FDA Removes Social Media Posts Against Ivermectin, Settles Lawsuit
- by Carolyn Hendler, JD
- Published
- Bioethics
The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) have agreed to remove social media posts and web pages cautioning the public not to take the FDA-approved drug Ivermectin to treat COVID-19 symptoms. The move comes as part of lawsuit settlement.
In 2022, three doctors, Drs. Mary Talley Bowden, Paul Marik and Robert Apter filed suit against the FDA claiming that it interfered with the doctor-patient relationship and prevented patients from getting prescribed treatment because pharmacists refused to fill prescriptions and insurance companies would not pay for prescriptions of Ivermectin.1 2
The FDA has agreed to remove and never republish posts such as the one from 2021 that had a picture of a horse and said, “You are not a horse. You are not a cow. Seriously, y’all Stop it” and, “Why You Should Not Take Ivermectin to Treat or Prevent COVID-19.”3 In return, the doctors suing the government agency have agreed to dismiss their claim.4
Dr. Marik said:
We are extremely pleased with the outcome of the settlement as it is 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.5
The FDA stated:
FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiff’s 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.6
Wonder Drug Ivermectin Has Been Used in Humans for a Long Time
Ivermectin has been used in humans for a long time, especially to treat and prevent malaria.7 Doctors have been prescribing this Nobel Prize winning drug to patients for decades.8 Known as a highly effective and safe drug to treat parasitic infections, it has also been used to treat viral and bacterial infections.9 10
A report titled “Ivermectin, ‘Wonder Drug’ from Japan: the human use perspective” available on PubMed concludes that Ivermectin…
has had an immeasurably beneficial impact in improving the lives and welfare of billions of people throughout the world… Ivermectin has continually proved to be astonishingly safe for human use. Indeed, it is such a safe drug, with minimal side effects.11
Lawsuit Accuses FDA of Overstepping Its Authority
The lawsuit, which alleged that the FDA overstepped its authority and acted as a medical doctor rather than a regulating authority when it promoted a ban on Ivermectin, was originally tossed out by federal judge Jeffrey Brown in 2022. Judge Brown sided with the government’s claim of sovereign immunity. Sovereign immunity prevents the government from being sued without its consent. The purpose behind the legal doctrine of sovereign immunity is to protect the government from being forced to change policies if someone disagree with them and brings legal action.12 13 14
At the time, Plaintiff’s lawyer explained:
If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out.15
Appellate Court Finds the FDA Overreached
The Plaintiffs appealed Judge Brown’s decision to the Fifth Circuit Court of Appeals in New Orleans which overturned the lower court decision finding that the FDA committed government overreach and allowed the doctors to proceed with their lawsuit.16
The Appellate Court found:
FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to. As such, the doctors can use the APA to assert their ultra vires claims against the agencies and the officials.17
The Appellate Court remanded the case back to Judge Brown,18 who decided that only one of the Plaintiffs, Dr. Bowden who worked as an ear, nose and throat doctor at Houston Methodist hospital,19 had standing to sue the FDA and the other two Plaintiffs did not. The parties settled the matter outside of court agreeing that the matter would be dismissed with prejudice meaning that neither party could bring the same action again.
Dr. Bowden cautioned:
The damage the FDA inflicted will linger, but future patients are now protected from one meaningful government intrusion into their medical care.20
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