Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging

A federal appeals court ruled Friday that a lawsuit against the Food and Drug Administration (FDA) over its campaign against the use of ivermectin to treat COVID-19 can continue, reversing a lower court decision.

Three doctors sued the FDA last year claiming that the agency’s anti-ivermectin campaign went too far, overstepping its authority and acting more as a medical body than a regulator.

A district court ruled that the suit could not continue, but the 5th Circuit Appeals Court revived the doctors’ hope in its Friday ruling, sending the case back to a lower court where it will be reconsidered.

“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 appeals court. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

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The FDA’s campaign, which included viral signs reading “You are not a horse,” emphasized agency recommendations that ivermectin — an anti-parasite medication often used for horses but sometimes prescribed to humans — should not be used to treat COVID-19.

“Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use,” the agency’s recommendations stated.

Some fringe conservative circles hailed the drug as a miracle cure, while others were hospitalized and some died from its side effects.

A review of 14 studies on ivermectin use in 2021 found little significant evidence supporting its use, noting that among the studies, “few are considered high quality.”

“It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings,” researchers wrote.

The World Health Organization and the National Institutes of Health are among the bodies that have also recommended against ivermectin use for COVID treatment. The drug’s manufacturer, Merck, said there is “no meaningful evidence” that is is effective at treating the disease.

The three doctors said their reputations were harmed by the FDA campaign because they promoted ivermectin use. One doctor was suspended from a hospital, while another was fired from a medical school.

“This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” the doctors’ attorney Jared Kelson said in a statement. “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”

Mary Talley Bowen, one of the plaintiffs, celebrated the ruling Friday.

“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny,” she said. “ONWARD!”