In recent developments, the U.S. Food and Drug Administration (FDA) acknowledged the right of doctors to prescribe ivermectin as a treatment for COVID-19.
The statement came to light during an oral argument on August 8, 2023, at the U.S. Court of Appeals for the 5th Circuit.
Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, stated, “FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.”
The context of this revelation was a lawsuit filed by three doctors against the FDA, accusing the latter of unlawfully impeding their medical practice with prior statements against the drug’s use for treating COVID-19.
Their case, however, was dismissed in 2022, leading to this appeal.
One of the key issues at stake is whether the FDA, after giving approval to a human drug for sale, can subsequently influence its usage within the doctor-patient relationship.
“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,” said Jared Kelson, the lawyer representing the doctors.
The FDA’s previous stance became popularly known due to a tweet from August 21, 2021, which read, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
This viral post, accompanied by a link to an FDA page, advised against using ivermectin for COVID-19 prevention or treatment.
Elaborating on this, Ms. Honold explained that the FDA’s past statements arose from incidents where individuals self-medicated with versions of ivermectin meant for animals, leading to hospitalizations.
While animal-specific versions of ivermectin exist, the FDA has approved its human equivalent for treating diseases caused by parasites.
Addressing whether the past statements like “Stop it” were commands, Ms. Honold responded, “In some contexts, those words could be construed as a command. 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.”
Emphasizing the FDA’s position, Ms. Honold clarified, “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.”
The plaintiffs in the case, Drs. Paul Marik, Mary Bowden, and Robert Apter, contend they faced professional backlash due to the FDA’s public advisories, with some being dismissed for attempting to prescribe ivermectin.
While Dr. Marik cited several studies in favor of using ivermectin against COVID-19, contrasting research found minimal or no benefits.
Addressing the boundaries of FDA’s authority, Mr. Kelson opined, “This is something the FDA has never been able to do. And it’s a bright line,” referencing the FDA’s role in providing information but not medical advice.
Ms. Honold countered by underscoring Congress’s empowerment of the FDA to safeguard public health and ensure the safety and efficacy of regulated products. She stated that the agency possesses the “inherent authority to further its mission by communicating information to the public about safe uses of drugs.”
The case is now pending judgment, with potential implications for the FDA’s scope of communication regarding approved drugs.