Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA

(CN) —Three doctors who prescribed ivermectin for Covid-19 patients have valid claims that the Food and Drug Administration overstepped its authority with a campaign warning people not to take the drug, a Fifth Circuit panel ruled Friday, reinstating the trio’s lawsuit against the agency.

Drs. Robert Apter and Mary Talley Bowden say between them they have treated or consulted more than 9,000 Covid patients and they each have a patient survival rate of more than 99%, despite regularly prescribing them ivermectin off-label to treat the respiratory illness.

But the doctors say pharmacies stopped filling their prescriptions for the drug — which the FDA approved in 1996 for human use to treat parasitic diseases caused by round worms and black flies — after the FDA launched a public relations campaign in spring 2021 sounding the alarm that people were being hospitalized after self-medicating with large doses of the drug intended for deworming livestock that they had purchased over the counter.

The FDA also sent letters to the Federation of State Medical Boards and National Association of Boards of Pharmacy warning against the use of ivermectin to treat Covid-19 with a link to an agency advisory that said taking it in high dosages is dangerous.

Apter and Talley Bowden, along with Dr. Paul Marik, sued the FDA, the Department of Health and Human Services and the agencies’ leaders in Galveston federal court in June 2022. They claimed the FDA had exceeded its authority and violated the Administrative Procedure Act by interfering with their practice of medicine — regulation of which, they contended, falls to states.

The FDA’s campaign, coupled with their advocacy of ivermectin, caused them problems: A major Houston hospital system forced Talley Bowden to resign her privileges; Apter was referred to physician regulatory boards of Arizona and Washington state for discipline; Marik was forced to resign from his post at Eastern Virginia Medical School, where he was a medical professor and chief of pulmonary and critical care.

Marik had developed a Covid-19 management protocol for the university and added ivermectin after finding it was effective treating the illness, especially in the early stages of infection.

After U.S. District Judge Jeffrey Brown dismissed their lawsuit, finding their allegations could not overcome the government’s sovereign immunity, they appealed to the Fifth Circuit.

A three-judge panel of the New Orleans-based appellate court heard arguments last month.

A Justice Department attorney told the panel the FDA “has to be able to make these kinds of public safety statements” about risky uses of drugs, an argument the judges rejected Friday.

Writing for the unanimous panel, U.S. Circuit Judge Don Willett, a Donald Trump appointee, focused on three FDA’s social media posts about ivermectin, in which the agency gave the impression the drug is only meant for horses and cows.

The posts stated: “You are not a horse. You are not a cow. Seriously, ya’ll. Stop it,” “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID,” and, “Hold your horses, ya’ll. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

Numerous media outlets published stories about the warnings. But Willett says a key point was lost in the uproar.

“Left unmentioned in most of the 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,” he wrote in the 24-page opinion.

Willett found the Administrative Procedure Act allows the three doctors to bypass the government’s sovereign immunity and assert claims that the two defendant agencies and their top officials acted beyond their authority.

“FDA is not a physician,” Willett wrote in conclusion. “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. … Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.” (Emphasis in original.)

The panel — rounded out by U.S. Circuit Judges Edith B. Clement, a George H.W. Bush appointee, and Jennifer W. Elrod, a George W. Bush appointee — reversed dismissal of the lawsuit and remanded it to Brown for further proceedings.

Neither the plaintiffs’ attorney nor the Justice Department responded late Friday to emails seeking comment on the order.

Follow @cam_langford

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