FDA Drops Ivermectin Bombshell
A lawyer for the US Food and Drug Administration (FDA) declared this week that doctors are free to prescribe ivermectin to treat COVID-19.
“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, stated during oral arguments in the United States Court of Appeals for the Fifth Circuit on August 8.
The government is defending the FDA’s numerous warnings to people not to use ivermectin for COVID-19, including a post with the words “Stop it.”
Three doctors filed the lawsuit, alleging that the FDA’s statements violated their right to practice medicine. In 2022, a federal judge dismissed the case, forcing an appeal.
“The essential issue in this instance is simple. Does the FDA have the ability to intervene with how a human medicine is used inside the doctor-patient relationship once it has been approved for sale? “The answer is no,” the doctors’ attorney, Jared Kelson, told the appeals court.
On August 21, 2021, the FDA posted on X, formerly known as Twitter, “You are not a horse.” You’re not a calf. Seriously, you guys. “Put a stop to it.” The message, which included a link to an FDA page stating that ivermectin should not be used to prevent or treat COVID-19, quickly went viral.
The FDA also stated that ivermectin “isn’t authorized or approved to treat COVID-19” and that “Q: Should I take ivermectin to prevent or treat COVID-19?” A: No.”
Whether or not to command
“FDA made these statements in response to multiple reports of consumers being hospitalized after self-medicating with ivermectin intended for horses, which is available without a prescription over the counter,” Ms. Honold explained.
Although an animal version of the medicine is available, the FDA has approved ivermectin for human treatment against parasitic infections.
Ms. Honold stated that the FDA did not intend to force or restrict anyone from doing anything.
“What about when it said, ‘No, stop it’?” Circuit Judge Jennifer Walker Elrod, a member of the panel hearing the appeal, inquired. “How come that isn’t a command?” That would be considered a command in English class.”
Ms. Honold called the remarks “merely quips.”
“Could you please answer the question?” “Is ‘Stop it’ a command?” Judge Elrod inquired.
“In some contexts, those words could be construed as a command,” Ms. Honold explained.
“However, in this case, where the FDA was simply using these words in the context of a quick tweet to share its informative article, those statements do not rise to the level of a command.”
Ms. Honold stated that the comments “do not preclude doctors from prescribing ivermectin to treat COVID or for any other purpose.” She highlighted that, in addition to the statements, the FDA stated that consumers should discuss their health care providers regarding COVID-19 therapies and that they could take medicine if prescribed by the practitioner.
“The FDA clearly acknowledges that doctors have the authority to prescribe human ivermectin for COVID treatment.” “As a result, they are not interfering with doctors’ authority to prescribe drugs or practice medicine,” she explained.
Judge Elrod joins Circuit Judges Edith Brown Clement and Don Willett on the panel. All three were appointed by President Trump.
Drs. Paul Marik, Mary Bowden, and Robert Apter are the plaintiffs. They claim that the FDA’s remarks have impacted their careers, including being fired for attempting to prescribe ivermectin to patients.
As the FDA has acknowledged, a number of studies support the use of ivermectin against COVID-19, according to Dr. Marik. Other studies have found little to no effect.
The judges agreed that the FDA lacked the authority to give medical counsel; Judge Clement stated, “You’re not authorized to give medical advice.”
Ms. Honold, on the other hand, stated that the government “isn’t conceding that in this case.”
She also claimed that Congress has given the FDA the “inherent authority to further its mission by communicating information to the public about safe drug uses” in order to protect public health and ensure that regulated goods are safe and effective.
She stated that a decision in favor of the doctors would preclude the FDA from reporting on customers suffering after cooking chicken with NyQuil or that opioid addiction is an issue.
Mr. Kelson stated that this was incorrect. “It’s when they go beyond that and start telling people how they should or shouldn’t use approved drugs,” he explained.
Ms. Honold also stated that agencies cannot be held accountable through the courts when they disclose inaccurate or misleading information: “The FDA is politically accountable, just like all other executive agencies.”
