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.
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.
If it works, they don’t want you to have it.