The FDA Refuses to Change Statements on Ivermectin Despite Court Ruling
The U.S. Food and Drug Administration (FDA) is standing firm on its stance against ivermectin, even after a court ruled that the agency exceeded its authority by advising against its use in treating COVID-19.
The U.S. appeals court stated that the FDA’s statements, including one explicitly telling people to “stop” using ivermectin for COVID-19, went beyond what Congress had authorized the agency to do.
According to U.S. Circuit Judge Don Willett, who wrote the ruling, “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
Despite the court ruling, the FDA has not made any changes to its social media posts or webpage.
For example, an August 21, 2021, Twitter post by the FDA, which has since been renamed X, still remains and states: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The FDA’s webpage on ivermectin has also not been updated and continues to advise against its use for COVID-19.
The appeals court did not require the FDA to take immediate action, but Dr. Robert Apter, the lead plaintiff in the case, believes the FDA should comply with the court’s directive.
Dr. Apter stated, “From an ethical standpoint, the FDA has been instructed not to do what they are doing. They have an ethical and moral obligation to stop advising against the use of effective repurposed drugs for early treatment of COVID.”
When contacted for comment, the FDA declined, stating that it does not comment on ongoing litigation.
In a statement following the court ruling, the FDA clarified that while ivermectin is approved for other uses, it has not authorized or approved it for treating or preventing COVID-19.
The FDA added that healthcare professionals may choose to prescribe approved drugs for unapproved uses if they deem it medically appropriate for individual patients. This practice, known as off-label prescriptions, is common in the United States.
There are indications that the FDA may have removed another webpage after the court ruling. The page stated, “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”
Archived records show that the page was still accessible this year, but it is unclear when it was taken down.
Ivermectin tablets packaged for human use. (Natasha Holt/The Epoch Times)
The Court Ruling
In a ruling by the U.S. Court of Appeals for the Fifth Circuit, Drs. Apter, Bowden, and Marik emerged victorious, overturning a previous decision.
The doctors filed a lawsuit against the FDA in 2022, arguing that the agency was unlawfully interfering with their medical practice by discouraging the use of ivermectin.
According to Jared Kelson, the doctors’ attorney, the FDA is authorized to inform consumers but not to provide medical advice. He made this argument during oral arguments before the panel.
Initially, U.S. District Judge Jeffrey Brown ruled in favor of the FDA, stating that the agency acted within its authority under the Federal Food, Drug, and Cosmetic Act.
However, the appeals court panel disagreed with Judge Brown’s ruling.
Judge Willett wrote, “FDA never points to any authority that allows it to issue recommendations or give medical advice. Nothing in the act’s plain text authorizes FDA to issue medical advice or recommendations.”
Mr. Kelson, the doctors’ attorney, stated, “The decision is pretty clear that the FDA is not a physician and cannot endorse specific treatments or advise on how to approach any specific illness.”
He declined to comment on whether the FDA should update its statements.
While the appeals court ruling supersedes the previous decision, the case will be returned to Judge Brown, who will reconsider the issue of standing.
The FDA had requested the appeals court to dismiss the case based on lack of standing, but the court chose not to address that issue.
The panel stated, “We believe it is more appropriate for the district court to address standing and any other jurisdictional issues. We express no view on those issues and trust the district court’s sound judgment.”
This means that Judge Brown will revisit the case, and his ruling on standing could be overturned.
The government also has the option to appeal the recent appeals court ruling to the U.S. Supreme Court. However, the U.S. Department of Justice, representing the FDA, has not responded to requests for comment.
What concerns are raised by the medical community and Dr. Robert Apter regarding the FDA’s refusal to change its stance on ivermectin?
N October 2020, arguing that the agency’s stance on ivermectin was hindering their ability to provide effective treatment for COVID-19 patients. The court agreed, stating that the FDA had exceeded its authority by advising against the use of ivermectin.
The ruling emphasized that while the FDA has the power to inform the public about the risks and benefits of medications, it does not have the authority to recommend that consumers stop using a particular drug. This distinction is crucial, as it highlights the limitations of the FDA’s role in advising the public.
Despite this clear ruling, the FDA has yet to make any changes to its statements on ivermectin. The agency’s social media posts and webpage on the topic still advise against its use for COVID-19. This refusal to comply with the court’s directive has raised concerns among the medical community and the lead plaintiff in the case, Dr. Robert Apter.
Dr. Apter believes that from an ethical standpoint, the FDA has an obligation to stop advising against the use of effective repurposed drugs for early treatment of COVID-19. He argues that the agency’s failure to do so is not only unethical but also detrimental to public health.
When contacted for comment, the FDA declined, citing ongoing litigation as the reason for their silence. While it is understandable that the agency may choose not to comment on a matter that is still before the courts, it is crucial for them to address the concerns raised by the court ruling.
In a statement following the ruling, the FDA clarified its position on ivermectin. While the medication is approved for other uses, the agency has not authorized or approved it for treating or preventing COVID-19. However, the FDA acknowledged that healthcare professionals may choose to prescribe approved drugs for unapproved uses if they believe it is medically appropriate for individual patients. This practice, known as off-label prescriptions, is common in the United States.
There are also indications that the FDA may have removed a webpage on ivermectin following the court ruling. The page
