Ivermectin proponents ask Fifth Circuit to revive lawsuit against FDA

(CN) — Counsel for three doctors who prescribe ivermectin to treat Covid-19 told the Fifth Circuit on Tuesday the Food and Drug Administration overstepped its authority with a public information campaign against taking the drug.

The widespread illness and deaths attributed to Covid-19, the respiratory illness caused by the coronavirus, have spawned some dubious treatment ideas.

Then-President Donald Trump infamously suggested in an April 2020 press briefing that injecting bleach might be a viable option to clear the virus out of one’s lungs.

That same month, a group of Australian medical researchers published the results of a study they concluded showed ivermectin — a drug used to treat and prevent parasites in horses and cows and approved by the FDA to get rid of parasitic worms in people — inhibits replication of the coronavirus.

The FDA has also authorized using the drug topically to treat head lice and skin conditions like rosacea.

But after receiving numerous reports of people ending up in the hospital after taking large doses of over-the-counter ivermectin intended for livestock, the FDA launched a public awareness initiative.

It published an advisory titled “Why You Should Not Use Ivermectin to Treat or Prevent Covid-19,” and sent letters to the Federation of State Medical Boards and National Association of Boards of Pharmacy directing them to read the missive.

It also spread the message on social media with pithy posts such as, “Ivermectin is only a horse dewormer. Don’t use a veterinary product to treat Covid-19,” and “You are not a horse. You are not a cow. Seriously, y'all. Stop it,” accompanied by juxtaposed photos of a veterinarian hugging a horse and a doctor examining a patient.

Three doctors who became proponents of ivermectin and prescribed it off-label to thousands of Covid patients sued the FDA, the Department of Health and Human Services and the agencies’ chiefs in Galveston federal court in June 2022.

They claim the FDA exceeded its authority and violated the Administrative Procedure Act by interfering with their practice of medicine, regulation of which, they argue, is the province of states.

One of the plaintiffs was referred to the doctor regulatory boards of Washington state and Arizona for disciplinary proceedings for prescribing the drug to treat Covid. Another was forced to resign her privileges by a Houston hospital system.

U.S. District Judge Jeffrey Brown, a Trump appointee, dismissed the lawsuit this past December. He determined plaintiffs’ allegations did not defeat the government’s sovereign immunity.

The doctors appealed to the Fifth Circuit and a panel of the New Orleans-based appellate court heard arguments Tuesday.

“The fundamental issue is straightforward,” the challengers’ attorney Jared Kelson of the Washington firm Boyden Gray & Associates began.

“After the FDA approves a human drug for sale, does it then have the authority to influence or interfere with how that drug is used within the doctor-patient relationship? The answer is no,” he added.

Kelson said the fact that these physicians are prescribing ivermectin off-label — for different purposes than the FDA has approved — makes no difference because federal law bars anything that would even deter off-label use, evidenced by the fact that nearly 40% of all U.S. prescriptions are for off-label use.

“That’s a bright line the FDA cannot cross,” Kelson stated.

But Justice Department attorney Ashley Honold argued that line between lawful FDA guidance on drugs and unlawful interference with doctors’ prescribing practices is not as clear-cut as the plaintiffs contend.

She characterized the agency’s ivermectin warnings as informational statements, and stressed they are not regulations, they have no legal consequences, and they don’t bar doctors from prescribing ivermectin to treat Covid or for any other purpose.

U.S. Circuit Judge Don Willett, a Trump appointee, pressed Honold to define the limits of the FDA’s jurisdiction.

“You concede the FDA has no authority to issue medical advice, correct? That is not arguable, right? The FDA cannot issue medical advice,” he said.

“No, your honor,” Honold replied. “The government is not conceding that in this case.”

She said when people are using drugs in unsafe ways, leading to hospitalizations, it “is not only permissible, it is imperative that the FDA be able to inform the public of its scientific views about safe uses of drugs.”

For example, Honold said, the FDA recently issued advisories warning people it is not safe to eat chicken cooked in the cough syrup NyQuil — a recipe that spread on the social media app TikTok. And in 2014, Honold noted, the FDA cautioned against using lidocaine off-label as a numbing agent for teething babies because it can cause seizures and deaths for them.

“The FDA has to be able to make these kinds of public safety statements. Under plaintiffs’ theory, FDA would not be able to communicate to the public in this way,” Honold argued.

At the end of the 40-minute hearing, U.S. Circuit Judge Jennifer Walker Elrod, a George W. Bush appointee, asked Kelson to address the government’s contention that a ruling in his clients’ favor could gut the FDA’s ability to warn the public about dangerous drug use.

Kelson insisted the agency had gone too far with ivermectin.

“The doctors have not challenged the FDA’s authority to communicate when they receive adverse medical reports. It’s when they step beyond that and tell people how they should or should not be using approved drugs,” he said.

Senior U.S. Circuit Judge Edith Clement Brown, another George W. Bush appointee, rounded out the panel. The judges did not say when they would rule on the appeal.  

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