- FDA Launches Fresh Bid to Toss Out High-Profile Ivermectin Case
The FDA is trying to get a federal judge to dismiss a case challenging its repeated COVID-19 ivermectin warnings.
The FDA filed a secret application with the U.S. District Court for the Southern District of Texas to dismiss the litigation by three doctors who claim the FDA posted illegal warnings.
According to a government brief, exhibits in the late 2023 motion “include confidential information” from a separate court process, sealing it.
Government lawyers promised to release redacted motions for public review but haven’t.
The doctors’ attorneys urged on Jan. 12 that the court should reject the government’s new motion to dismiss the lawsuit.
“The FDA exceeded its authority by repeatedly issuing public directives not to use ivermectin for COVID-19, even though the drug remains fully approved for human use,” they said.
You are not a horse, stated one order. Stop #Ivermectin. Not approved for #COVID treatment.”
The government motion followed an appeals court ruling that the FDA likely overstepped with the warnings.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” Trump-appointed U.S. Circuit Judge Don Willett wrote.
The appellate court sent the matter to U.S. District Judge Jeffrey Brown, who reported in 2022 that the doctors failed to establish their claims.
In a secret document, the FDA requested Judge Brown, another Trump appointment, to dismiss the case.
According to doctors’ lawyers, the FDA’s application argues that the plaintiffs haven’t incurred FDA-related harms that can’t be addressed by a finding in their favour.
“The FDA is wrong,” lawyers stated. Plaintiffs have suffered interference with their practice of medicine and the doctor-patient relationship, economic harm, reputational harm, increased malpractice liability, and disciplinary proceedings and forced resignations due to the FDA’s campaign against ivermectin, which would be remedied by equitable relief.
The FDA can authorise or approve pharmaceuticals for a specified application, but doctors can prescribe authorised drugs for other uses in “off-label” prescribing. The law doesn’t let the FDA control off-label use.
For administering ivermectin to treat COVID-19, two state medical boards examined Dr. Robert Apter, a plaintiff. Some FDA warnings against using the medicine to treat COVID-19 are referred to the boards.
A synopsis of the sealed request states that the FDA wants to dismiss the plaintiffs because third parties like pharmacies are taking unfavourable actions against them. It stated that the referrals “are not fairly traceable” to FDA pronouncements.
One referral came from a chemist who referenced FDA documentation as a justification for “increased scrutiny” of ivermectin prescriptions, according to an FDA exhibit. The chemist noted that Dr Apter was administering ivermectin without a “valid medical reason” and was “inappropriate prescribing.”
“The FDA is the common thread through all of [the] plaintiffs’ injuries, which began only after the FDA began its campaign to stop the use of ivermectin for COVID-19 and often involve explicit invocation of the FDA’s directives and recommendations,” the plaintiffs’ lawyers claimed.
Their request is to have the FDA remove or alter its warnings. Their measures against the plaintiffs would be unjustified, lawyers said.
