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The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.
organ transplant

New Regulations for Organ Procurement Organizations Pose Concerns

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By Alexandra Glazier

The United States has one of the highest organ donation and transplant rates in the world. A poorly crafted regulatory change could disrupt our world-leading system and put patients at risk.

Recently, new performance regulations for organ procurement organizations (OPOs) were promulgated by CMS in the last stretch of the Trump Administration, which should be reviewed by the incoming Biden Administration.

While there is widespread support for reform to the system of organ donation and transplantation, including consensus that changes to the CMS metrics measuring OPO performance are warranted, there are significant differences in opinion on how that can be accomplished best.

Bipartisan groups and delegations of both Democrats and Republicans, donor families, the medical community, and donation and transplant professionals as well as OPOs have raised a range of concerns about specific aspects of the proposed and final regulations, making suggestions on how the regulations could be improved to achieve the goal of transplanting more patients.

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AbbVie Wins First Round in Humira Antitrust Lawsuit

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By Ryan Knox and Gregory Curfman

Since receiving FDA approval for Humira® (adalimumab) in 2002, AbbVie, the drug’s manufacturer, has filed hundreds of submissions to the U.S. Patent and Trademark Office for secondary patents – almost half of which were filed after 2014, just two years before the expiration of its core patent.

These patents were largely directed to methods of use and potential formulation changes, but they did not include claims that affect the clinical efficacy of the biologic, which is used in the treatment of rheumatoid arthritis, Crohn’s disease, and psoriasis, among other conditions. Instead, the purpose of the secondary patent filings was to assemble a thicket of patents, 132 in all, to prohibit competition from biosimilar companies.

And so far, the strategy has worked. AbbVie remains the sole U.S. manufacturer of the biologic, and has successfully defended its domain: in June 2020, a federal district court judge in Chicago dismissed an antitrust lawsuit against AbbVie.

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Federal, State, and Local Responses to Student Absenteeism during COVID-19

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By Eileen Macron, J.D.

In the past several years, school attendance and absenteeism have been key focus areas of education policy. Consistent school attendance is necessary for students’ long-term academic success, and the Every Student Succeeds Act of 2015 heightened the role that attendance plays in school performance metrics. The Act requires states to submit multi-factor education plans for measuring and attaining student achievement to the federal government. Most states have chosen to include chronic absenteeism in their plans as one of the ways that they assess student progress. And in many districts, school funding depends partly on daily attendance, a relationship that has been a source of anxiety for — and inequality between — school districts.

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All Rise, All Mute: Online court proceedings, coronavirus, and access to justice

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By Seth Rubinstein, J.D.

“[O]ur system of courts is archaic and our procedure behind the times.”

– Roscoe Pound (Former Dean of Harvard Law School), 1906

The coronavirus pandemic has given new urgency to the failings of the U.S. legal system to provide meaningful access to justice for many Americans. These failings are by no means new, but the pandemic has shone a spotlight on them.

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Protecting Workers During the COVID-19 Pandemic

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By Chris Zheng, J.D.

The absence of a cohesive federal strategy during the pandemic has allowed many businesses to continue operating without standard safety guidelines, endangering employee health. And with new cases of COVID-19 in the United States nearing 200,000 per day, employees’ risk of exposure will only continue to grow. Early litigation and regulatory measures have highlighted two particularly vulnerable groups in need of protection in the workplace: older employees and disabled employees. This post will first examine general deficiencies in employee health protections. Then, it will assess two primary pieces of legislation that afford legal protections to aging and disabled workers. Finally, it will explore possibilities for how to best protect American workers moving forward.

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Cartoon of contact tracing for COVID-19.

The Constitutionality of Technology-Assisted Contact Tracing

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By Dessie Otachliska

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.

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The Education Divide Caused by COVID-19

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By Annie Kapnick

The United States has entered a ‘third’ wave of Covid-19 , and many students are entering yet another month of online learning. The American education system has long been plagued with racial and socio-economic inequalities, but the COVID-19 pandemic and the nationwide shift to online learning has transformed what was an already widening inequality gap into a massive chasm.

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Bill of Health - California USA, truck patrolls road next to fence seperating USA from Mexico, mexico immigration, restrictions on mexican immigration

Unprecedented Expulsion of Immigrants at the Southern Border: The Title 42 Process

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By Morgan Sandhu

In March, President Trump relied on a little-used public health rule to drastically restrict immigration at the United States’ land borders­. President Trump determined that, because COVID-19 was present in Mexico and Canada, there was a serious danger that migrants might further introduce coronavirus into the United States. Although it applies to both borders equally, this new restriction has primarily impacted immigrants at the Southern border.

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Person receiving vaccine.

What You Should Know About the COVID-19 Vaccine

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Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020. 

By Jeff Neal

The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.

On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.

To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.

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