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Food And Drug Regulation: Statutory And Regulatory Supplement (2023), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than

‘A Most Equitable Drug’: How The Clinical Studies Of Convalescent Plasma As A Treatment For Sars-Cov-2 Might Usefully Inform Post-Pandemic Public Sector Approaches To Drug Development, Quinn Grundy, Chantal Campbell, Ridwaanah Ali, Matthew Herder, Kelly Holloway

Articles, Book Chapters, & Popular Press

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021. We found that studies were mobilized and scaled at record pace due to well-connected investigators who engaged in widespread sharing of clinical trials resources, regulatory facilitators, 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.

Training A Public Accommodations Lens On Vaccine Passports, Paul Diller

Lewis & Clark Law Review

The Covid pandemic and the rise of smartphone technology enabled the use of “vaccine passports”—that is, a requirement to show proof of vaccination against Covid—on a scale unmatched before in human history. In the United States, many public accommodations such as restaurants, coffee shops, stadiums, and movie theaters required patrons to show proof of vaccination in order to enter or consume food and drink on the premises. In approximately two dozen local jurisdictions as well as the District of Columbia and Puerto Rico, government mandated that public accommodations do this, with varied carveouts for religious objections and medical or age-based …

Interagency Dynamics In Matters Of Health And Immigration, Medha D. Makhlouf

Faculty Scholarly Works

When Congress delegates authority to an executive agency, it tells us something important about the expertise that Congress wishes to harness in policymaking on an issue. In the legal literature on interagency dynamics and cooperation, issues at the nexus of health and immigration are largely understudied. This Article extends this literature by examining how delegations of authority on issues at the intersection of health and immigration influence policymaking. In an analysis of how administrative law models apply to three topics in the shared regulatory space of the Department of Health and Human Services (“HHS”) and the Department of Homeland Security …

The Democratic Problems With Washington As The Capital, David Fontana

GW Law Faculty Publications & Other Works

Democracy demands a capital city that represents a country and is not removed from it. If the government is to be of the people and for the people, then the capital must be able to relate to the people—and the people to the capital. In the United States, democracy struggles not just because of what happens outside of and comes to Washington, but because of what happens inside Washington. The federal government, in other words, faces democratic problems because of the type of place that Washington is. There are many factors to consider in deciding where a country should be …

Privacy For Student-Patients: A Call To Action, Stacey A. Tovino

Emory Law Journal

Consider a law student who has a mental or reproductive health issue that the student wishes to keep private. If the student seeks care at an off-campus health clinic that is not affiliated with the student’s law school or university, the student typically has a number of federally enforceable privacy rights. For example, the federal HIPAA Privacy Rule will typically apply and prohibit the clinic from disclosing the student’s protected health information to professors, parents, and other third parties without the student’s prior written authorization. The law student also will have the right to receive a notice of privacy practices, …

Restorative Justice Diversion As A Structural Health Intervention In The Criminal Legal System, Thalia González

Journal of Criminal Law and Criminology

A new discourse at the intersection of criminal justice and public health is bringing to light how exposure to the ordinariness of racism in the criminal legal system—whether in policing practices or carceral settings—leads to extraordinary outcomes in health. Drawing on empirical evidence of the deleterious health effects of system involvement coupled with new threats posed by COVID-19, advocates and academics have increasingly called for race-conscious public health-driven reforms to carcerality in the United States. Recognizing the significance of health to carceral reform, the initiation of a health justice grounded lexicon in criminal justice has opened the doorway to new …

Childhood Vaccination Crisis: A Constitutional Analysis Of New York’S Response To Abuse Of The Religious Exemption, Megan O’Boyle

Student Works

No abstract provided.

Digital Contact Tracing – Is It Worth The Hype?#, Miruh Linda Jeon

Student Works

No abstract provided.

Taking Care Of Business: An Empirical Examination Of The Top S&P 500 Companies And Their Role As Public Health Regulators During The Covid-19 Pandemic, Megan M. O’Malley

Student Works

No abstract provided.

Gag With Malice, Shaakirrah R. Sanders

Washington and Lee Law Review

This Article brings agriculture privacy and other commercial gagging laws into the ongoing debate on the First Amendment actual malice rule announced in New York Times v. Sullivan. Despite a resurgence in contemporary jurisprudence, Justices Clarence Thomas and Neil Gorsuch have recently questioned the wisdom and viability of Sullivan, which originally applied actual malice to state law defamation claims brought by public officials. The Court later extended the actual malice rule to public figures, to claims for infliction of emotional distress, and—as discussed in this Article—to claims for invasion of privacy and to issues of public importance or concern.

