New FDA authority to ban off-label uses alarms doctors – IOTW Report

New FDA authority to ban off-label uses alarms doctors

JTN: 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. more

11 Comments on New FDA authority to ban off-label uses alarms doctors

  1. Guess what won’t be banned off label – puberty sterilization blockers that ruin lives and reduce life spans. Ivermectin proven to work for covid – dead on arrival.

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  2. Creeping totalitarianism, again.. and again and again and again… I didn’t put up a fuss over the lockdowns or the institutional coercion over the shots, just found workarounds. Long ago, helmet laws for motorcyclists… car seat and strap in for the kids law… law against smoking in your own office.

    Off label prohibition is severe. It is reaction and deliberate reaction to COVID medical practice and the catastrophic failure of the shots and every institution associated with those injections. This is a form of professional censorship that is really unprecedented. It follows censorship of speech like the dog follows the bitch.

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  3. Therapeutic organic essential oils treats many diseases and disorders such as virus, hair loss, weight loss, arthritis, skin issues, gastric disturbances and many others. Phake Pharma is trying to gain control of these E.O.s and the small biz which offers them to discourage people from using them as opposed to toxic poisonous rx meds.

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