The U.S. Food and Drug Administration (FDA) likely overstepped its authority when it told Americans to "stop" using ivermectin against COVID-19, a federal court ruled on Sept. 1.
"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 ruling.
The FDA has authority under the Federal Food, Drug, and Cosmetic Act to convey information to consumers.
The FDA during the COVID-19 pandemic issued multiple statements discouraging people from taking ivermectin against COVID-19.
The page it linked to is titled, "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19."
Three doctors sued the FDA over its statements on ivermectin, arguing that the agency cannot advise doctors on which drugs to prescribe.
Ivermectin is approved by the agency as an antiparasitic drug for both humans and animals.
Federal law gives the government immunity against legal actions, with some exceptions. One exception, known as ultra vires, is when an official acts outside their authority. Plaintiffs challenging the acts must show that the official was "acting ‘without any authority whatever,’ or without any ‘colorable basis for the exercise of authority,'" according to an earlier court ruling.
The FDA does have the authority to share data and facts, the parties agree. But they diverge on whether the FDA can issue recommendations on medical matters, such as treatments.
The FDA has claimed that the posts do not contain advice, stating in one brief that they were "informational statements" that "do not ‘direct’ consumers, or anyone else, to do or refrain from doing anything.” At the same time, the FDA acknowledged that the statements "provided recommendations" and "advise[d] consumers."
"Despite these concessions, FDA never points to any authority that allows it to issue recommendations or give medical advice," Judge Willett wrote.
"Rather, FDA argues that some posts included a hyperlink that leads to the update. The update, in turn, directs consumers to '[t]alk to your health care provider.' But not all of the social-media posts included such a link. And even for those posts that did include a link, the posts themselves offer advice, not mere information."
The update itself is problematic because of its title, "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19," the judge said. Even though it later says that people can take ivermectin if prescribed by a health care provider, "the trailing qualifier does not lessen the opening instruction’s imperative character," he said.
Judge Brown erred on the second point as well, according to the new ruling.
"Nothing in the Act’s plain text authorizes FDA to issue medical advice or recommendations," Judge Willett said.
The judge, who sits on the U.S. Court of Appeals for the Fifth Circuit, was joined by U.S. Circuit Judges Edith Brown Clement and Jennifer Walker Elrod.
Judges Willett and Brown were appointed under President Donald Trump. Judges Clement and Elrod were appointed under President George W. Bush.
Dr. Robert Apter, one of the plaintiffs, called the ruling "a big win for doctors and for patients!"
“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” added Jared Kelson, a lawyer at Boyden Gray who is representing the plaintiffs. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”
The U.S. government has not yet reacted to the ruling.
