Tag: off-label use

Businessman's hands typing on laptop keyboard in morning light

Sorry, You Probably Cannot Get MDMA Through Telehealth

Vincent Joralemon Leave a comment

By Vincent Joralemon

The U.S. Food and Drug Administration’s recent acceptance of an MDMA-assisted therapy New Drug Application has experts buzzing over expanded access to the infamous substance commonly known as “ecstasy” or “molly.” 

Yet, once approved, FDA will put limits on the approved drug. If past psychedelics are any indication, this means that MDMA will probably need to be provided in a clinic under certain protocols. This means patients will need to wait for other MDMA products to complete clinical trials before we’ll see at-home, private use of the drug.

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Vial and syringe.

Can Children Consent to the COVID Vaccine? The Case of Foster Care and Juvenile Justice

The Petrie-Flom Center Staff Leave a comment

By Victoria Kalumbi

Despite pediatric COVID-19 vaccine availability, many youth remain unvaccinated, and are thus at higher risk of life-altering outcomes as a result of contracting COVID-19.[1]

Some children may be unvaccinated by no choice of their own, but instead because of decisions made by parents, guardians, or state or local government officials.

In this post, I argue that young people should have the opportunity to consent to vaccines. I focus on the specific case of children in foster care and the juvenile justice system, as they are particularly vulnerable amid the ongoing pandemic. However, the legal and political avenues explored in this piece to ensure that young people have a stake in their health and vaccine status are broadly generalizable to all children.

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Child with bandaid on arm.

Reflections on Procedural Barriers to Pediatric COVID Vaccine Access

The Petrie-Flom Center Staff Leave a comment

By Fatima Khan

When news broke last week that Pfizer-BioNTech was submitting for Emergency Use Authorization (EUA) a two-dose COVID vaccine regimen for children under 5 to the U.S. Food and Drug Administration (FDA), many parents felt a glimmer of hope after a long time.

Up until a few days before, the public was expecting approval to possibly drag into summer. While the regimen would likely require a third dose, it became a possibility that children could start getting some level of protection as early as March. Finally children were acknowledged during a time when their needs have often been neglected or even ignored.

The shift in the FDA’s decision process is a critical moment to reflect on how we got here, and what we should strive for to ensure children aren’t repeatedly left behind amidst our new COVID reality.

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Baby held in someone's arms.

Remember the Babies: The Need for Off-Label Pediatric Use of COVID-19 Vaccines

Carmel Shachar Leave a comment

By Carmel Shachar

As trials stall and the omicron variant surges, the U.S. Centers for Disease Control and Prevention (CDC) is failing parents by preventing off-label use of our existing COVID-19 vaccines in the under-five set.

The cries of frustration, anger, and fear from parents of small children have reached a new pitch amidst the ruckus of 2022. Parents of children under five years old need to navigate omicron-fueled rising pediatric hospitalization rates while their kids remain entirely unvaccinated. They must also juggle childcare and work responsibilities amid unpredictable, lengthy daycare and schooling closures. Give us the vaccine to help protect our kids, shorten quarantines, and keep children in care they all clamor.

But where are the vaccines for the pediatric set — the same vaccines that have been proven safe, both in adult populations and in older children? So far the story has focused on disappointing efficacy results and delays in studies from Pfizer and Moderna. But that is not the entire explanation for why parents of small children are blocked from vaccinating their offspring.

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Child with bandaid on arm.

Should Vaccinating Children Off-Label Against COVID-19 Be Universally Prohibited?

The Petrie-Flom Center Staff Leave a comment

By Govind Persad, Patricia J. Zettler, and Holly Fernandez Lynch

As children are experiencing the highest rates of COVID-19 in many states, can efforts to universally preclude vaccination of those under 12 until the U.S. Food and Drug Administration (FDA) specifically authorizes use in that age group be justified?

In a case commentary published today in Pediatrics, we argue that the answer is no.

This view diverges from the positions of the American Association of Pediatrics, FDA, and the U.S. Centers for Disease Control and Prevention (CDC). In fact, the CDC, which controls the nation’s supply of COVID-19 vaccines, has taken steps to currently ban the practice of vaccinating youth under the age of 12.

We acknowledge that recommendations to widely vaccinate 5-11 year olds should await FDA and CDC guidance (which is expected soon, given upcoming advisory committee meetings). But, especially at the lower dose offered in pediatric clinical trials, we think that off-label pediatric administration of approved COVID-19 vaccines, like Pfizer’s Comirnaty mRNA vaccine, should be treated like other off-label uses and left to the individual risk-benefit judgments of doctors and patients (or here, parents).

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Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson.

Access to Drugs Before FDA Approval: Video Explainer with Christopher Robertson

The Petrie-Flom Center Staff Leave a comment

The COVID-19 pandemic has raised many questions about the regulation of drugs in the United States.

One such concern relates to the use of drugs for treatment of COVID-19 that have not yet been FDA approved.

In this video explainer produced by the James E. Rogers College of Law of The University of Arizona, Christopher Robertson, Professor of Law and Associate Dean for Research & Innovation, discusses these issues, including the Right to Try Act and off-label use of pharmaceuticals, with NYU Grossman School of Medicine’s Alison Bateman-House, MPH, PhD.