The U.S. Food and Drug Administration spent the better part of 2021 vilifying ivermectin as a means of treating or preventing COVID-19, a drug the agency certified decades ago and which won a Nobel Prize in 2015 for its treatment of parasitic infections.
Despite its long safety record, FDA statements about the drug for COVID-19 use were peppered with cautionary language, and the agency followed up with social media posts featuring a horse, telling people to "stop it."
"You are not a horse. You are not a cow. Seriously, y'all. Stop it," FDA said of the drug, which also comes in various forms approved for use as an anti-parasite drug for animals.
You are not a horse. You are not a cow. Seriously, y'all. Stop it. https://t.co/TWb75xYEY4
— U.S. FDA (@US_FDA) August 21, 2021
Another post followed the same theme: "Hold your horses, y'all. Ivermectin may be trending, but it still isn't authorized or approved to treat COVID-19."
Despite the government's warnings, some studies have shown the drug as a promising treatment and prophylaxis for COVID-19, and doctors across the country prescribed it for off-label use during the pandemic. But the FDA's position set in motion one roadblock after another, as the American Medical Association, the American Society of Health-System Pharmacists, and the CDC also lined up in opposition to ivermectin for COVID-19 use. Even if a patient had a prescription for it, pharmacies began refusing to fill it.
Fast forward to October, when three doctors who were disciplined for prescribing the drug sued the FDA for interfering in their decision-making.
But in a Nov. 1 hearing in federal court, the government argued the statements were just 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," one of the government's attorneys, Isaac Belfer, said, according to The Epoch Times.
Jared Kelson, an attorney representing the plaintiffs, told the court during the hearing that that informal claim “doesn’t explain the language they actually used: ‘Stop it. Stop it with the ivermectin.'”
The FDA’s actions “clearly convey that this is not an acceptable way to treat these patients,” he argued.
Plaintiffs in the case include Dr. Paul Marik, who began utilizing ivermectin in his COVID-19 treatment protocol in 2020 while he was chief of pulmonary and critical care medicine at Eastern Virginia Medical School and director of the intensive care unit at Sentara Norfolk General Hospital.
After the FDA’s statements, Marik was told to remove the protocol from the school’s servers while Sentara issued a memorandum to hospitals telling them to stop using ivermectin against COVID-19, with a citation to the FDA.
Marik was forced to resign from his positions because he couldn’t prescribe ivermectin due to the FDA’s statements, the suit alleges.
The government has moved to dismiss the complaint, asserting plaintiffs lack standing because the injuries cannot be traced back to the FDA.
During the recent hearing, which was on the motion to dismiss, the government said the FDA could not be blamed for the injuries.
“Plaintiffs have also not shown that any of their claimed injuries are fairly traceable to defendants’ statements because their injuries were caused by independent third-party conduct that was not a predictable response to those statements,” Belfer, the government lawyer, said.
Belfer noted that the FDA’s pages say people can use ivermectin if their health care provider prescribes it, argued the statements “did not bind the public or FDA, did not interpret any substantive rules, and did not set agency policy,” and said the FDA’s position could change in the future if new data become available.
“They also do not have legal consequences for anyone but simply provide nonbinding recommendations to consumers,” he said.
Kelson disagreed.
“If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said. “That is enough of a harm to get into court,” or have the motion to dismiss rejected, he said. (The Epoch Times)
The judge, U.S. District Judge Jeffrey Brown, a Trump appointee, said he would rule as "quickly" as possible.
