By Zachary Stieber
Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.
“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during Aug. 8 oral arguments in the U.S. Court of Appeals for the Fifth Circuit.
The government is defending the FDA’s repeated exhortations to people to not take ivermectin for COVID-19, including a post that said “stop it.”
The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements. A federal judge dismissed the case in 2022, and it’s now on appeal.
“The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does then have authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,” Jared Kelson, representing the doctors, told the appeals court.
The FDA on Aug. 21, 2021, wrote on Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The post linked to an FDA page that says people should not use ivermectin to prevent or treat COVID-19.
The post went viral, generating excitement within the agency.
In other statements, the FDA said that ivermectin “isn’t authorized or approved to treat COVID-19” and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”
“FDA made these statements in response to multiple reports of consumers being hospitalized, after self medicating with ivermectin intended for horses, which is available for purchase over the counter without the need for prescription,” Ms. Honold said.
Ivermectin is approved for human use by the FDA against diseases caused by parasites. A version for animals is also available.
“FDA did not purport to require anyone to do anything, or to prohibit anyone from doing—” Ms. Honold said.
“What about when it said, ‘no, stop it?” said Circuit Judge Jennifer Walker Elrod, sitting on the panel that is hearing the appeal. “That seems to me it’s that’s if you were an English class, they would say that was a command.”
Ms. Honold described the statements as “primarily quips.”
“Can you answer the question, please? Is that a command, ‘stop it?'” Ms. Elrod asked.
“In some contexts, those words could be construed as a command,” Ms. Honold said. “But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command.”
The statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose” Ms. Honold said. She noted that the FDA, along with the statements, said that people should consult their health care providers about COVID-19 treatments and that they could take medicine if it was prescribed by the provider.
“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” she said.
Ms. Elrod is on the panel with Circuit Judges Edith Brown Clement and Don Willett. All three were appointed under President Donald Trump.
Plaintiffs in the case are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA’s statements, including being terminated over efforts to prescribe ivermectin to patients.
Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.
Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.
“This is something the FDA has never been able to do. And it’s a bright line,” he told the court, adding later: “The clearest examples of where they have gone over the line are when they say things like, ‘you are not a horse, you are not a cow. Seriously ya’ll, stop it.'”
Judges indicated they also think the FDA lacks the power to give medical advice. “You’re not authorized to give medical advice,” Ms. Clement said. But Ms. Honold said the government “isn’t conceding that in this case.”
She also argued that Congress has empowered FDA to protect public health and make sure regulated products are safe and effective, giving it the “inherent authority to further its mission by communicating information to the public about safe uses of drugs.”
A ruling in favor of the doctors would prevent the FDA from reporting on consumers suffering after cooking chicken with NyQuil or that opioid addiction is a problem, she claimed. Mr. Kelson said that was not accurate. “It’s when they step beyond that start telling people how they should or should not be using approved drugs,” he said.
Ms. Honold also said that the courts cannot hold agencies accountable when they provide false or misleading information. “The FDA is politically accountable, just like all other executive agencies,” she said.