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, prescribed to treat neglected tropical diseases in humans like river blindness and scabies, can also be bought over-the-counter at livestock supply centres to help deworm animals horses and cows.
CNN reports that the lawsuit was filed in June 2022 by Drs Robert Apter, Mary Talley Bowden and Paul Marik against the FDA, the US Department of Health and Human Services and their leaders. It claimed the agencies were interfering with their ability to practise medicine by overstepping their authority and violating the Administrative Procedure Act.
The lawsuit alleged the doctors “have been pressured, unable to prescribe medication, and threatened with or subjected to professional discipline”.
Some conservative outlets had touted the drug as safe and effective against Covid even though the FDA and the WHO encouraged people not to use it, saying it was ineffective against Covid and could even be dangerous if someone took too much.
Others, including lawmakers, said information about the effectiveness of the drug was being downplayed because of its low price.
In August 2021, the US Centres 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 centres about severe illness resulting from its use.
Some people who took higher than recommended doses or used the animal formulation developed neurological symptoms, and a number were hospitalised.
Resolution
The FDA told CNN it had “chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old”.
The agency added it had “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 authorised or approved Ivermectin for use in preventing or treating Covid-19.”
It added 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”.
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 the FDA’s advice about the off-label use of ivermectin was “unlawful”.
“The settlement with the FDA is a major win for the doctor-patient relationship,” Marik said. “It vindicates our position that the FDA overstepped its regulatory authority by trying to dictate appropriate medical care.”
On a social media post, independent presidential candidate Robert F. Kennedy Jr said the FDA “is biased against many low-cost, generic, and/or natural therapies” and implied it was in league with the pharmaceutical industry.
See more from MedicalBrief archives:
US doctors charged for anti-vax actions sue regulator
Increased human use of veterinary Ivermectin reflected in Oregon Poison Centre calls
Ivermectin: When desperate patients litigate for unproven treatments
Fact File: Making sense of the Ivermectin controversy