 2020). Racial and ethnic minorities are disproportionately employed as essential workers, with Black Americans the most likely to be essential workers (Petition for Emergency, 2020). Essential workers have been left vulnerable to workplace COVID-19 infections and deaths in large part due to the federal and state …

Covid-19 Employee Health Checks, Remote Work, And Disability Law, Elizabeth Pendo

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The Americans with Disabilities Act (ADA) prohibits discrimination against people with disabilities, about 61 million individuals in the U.S. The law’s protections in the workplace are especially important during COVID-19, which has worsened pre-existing disparities experienced by people with disabilities. The ADA also applies to new strategies to reduce the risk of COVID-19 infection in the workplace. This Chapter will focus on two strategies that impact individuals with and without disabilities – employee health screening, testing and vaccination policies, and new or expanded remote work programs.

Vaccine Clinical Trials And Data Infrastructure, Ana Santos Rutschman

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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 …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

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This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Administrative Law In A Time Of Crisis: Comparing National Responses To Covid-19, Cary Coglianese, Neysun A. Mahboubi

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Beginning in early 2020, countries around the world successively and then together faced the same rapidly emerging threats from the COVID-19 virus. The shared experience of this global pandemic affords scholars and policymakers a comparative lens through which to view how differences in countries’ governance structures and administrative responses affected their ability to manage the various crisis posed by the pandemic. This article introduces a special series of essays in the Administrative Law Review written by leading administrative law experts across the globe. Case studies focus on China, Chile, Germany, Italy, New Zealand, South Africa, and the United States, as …

Sustaining Lawyers, Seema Saifee

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Many lawyers are drawn to a career in social justice, in part, to help others and, in part, to fulfill their own path to wellness. Advocacy that sustains personal well-being, however, also poses considerable obstacles to well-being. Some of these obstacles are inherent to social justice work but some are embedded within organizational culture. These cultural norms impair the health of advocates, harm the communities with whom they work, and portend far-reaching consequences for the future of progressive struggles for freedom. Drawing on the author's personal experience, this Essay identifies three cultural norms, described as pathologies, that are rarely discussed …

FacebookʼS Latest Attempt To Address Vaccine Misinformation — And Why ItʼS Not Enough, Ana Santos Rutschman

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On October 13, 2020 Facebook announced the adoption of a series of measures to promote vaccine trust “while prohibiting ads with misinformation that could harm public health efforts.” In the post written by Kang-Xing Jin (head of health) and Rob Leathern (director of product management), the company explained that the new measures were designed with an emphasis on encouraging widespread use of this yearʼs flu vaccine, as well as in anticipation of potential COVID-19 vaccines becoming available in the near future.

The changes focus mainly on the establishment of a multiprong informational campaign about the seasonal flu vaccine, which includes …

Pandemic Response As Border Politics, Michael R. Kenwick, Beth A. Simmons

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Pandemics are imbued with the politics of bordering. For centuries, border closures and restrictions on foreign travelers have been the most persistent and pervasive means by which states have responded to global health crises. The ubiquity of these policies is not driven by any clear scientific consensus about their utility in the face of myriad pandemic threats. Instead, we show they are influenced by public opinion and preexisting commitments to invest in the symbols and structures of state efforts to control their borders, a concept we call border orientation. Prior to the COVID-19 pandemic, border orientation was already generally …

Resolving Tensions Between Disability Rights Law And Covid-19 Mask Policies, Elizabeth Pendo, Robert Gatter, Seema Mohapatra

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As states reopen, an increasing number of state and local officials are requiring people to wear face masks while out of the home. Grocery stores, retail outlets, restaurants and other businesses are also announcing their own mask policies, which may differ from public policies. Public health measures to stop the spread of the coronavirus such as wearing masks have the potential to greatly benefit millions of Americans with disabilities, who are particularly vulnerable to the impact of COVID-19. But certain disabilities may make it difficult or inadvisable to wear a mask.

Mask-wearing has become a political flashpoint, putting people with …

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

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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 …

The Reemergence Of Vaccine Nationalism, Ana Santos Rutschman

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This short essay explores the reemergence of vaccine nationalism during the COVID-19 pandemic. The essay traces the pre-COVID origins of vaccine nationalism and explains how it can have detrimental effects on equitable access to newly developed vaccines.

PortugalʼS Response To Covid-19, Ana Santos Rutschman

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This essay for the Regulatory Review's special series on Comparing Nations’ Responses to COVID-19 examines the early response to the pandemic in Portugal. The essay focuses on measures adopted in connection with the declarations of state of emergency and state of calamity, as well as the treatment of migrant populations throughout the pandemic.

The Case For Face Shields: Improving The Covid-19 Public Health Policy Toolkit, Timothy L. Wiemken, Ana Santos Rutschman, Robert Gatter

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As the United States battles the later stages of the first wave of COVID-19 and faces the prospect of future waves, it is time to consider the practical utility of face shields as an alternative or complement to face masks in the policy guidance. Without face shields specifically noted in national guidance, many areas may be reluctant to allow their use as an alternative to cloth face masks, even with sufficient modification.

In this piece, we discuss the benefits of face shields as a substitute to face masks in the context of public health policy. We further discuss the implications …

Covid-19 And The Conundrum Of Mask Requirements, Robert Gatter, Seema Mohapatra

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As states begin to loosen their COVID-19 restrictions, public debate is underway about what public health measures are appropriate. Many states have some form of mask-wearing orders to prevent the spread of COVID-19 infection. Public health guidance from the Centers for Disease Control and Prevention and the World Health Organization has conflicted. From a public health point of view, it is not clear what the right answer is. In the absence of directives, individuals are also making their own choices about mask use. At a time when public health measures, like shelter-in-place orders and social distancing, are being used to …

Vaccines And Ip Preparedness In The Coronavirus Outbreak, Ana Santos Rutschman

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The COVID-19 pandemic has shed renewed light on the importance of research and development (R&D) on biopharmaceutical products needed to prevent or lessen the burden posed by outbreaks of infectious diseases. Among these, the need for new vaccines has become of paramount importance. While a race to develop different types of vaccines unfolds at unusual speed, there are still significant shortcomings in the ecosystem that leads to the production and dissemination of vaccines targeting infectious diseases like COVID-19.

Law, Structural Racism, And The Covid-19 Pandemic, Ruqaiijah Yearby, Seema Mohapatra

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Racial and ethnic minorities have always been the most impacted by pandemics because of: disparities in exposure to the virus; disparities in susceptibility to contracting the virus; and disparities in treatment. This article explains how structural racism, the ways in which laws are used to advantage the majority and disadvantage racial and ethnic minorities, has caused these disparities. Specifically, this article focuses on how employment, housing, health care, and COVID-19 relief laws have been manipulated to disadvantage racial and ethnic minorities, making minorities more susceptible to COVID-19 infection and death. This article uses Blumenshine’s 2008 framework to outline how structural …

Structural Discrimination In Covid-19 Workplace Protections, Ruqaiijah Yearby, Seema Mohapatra

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Workers, who are being asked to risk their health by working outside their homes during the COVID-19 pandemic, need adequate hazard compensation, safe workplace conditions, and personal protective equipment (PPE). Sadly, this is not happening for many essential workers, such as those working in home health care and in the meat processing industry. These workers are not only being unnecessarily exposed to the virus, but they are also not receiving paid sick leave, unemployment benefits, and affordable health care and childcare. The lack of these protections is due to structural discrimination and has disproportionately disadvantaged women of color and low-wage …