During oral arguments on August 8th, in the U.S. Court of Appeals for the 5th Circuit, Ashley Cheung Honold, a representative of the U.S. Food and Drug Administration (FDA) from the Department of Justice, stated that physicians possess the freedom to prescribe ivermectin for the treatment of COVID-19.
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Ashley Cheung Honold, a lawyer from the Department of Justice representing the FDA, highlighted in a court session on August 8th that the FDA explicitly acknowledges doctors’ jurisdiction to prescribe ivermectin as a COVID-19 treatment.
The government is upholding the FDA’s reiterated advisories cautioning the public against using ivermectin for COVID-19, which even included a message that read “Cease usage.”
Three medical practitioners have initiated a legal case, asserting that the FDA unlawfully disrupted their medical practice through these declarations. The case was initially dismissed by a federal judge in 2022, prompting an appeal.
Jared Kelson, who is representing the doctors in the appeal, stated to the court, “The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no.”
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On August 21, 2021, the FDA conveyed a message via X, formerly referred to as Twitter, that said, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The post, connected to an FDA web page discouraging the use of ivermectin for COVID-19 prevention or treatment, rapidly gained widespread attention.
In alternate statements, the FDA emphasized that ivermectin “isn’t authorized or approved to treat COVID-19” and addressed the query, “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”
Command or Not
“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 endorsed by the FDA for addressing human diseases stemming from parasites, although there is an animal variant of the drug.
According to Ms. Honold, the FDA never intended to impose obligatory actions or prohibit specific actions on anyone.
Circuit Judge Jennifer Walker Elrod, a member of the appellate panel, inquired, “What about when it said, ‘No, stop it’?” She continued, “Why isn’t that a command? If you were in English class, they would say that was a command.”
Characterizing the statements as “simple quips,” Ms. Honold offered her perspective.
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“Can you answer the question, please? Is that a command, ‘Stop it’?” Judge 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.”
Ms. Honold clarified that these statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose.” She pointed out that the FDA, in conjunction with these statements, advised individuals to consult their healthcare providers concerning COVID-19 therapies and to consider medication if recommended by their healthcare 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.
The panel comprises Judge Elrod, alongside Circuit Judges Edith Brown Clement and Don Willett, all three of whom were nominated during the presidency of Donald Trump.
The individuals bringing forth the case are Dr. Paul Marik, Dr. Mary Bowden, and Dr. Robert Apter. They assert that the FDA’s declarations had adverse professional repercussions, even leading to their dismissal due to their attempts to prescribe ivermectin to patients.
Dr. Marik has underscored the presence of several studies endorsing the use of ivermectin for COVID-19, a point acknowledged by the FDA itself. However, some other studies show minimal or no discernible impact.
Mr. Kelson noted that federal law permits the FDA to disseminate information, such as reports about adverse reactions to drugs, but not medical counsel.
“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, y’all. Stop it.'”
Judges have indicated concurrence with the notion that the FDA lacks the authority to provide medical advice; Judge Clement stated, “You’re not authorized to give medical advice.”
Nonetheless, Ms. Honold countered by saying that the government is not conceding this point in the current case.
She further contended that Congress has bestowed the FDA with the mandate to safeguard public health and ensure the safety and efficacy of regulated products, granting it the “inherent authority to further its mission by communicating information to the public about safe uses of drugs.”
The doctors’ proposed verdict would hinder the FDA from reporting instances of consumers experiencing issues after combining chicken with NyQuil or addressing the problem of opioid addiction, according to her argument.
Mr. Kelson contested this notion, stating, “It’s when they step beyond that [and] start telling people how they should or should not be using approved drugs.”
A new book titled “The War On Ivermectin” by Dr. Pierre Kory and Jenna McCarthy delves into the history of Ivermectin during the COVID-19 pandemic in the United States.
Ms. Honold also maintained that the legal system cannot hold agencies accountable for disseminating inaccurate or misleading information, asserting, “The FDA is politically accountable, just like all other executive agencies.”