March 22, 2024
FDA Settles Ivermectin Case, Agrees to Remove Controversial ‘Stop It’ Post
The U.S. Food and Drug Administration (FDA) has agreed to remove Social Media posts and webpages that urged people to stop taking ivermectin to protect against COVID-19, according to a settlement filed on March 21. The FDA has already removed a page that said, “should I take ivermectin to prevent or treat COVID-19? No.” The FDA in the settlement is also agreeing to delete multiple social media posts that came out strongly against ivermectin, including one that stated: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” In exchange, doctors who sued the agency are dismissing their claims, the filing states. “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,” Dr. Mary Talley Bowden, one of the doctors, said in a statement. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship,” she added. The FDA did not immediately respond to a request for comment. Ivermectin was approved by the FDA in 1996 to treat several conditions, including onchocerciasis, a tropical disease caused by a parasitic worm. In the United States, it’s common for doctors to prescribe medicine off-label, or for a different purpose than the one for which the medicine is approved. After some doctors began prescribing ivermectin for COVID-19, the FDA ramped up its campaign, including the Aug. 21, 2021, post on Twitter, now known as X. Dr. Bowden and two other doctors sued the FDA, arguing the agency was taking illegal steps. Dr. Apter, for instance, said that pharmacists refused to fill the prescriptions, citing the FDA. “This refusal delays his patients in obtaining their prescribed treatment—when early intervention is paramount—while they look for a pharmacy to fill their prescription, if they can find one at all,” the suit states. He also said that insurance companies were refusing to pay for ivermectin to treat COVID-19. The suit said the FDA illegally interfered with the relationships between the doctors and patients. The doctors said with regard to ivermectin, the FDA overstepped the authority conferred on it in the Federal Food, Drug, and Cosmetic Act. Government lawyers argued that the FDA was acting within the confines of the law, and succeeded in getting the dismissal. Judge Brown, appointed under President Donald Trump, said the FDA’s powers were only limited with regard to medical devices. “As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” he wrote in his ruling. “Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.” A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit disagreed, finding that the law did not authorize the FDA to give medical advice. “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett, appointed under President Trump, wrote for the court. The appeals court remanded the case back to the district court.
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