United …

Sustainable Development Goals, Between Politics And Soft Law: The Emergence Of “Political Normativity” In International Law, Ilias Bantekas, Katerina Akestoridi

Emory International Law Review

International lawyers tend to draw sharp distinctions between law and politics. Yet, despite the Sustainable Development Goals (SDGs) and its predecessors being a product of politics, the commitments undertaken therefrom suggest a new brand of politics where functionality overrides the search for normative characteristics. The political dimension of the SDGs overshadows its legal dimension because the implementation of the key stakeholders’ political commitments is crucial in achieving the SDGs’ stated aims. As international law and international relations are moving towards universal common interests and away from strict international normativity, the SDGs can best be described as a hybrid between soft …

Duped By Dope: The Sackler Family’S Attempt To Escape Opioid Liability And The Need To Close The Non-Debtor Release Loophole, Bryson T. Strachan

Law Student Publications

The opioid epidemic continues to rage on in the United States, ravaging its rural populations. One of its main causes? OxyContin. Purdue Pharma (“Purdue”), the maker of OxyContin, aggressively marketed opioids to the American public while racking up a fortune of over $13 billion dollars for its owners,3 the Sackler family. As a result, roughly 3,000 lawsuits were filed against Purdue and members of the Sackler family. Generally, the lawsuits alleged that Purdue and members of the Sackler family knew OxyContin was highly addictive yet aggressively marketed high dosages of the drug and misrepresented the drug as nonaddictive and without …

Privacy For Student-Patients: A Call To Action, Stacey A. Tovino

Faculty Articles

Consider a law student who has a mental or reproductive health issue that the student wishes to keep private. If the student seeks care at an off-campus health clinic that is not affiliated with the student’s law school or university, the student typically has a number of federally enforceable privacy rights. For example, the federal HIPAA Privacy Rule will typically apply and prohibit the clinic from disclosing the student’s protected health information to professors, parents, and other third parties without the student’s prior written authorization. The law student also will have the right to receive a notice of privacy practices, …

Taming Online Public Health Misinformation, Tomer Kenneth

Faculty Scholarship

No abstract provided.

Physicians Spreading Medical Misinformation: The Uneasy Case For Regulation, Richard S. Saver

Minnesota Law Review Vols. 106:2 onward (2021-present)

Physicians have played a surprisingly prominent role in the current “infodemic” of false and misleading medical claims. Yet, state medical boards, the governmental agencies responsible for professional licensure and oversight, have sanctioned remarkably few physicians. Pushing back against the widespread criticism of medical boards for insufficient action, this Article questions the overall suitability of licensure regulation to police medical misinformation. First, uncertainty exists about medical boards’ jurisdiction and legal authority. Many misinformation claims have involved physicians communicating publicly, not while treating patients. Given the primarily patient-centered legal and ethical frameworks governing the practice of medicine, serious challenges arise in making …

Inequitable By Design: The Patent Culture, Law, And Politics Behind Covid-19 Vaccine Global Access, Ximena Benavides

University of Michigan Journal of Law Reform

COVID-19 vaccine access has been highly inequitable worldwide, with coverage depending largely on a country’s wealth. By the end of 2021, 64.1% of people living in high-income countries had received at least one dose of the vaccine, compared to only 5.4% of those in low-income countries. Similarly, only high- and upper-middle-income countries had received the most effective vaccines.

The uneven distribution of these lifesaving vaccines is made complex due to the convergence of several factors, but it suggests that the extraordinary expanding and ossifying market and political power of a few vaccine manufacturers founded on intellectual property and complementary policies …

Policies For Expanding Hepatitis C Testing And Treatment In United States Prisons And Jails, Tessa Bialek, Dr. Matthew J. Akiyama M.D.

University of Michigan Journal of Law Reform

Hepatitis C virus (HCV) is highly prevalent in United States prisons and jails. In prisons and jails, rates of infection are ten to twenty times greater than national levels. And, more than thirty percent of all people living with HCV in the United States will spend time in prisons and jails in any given year. Rates are especially high among people who inject drugs (PWID), a population whose members are also likely to move between carceral settings and the community. Thus, addressing HCV among incarcerated populations would have a significant effect on the virus’s transmission both in and out of …

Pathways To Justice: Positive Rights, State Constitutions, And Untapped Potential, Dustin Coffman

Marquette Benefits and Social Welfare Law Review

Positive rights, as a concept, are nothing new. Though they may not have always had such a deceptively unequivocal name, positive rights have existed in various forms and mediums throughout history. They've been utilized, underutilized, and, in some cases, outright ignored. At their core, positive rights are the imposition of an obligation upon the state to fulfill some declared right or benefit. One basis for this imposition is that because citizens give up certain rights by being parties to the "social contract," they should be entitled to certain positive protections guaranteed by the state created by way of said "contract." …

Advancing Racial Justice Through Civil And Criminal Academic Medical-Legal Partnerships, Yael Cannon, Vida Johnson

Georgetown Law Faculty Publications and Other Works

The medical-legal partnership (MLP) model, which brings attorneys and healthcare partners together to remove legal barriers to health, is a growing approach to addressing unmet civil legal needs. But MLPs are less prevalent in criminal defense settings, where they also have the potential to advance both health and legal justice. In fact, grave racial health inequities are deeply intertwined with both civil and criminal injustice. In both spheres, health justice is racial justice. Building on the experiences of the authors in their respective civil and criminal law school clinics at Georgetown University in Washington, D.C., this Article argues that academic …

A Pandemic Of Division: Finding Justice At Work In Challenging Times, Catherine L. Fisk

University of San Francisco Law Review

No abstract provided.

