Tag: COVID19

Assortment of menstrual products.

Period Poverty and the COVID-19 Pandemic: Policy Challenges and Opportunities

Cara Tenenbaum Leave a comment

By Cara Tenenbaum

Despite the need for period products among all who menstruate, there are few policies addressing the associated financial burdens.

Monthly menstrual product expenses average $13.25 per month, according to one survey. These costs are prohibitive for some, contributing to the phenomenon known as “period poverty,” which describes a lack of access to period products due to cost.

Period poverty, like so many other health inequities, has gotten worse during the Coronavirus pandemic. This post addresses the challenges and opportunities to address period poverty at federal, state, and local levels.

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Vial and syringe.

What Can Policymakers Learn from the Slow COVID-19 Vaccine Rollout?

The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on January 12, 2021. 

By Lisa Larrimore Ouellette, Nicholson Price, Rachel Sachs, and Jacob S. Sherkow

In the middle of a record number of COVID-19 infections and deaths—and continued evidence of racial disparities in the pandemic’s effects—December brought some good news to the fight against the pandemic: the FDA’s emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna vaccines and the ensuing nationwide rollouts. The record-breaking vaccine development timeline and the videos of healthcare workers receiving early vaccines are worth celebrating.

But the subsequent distribution has been tragically slow—echoing distribution challenges for COVID-related goods ranging from PPE to diagnostics. On Dec. 29, Dr. Leana Wen noted that at the initial vaccination rate, it would take 10 years to vaccinate the roughly 80% of Americans needed to achieve herd immunity. According to Bloomberg’s vaccine tracker, as of today, fewer than 10 million vaccines have been administered in the United States. States are still sitting on nearly two-thirds of the doses they have received, and the federal government is holding half the U.S. supply in reserve. In this post we explain what went wrong and how policymakers can correct course for COVID-19 and avoid such disasters in the future.

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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

The Petrie-Flom Center Staff Leave a comment

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

By Jonathan Iwry

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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Photograph of a stack of magazines on a chair

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Beatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of December. The selections feature topics ranging from an analysis of potential approaches for evaluating novel SARS-CoV-2 vaccine candidates after other vaccines have already been authorized; to an examination of social, cultural, and economic aspects of microbial resistance; to a study on clinical evidence supporting FDA clearance of novel therapeutics devices via the de novo pathway. A full posting of abstracts/summaries of these articles may be found on our website.

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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.

The Consequences of Public Health Law Vacuums

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By Daniel Goldberg

Pandemic planning documents and materials from the early 2000s to the present anticipated a great deal of what the U.S. has been experiencing during the COVID-19 pandemic. The best of such plans documented exactly what be required to manage, respond, and control a pandemic spread by a highly communicable respiratory virus like SARS-CoV-2.

What the plans did not account for was what we are now experiencing: That governments would simply refuse to govern.

Few truly accounted for the possibility that the very entities charged with regulating for the health, safety, and welfare of their residents and citizens would simply decline to do so, choosing instead the public health law vacuums in which we find ourselves at the present time. Read More

Syringe being filled from a vial. Vaccine concept illustration.

Is Israel Trading Medical Information for Vaccines? Ethical and Legal Considerations

Shelly Simana Leave a comment

By Shelly Simana

On January 7, Israeli Prime Minister Benjamin Netanyahu announced that millions of vaccines are expected to arrive in Israel, and that by March, anyone who wishes to get vaccinated will be able to do so.

He concluded his speech with a controversial statement: “as part of the agreement [with Pfizer], we stipulated that Israel will serve as a global model state for a rapid vaccine rollout of an entire country… Israel will share with Pfizer, with all of humanity, the statistics that will help in developing strategies to defeat the coronavirus” (my translation, from Hebrew).

But which statistics, what kind of data, will be shared with Pfizer? This question remains a mystery.

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COVID-19 fake news concept illustration.

COVID-19 Vaccine Misinformation and the Anti-Vaccine Movement

Dorit Reiss 18 Comments

By Dorit Rubinstein Reiss

The anti-vaccine movement is aggressively working to promote misinformation about COVID-19 vaccines, up to and including promoting fake claims of deaths from vaccines. We need to be aware of its efforts, and be prepared to respond.

It’s worth emphasizing that this blog post is focused on the anti-vaccine movement, not people with concerns about vaccines (the “vaccine hesitant”).

In relation to COVID-19, anti-vaccine activists have aggressively promoted misinformation from the start of the pandemic.

In March 2020, anti-vaccine activists incorrectly alleged – by misrepresenting a study – that flu vaccines increase COVID-19 risks. In June, anti-vaccine activist Del Bigtree described COVID-19 as a “cold,” blamed those who died for their own deaths, and called on his followers to “catch that cold.”

And from the beginning, anti-vaccine activists were committed to the ideas that COVID-19 vaccines would not work, would be dangerous, and would be promoted by a nefarious global conspiracy. They continue to spread these allegations, for example, using the fact that there are liability protections for COVID-19 vaccines to imply the vaccines are dangerous. Liability protections for COVID-19 vaccine manufacturers are real; but they are not evidence that the vaccines are unsafe.

This post will focus on one type of misinformation: alleged deaths from COVID-19 vaccines.

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Empty classroom.

Can Schools Require the COVID-19 Vaccine? Education, Equity, and the Courts

The Petrie-Flom Center Staff Leave a comment

By Emily Caputo and Blake N. Shultz

As school systems consider policy options for the spring semester, both vaccination requirements and proposals to address inequities in access to education may be top of mind. However, policymakers should be aware of the possible legal challenges they may face.

The COVID-19 pandemic has created an educational crisis in the United States by disrupting the learning of millions of students across the country. School closures, remote learning, and generalized societal stress have all raised serious concerns about persistent harm to adolescent learning and development — particularly among low-income and minority students.

While the pandemic has exposed widespread inequities in educational opportunity, it has also revealed the relative inability of the courts to promote access to education. A recent California lawsuit illustrates the manner in which students must rely on state-level, rather than federal, protections to ensure equal access to education. And COVID-19 vaccination requirements, which could facilitate a return to in-person education, are likely to result in lawsuits, and may be struck down by a skeptical and conservative Supreme Court.

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hospital equipment

Balancing Health Care Rationing and Disability Rights in a Pandemic

The Petrie-Flom Center Staff Leave a comment

By Yolanda Bustillo and Rachel Perler

Amid the present surge of the coronavirus pandemic, it is crucial that disability rights are a factor in the development of triage protocols.

During the last week of December, the CDC recorded a record of 225,269 new coronavirus cases and 118,948 total hospitalizations. Health care systems across the country have predicted that they soon may face shortages of ventilators, personal protective equipment (PPE), and other limited resources.

In Utah, for example, hospital administrators have implemented informal triage protocols that prioritize patients based on health status, clinical factors, and the time sensitivity of their needed procedures. Hospitals in California have similarly begun rationing care.

If these dire circumstances worsen, hospital systems may apply triage protocols that deviate from best practices and impermissibly discriminate against people with disabilities.

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