U.S. 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 treat COVID-19, according to a settlement dated March 21.

The FDA has already removed a page that said: “Should I take ivermectin to prevent or treat COVID-19? No.”

Within 21 days, the FDA will remove another page titled, “why you should not use ivermectin to treat or prevent COVID-19,” according to the settlement announcement, which was filed with federal court in southern Texas.

“The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals,” the page currently states. It also says that data do not show ivermectin is effective against COVID-19, despite how some studies it cites show ivermectin is effective against the illness.

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.”

“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” added Dr. Paul Marik, chief scientific officer of the FLCCC Alliance and another plaintiff. “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.’”

An FDA spokesperson told The Epoch Times in an email that the agency “has chosen to resolve this 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.”

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’s actions went beyond its authority, as conferred on it by Congress.

U.S. District Judge Jeffrey Brown dismissed the case in 2022, ruling that the FDA did not act outside the authority. But an appeals court in 2023 ruled in favor of the doctors, finding that the agency “has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”

Between the time of the ruling and the settlement, the FDA refused to change any of its statements on ivermectin, and asked for a fresh dismissal of the suit.

The Case

Drs. Robert Apter, Bowden, and Marik brought the case in 2022. They said they suffered repercussions after prescribing ivermectin to patients with COVID-19, and that the FDA was to blame.

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.

Reposted from: https://www.theepochtimes.com/health/fda-settles-ivermectin-case-agrees-to-remove-controversial-stop-it-post-5612010

Related: FDA Concedes on Ivermectin, Yet Deeper Concerns Exist

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