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The U.S. Food and Drug Administration is authorized to provide guidance on drugs and convey that information to the public. When the FDA approves a medication, it means the agency considers the drug safe and effective for its intended use. Doctors still may prescribe drugs off-label for unapproved uses based on their medical judgment, the FDA says.
The FDA has not changed its guidance on ivermectin. It has not approved the drug for use in preventing or treating COVID-19.
Recently, an attorney representing the FDA said the agency’s guidelines about ivermectin do not prevent doctors from prescribing the drug off-label, or for different, non-FDA-approved uses. The attorney did not say ivermectin is approved by the agency as a treatment for COVID-19.
Conservative pundits, politicians and social media users are claiming that the U.S. Food and Drug Administration recently reversed its guidance on the use of ivermectin as a treatment for COVID-19.
"We learned this morning that the FDA is now saying that it’s OK to take ivermectin if you have COVID," said Fox Business host Maria Bartiromo on an Aug. 11 "Mornings with Maria" segment with Sen. Ron Johnson, R-Wis.
In response, Johnson pushed baseless conspiracy theories about COVID-19, claiming the pandemic was "preplanned" by unnamed elites. After the segment, Johnson posted on X, formerly Twitter, "Now the FDA quietly approves ivermectin’s use? What’s going on?"
PolitiFact reached out to Bartiromo for comment, but did not receive a reply before publication.
Conservative commentator Charlie Kirk shared the Fox Business clip on X and said, "The FDA has now endorsed treating COVID with Ivermectin!"
These posts were flagged as part of Meta’s efforts to combat false news and misinformation on its News Feed. (Read more about our partnership with Meta, which owns Facebook and Instagram.)
But the claims misrepresent an FDA attorney’s recent remarks about ivermectin.
The agency has not changed its guidance on the drug. A spokesperson told PolitiFact that the FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19.
The ivermectin debate has persisted since the start of the pandemic, but there’s no conclusive evidence that the drug is effective in treating COVID-19. And the FDA says that in large doses, it can be dangerous.
The federal agency has approved the use of ivermectin to treat humans with certain parasitic infections, such as pediculosis caused by head or body lice, or skin conditions, such as rosacea. The FDA urges people to take ivermectin only as prescribed by a health care provider.
The claims follow recent testimony in a federal court case involving the FDA and ivermectin proponents.
In June 2022, three doctors who support using ivermectin to treat COVID-19 filed a federal lawsuit in Texas, claiming the FDA exceeded its authority and violated the Administrative Procedure Act, which governs federal agencies’ process of developing and issuing regulations, by interfering with their practice of medicine.
A judge at the Texas district court dismissed the case in December 2022, and the plaintiffs appealed to the New Orleans-based 5th U.S. Circuit Court of Appeals. A panel of three judges heard oral arguments Aug. 8.
Jared Kelson, the plaintiffs’ attorney, argued the FDA lacks the authority to influence or interfere with how physicians prescribe ivermectin, even if it is for purposes different than what the FDA has approved.
Ashley Cheung Honold, a Justice Department attorney representing the FDA, argued the agency has the authority to provide guidance on drugs and convey that information to the public, and the FDA was doing so with its statements on ivermectin. Honold said these statements were not regulations and carry no legal consequences.
When the FDA approves a medication, it means the drug is safe and effective for its intended use, according to the agency’s website.
Honold was not saying that the FDA recommends using ivermectin to treat COVID-19; she was arguing that the agency’s guidelines about how to use ivermectin do not prevent doctors from prescribing the drug off-label, or for different uses than what the FDA has approved.
Here is Honold’s full quote, which is about 22 minutes into the oral arguments: "Your Honor, the FDA has multiple overlapping sources of authority that I'm happy to walk through that gives the FDA authority to convey information to the public, but here the FDA is not regulating the off-label use of drugs. These statements are not regulations, they have no legal consequences.
"They don't prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose."
Bartiromo claimed that "the FDA is now saying that it’s OK to take ivermectin if you have COVID."
Bartiromo and social media users took out-of-context remarks made during federal court proceedings involving the FDA. The attorney representing the FDA said the agency’s ivermectin guidelines do not prevent doctors from prescribing the drug off-label, or for uses different from what the FDA has approved.
The attorney did not say ivermectin is approved by the FDA as a treatment for COVID-19.
The FDA has not changed its guidance on ivermectin. The agency has not authorized the drug for use in treating or preventing COVID-19.
We rate this claim False.
Fox Business, "Media’s ‘game plan’ is to ‘downplay’ the severity of corruption in Biden admin: Sen. Ron Johnson," Aug. 11, 2023
Instagram post, Aug. 13, 2023
Instagram post, Aug. 14, 2023
X post, Aug. 11, 2023
Sen. Ron Johnson, X post, Aug. 11, 2023
Email exchange with Chanapa Tantibanchachai, spokesperson for the U.S. Food and Drug Administration, Aug. 14, 2023
U.S. Food and Drug Administration, "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19," Dec. 10, 2021
U.S. Food and Drug Administration, "Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19," April 13, 2023
YouTube, "22-40802 Apter v. Dept of Health & Human Svc," Aug. 8, 2023
U.S. Court of Appeals for the Fifth Circuit, "Apter v. Dept of Health & Human Svc oral argument recording," Aug. 8, 2023
U.S. District Court for the Southern District of Texas, "Apter v. Dept of Health & Human Svc," June 2, 2022
Courthouse News Service, "Ivermectin proponents ask Fifth Circuit to revive lawsuit against FDA," Aug. 8, 2023
Verify, "No, the FDA did not approve the use of ivermectin to treat COVID-19," Aug. 14, 2023
PolitiFact, "A Nobel Prize and a horse dewormer: Explaining the controversy over ivermectin and COVID-19," Sept. 8, 2021
PolitiFact, "Ivermectin was approved by the FDA to treat some diseases, not COVID-19," Sept. 15, 2021
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