people waiting in a line.

How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line

Cross-posted from COVID-19 and The Law, where it originally appeared on January 27, 2021. 

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Since the Food & Drug Administration granted emergency use authorization for the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna in December 2020, there have been many debates on vaccine allocation and prioritization.

As noted by Harvard Law School Professor Glenn Cohen in a recent interview with Annie Kapnick for the COVID-19 and The Law series, the issue of vaccine distribution is “complicated” because of competing factors decision-makers must consider. The relative weights placed on these factors has led to very different prioritization schemes. Initially, the Centers for Disease Control and Prevention (CDC) recommended a hybrid plan that appeared to prioritize individuals who were most likely to contract the virus (e.g., first responders, grocery store workers) over individuals most vulnerable to severe symptoms or death from the virus if contracted (e.g., individuals over the age of 65 not in long-term care facilities). In the United Kingdom, the prioritization groups were primarily based on vulnerability. Similarly, when looking more narrowly at the various plans being implemented at the state level in the United States, there are high degrees of variation.

This post does not seek to evaluate the merits of these or other specific vaccine allocation plans. Rather, it will address a risk that all plans likely face: the potential of individuals using their wealth and access to “cut the line” and be vaccinated ahead of schedule.
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Syringe being filled from a vial. Vaccine concept illustration.

From 9/11 to COVID-19: A Brief History of FDA Emergency Use Authorization

Cross-posted from COVID-19 and The Law, where it originally appeared on January 14, 2021. 

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The ongoing fight against COVID-19 has thrown a spotlight on the Food and Drug Administration (FDA) and its power to grant emergency use authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety.

Under § 564 of the Food, Drug, and Cosmetic Act (FD&C Act), use of FDA’s EUA authority requires a determination that an emergency exists by secretaries of the Department of Homeland Security, the Department of Defense, or the Department of Health and Human Services (HHS), as well as a declaration by the HHS Secretary that emergency circumstances exist warranting the issuance of EUAs. Each issuance of an EUA requires that FDA conclude that:

  • it is reasonable to believe that a given product “may be effective” as an emergency countermeasure,
  • the known and potential benefits of authorization outweigh the known and potential risks, and
  • no formally approved alternatives are available at the time.

Annie Kapnick’s post on COVID-19 and FDA’s EUA authority provides a helpful overview of FDA’s emergency powers and their use in response to the pandemic. A brief look at the history of FDA’s emergency powers, including key events leading up to their enactment — Thalidomide, swine flu, AIDS, and 9/11 — offers perspective on the situation facing FDA today and its implications for the future. The history of EUA illustrates how its use today against COVID-19 involves fundamental questions about the role of public officials, scientific expertise, and administrative norms in times of crisis.

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Cartoon of contact tracing for COVID-19.

The Constitutionality of Technology-Assisted Contact Tracing

Cross-posted from COVID-19 and The Law, where it originally appeared on December 1, 2020. 

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The COVID-19 pandemic has posed an impossible set of choices for governments, forcing them to weigh the competing interests of protecting public health, ending social isolation, and safeguarding privacy and civil rights. Each of these ends offer distinct societal benefits, but without a vaccine or effective COVID treatment, governments can only accomplish two of the three at one time. South Korea provides an interesting example of the tradeoffs countries have made in pursuit of these competing objectives. The country is widely regarded as a model for successfully managing the pandemic, averaging approximately 77 new cases a day since April—roughly the equivalent of 480 cases a day in U.S. population terms. South Korea’s story is especially impressive given that, in March, the country was considered one of the biggest infection hot spots outside of China. Comparing these statistics with the actual infection rate in the U.S. illustrates the success of the South Korean approach: on November 23, 2020, the CDC reported 147,840 new cases, for a total of 12,175,921 known infections in the U.S. since the pandemic began.

Click here to read the full post on COVID-19 and The Law.

Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

COVID-19 and the FDA Emergency Use Authorization Power

Cross-posted from COVID-19 and The Law, where it originally appeared on November 10, 2020. 

By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs. In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices. The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.” This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

Click here to read the full post on COVID-19 and The Law.

Gloved hand holding medical rapid test labeled COVID-19 over sheet of paper listing the test result as negative.

Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts

By Barbara J. Evans and Ellen Wright Clayton

The federal government recently used preemption unlawfully to prevent state public health efforts to protect vulnerable people from COVID-19.

