FDA and Off Label Drug Use

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.