A panel of appeals court judges has ruled that a lawsuit from several doctors challenging the Food and Drug Administration over its messaging on ivermectin can move forward after a federal judge had blocked the suit.
The doctors sued the Department of Health and Human Services and the FDA, claiming their medical practices were harmed due to the FDA telling people not to take ivermectin, which some doctors have said could be used as a possible COVID treatment. HHS Secretary Xavier Beccera and FDA Commissioner Robert Califf are also named in the suit.
“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett wrote for the U.S. Court of Appeals for the Fifth Circuit. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”
The ruling referenced an FDA post to X that instructed people not to take ivermectin because “you are not a horse.” The FDA has approved ivermectin to treat certain infections, but it has urged the public not to use it to treat COVID.
“The messaging traveled widely across legacy and online media. Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose,” the ruling said.
According to the ruling, the doctors each prescribed ivermectin to treat COVID and said the FDA’s messaging interfered with their medical practice. The doctors allege that the FDA’s actions on ivermectin violate the Administrative Procedure Act (APA), which governs how administrative agencies operate.
“As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials,” the ruling said. “Even tweet-sized doses of personalized medical advice are beyond the FDA’s statutory authority.”
“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” said Jared Kelson, counsel at Boyden Gray PLLC, the firm that represented the doctors. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”
Mary Talley Bowden, one of the doctors challenging the FDA, celebrated the ruling with a post to X.
“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny. ONWARD!” she wrote.
Bowden was suspended from Houston Methodist Hospital after she vocally opposed vaccine mandates and advocated using ivermectin to treat COVID. The hospital said her statements and actions were “harmful to the community.”
“Dr. Mary Bowden, who recently joined the medical staff at Houston Methodist Hospital, is using her social media accounts to express her personal and political opinions about the COVID-19 vaccine and treatments,” the hospital said.