‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19
By Matthew Lysiak – September 2, 2023
A federal appeals court in New Orleans ruled on Friday that the Food and Drug Administration (FDA) had overstepped its authority in their ruling that three doctors will be able to move forward with their lawsuit over the use of ivermectin off-label to treat COVID-19.
Dr. Mary Talley Bowden, one of three doctors who initially filed the charges, trumpeted the ruling as a victory for not only the truth, but patient rights.
“The FDA misled the public into thinking it has more authority than it does,” Dr. Bowden, a practitioner and founder of Coalition of Health Freedom, told The Epoch Times. “This decision confirms that the FDA is not your doctor and has no authority to tell doctors how to practice medicine.”
Judge Don Willett wrote for the three person panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”
“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.”
The anti-ivermectin messaging put out by FDA officials also drew the ire of Judge Willett, who wrote that “Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.”
In the ruling social media posts made by the agency were cited as evidence, citing that “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority,” he wrote.
The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The National Institutes of Health COVID treatment guidelines recommend against using ivermectin for COVID treatment, citing a purported lack of evidence supporting its effectiveness. Other studies have found ivermectin to be effective.
The lawsuit was initially filed in June 2022 by Dr. Bowden, Drs. Robert L. Apter, and Paul E. Marik for interfering with both their authority to prescribe an approved medication and the doctor-patient relationship. All three alleged their reputations were harmed by the FDA campaign. Dr. Bowden lost admitting privileges at a Texas hospital while Dr. Marik alleged he lost his jobs at a medical school and at a hospital for promoting the use of ivermectin.
The ruling comes as a blow to the FDA. The agency had argued that the case should not be allowed to move forward, claiming that the complaints didn’t overcome the FDA’s “sovereign immunity,” which protects government entities from many civil lawsuits regarding their responsibilities.
The FDA did not immediately respond to requests for comment.
The refusal of pharmacists nationwide to fill prescriptions for ivermectin has become a hot-button issue, raising questions over medical autonomy and who ultimately has control over patient care.
Ivermectin has been around for decades but became the center of controversy in 2020 after medical opinion became divided over its effectiveness as a treatment for COVID. In the aftermath, many pharmacists refused to fill prescriptions for the medication.
On Aug. 8 a lawyer representing the FDA confirmed that doctors were allowed to prescribe ivermectin to treat COVID.
“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, told the U.S. Court of Appeals for the 5th Circuit.
Dr. Bowden claims that despite the endorsement from the FDA, the practice of pharmacists refusing to fill prescriptions for ivermectin continues.
“This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license,” said Dr. Bowden told the Epoch Times on Friday. “They have no accountability for this yet they are allowed to dictate patient care.”
“I see it every single day. Enough is enough,” Dr. Bowden added.
Matthew Lysiak is a nationally recognized journalist and author of “Newtown” (Simon and Schuster), “Breakthrough” (Harper Collins), and “The Drudge Revolution.” The story of his family is the subject of the series “Home Before Dark” which premiered April 3 on Apple TV Plus.