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Not just ivermectin: New FDA authority to ban off-label uses alarms doctors
Just The News ^ | February 22, 2023 | Greg Piper

Posted on 02/23/2023 8:24:13 AM PST by Twotone

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.

(Excerpt) Read more at justthenews.com ...


TOPICS: Crime/Corruption; Government; News/Current Events
KEYWORDS: fda; ivermectin; offlabel
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To: Twotone

21 posted on 02/23/2023 11:06:57 AM PST by MrBambaLaMamba (The only good commie is one that's dead - Country Joe McDonald)
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To: Twotone
"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...."

LOL...Who knew there'd be consequences for passing a bill WITHOUT reading it.

22 posted on 02/23/2023 11:47:12 AM PST by moovova ("The NEXT election is the most important election of our lifetimes!“ LOL...)
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To: beef

Cheaper at Tractor Supply.

Don’t ask how I know...


23 posted on 02/23/2023 11:48:59 AM PST by moovova ("The NEXT election is the most important election of our lifetimes!“ LOL...)
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To: Twotone

What’s the point in going to school for so many years to get a medical degree if you are just going to do whatever the FDA tells you?


24 posted on 02/23/2023 11:50:45 AM PST by Boogieman
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To: DIRTYSECRET

“Is ivermectin something that could be sold over the counter?”

It is for animal use. Which is the same exact formula as for human use. Just not in conveniently premeasured doses.


25 posted on 02/23/2023 11:52:07 AM PST by Boogieman
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To: William of Barsoom

“This effort extended to even the simplest and most widely used vitamins like C and D.”

Hmm, maybe when people need to get a prescription to buy a bag of oranges, they’ll finally be fed up enough to rid themselves of this irksome bureaucracy.


26 posted on 02/23/2023 11:53:54 AM PST by Boogieman
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To: William of Barsoom

“For years FDA has wanted the power to ‘drug-i-fy’ vitamins. This effort extended to even the simplest and most widely used vitamins like C and D.”

If scurvy wasn’t a well-understood disease and was discovered today, the FDA would ban vitamin C, Jimmy Kimmel would mock advocates for using vitamin C to treat it, and Pfizer would announce a vaccine to prevent it. The uniparty would fund the vaccine and mandate it. Talks of scurvy being related to vitamin C deficiency would be considered disinformation and could get you banned, demonetized, and fired.


27 posted on 02/23/2023 12:15:24 PM PST by unlearner (RIP America. July 4, 1776 - December 13, 2022. )
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To: Twotone

EPA banned pellet rat poison and the most effective types of poison last year.


28 posted on 02/23/2023 12:25:08 PM PST by daniel1212 (Turn to the Lord Jesus as a damned+destitute sinner, trust Him who saves, be baptized + follow Him!)
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To: Twotone; ransomnote; bitt; Jane Long; metmom; Jan_Sobieski

Thanks, Twotone.

*PING* to the rest of you. Yikes!


29 posted on 02/23/2023 12:31:55 PM PST by grey_whiskers ( The opinions are solely those of the author and are subject to change without notice.)
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To: GulliverSwift

Sod off, Swampy.


30 posted on 02/23/2023 12:41:12 PM PST by grey_whiskers ( The opinions are solely those of the author and are subject to change without notice.)
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To: Twotone

ANY bill or regulation 4,155 pages long is full of corruption. What are we citizens to do?


31 posted on 02/23/2023 12:54:08 PM PST by The Truth Will Make You Free (o )
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To: Boogieman
What’s the point in going to school for so many years to get a medical degree if you are just going to do whatever the FDA tells you?

Why, to maintain one's bought-off status as a sheepskin recipient entitled to $100/hour+ for services rendered, of course! In such a circumstance, defending oneself against malpractice will likely become a more likely successful outcome and malpractice insurance is likely to be less expensive.

32 posted on 02/23/2023 1:06:36 PM PST by rx
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To: Twotone

The FDA, at the urging of Pfizer CEO Albert Bourla, et al, saw to it this ridiculous idea made it into law. Why? Because Bourla, et al realized how much money they were losing because folks, me included, were taking IVM and/or HCQ instead of risking their lives with the bioweapon clot shots.


33 posted on 02/23/2023 1:29:32 PM PST by upchuck (When you never took the vaccine or boosters: Still alive and healthy with no chance of side effects.)
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To: aimhigh
This is a clear example of why there will never be a real cancer cure - too much existing profit at stake.

MEGA Bump and Amen!

34 posted on 02/23/2023 1:34:43 PM PST by upchuck (When you never took the vaccine or boosters: Still alive and healthy with no chance of side effects.)
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To: DIRTYSECRET

Its sold OTC in many other countries


35 posted on 02/23/2023 3:14:42 PM PST by boxlunch (Red State governors, kick the fednazis OUT of red states! BTW, We are a REPUBLIC not a democracy!)
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To: DIRTYSECRET

Its sold OTC in many other countries


36 posted on 02/23/2023 3:14:43 PM PST by boxlunch (Red State governors, kick the fednazis OUT of red states! BTW, We are a REPUBLIC not a democracy!)
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To: Twotone; Fred Nerks; bitt; SeekAndFind

Big Pharm and Congress are doubling down on restricting Ivermectin, a proven cure for Covid, even as Ivermectin using physicians are suing the FDA for restricting IVM previously.

See:

Doctors Sue FDA For Prohibiting Ivermectin To Treat Covid-19

https://thefederalist.com/2023/02/21/doctors-sue-fda-for-prohibiting-ivermectin-to-treat-covid-19/

Now there is another cure for spike protein causing clots in recently vaxed individuals, “ Nattokinase,” an inexpensive over the counter enzyme which rids the body of spike protein.AVAILABLE AT AMAZON.].Will the FDA ban that as well?

See:
Dissolution of Spike Protein by Nattokinase (Peter McCullough)

https://freerepublic.com/focus/f-chat/4133137/posts


37 posted on 02/23/2023 5:43:03 PM PST by Candor7 ( ( Ask not for whom THE Trump trolls...He trolls for thee!))
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To: GulliverSwift

WHY WOULD THOUSANDS OF PHYSICIANS USE IVERMECTIN IF IT WAS NOT EFFECTIVE?

https://covid19criticalcare.com/

I wager you also suffer from Trump Derangement Syndrome.


38 posted on 02/23/2023 5:47:57 PM PST by Candor7 ( ( Ask not for whom THE Trump trolls...He trolls for thee!))
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To: boxlunch; DIRTYSECRET

INdiamart.com. search term “Ivermectin 12 mg”


39 posted on 02/23/2023 5:49:34 PM PST by Candor7 ( ( Ask not for whom THE Trump trolls...He trolls for thee!))
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To: Twotone

There are a lot of off-label uses out there.

Eventually Carter will insult every singe voter he ever had,


40 posted on 02/23/2023 6:38:57 PM PST by DoughtyOne (I pledge allegiance to the flag of the USofA & to the Constitutional REPUBLIC for? which it stands.)
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