As 1,000 current and former CDC epidemiologists noted in an open letter, the federal government has failed to use legal powers it does have to manage the crisis, leaving states to “invent their own differing systems” to manage COVID-19. We add that the federal government is now asserting emergency powers it does not have to disable state public health responses.

Early this month, Nevada officials halted the use of two rapid coronavirus tests that produced high false-positive rates when used for screening vulnerable people in Nevada’s nursing homes, assisted-living, long-term care, and other congregate facilities. More than half the positive test results were false.

On October 8, the U.S. Department of Health and Human Services (HHS) sent a letter threatening that the Nevada officials’ action was “inconsistent with and preempted by federal law and, as such, must cease immediately or appropriate action will be taken against those involved.” Nevada yielded to this threat and, on October 9, removed its directive to stop using the tests.

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Up close shot of an orange prison jumpsuit

COVID-19 and Women in the US Criminal Legal System

By Cynthia Golembeski, Carolyn Sufrin, Brie Williams, Precious Bedell, Sherry Glied, Ingrid Binswanger, Donna Hylton, Tyler Winkelman, and Jaimie Meyer

Health and economic inequities exacerbated by the COVID-19 pandemic disproportionately harm women, and particularly women of color, involved in the criminal legal system.

Structural racism, sexism, poverty, substandard healthcare in jails and prisons, and the health effects of incarceration worsen women’s health. The pandemic only compounds these effects. Often overlooked or less visible, incarcerated women are at significantly increased risk of acquiring infectious illness, including COVID-19.

Alternatives to incarceration, and care continuity for chronic health conditions, including substance-use and psychiatric disorders, which disproportionately affect women, are necessary within the current pandemic and beyond.

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Austin, Tx/USA - May 23, 2020: Family members of prisoners held in the state prison system demonstrate at the Governor's Mansion for their release on parole due to the danger of Covid-19 in prisons.

Jails and COVID-19: An Overlooked Public Health Crisis in Philadelphia

By Katherine Zuk

Since the start of the pandemic, jails and prisons have continuously struggled to stop the spread of COVID-19 cases.

The novel coronavirus has been ravaging the U.S. since late February, with over 6 million cases and 185,092 deaths. Emerging data shows alarmingly high rates of COVID-19 in jails and prisons nationwide, including over 85% of inmates testing positive at two facilities in Ohio. As of September 3, there have been at least 180,045 cases and 928 deaths in prisons alone – and many fear these numbers are severely underreported.

Philadelphia offers an unfortunate case study.

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Madison, Wisconsin / USA - April 24th, 2020: Nurses at Reopen Wisconsin Protesting against the protesters protesting safer at home order rally holding signs telling people to go home.

Great Responsibility: Navigating Moral Hazards During COVID-19

By Jacqueline Salwa

Younger people may be driving the COVID-19 pandemic in part because they perceive the costs of complying with public health measures as higher and the expected benefits as lower compared with older individuals.

”Indemnifying Precaution: Economic Insights for Regulation of a Highly Infectious Disease,” a paper recently published in the Journal of Law and the Biosciences, explores how to align costs and benefits so that individuals of all ages adhere to precautions.

Younger people tend to experience less severe symptoms from COVID-19 infection, and may be disproportionately affected by other aspects of the pandemic.  These include depression from lack of social interaction, stifled career advancement, and difficulties with providing for dependents.  Compared to younger people, older people have a greater chance of being settled down, retired, and not responsible for dependents. As a result, those that  receive the least benefit from taking precautions, and incur the greatest personal costs for abiding by these precautions, have a lack of incentive to follow precautionary public health measures. This is known, in economic terms, as a moral hazard.

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basketball on court

The Long-Term Harm of Favoritism in COVID-19 Testing

By Jonathan M. Marron and Paul C. McLean

One of us is a sports fan, childhood cancer doctor, and bioethicist. The other is a former sportswriter drawn to medical ethics since the cure of his only child. If sports and ethics have something in common, it’s the value of a level playing field. Fairness matters. There’s a coin toss: heads or tails. Fairness, not favoritism.

We view the doctor-patient relationship through slightly different lenses, but it’s precious either way. It’s a relationship — above all else — built on trust. And that relationship, a cornerstone of healthcare, is suddenly like an already vulnerable person facing an uncertain prognosis. If the doctor-patient relationship is to survive the novel coronavirus (COVID-19) pandemic, it will require a unified team, trust, and a level playing field, regardless of how much money or influence you have.

What does sports have to do with this?

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