After a string of court losses concerning the ability for doctors to prescribe drugs for off-label uses for which they were not approved, Congress has quietly given the Food and Drug Administration (FDA) more power to prohibit off-label use.
Buried in page 3,542 of the 4,155-page omnibus appropriations bill is the authority to ban off-label uses, under a section which applies to “banned devices” that some doctors fear could be broadly interpreted to cover drug treatments, Just the News reports.
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.” -Just the News
“FDA lobbyists got congress [sic] to grant the agency (not practicing doctors) the power to ban some uses of medications,” said Johns Hopkins medical professor and National Academy of Medicine member Marty Makary in a Tuesday tweet.
FDA gets sweeping new powers in the omnibus appropriations bill. FDA lobbyists got congress to grant the agency (not practicing doctors) the power to ban some uses of medications. Good piece by Joel Zinberg @WSJ https://t.co/lu3nLbLZzT
— Marty Makary MD, MPH (@MartyMakary) February 21, 2023
“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,” said medical device and drug regulatory attorney Brad Thompson in a comment to WBUR.
“It may be that the clause is specifically directed to forbidding use of e.g. ivermectin in COVID,” in which case the “data are mixed,” according to retired microbiologist David Livermore in an emailed statement to Just the News.
Livermore called it a “disgrace and a dereliction of duty” that the NIH has failed to “properly study ivermectin either as a treatment or a prophylactic for COVID,” and has given the FDA cover to potentially ban its use.
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.” -Just the News
“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,” wrote Joel Zinberg, associate clinical professor of surgery at the Icahn School of Medicine and former Columbia law , who accused the FDA of “unwarranted intrusion into the physician-patient relationship.”
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