The FDA has resolved a legal dispute concerning its ivermectin communications, including a notable social media campaign during the pandemic.
In August 2021, to deter individuals from utilizing ivermectin for Covid-19 prevention or treatment, the FDA tweeted, "You are not equines or bovines. Seriously folks, desist." The post received nearly 106,000 likes.
This antiparasitic medication, often prescribed for human neglected tropical illnesses such as river blindness and scabies, is also available without prescription in agricultural supply stores for deworming purposes in livestock like equines and bovines.
Certain right-leaning media outlets promoted ivermectin as a viable Covid treatment, despite FDA and WHO warnings against its use, citing ineffectiveness and potential dangers from overconsumption.
Conservative figures and lawmakers accused authorities of underplaying ivermectin's efficacy due to its affordability. Dr. Pierre Kory, a pulmonologist and president of the Frontline COVID-19 Critical Care Alliance, lauded it as a "wonder drug" during a US Senate hearing in December 2020. Even podcaster Joe Rogan, who used ivermectin along with other medications after contracting Covid, engaged in a heated debate with CNN's Dr. Sanjay Gupta on the matter.
In August 2021, the CDC issued a health advisory concerning a surge in ivermectin prescriptions and related poison control reports. Studies revealed neurological symptoms and hospitalizations among those consuming excessive doses or using animal formulations.
In an email to CNN, the FDA stated that it opted to settle the lawsuit instead of prolonging litigation over statements dating back between two and almost four years.
The FDA clarified that it hasn't confessed to any legal breaches or misconduct, disagrees with the plaintiffs' claims of exceeding its authority in issuing the contested statements, and reaffirms its prerogative to communicate with the public regarding regulated products.
"The FDA maintains its stance that existing clinical trial evidence does not support the efficacy of ivermectin against COVID-19. The agency has not sanctioned or endorsed the use of ivermectin for prevention or treatment of COVID-19."
In June 2022, Drs. Rober Apter, Mary Talley Bowden, and Paul Marik lodged a lawsuit against the FDA, the US Department of Health and Human Services, and their respective leadership. The lawsuit alleges that these agencies have encroached upon their medical practice rights, exceeded their jurisdiction, and breached the Administrative Procedure Act.
The legal action contends that the doctors have faced coercion, limitations in prescribing medications, and intimidation tactics, including the threat of professional repercussions.
Bowden, for instance, commenced advocating for the use of ivermectin to treat Covid in early 2020. Allegedly, she faced scorn from Houston Methodist Hospital and was compelled to relinquish her privileges there as a consequence.
Marik found himself compelled to resign from his positions at Eastern Virginia Medical School and Sentara Norfolk General Hospital due to his advocacy for ivermectin, subsequent to actions taken by the FDA, as per the lawsuit.
The FDA informed CNN on Wednesday that the lawsuit contested its authority to issue a Consumer Update in March 2021, various tweets, and other social media posts from 2021 and 2022 that referenced the article, as well as two FAQs published in 2020, which the FDA stated have "already been retired from the agency’s website." These posts and materials will be taken down and archived as mandated by law.
Initially, the FDA invoked sovereign immunity, leading to the dismissal of the suit by a lower court judge in Texas. Subsequently, the doctors appealed the case to the 5th Circuit, which reinstated the lawsuit last year. Last month, the judges of the 5th Circuit heard arguments on the matter.
Attorneys representing the physicians stated in a release shared on Boyden Gray PLLC’s website that the FDA "has consented to remove its most widely circulated social media campaign of all time" and asserted that the FDA's guidance on the off-label use of ivermectin was "unlawful."
Marik expressed in the statement, "Today's resolution with the FDA marks a significant victory for the doctor-patient rapport. It validates our stance that the FDA exceeded its regulatory jurisdiction by attempting to prescribe appropriate medical treatment."
Robert F. Kennedy Jr., an independent presidential candidate, posted on X, formerly Twitter, on Wednesday, alleging that the FDA "exhibits bias against numerous low-cost, generic, and/or natural therapies" and insinuated that the FDA colludes with the pharmaceutical industry.
