FDA Refuses to Change Anti-Ivermectin Statements After Court Ruling

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) is refusing to change its statements against ivermectin, even after a court said it acted outside of its authority when it told people to stop using it to treat COVID-19.

The U.S. appeals court said that the FDA’s statements, including one telling people to “stop” using ivermectin as a COVID-19 treatment, went beyond the authority conferred on the agency by Congress.

“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett wrote in the Sept. 1 ruling.

Two weeks later, FDA social media posts and a key webpage remain unchanged.

That includes an Aug. 21, 2021, Twitter post, on the social media site since renamed X, that hyperlinked to a FDA webpage and stated: “You are not a horse. You are not a cow. Seriously, y'all. Stop it.”

The page has not been updated either. It says people “should not use ivermectin to treat or prevent COVID-19.”

The appeals court did not order the FDA to take any action and remanded the case to a lower court for consideration on standing.

But Dr. Robert Apter, the lead plaintiff in the case that led to the ruling, said that the FDA should still take action.

“From an ethical point of view, the FDA has been told not to do what they are doing. They have an ethical and moral obligation to follow the court’s directive and stop giving advice against using effective repurposed drugs for early treatment of COVID,” Dr. Apter told The Epoch Times in a message.

The FDA declined to comment.

“The FDA does not comment on possible, pending, or ongoing litigation,” a spokesperson told The Epoch Times via email.

In a statement after the ruling was handed down, the agency noted that ivermectin is approved by the FDA but for other uses. The FDA “has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the agency said.

“Health care professionals generally may choose to prescribe an approved human drug for an unapproved use when they judge that the unapproved use is medically appropriate for an individual patient,” it added.

Such prescriptions are known as off-label prescriptions and are common in the United States.

Another FDA page may have been removed in the wake of the ruling. That page said, in part: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

Archives show it was still up as of this year but it’s unclear exactly when it was taken down.

Ivermectin tablets packaged for human use. Natasha Holt/The Epoch Times

Ruling

In the ruling, a U.S. Court of Appeals for the Fifth Circuit panel found in favor of Drs. Apter, Mary Talley Bowden, and Paul Marik, overturning a previous decision.

The doctors sued the FDA in 2022 over its anti-ivermectin statements, arguing the agency was illegally interfering with their practice of medicine.

While the Federal Food, Drug, and Cosmetic Act enables the FDA to inform consumers, it does not let the agency give medical advise, Jared Kelson, an attorney representing the doctors, told the panel during oral arguments.

U.S. District Judge Jeffrey Brown had ruled against the plaintiffs, finding the FDA acted within the authority conferred by the act.

The panel disagreed.

“FDA never points to any authority that allows it to issue recommendations or give medical advice,” Judge Willett wrote. “Nothing in the act’s plain text authorizes FDA to issue medical advice or recommendations,” he also said.

“The decision is pretty clear that the FDA is not a physician, and that while it might have authority to inform the public, it can’t endorse particular treatments or advise on how to approach any specific illness,” Mr. Kelson told The Epoch Times.

He declined to comment on whether the FDA should update its statements.

The appeals court decision trumps the previous ruling, but the panel also sent the case back to Judge Brown.

The FDA had asked the appeals court to dismiss the case based on lack of standing. The court said it chose not to decide on the standing issue.

“We see greater wisdom in remanding for the district court to address standing and any other jurisdictional issues in the first instance,” the panel said. “We express no view on those issues, and instead we trust their initial determination to the district court’s sound judgment.”

That means Judge Brown will take up the case again, but that his ruling on standing could be overturned.

The government could also appeal the recent appeals court ruling. That appeal would go to the U.S. Supreme Court. The U.S. Department of Justice, which is representing the FDA, did not respond to a request for comment.