Not just ivermectin: New FDA authority to ban off-label uses alarms doctors

Provision is buried in omnibus appropriations bill after FDA kept losing in court. "Potentially catastrophic for use of antibiotics," says former Public Health England director.

Published: February 22, 2023 4:29pm

Updated: February 28, 2023 12:30am

Doctors are speaking out against a new law that arguably paves the way for the FDA to prohibit treatments for purposes it hasn't expressly authorized, going far beyond highly politicized subjects such as treating COVID-19 with ivermectin.

The authority to ban off-label uses was buried on page 3,542 of the 4,155-page omnibus appropriations bill signed into law at year's end, though it's specifically applied to "banned devices."

The FDA requested this "very unprecedented" update after a string of court losses, Endpoints News senior editor Zachary Brennan told WBUR earlier this month, while cautioning that it's not clear whether the agency could broadly interpret "devices" to cover drug treatments.

Law firm Morrison Foerster specifically credited the revision to a 2021 ruling by the U.S. Court of Appeals for the D.C. Circuit that prohibited the FDA from banning "individual intended usages of an otherwise legally marketed device," in that case "electrical stimulation devices used to treat aggressive or self-injurious behavior."

Some physicians aren't trusting the FDA to restrain itself. "FDA lobbyists got congress [sic] to grant the agency (not practicing doctors) the power to ban some uses of medications," Johns Hopkins medical professor and National Academy of Medicine member Marty Makary tweeted Tuesday.

"That's truly arrogant to think that the federal government is the one and only one who knows better than the physicians at the state boards of medicine about what good medicine is or what it isn't," medical device and drug regulatory lawyer Brad Thompson told WBUR.

"It may be that the clause is specifically directed to forbidding use of e.g. ivermectin in COVID," for which "data are mixed," David Livermore, retired professor of medical microbiology at the University of East Anglia, told Just the News in an email.

He called it "a disgrace and a dereliction of duty" that the National Institutes of Health has yet to "properly study ivermectin either as a treatment or a prophylactic for COVID," giving the FDA cover to potentially ban such use. (The feds relied on "fake studies" to demonize low-cost COVID treatments, Yale epidemiologist Harvey Risch has argued.)

The new FDA authority could complicate a lawsuit by doctors that claims the agency effectively banned them from prescribing ivermectin to treat COVID by repeatedly telling the public the award-winning antiviral was dangerous for humans and providing false grounds for medical license investigations.

The agency claimed at a court hearing last fall that its guidance was "not mandatory." The litigants, including cancellation target Mary Talley Bowden, told the 5th U.S. Circuit Court of Appeals earlier this month that the FDA "cannot use unlawful means to accomplish exactly what it intended, then seek to wash its hands of the consequences."

Under 5th Circuit precedent, which recognizes off-label use as the "standard of care" in many medical contexts, federalism constraints prevent the agency from even "advis[ing] whether or for what purpose a doctor should prescribe" an approved drug, they said. The doctors' lawyers didn't respond to Just the News queries on how the revision could affect their litigation.

The omnibus language is not easily understood by the layman. It adds new clauses about "intended uses" to Section 516(a) of the Federal Food, Drug, and Cosmetic Act.

Applied to existing law, the revisions grant the secretary of health and human services authority to initiate a regulatory proceeding for an already approved "device intended for human use" to ban intended uses that present "substantial deception or an unreasonable and substantial risk of illness or injury."

Just the News confirmed this legislative construction with Joel Zinberg, associate clinical professor of surgery at the Icahn School of Medicine and former Columbia law lecturer, who was apparently the first to widely publicize the omnibus provision in a Wall Street Journal op-ed accusing the FDA of "unwarranted intrusion into the physician-patient relationship." 

"Since the new provision lets the FDA skirt the ban on interfering with the practice of medicine by banning devices for particular uses, the agency will likely claim this as a precedent allowing it to ban off-label uses of drugs as well," Zinberg wrote in the op-ed.

Zinberg directs the Paragon Health Institute's Public Health and American Well-Being Initiative. The free-market group was founded in 2021 by Trump administration alumni, including Zinberg, who served as general counsel to the Council of Economic Advisers.

"In some fields off-label use is the rule, not the exception," including oncology and pediatrics, "where scientific, ethical and logistical concerns preclude conducting large trials for approval in children," Zinberg said. The antibiotic erythromycin, for example, "is widely used off label to increase stomach motility and tolerance of oral feeding," he noted.

Livermore and other doctors discussed the ramifications of the new authority on the listserv for the Brownstone Institute, which publishes research that undermines COVID mandates, and gave Just the News permission to cite them.

"Damn — 3/4 of the stuff we use Is off label," former University of Kentucky medical professor Lisbeth Selby wrote. "This is a ploy to get more money for drug companies."

"Potentially catastrophic for use of antibiotics," said Livermore, former director of antibiotic resistance monitoring at Public Health England. Restricting their use to "indication only" would "deny useful treatments to patients with highly resistant bacteria simply because these drugs never had an appropriate trial in the setting," such as tigecycline for hospital pneumonia, he told Just the News.

Selby provided Just the News an exhaustive list of the off-label treatments she uses regularly in her gastroenterology practice at the Lexington Veterans Affairs Medical Center, with asterisks on "those used daily." 

"Older medications have more off label usages for a variety of reasons including time to accumulate experience using it off label," and there's "no financial reason to go back and get FDA approval for a generic medication," Selby wrote in an email, citing epinephrine specifically as a "key medication in Advanced Cardiac Life Support protocols."

Asked to respond to criticism from doctors and explain how it interprets the breadth of the new authority, FDA spokesperson Chanapa Tantibanchachai told Just the News: "We’ll let you know if we have anything to add."

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