Tag: research

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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Empty classroom.

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

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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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child getting vaccinated

How Can Policymakers Encourage COVID-19 Vaccine Trials for Children?

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Cross-posted from Written Description, where it originally appeared on December 18, 2020. 

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

The past two weeks have been full of exciting COVID-19 vaccine news, including the FDA’s emergency use authorizations (EUAs) for the Pfizer–BioNTech and Moderna vaccines and the nationwide rollout of Pfizer’s vaccine. Choosing how to allocate access to vaccine doses has been left to individual states, leaving policymakers with difficult decisions about how to prioritize their populations, complicated in part by the federal government’s reduction in some vaccine shipments.

With a limited supply of doses, who should get the first shots? Some commentators have suggested prioritizing children early for a host of reasons, including hope about children returning to school. Last month a New York Times column asserted that “saving the most lives could mean prioritizing the vaccination of children and young adults.” But there is an important reason that kids can’t be part of the vaccine line yet: we don’t know whether these vaccines work for them. In this post, we explain why COVID-19 vaccines are only just starting to be tested in children and what policymakers can do to spur pediatric vaccine trials.

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Senior citizen woman in wheelchair in a nursing home.

Seniors’ Perspectives on Dementia and Decision-Making

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By James Toomey

In order to make a decision recognized in law — to enter into or enforce a contract, buy or sell property, or get married or divorced — an individual must have the mental capacity the law requires for the decision. As people, especially older adults, develop dementia, their decision-making abilities are increasingly compromised, and the law begins to find that they lack capacity for particular decisions.

The standards governing capacity determinations, however, are notorious for being vague, inconsistently applied, and excessively curtailing the rights of those with dementia. Part of the problem, I think, is the lack of an agreed-upon normative theory for when in the course of dementia the law ought to intervene in individual decision-making. That is why, here on Bill of Health, I’ve previously called for understanding the perspectives of seniors — the population affected by the doctrine of capacity most closely and most often — on this normative question.

In my recent publication “Understanding the Perspectives of Seniors on Dementia and Decision-Making” in AJOB Empirical Bioethics, I’ve begun to do so, reporting the results of an empirical study that I conducted with the Petrie-Flom Student Fellowship in the 2018-19 academic year. The study, which involved an online survey of and interviews with older adults, revealed a heterogeneity of ways of thinking about the problem, supporting a flexible legal doctrine that would assist people in making their own choices. Notwithstanding the diversity, however, the data reveal several conclusions and tensions of interest to academics and healthcare and legal practitioners.

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

COVID-19 and the FDA Emergency Use Authorization Power

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By Anne Kapnick

The Food and Drug Administration (FDA) is responsible for protecting public health by regulating the production, distribution, and consumption of food, cosmetics and drugs.[1] In the healthcare arena (the focus of this post), the FDA strives to ensure the safety, efficacy, and security of drugs, biological products, and medical devices.[2] The FDA also ensures that the “public get[s] the accurate, science-based information they need to use medical products and foods to maintain and improve their health.”[3] This blog post provides an overview of the FDA’s emergency authorization powers, analyzes the extent of their usage in the COVID-19 pandemic, and concludes by flagging potential concerns regarding the FDA’s management of this vast power.

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Vaccine.

How are COVID-19 Vaccine Manufacturers Building Trust in the FDA’s Approval Process?

The Petrie-Flom Center Staff Leave a comment

Cross-posted from Written Description, where it originally appeared on October 2, 2020. 

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

In recent weeks, a number of articles have reported great concern around the politicization of the approval process for future COVID-19 vaccines. Public trust in public health agencies is arguably at an all-time low. After several missteps, the FDA has been working publicly to shore up public confidence in an approved vaccine once it comes out. But pharmaceutical companies themselves are now also engaging the public themselves in an attempt to build trust in their products. This is an unusual step for, of course, unusual times. What are vaccine developers doing, how should policymakers think about these efforts, and how can we encourage these lines of communication in the future?

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Map of United States made up of pills.

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 September. The selections feature topics ranging from commentaries on political pressures and questions of integrity facing the FDA, to a critique of the financial incentive structure for antibiotic development, to an estimation of how much NHS England would spend if it paid U.S. Medicare Part D prices. A full posting of abstracts/summaries of these articles may be found on our website.

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Society or population, social diversity. Flat cartoon vector illustration.

The Cost of Exclusion in Psychedelic Research

The Petrie-Flom Center Staff Leave a comment

By Xinyuan Chen, Mackenzie Bullard, Christy Duan, Jamilah R. George, Terence Ching, Stephanie Kilpatrick, Jordan Sloshower, and Monnica Williams

In the last two decades, researchers have started to reexamine psychedelics for their therapeutic potential. Though initial results seem promising, the research has a significant shortcoming: the lack of racial and ethnic diversity among research teams and study participants.

In the 1960s, psychedelic substances such as LSD, psilocybin, and mescaline were a major part of American counterculture. Less well-known is that, concurrently, researchers were studying potential therapeutic uses of these mind-altering substances. Unfortunately, psychedelics were classified as Schedule I drugs in 1970, halting research into their therapeutic benefits.

The recent renaissance of psychedelic research shows these substances have significant capabilities for treating anxiety, depression, posttraumatic stress disorder (PTSD), and substance use disorders. But these promising results are limited in their applicability: an analysis from 2018 showed that 82.3% of all study participants in psychedelic trials internationally were non-Hispanic Whites, and only 2.5% were African-American.

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3D illustration of man with his brain highlighted

What Psychedelic Research Can Learn from Science, and What It Can Teach

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By Manoj Doss

As a psychedelic researcher, I find myself increasingly frustrated by the tendency of the field to make lofty claims about the drugs that stray from the realities and limitations of the data.

For example, psychedelic research that uses neuroimaging employs measures of brain function that are, in fact, quite crude. Typically, one signal in a brain scan can mean many things (amygdala activation can occur when one is scared, happy, observing something salient, etc.).

For this reason, cognitive neuroscientists typically constrain mental activity using behavioral tasks in order to make more educated inferences regarding what is happening in the mind. Yet for some reason, psychedelic scientists believe they can infer mental function from the activity of a few tripping brains under task-free conditions. That is, participants are essentially doing whatever they want in the scanner, making the number of possible inferences one could make nearly infinite. And worse, they base their claims on outdated Freudian theory.

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Young male doctor in telehealth concept

COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are

The Petrie-Flom Center Staff 2 Comments

By Sarah V. Ferranti and Shine Chen Schattgen

“Decentralized” clinical trials (referred to as “DCTs”) are not novel, but nevertheless failed to gain real momentum given the regulatory and operational complexities involved. In light of COVID-19, however, it seems almost certain that the remote and virtual study activities that characterize DCTs, and a site and sponsor’s ability to flex to “meet the participant where they are” will be critical to the conduct of clinical trials going forward.

In the first half of 2020, as health care facilities prepared for capacity-exceeding patient volumes and equipment shortages, non-essential clinical care and non-COVID-related clinical trials came to a screeching halt. According to ClinicalTrials.gov, 1473 clinical trials were suspended, terminated, or withdrawn between December 1, 2019 and July 1, 2020, with a reported reason that explicitly mentioned COVID-19.

At the same time, initiation of clinical trials for COVID-19 vaccines and treatments exploded at speeds previously considered unachievable within the clinical trial industry. As of October 13, 2020, 811 COVID-19-related clinical trials had been initiated in the United States. To enable COVID-19 trials and, more recently, to restart previously paused non-COVID trials, clinical trial sponsors and sites have been forced to quickly adapt to protect participants and preserve the integrity of clinical trial data and results.

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