The FDA has not changed its position on ivermectin

By: Nikolaj Kristensen
August 15 2023

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Context

A claim is circulating on social media that the U.S. Food and Drug Administration (FDA) has now endorsed or allowed for the drug ivermectin to be used to treat COVID-19 in humans.

The claim follows a court hearing in which an FDA lawyer said that the FDA recognizes doctors’ authority to prescribe ivermectin to treat COVID-19.

This was reported in the Epoch Times, a notorious misinformation repository, with the headline "Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer" published on August 10, 2023. And on August 11, Fox anchor Maria Bartiromo said on air, “The FDA is now saying it’s okay to take ivermectin if you have COVID.” 

The FDA has opposed using ivermectin – originally a veterinary medicine approved for some uses in humans – in treating COVID-19. In one tweet, the FDA wrote, “You are not a horse. You are not a cow. Seriously, y'all. Stop it,” linking to an article about why ivermectin shouldn’t be used to treat COVID-19. 

However, the FDA has not changed its position on ivermectin, as the FDA still has not authorized or approved the drug for treating COVID-19 in humans. The FDA lawyer’s statements reflect what has always been the case, namely that doctors can prescribe approved drugs for unapproved uses.

In fact

On August 8, 2023, there was a hearing in the U.S. Court of Appeals for the Fifth Circuit regarding possible misconduct by the FDA in interfering with the early treatment of COVID-19 by ivermectin.  

During the hearing, the FDA’s lawyer said, “the FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” pointing to various statements made by the FDA during the pandemic. 

This is not a new position, as doctors can prescribe approved drugs for unapproved uses, so-called off-label use, when they judge that it is medically appropriate for their patient. 

Since ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea, it can be prescribed for off-label uses. 

“Currently, the FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans,” a spokesperson for the FDA told Logically Facts.

The FDA lawyer even said as much during the court hearing, stating that "It was proper for FDA to identify what ivermectin was FDA authorized for. It's FDA approved for certain conditions like skin conditions or parasites, and it's not FDA approved for treating COVID."

In an October 2021 article on the FDA webpage, the FDA informs that currently available data does not show ivermectin is effective against COVID-19 and that taking large doses of ivermectin is dangerous. Comprehensive reviews have found evidence of varying certainty that ivermectin has no beneficial effects for the treatment of COVID-19.

The verdict

Recent statements by an FDA lawyer that the FDA explicitly recognizes that doctors have the authority to prescribe ivermectin to treat COVID-19 does not mean the FDA has changed its position on ivermectin. Ivermectin is approved for human use to treat parasitic infections, and doctors can prescribe approved drugs for unapproved uses. The FDA has not authorized or approved ivermectin to prevent or treat COVID-19 in humans. Therefore, we have marked this claim as misleading.

This article was updated on 30 August 2023 to add what the FDA lawyer said during the court hearing.