The U.S. Food and Drug Administration’s (FDA) guidance for people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.
“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, said during a Nov. 1 hearing in federal court in Texas.
“They use informal language, that is true. It’s conversational but not mandatory.”
The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.
Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for nonapproved purposes in the United States; the practice is known as an off-label treatment.
The FDA created a webpage in 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and later posted a link to the page on Twitter while writing: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
A second post stated: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”
On a separate page, the FDA stated: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”
Those actions interfered with the doctors’ practice of medicine, violating the laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit alleges.
It asked the court to rule the actions unlawful and bar the FDA from directing or opining as to whether ivermectin should be used to treat COVID-19.
