Pile of colorful pills in blister packs

Expanding The Right to Try Unproven Treatments: A Dangerous, Deregulatory Proposal

By Richard Klein, Kenneth I. Moch, and Arthur L. Caplan

A new proposal out of the Goldwater Institute (GI), a libertarian think tank, advances an oversimplified critique of the U.S. regulatory process for approving medicines for COVID-19 and other diseases, with the ultimate goal of weakening the U.S. Food and Drug Administration.

You may remember the Goldwater Institute as the architect of the initial state “Right to Try” (RtT) legislation from a few years ago. The idea, marketed as increasing access to experimental medicines, was actually calculated to circumvent FDA oversight so that individuals could try still-unproven experimental medicines without what Goldwater viewed as pointless bureaucratic paternalism. RtT legislation was adopted by 41 states and ultimately by the U.S. Congress.

When former President Trump signed the Right to Try bill into federal law with great fanfare on May 20, 2018, he stated that “countless American lives will ultimately be saved.” Three years later, the promise proved to be meaningless, as evidenced by the difficulty in identifying more than a handful of individuals who have even pursued the RtT pathway, much less finding data to show that it has saved lives.

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Close up of a Doctor making a vaccination in the shoulder of patient.

The Legality and Feasibility of COVID-19 Vaccine Mandates for Children

By Dorit Rubinstein Reiss

On May 10, 2021 the U.S. Food and Drug Administration (FDA) expanded its Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include children aged 12-15.

The vaccine was previously authorized for use in those aged 16 and older. The company has announced it will seek emergency use authorization for younger children by September.

Now that children over the age of 12 can get vaccinated against COVID-19, will immunization against SARS-CoV-2 become a requirement for the return to public schools this fall?

My answer: In the near term, we probably will not see COVID-19 vaccine mandates for school children. And in the longer term, it depends.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

By Chloe Reichel

On February 26th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

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Empty classroom.

Can Colleges and Universities Require Student COVID-19 Vaccination?

This post originally appeared on the Harvard Law Review Blog.

By I. Glenn Cohen and Dorit Rubinstein Reiss

In the last year, colleges and universities across the U.S. struggled with how to operate during the COVID-19 pandemic. The most recent data, from January 2021, shows a mix of online and in-person modes of instruction.

Pie chart of modes of instruction for higher education institutions during the pandemic.

At the same time, a study of the experience in early fall 2020 found an association between colleges and universities with in-person instruction and increased infection incidence in the counties within which the schools were located. With vaccine authorization in the U.S. and the promise of potential availability for student populations in late spring and summer 2021 (in most states’ allocation plans these students are among the last groups in prioritization), there is increasing interest by higher education institutions in moving more of their fall 2021 educational instruction and non-instructional activities to in-person modes. Vaccinating students is a key step to safely reopening campuses, in whole or in part, in a way that is safe for students, faculty, staff, and local communities. At the same time, university leaders are likely reasonably concerned about the legality of mandating COVID-19 vaccines. Not all students, faculty or staff may appreciate such a requirement, and anti-vaccine groups are more than ready to assist in litigation — as, for example, they did when the University of California required influenza vaccines for on-campus attendance (a preliminary injunction in that case was denied). In this essay, we discuss whether universities can legally require vaccination as a condition of attendance and with what accommodations.

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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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Patient receives Covid-19 vaccine.

Can Employers Mandate a Vaccine Under Emergency Use Authorization?

By Dorit Rubinstein Reiss

Several months ago, I wrote a post asking whether employers can mandate the uptake of a vaccine under an Emergency Use Authorization (EUA). My view then was that there was substantial legal uncertainty, but that the balance indicated that at the least, they may be possible, at the discretion of the Secretary of the Department of Health and Human Services (HHS).

Much of that discussion is still relevant, but developments and new points brought to my attention since have changed my view.

At this point, while there is still legal uncertainty, my view is that the balance of factors supports the ability of employers (or states) to require EUA vaccines. Courts vary, but my current assessment is that most courts would be inclined to uphold an employer mandate for an EUA COVID-19 vaccine.

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Person receiving vaccine.

Complex Regulations Push Employers Toward Voluntary Vaccination Programs, Not Mandates

By Lauren Hammer Breslow, JD, MPH

As COVID-19 vaccines become increasingly available, employers have been thrust into the spotlight on the public health question of whether or not to mandate vaccination for employees.

Despite strong evidence that mandatory vaccines best serve public health, a rubric of laws making mandatory programs complicated to deploy is leading many employers to favor vaccine encouragement policies.

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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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Stacks of books against a burgundy wall

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 November. The selections feature topics ranging from an analysis of Medicare Part D spending on inhalers from 2012 to 2018, to an overview of vaccine development and regulations to better understand how COVID-19 vaccines will be evaluated, to an analysis of the ethical implications of emergency authorization of COVID-19 drugs for patient care. A full posting of abstracts/summaries of these articles may be found on our website.

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Close up of a Doctor making a vaccination in the shoulder of patient.

Authorize Emergency Vaccines for COVID-19, but Do It Well

By Holly Fernandez Lynch, Alison Bateman-House, and Arthur Caplan

The U.S. Food and Drug Administration (FDA) is expected to grant emergency use authorization (EUA) for one or more COVID-19 vaccines before the end of the year — perhaps even before the end of the day, given today’s advisory committee meeting.

The agency’s decision on these EUAs will balance the need for additional data on safety and efficacy against the potential to protect at-risk groups as quickly as possible. EUAs tip the balance in favor of speed, which can be reasonable for these populations given the circumstances, especially in light of the strong trial data reported for three COVID-19 vaccines since mid-November. But the tradeoff is very real: vaccine EUAs will substantially lower the likelihood of ongoing trials completing and new trials successfully recruiting volunteers. There are a few ways to minimize these consequences.

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