The U.S. Food and Drug Administration (FDA) has agreed to remove—and never republish—all posts and consumer directives from its website and social media posts made during the pandemic that discouraged people from using ivermectin to prevent and treat COVID-19.
The agreement was part of a settlement reached in a landmark case filed in federal court against the agency, the Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra, and FDA Commissioner Dr. Robert Califf.
The U.S. Court of Appeals for the Fifth Circuit in September 2023 ruled the FDA “has identified no authority allowing it to recommend consumers’ stop’ taking medicine” or to otherwise offer medical advice in “tweet-sized doses.”
The settlement stipulates the FDA will withdraw a consumer update titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and must delete and never republish posts to Twitter (now X), LinkedIn, and Facebook that stated, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
A post published on Instagram must also be removed. It read, “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”
Additionally, a Twitter post that stated, “Hold your horses, y’all. Ivermectin may be trending, but it isn’t authorized or approved to treat COVID-19,” must also be removed.
“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” said Dr. Paul Marik, a plaintiff in the case, chairman and chief scientific officer of the FLCCC Alliance (FLCCC) and former Chief, Pulmonary and Critical Care Medicine at Eastern Virginia Medical School. “The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.'”
“I couldn’t be prouder of Paul and our colleagues for taking a stand for all of us against a government health agency that overstepped its authority,” said Dr. Pierre Kory, president and chief medical officer of the FLCCC. “The FDA knew exactly what it was doing when it tweeted that ivermectin was for horses and that people should ‘stop it.’ I hope this case will serve as precedent the next time a federal health agency steps out of its authority and tries to practice medicine.”
“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history. This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship,” Dr. Mary Bowden, another plaintiff in the case, said in a post on X.
Drs. Bowden, Marik, and Dr. Robert Apter, on June 2, 2022, filed a lawsuit in federal court alleging the FDA exceeded its authority as a federal health agency and illegally interfered with the practice of medicine when it aggressively tried to prevent them from using ivermectin to treat COVID-19.
The FDA’s marketing campaign against the use of ivermectin involved publishing posts on Twitter, Instagram, Facebook, and LinkedIn claiming ivermectin was for horses, not humans. Yet ivermectin, an FDA-approved drug, has been prescribed to humans for various reasons for decades—and the agency is not authorized to give medical advice.
The lower court initially dismissed the case over sovereign immunity—a legal concept that often shields government agencies from liability for wrongdoing or harm. The U.S. Court of Appeals for the Fifth Circuit reversed the lower court’s dismissal of the lawsuit, stating that the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.”
The ruling further states that the FDA can “inform,” but is without authority to recommend consumers stop taking medicine.
