A group of doctors is urging a U.S. court to block the Food and Drug Administration (FDA) from issuing guidance on using ivermectin, in an appeal lodged after a district court judge rejected their bid.
The FDA “cannot advise whether or for what purpose a doctor should prescribe, or a patient should take, an approved drug,” lawyers for Drs. Robert Marik, Mary Talley Bowden, and Robert Apter said in a February brief to the U.S. Court of Appeals for the Fifth Circuit.
Ivermectin is approved for several uses, including treating parasites. It is not approved for COVID-19, but prescribing drugs for a different purpose from which they were approved is common and known as off-label use.
Apter, Bowden, and Marik have all prescribed patients ivermectin but got into trouble with various organizations, who cited the FDA’s warning not to treat COVID-19 with ivermectin.
The FDA in 2021, for instance, told people on social media to “stop” using ivermectin against COVID-19.
That guidance violated the Federal Food, Drug, and Cosmetic Act (FDCA), which says the FDA is not authorized to “limit or interfere” with the practice of medicine, the doctors alleged in their lawsuit.
U.S. District Judge Jeffrey Brown, a Trump appointee, rejected the suit in late 2022, finding that the law only applies to medical devices, not drugs, and that the FDA had authority to act because it is charged with Congress to protect public health.
Brown was wrong, the appeal states.
While he reasoned that, “as there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” agencies “must point to explicit congressional authority justifying their decisions,” the doctors told the appeals court, citing one of its previous rulings.
“The District Court then relied on the FDA’s mission statement … which the court summarized as ‘protecting public health and ensuring that regulated medical products are safe and effective, among other things.’ The court presumed the FDA has ‘authority, generally, to make public statements in-line with these purposes.’ But ‘statements of purpose … cannot override a statute’s operative language,’ and the FDA wasn’t ensuring that any product was safe and effective, anyway, which is how the mission statement directs the FDA to promote public health,” they added. “The agency was instead playing doctor and telling physicians and patients what already-approved medications should be used and for what purpose. That transgressed a bright line the FDA was not authorized to cross.”
Government Argument
Government lawyers challenged the position, telling the appeals court that Brown’s ruling was correct.
While the FDA offered statements on ivermectin, they were merely conveying information, the lawyers claimed.
“None of FDA’s informational statements purports to impose any requirements, restrictions, or limitations on anyone,” the government’s brief, entered in March, said, adding later, “None of these statements purports to impose any legal requirements on anyone, and, in particular, none of them requires doctors to refrain from prescribing ivermectin products to prevent or treat COVID-19.”
The Department of Justice lawyers also said the doctors failed to allege an injury that is “fairly traceable” to the statements, prove standing based on their allegations, and demonstrate standing based on the alleged injuries to patients.
Those injuries, according to court filings, include patients of the doctors unable to get ivermectin because pharmacies refused to fill the prescriptions, citing the FDA’s statements.
Apter has also been referred for discipline in both Arizona and Washington for prescribing ivermectin for COVID-19. The referrals included copies of the FDA’s statements. Marik has said he was forced to resign as chief of pulmonary and critical care medicine at Eastern Virginia Medical School and as director of the intensive care unit at Sentara Norfolk General Hospital because he promoted ivermectin.
Reply
In a reply brief, filed in late March, the doctors emphasized the view that the FDA lacks authorization for its actions.
“Nothing in the FDCA or Public Health Service Act authorizes FDA to advise the public on whether to use specific drugs for specific purposes, let alone say ‘Stop’ an off-label use,” they said. One part of the former, they noted, actually says that the law shall not be construed to “limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
The FDA’s claim that its statements are purely informational is also wrong, the doctors said.
“Statements identifying whether a drug is approved and for what purposes, or notifying the public about adverse event reports, are informational. Dispensing medical advice and directing the public on what FDA-approved drugs should or should not be used, and for what purposes, is not,” they said.
The brief also said that doctors have demonstrated injuries that are traceable to the FDA statements.
“FDA completely ignores that third parties are explicitly relying on FDA’s ivermectin statements,” they said. “That is as clear as causality gets.”