FDA settles lawsuit over ivermectin content that doctors claimed harmed their practice

By CNN Newsource

Published March 27, 2024 3:48 PM

By Jen Christensen, CNN

(CNN) — The US Food and Drug Administration has settled a lawsuit over some of its posts about ivermectin, including what may have been one of its more popular pandemic-era social media campaigns.

In August 2021, to discourage people from using ivermectin to prevent or treat Covid-19, the FDA tweeted “You are not a horse. You are not a cow. Serious y’all. Stop It.” and posted a similar message on Instagram. The tweet got nearly 106,000 likes.

The antiparasitic drug, which is prescribed to treat neglected tropical diseases in humans like river blindness and scabies, can also be bought over-the-counter at livestock supply centers to help deworm animals such as horses and cows.

Some conservative outlets touted the drug as safe and effective against Covid even though the FDA and the World Health Organization encouraged people not to use it, saying it was ineffective against Covid and could even be dangerous if someone took too much.

Some conservative media personalities and lawmakers said information about the effectiveness of ivermectin was being downplayed because of its low price. It was also praised as a “miracle drug” by Dr. Pierre Kory, a pulmonologist and president of the Frontline COVID-19 Critical Care Alliance, who testified at a US Senate committee hearing in December 2020. Even popular podcaster Joe Rogan, who took the drug along with several other medicines after testing positive for Covid, got into a spirited discussion with CNN Chief Medical Correspondent Dr. Sanjay Gupta about it at the time.

In August 2021, the US Centers for Disease Control and Prevention sent a health advisory warning doctors and the public about the “rapid increase” in prescriptions for ivermectin and an increase in reports to poison centers about severe illness caused by the drug. Some people who took higher than recommended doses or used the animal formulation developed neurological symptoms, and some were hospitalized, studies show.

The FDA said in an email to CNN on Wednesday that it “has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”

The agency added that it 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.

“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.”

The lawsuit was filed in June 2022 by Drs. Rober Apter, Mary Talley Bowden and Paul Marik against the FDA, the US Department of Health and Human Services and their leaders. It claimed that the agencies were interfering with their ability to practice medicine by overstepping their authority and violating the Administrative Procedure Act.

The lawsuit says the doctors “have been pressured, unable to prescribe medication, and threatened with or subjected to professional discipline.”

Bowden, for example, began recommending ivermectin to treat Covid in early 2020 and, according to the suit, was “derided by Houston Methodist Hospital and forced to resign her privileges there as a result.” Marik was forced to resign his positions at Eastern Virginia Medical School and Sentara Norfolk General Hospital for promoting the use of ivermectin after the FDA’s actions, according to the lawsuit.

The FDA told CNN on Wednesday that the lawsuit challenged its authority to issue a Consumer Update in March 2021, several tweets and other social media posts from 2021 and 2022 that linked to the article, and two FAQs posted in 2020, which the FDA said have “already been retired from the agency’s website.” The posts and other materials will be removed and archived as required by law.

Initially, the FDA claimed sovereign immunity, and a lower court judge in Texas dismissed the suit. The doctors appealed the case to the 5th Circuit, which reinstated the lawsuit last year, and its judges heard arguments last month.

Lawyers representing the doctors said in a statement posted on Boyden Gray PLLC’s website that the FDA “has agreed to delete its most viral social media campaign of all time” and claimed that the FDA’s advice about the off-label use of ivermectin was “unlawful.”

“Today’s settlement with the FDA is a major win for the doctor-patient relationship,” Marik said in the statement. “It vindicates our position that the FDA overstepped its regulatory authority by trying to dictate appropriate medical care.”

Independent presidential candidate Robert F. Kennedy Jr. posted on X, formerly Twitter, on Wednesday that the FDA “is biased against many low-cost, generic, and/or natural therapies” and implied that the FDA is in league with the pharmaceutical industry.