The U.S. Food and Drug Administration (FDA) is seeking to persuade a federal court to dismiss a lawsuit challenging its repeated advisories against using ivermectin to treat COVID-19.
The FDA in a sealed motion asked the U.S. District Court for the Southern District of Texas to dismiss the suit, which was brought by three doctors who allege the FDA’s warnings were illegal.
The late 2023 motion was sealed because exhibits the government cited “include confidential information” from a separate legal proceeding, according to a government brief.
Government lawyers said they would file redacted versions of the motion for public perusal but still have not done so.
Attorneys for the doctors said on Jan. 12 that the court should reject the government’s fresh bid to throw out the case.
“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 wrote.
One of the directives said: “You are not a horse. Stop it with the #Ivermectin. It’s not authorized for treating #COVID.”
The government motion came after an appeals court found the FDA likely overstepped its authority with the warnings.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ’stop' taking medicine,” U.S. Circuit Judge Don Willett, an appointee of former President Donald Trump, wrote in the ruling.
The appeals court remanded the case back to U.S. District Judge Jeffrey Brown, who said in 2022 that the doctors failed to prove their allegations.
The FDA in the sealed motion asked Judge Brown, another appointee of President Trump, to dismiss the case.
According to lawyers for the doctors, the FDA’s motion includes arguments that claim the plaintiffs have not suffered injuries that are traceable to the FDA, and that cannot be remedied by a ruling in favor of the plaintiffs.
“The FDA is wrong,” the lawyers said. “Plaintiffs have suffered interference with their practice of medicine and the doctor-patient relationship, economic harm, reputational harm, and increased exposure to malpractice liability, and have been subject to disciplinary proceedings and forced resignations, all of which clearly trace to the FDA’s campaign against ivermectin and would be remedied by equitable relief.”
The Federal Food, Drug, and Cosmetic Act enables the FDA to authorize or approve drugs for a specific use but doctors are free to prescribe cleared drugs for other purposes, in what’s known as “off-label” prescribing. The law does not grant authority to the FDA to regulate off-label use.
The plaintiffs include Dr. Robert Apter, who was investigated by medical boards in two states for prescribing ivermectin to treat COVID-19. The referrals to the boards include some of the FDA’s warnings against using the drug as a COVID-19 treatment.
The FDA’s position in seeking a dismissal stems in part from the negative actions against the plaintiffs being taken by third parties such as pharmacies, according to a description of the sealed motion. It was quoted as saying that the referrals “are not fairly traceable” to the FDA’s statements.
An exhibit included by the FDA, however, showed one of the referrals came from a pharmacist who cited FDA documents as a reason for “increased scrutiny” with regard to ivermectin prescriptions. The pharmacist wrote that Dr. Apter would not provide a “valid medical reason” for the ivermectin prescription and was thus engaging in “inappropriate prescribing.”
“The FDA is the common thread through all of [the] plaintiffs’ injuries, which began only after the FDA embarked on its campaign to stop the use of ivermectin for COVID-19 and which often involve explicit invocation of the FDA’s directives and recommendations,” the plaintiffs’ lawyers said.
They are seeking an order that would force the FDA to rescind or amend its warnings. That would remove the justification of the parties that have taken negative actions against the plaintiffs, the lawyers added.
