"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," Just the News reported this week.
The updated authority to ban off-label uses was included in the 4,155-page omnibus appropriations bill signed into law at the end of the year, but it was only mentioned on page 3,542 and specifically applied to "banned devices." The FDA requested this update following a series of court losses, and some experts have expressed uncertainty about whether the agency could broadly interpret "devices" to include drug treatments, the outlet reported.
The law firm Morrison Foerster credited the revision to a 2021 ruling by the U.S. Court of Appeals for the D.C. Circuit, which prevented the FDA from banning "individual intended usages of an otherwise legally marketed device." The case in question involved electrical stimulation devices used to treat aggressive or self-injurious behavior.
But some doctors rightfully do not trust the FDA to refrain from imposing the agency's will whenever and however it wants.
"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 Dr. Marty Makary tweeted Tuesday.
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," 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, a retired professor of medical microbiology at the University of East Anglia, told Just the News.
He also described 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 ban such use potentially, the outlet continued.
The update to the FDA's authority could potentially complicate a lawsuit by doctors who claim that the agency effectively prohibited them from prescribing ivermectin as a treatment for COVID-19. The doctors allege that the FDA repeatedly told the public that ivermectin was dangerous for human use and provided false grounds for medical license investigations, Just the News noted.
During a court hearing last fall, the FDA claimed that its guidance on ivermectin was "not mandatory." However, the litigants, which include Mary Talley Bowden, a target of cancellation, argued earlier this month in front of the 5th U.S. Circuit Court of Appeals that the FDA cannot use unlawful means to accomplish its intended goals and then seek to avoid responsibility.
According to the litigants, the 5th Circuit's precedent recognizes off-label use as the "standard of care" in many medical contexts, and federalism constraints prevent the agency from advising doctors on whether or how to prescribe approved drugs, the outlet reported.
The Biden regime is obviously beholden to its COVID-19 'religion' and won't allow any uses of ivermectin because it's much more effective than the worthless vaccines.
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