War On Covid: Warfare And Its Discontents, Catherine Powell

Faculty Scholarship

This essay analyzes the wartime framing of “fighting” a war on COVID-19—to “fight that invisible enemy,” coronavirus. How might lawmakers address social crises, such as COVID, with the urgency of an emergency without reinforcing our overly-militarized, securitized, and policed state? The problem with a securitized approach is that the notion of security combines conceptual ambiguity with heightened urgency and this indeterminacy can shape and even distort legality in exceptional moments.

I examine the use of the security framework in the context of war-related legal authority to address the pandemic and steps necessary for building a post-pandemic recovery. Importantly, this project …

Remote Justice & Domestic Violence: Process Pluralism Lessons From The Pandemic, Andrea K. Schneider, Heather Hlavka, Sameena Mulla, Erin Schubert, Aleksandra J. Snowden, Jennica Webster

Articles

Domestic violence procedures, like so many court processes around the world, were forced to go online and remote during the pandemic. The impact was dramatic-there were fewer restraining order petitions filed in the first place and an even lower amount granted. In short, domestic violence survivors, among the most vulnerable in our court system, were even more challenged in the last two years. Like many court systems, Milwaukee will never go back to being fully in-person for all procedures in conjunction with domestic violence. The evolving hybrid choices could provide additional access to justice, or these processes could create additional …

Muted Voices: United States Employees’ Role In Regulating And Protecting Workplace Health, James J. Brudney

Faculty Scholarship

The COVID-19 pandemic has given workplace health a higher profile, perhaps its highest since passage of the Occupational Safety and Health Act of 1970 (OSH Act). Increased visibility and public support are based on national awareness of how frontline essential (FE) workers risked their health and lives to protect fellow Americans and preserve economic stability. That said, the greater attentiveness to workplace health risks, and the heroism of FE workers, has been accompanied by what is at best a limited role for employee voice and participation in improving workplace protections. In a larger context, while unions have been heavily involved …

A Meta-Critique Of Frontier Scholarships On The Laws Of Peacetime Espionage: Towards A Systemic Framework For Lex Specialis, Yang Liu

Journal of Law, Technology, & the Internet

No abstract provided.

Humans In The Loop, Nicholson Price Ii, Rebecca Crootof, Margot Kaminski

Articles

From lethal drones to cancer diagnostics, humans are increasingly working with complex and artificially intelligent algorithms to make decisions which affect human lives, raising questions about how best to regulate these “human in the loop” systems. We make four contributions to the discourse.

First, contrary to the popular narrative, law is already profoundly and often problematically involved in governing human-in-the-loop systems: it regularly affects whether humans are retained in or removed from the loop. Second, we identify “the MABA-MABA trap,” which occurs when policymakers attempt to address concerns about algorithmic incapacities by inserting a human into decision making process. Regardless …

Pay No Attention To The Influencer Behind The Curtain, Eliza Logan

Cardozo Arts & Entertainment Law Journal

The note argues that the Federal Trade Commission (FTC) must strengthen its regulation of social media influencers, particularly on platforms like Instagram, due to their significant influence on consumer behavior and the potential for deceptive marketing practices. It emphasizes that influencers should be held accountable similarly to advertising agencies, as their unique ability to build trust and authenticity with followers makes their endorsements more impactful than traditional advertising.

Should The Ncaa Be Subject To Title Ix?, Sarah Allen

Cardozo Arts & Entertainment Law Journal

The note argues that the National Collegiate Athletic Association (NCAA) should be held accountable under Title IX of the Education Amendments of 1972, despite its current exemption, due to its significant role in college athletics and the persistent gender disparities in treatment of male and female athletes. It advocates for overturning the Supreme Court's decision in NCAA v. Smith to bring the NCAA under Title IX purview.

Compensating Differentials For Occupational Health And Safety Risks: Implications Of Recend Evidence, W. Kip Viscusi, Thomas J. Kniesner

Vanderbilt Law School Faculty Publications

The most enduring measure of how individuals make personal decisions affecting their health and safety is the compensating wage differential for job safety risk revealed in the labor market via hedonic equilibrium outcomes. The decisions in turn reveal the value of a statistical life (VSL), the value of a statistical injury (VSI), and the value of a statistical life year (VSLY), which have both mortality and morbidity aspects that we describe and apply here. All such tradeoff rates play important roles in policy decisions concerning improving individual welfare. Specifically, we explicate the recent empirical research on VSL and its related …