Photograph of a stack of magazines on a chair

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

By Ameet SarpatwariBeatrice 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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Syringe being filled from a vial. Vaccine concept illustration.

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

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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Police car.

Police Should Not Be Enforcing Emergency Public Health Orders

Cross-posted from COVID-19 and The Law, where it originally appeared on November 9, 2020. 

By Daniel Polonsky

On a weekend when police officers were handing masks to white residents in parks around New York City, NYPD Officer Francisco Garcia forced Donni Wright, a 33-year-old Black man, to the ground and knelt on his neck. Officer Garcia was one of 1,000 NYPD officers dispatched to enforce social distancing and mask-wearing. He had been investigating a report of individuals not wearing masks, although he himself was not wearing one. Police Chief Terence Monahan had previously assured reporters that the police would be educating the public and only breaking up large gatherings, not bothering individuals merely walking outside—“They don’t have a mask, we’ll give them a mask.” But Officer Garcia, who has settled six lawsuits for police misconduct for a combined $182,500, did more than educate that day. Multiple officers were in the middle of arresting two individuals after allegedly spotting a bag of marijuana when Mr. Wright spoke up in their defense. In response, Officer Garcia called him a racial epithet and accosted him, causing severe injuries to Mr. Wright’s back, ribs, and chest. What started as social distancing enforcement ended in racist, excessive use of force.

This incident highlights the overlap between the twin crises state and local governments face: halting the spread of COVID-19 and grappling with the systemic racism that characterizes the American system of policing.

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

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. 

By

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.

Field with sky and clouds.

COVID-19 in Rural America and the Indian Nations

Cross-posted from COVID-19 and The Law, where it originally appeared on October 22, 2020. 

By Chris Zheng

For many, the COVID-19 pandemic is likely to conjure scenes of once-bustling urban centers grinding to a halt. However, for the one in five Americans that live in rural communities, the reality of the pandemic has been markedly different from that of its metropolitan neighbors. The combination of insufficient resources and a particularly vulnerable population has resulted in disproportionate and devastating effects on remote communities.

COVID-19 has also exacerbated gaps in access to care for the 54% of American Indian and Alaska Native people who live in rural towns or reservations. As such, there have been many questions as to what legal measures native groups can take to protect their communities. This piece will first address the unique public health challenges facing rural and native communities during the COVID-19 pandemic. Then, it will conclude by proposing group-specific solutions towards mitigating further harm.

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

Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

HHS Recognizes Key Role of Telehealth in Amended PREP Act Declaration

By Vrushab Gowda

On December 3rd, the Department of Health and Human Services (HHS) extended its provisions to cover telehealth services in amending its Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for Medical Countermeasures Against COVID–19.

This represents the first time HHS has covered telehealth services under the authority of the PREP Act. Telehealth providers are now permitted to deliver a range of COVID-related care across the country, including states in which they do not hold professional licenses. The Declaration, moreover, offers them expansive liability protection, effectively immunizing them against a host of claims in connection to their administration of designated countermeasures.

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Centers for Disease Control and Prevention. Georgia, Atlanta USA March 6, 2020.

The Politics of CDC Public Health Guidance During COVID-19

A version of this post first ran in Ms. Magazine on October 28, 2020. It has been adapted slightly for Bill of Health. 

By Aziza Ahmed

In recent months, public health guidance from the U.S. Centers for Disease Control and Prevention (CDC) has become a site of political reckoning.

The agency has taken an enormous amount of heat from a range of institutions, including the executive and the public, during the COVID-19 pandemic. The former has sought to intervene in public health guidance to ensure that the CDC presents the President and administration’s response to COVID-19 in a positive light. The latter consists of opposed factions that demand more rigorous guidance, or, its opposite, less stringent advice.

Importantly, these tensions have revealed how communities experience the pandemic differently. CDC guidance has produced divergent consequences, largely depending on demographics. These differences have been particularly pronounced along racial lines.

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Grocery store.

COVID-19 Highlights the Vital Connection Between Food and Health

By Browne C. Lewis

Together, food insecurity and COVID-19 have proven to be a deadly combination for Black and Brown people.

Data published by the Centers for Disease Control and Prevention indicates that COVID-19 hospitalization rates among Black and Latino populations have been approximately 4.7 times the rate of their white peers. The CDC suggests that a key driver of these disparities are inequities in the social determinants of health.

Healthy People 2020 defines social determinants of health as “conditions in the environments in which people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.” The lack of access to good quality food is one of the main social determinants of health. People who eat unhealthy food are more likely to have diet-related medical conditions, like hypertension and diabetes, that make them more susceptible to developing severe or fatal COVID-19.

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Janitor mopping floor in hallway office building or walkway after school and classroom silhouette work job with sun light background.

Overworked, Overlooked, and Unprotected: Domestic Workers and COVID-19

By Mariah A. Lindsay*

The COVID-19 pandemic has disproportionately affected communities already facing multiple oppressions, including women, people of color, people living with low incomes, and immigrants.

This post focuses on the impacts of the pandemic on a group that encompasses many of these identities: domestic workers, such as home health care workers, house cleaners, and child care workers.

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a crowd of people shuffling through a sidewalk

COVID-19 Immunity as Passport to Work Will Increase Economic Inequality

By Ifeoma Ajunwa

As scientists develop increasingly accurate tests for COVID-19 immunity, we must be on guard as to potential inequities arising from their use, particularly with respect to their potential application as a prerequisite for returning to the workplace.

A focus on immunity as a yardstick for return to work will only serve to widen the gulf of economic inequality, especially in countries like the U.S., which has severe racial health care disparities and uneven access to effective healthcare. This focus could also serve to diminish societal support for further understanding and curtailing the disease.

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