U.S. Supreme Court

The Supreme Court’s Rulings on COVID-19 Vaccine Mandates, Explained

By Kaitlynn Milvert

In a pair of rulings issued January 13, the Supreme Court put on hold the federal vaccine-or-test requirements for large employers, but allowed federal vaccination requirements for health care workers to take effect while they are litigated in the lower federal courts.

The Court decisions each addressed questions of whether federal agencies — the Occupational Safety and Health Administration (OSHA) and the Centers for Medicare and Medicaid Services (CMS) — have authority to set these vaccination-related requirements.

In doing so, the Court drew new and unprecedented lines between the kinds of risks that agencies operating outside of the health care context — such as OSHA — have power to address through federal regulations. The Court’s decisions on these issues are likely to loom large in future litigation as federal vaccine requirements continue to be litigated in the lower courts.

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Person filling syringe from vial.

The Beginning of the End of Federalism As We Know It Here on Earth One and Earth 616?

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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Desolate winter scene.

A Timeline of Biden’s Pandemic Response, Part 4: Winter of Death (December 2021 – Present)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first, second, and third parts here.

By Justin Feldman

On December 1, 2021, the CDC issued a press release announcing that it had identified a case of the Omicron variant in the U.S. for the first time.

White House insiders admit that they were unprepared for Omicron, just as they were unprepared for Delta. Vice President Harris recently told an interviewer that the administration was caught flatfooted because their scientific advisors never warned that such variants could crop up (at least two of these advisors, Rick Bright and Celine Gounder, begged to differ).

While vaccination still provides powerful protection against hospitalization and death due to infection from Omicron, protection against symptomatic illness is weaker than before, particularly among those who have not received boosters. And though evidence is mounting that the risk of hospitalization and death is lower for each person infected compared to Delta, Omicron’s extremely high transmissibility means that a large fraction of the population will become infected in a short time period, particularly in the absence of additional public health measures.

On December 21, as the highly contagious variant started to sweep the country, President Biden delivered remarks about the new threat. For the hundred million Americans who remain unvaccinated, the president’s speech warned of the imminent risk of hospitalization and death. For the vaccinated and boosted, Biden’s message was: Keep Calm and Carry On, all will likely be fine. And for Wall Street, the speech was meant to provide a crucial piece of reassurance: There would be no federal support for public health measures that restrict commerce.

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Empty toolbox.

A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first and second parts here.

By Justin Feldman

Over the summer of 2021, concern grew that the vaccines were not providing the near-perfect protection against symptomatic disease and transmission that had first emboldened the administration to jettison other public health measures.

It was initially unclear whether the issue was Delta’s higher transmissibility or waning immunity from vaccines, as the first groups had been vaccinated nearly a year prior. There was noticeable concern from CDC, which acknowledged the “war has changed” in a set of leaked slides from July 29, 2021. Of particular concern were case reports from Massachusetts and internationally of high viral loads observed among those who were vaccinated and infected. In late July, CDC reversed course on its mask guidance and recommended indoor masking for all, including the fully vaccinated, in counties with high transmission. In late September 2021, CDC reversed course on its quarantine guidance, which had previously stated that fully vaccinated people should not quarantine after a known SARS-CoV-2 exposure.

These changing epidemiologic realities could have brought about a course correction and a push for other public health policies to complement vaccination. Instead, the administration mostly adapted by shifting its messaging.

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BETHESDA, MD - JUNE 29, 2019: NIH NATIONAL INSTITUTES OF HEALTH sign emblem seal on gateway center entrance building at NIH campus. The NIH is the US's medical research agency.

Will NIH Learn from Myriad when Settling Its mRNA Inventorship Dispute with Moderna?

By Jorge L. Contreras

The National Institutes of Health (NIH) is currently embroiled in a dispute over the ownership of patent rights to Moderna’s flagship mRNA COVID-19 vaccine (mRNA-1273).

The NIH, which funded much of Moderna’s research on the COVID-19 vaccine, should be assertive in exerting control over the results of this taxpayer-funded research. Failing to do so would be a missed opportunity for the public sector to have a say in the distribution and pricing of this critical medical technology.

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Vial and syringe.

A Timeline of Biden’s Pandemic Response, Part 2: A Pandemic of the Unvaccinated (May – Sept. 2021)

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. Read the first part here.

By Justin Feldman

Framing vaccination as a way to opt out of the pandemic, and understanding the unvaccinated to be political enemies, has helped absolve the Biden administration of its responsibilities to protect the public’s health and facilitated the relentless push to restore “normalcy” (i.e., full economic activity).

The administration knows better: In September 2020, while the vaccines were still being tested, key figures in Biden’s orbit warned that it was unlikely vaccination alone could sufficiently control the pandemic.

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President Joe Biden and Vice President Kamala Harris.

From Shutting Down the Virus to Letting it Rip: A Timeline of Biden’s Pandemic Response

This series, which will run in four parts, has been adapted from “A year in, how has Biden done on pandemic response?” which was originally published on January 5, 2022 on Medium. 

By Justin Feldman

Welcome to our “winter of severe illness and death.”

Hospitals are becoming overwhelmed in various parts of the U.S., and one model predicts more than 120,000 COVID deaths will occur in the first two months of 2022.

How did we get here? How is our Democratic president — who ran, in part, against Trump’s horrid pandemic response — letting the virus rip? How did we get to a point where a key organizer of the Great Barrington Declaration, a right-wing libertarian campaign opposed to public health measures, has stated that Republican and Democratic states alike have adopted policies in line with their philosophy? As hospitals fill up around the country, why are political leaders doing nothing to at least try to “flatten the curve”?

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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Stacks of books against a burgundy wall

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

By Ameet Sarpatwari, Beatrice Brown, Aviva Wang, 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 November. The selections feature topics ranging from an analysis of cost-effectiveness studies of oncology drugs approved between 2015 and 2020, to payer-specific negotiated prices for prescription drugs at top-performing US hospitals, to an assessment of access to COVID-19 vaccines in countries where they were tested.

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