Ivermectin is an antiparasitic drug typically prescribed to treat tropical diseases in humans such as river blindness and scabies. It is also used at livestock supply centres to deworm animals including horses and cows.
During the pandemic, the drug began to gain traction as an ‘alternative’ treatment for COVID-19, with Dr. Pierre Kory, president of the Front Line COVID-19 Critical Care Alliance, touting it as a ‘miracle drug’.
Popular podcaster Joe Rogan also revealed he had taken the drug after testing positive for the virus, alongside numerous other medications.
The lawsuit was filed in June 2022 by Drs. Paul Marik, Mary Talley and Rober Apter, and accused the FDA, US Department of Health and Human Services and its leaders of overstepping their authority and breaching the Administrative Procedure Act.
The doctors ‘have been pressured, unable to prescribe medication, and threatened with or subjected to professional discipline’, the lawsuit states.
For instance, Dr. Apter claimed pharmacists had refused to fill ivermectin prescriptions and insurance companies were declining to pay for ivermectin, both citing the FDA.
According to the FDA, the lawsuit questioned its authority to issue a Consumer Update in March 2021 and found issue with several tweets and social media posts that promoted the article.
One such tweet, which stated: ‘You are not a horse. You are not a cow. Serious y’all. Stop It.’ became the most popular ever posted by the FDA, garnering nearly 106,000 likes.
Another post on X read: 'Hold your horses, y'all. Ivermectin may be trending, but it isn't authorized or approved to treat COVID-19.'
In addition, the organization has already removed a page that said: ‘Should I take ivermectin to prevent or treat COVID-19? No.’
The suit was initially dismissed by a lower court judge in Texas after the FDA claimed sovereign immunity. However, the doctors appealed to the 5th Circuit, which reinstated proceedings in 2023.
“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 plaintiffs, said in a statement.
“This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”
Dr. Paul Marik, another plaintiff, said he was ‘extremely pleased’ with the outcome, calling it a ‘victory for every doctor and patient in the United States’.
“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,” he added.
An FDA spokesperson said the agency had chosen to resolve the lawsuit rather than ‘continuing to litigate over statements that are between two and nearly four years old’.
“FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” the spokesperson said.
“FDA has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”
Independent presidential candidate Robert F. Kennedy Jr, who has previously called big pharma a 'criminal enterprise', also wrote on X: 'Ivermectin is not an exceptional case. The FDA is biased against many low-cost, generic, and/or natural therapies with low profit potential. Could it be because half its funding comes from Big Pharma?'
