FDA: Campaign against ivermectin use was only a suggestion

The Food and Drug Administration (FDA) is trying to claim its aggressive crusade against the use of ivermectin to treat COVID-19 was just a suggestion. 

The agency made the remarks this month in court while trying to defend itself against three prominent physicians who are suing the FDA for its statements on ivermectin. 

The FDA has repeatedly discouraged the use of ivermectin as an early COVID-19 treatment, harping on the fact that the drug was originally approved as an antiparasitic which is often used on animals.  

“You are not a horse. You are not a cow. Seriously, y’all. Stop it,” tweeted the FDA last year. In a similar post, the agency wrote, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.” Reponses show that the tweet had its intended effect.  

The tweets were surprising to many because the FDA, which approved the drug in 1966, was fully aware that ivermectin is manufactured as an antiparasitic both for animals and humans.  

Also puzzling was the FDA’s interference in the off-label use of an approved drug. About 20% of all prescriptions are written for off-label use, and the FDA typically leaves it up to physicians to determine its use.   

“From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient,” says the FDA on its website. 

But when it came to ivermectin, the FDA was emphatic: “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” reads the title of a webpage the FDA created last year. In a separate factsheet, the FDA responds to the question “Should I take ivermectin to prevent or treat COVID-19?” by answering “No,” explaining that it has not been approved for that use. 

Now the FDA is saying its statements were only “recommendations". 

“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, told a federal court in Texas during a Nov. 1 hearing, according to The Epoch Times. 

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.” 

The three physicians suing the FDA are Dr. Mary Bowden, Dr. Robert Apter and Dr. Paul Marik, who was prescribing ivermectin for early COVID-19 and was forced to resign due to the FDA’s statements. The Association for American Physicians and Surgeons (AAPS) last month filed an amicus brief in support of the motion.