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FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a Recommendation

FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a Recommendation

The U.S. Food and Drug Administration (FDA) telling people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, told the court during the Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for non-approved purposes in the United States; the practice is known as off-label treatment.

The FDA created a webpage in 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and later posted a link to the page on Twitter while writing: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

 

A second post stated: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

In a separate page, the FDA said:

“Q: Should I take ivermectin to prevent or treat COVID-19?

A: No.”

Those actions interfered with the doctors’ practice of medicine, violating the laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit alleges.

It asked the court to rule the actions unlawful and bar the FDA from directing or opining as to whether ivermectin should be used to treat COVID-19.

Jared Kelson, an attorney representing the plaintiffs, told the court during the hearing that that informal claim “doesn’t explain the language they actually used: ‘Stop it. Stop it with the ivermectin.'”

The FDA’s actions “clearly convey that this is not an acceptable way to treat these patients,” he argued.

Plaintiffs in the case include Dr. Paul Marik, who began utilizing ivermectin in his COVID-19 treatment protocol in 2020 while he was chief of pulmonary and critical care medicine at Eastern Virginia Medical School and director of the intensive care unit at Sentara Norfolk General Hospital.

After the FDA’s statements, Marik was told to remove the protocol from the school’s servers while Sentara issued a memorandum to hospitals telling them to stop using ivermectin against COVID-19, with a citation to the FDA.

Marik was forced to resign from his positions because he couldn’t prescribe ivermectin due to the FDA’s statements, the suit alleges.

The government has moved to dismiss the complaint, asserting plaintiffs lack standing because the injuries cannot be traced back to the FDA.

 

More From the Hearing

During the recent hearing, which was on the motion to dismiss, the government said the FDA could not be blamed for the injuries.

“Plaintiffs have also not shown that any of their claimed injuries are fairly traceable to defendants’ statements because their injuries were caused by independent third-party conduct that was not a predictable response to those statements,” Belfer, the government lawyer, said.

Belfer noted that the FDA’s pages say people can use ivermectin if their health care provider prescribes it, argued the statements “did not bind the public or FDA, did not interpret any substantive rules, and did not set agency policy,” and said the FDA’s position could change in the future if new data become available.

“They also do not have legal consequences for anyone but simply provide nonbinding recommendations to consumers,” he said.

Kelson disagreed.

“If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said. “That is enough of a harm to get into court,” or have the motion to dismiss rejected, he said.

Ivermectin is used on animals in addition to humans. The FDA used a picture of a horse in its Twitter posts and on one of its pages.

“The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” Kelson said.

U.S. District Judge Jeffrey Brown, a Trump appointee overseeing the case, said that he was most concerned about the social media statements because they did not include any qualifiers.

Belfer argued the statements were aimed at consumers and that the Twitter posts linked to one of the pages, which does include the qualifier.

“So it was predictable that if you include the link to the article, people will click on the link and will see the full article, which includes that disclaimer that if your doctor writes you a prescription, you should fill it exactly as prescribed,” he said.

“The plaintiffs, by their own admission, have continued to prescribe ivermectin. So they always had the authority. It may be that patients were not able to fill prescriptions, but the doctors themselves always had the authority,” he added later.

Brown said he appreciated the briefing from the parties and that he would rule “as quickly as we can for ya’ll.” As of Nov. 19, he has not issued a ruling.

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Comments

Art70
8 hours ago
It appears the U.S. is under attack ?
More like those who are in charge of the U S. are responsible.
snooky
Yesterday
Go down any old rathole and there will be treasonous duel-citizen at the helm- Nobody talks about Avril Haines the wicked Jewish bitch who oversees all US intelligence services- she’s the culprit behind the screen letting the worst things happen on her watch- High Treason
LindaL23
Yesterday
76 years of blessing Israel. See where that has gotten us.
Those who bless evil will be cursed by God.
hereforthecake
Yesterday
The USA is attacking the USA
Kodiak
6 hours ago
Almost perfectly said.
Better said!
The Jew controlled USA is attacking the USA
Sludgehammer
Yesterday
This is what the libtards want.
Mattie J
Yesterday
Another possibility: New Madrid

SOZT
As we have explained repeatedly, a plate jolt to objects on water does not have a brake. Thus anything on the water will continue to move on the path the jolt pushed it into, unlike objects on land which will be grounded and thus stop moving. Friction with the land is the brake. The SE Portion is being jerked to the SE, along with Africa when it rolls, and these jerks have only started. It may be rivers and lakes and bays that are a concern now, but quake devastated cities and highways will be next. This is the New Madrid Adjustment, now starting.
EOZT

https://poleshift.ning.com/forum/topics/zetatalk-chat-for-april-30-2024?id=3863141%3ATopic%3A1161422&page=2#comments
Bayeranton
Yesterday
This is the result of a open border and Obama bringing in Muslims and finding terrorism through Iran
Red Deer
7 hours ago
That may have contributed but I feel it is an inside job. Emigrants become useful idiots and scapegoats for treasonous acts from within. Just look at the legislation our "leaders" have allowed and the the corruption of the courts. This is all done within the framework of our government serving the people they represent.
Remember the Russians did not allow Biden to win, nor have they benefited from the election. They had better relations with Trump and we had better government.
D61h
Yesterday
Funny how these acts of terrorism just so happen to progress the great reset agenda. Coincidence I'm sure.
Sludgehammer
Yesterday
✡️💩💲
Johann Gambolputty
Yesterday
Those are good targets for fifth generation warfare.

Send in the migrant operatives and have them hit easy, soft targets. That and setting forest fires. Also sabotaging rail lines. That's another easy one.

Cost nothing to do. No weapons or direct killing of civilians, and it messes up infrastructure.
BondGirl
Yesterday
Gosh in two weeks time this is the fourth barge event. Note in Barack and Michael Hussein's movie "Leave the World Behind" the first scenes of despair were barges going rogue..then the bridges collapsing. Things that make you go HMMMMMMMM
gravedigergary
Yesterday
Very interesting.
Witness
Yesterday
It’s funny how it is obviously terrorism, but there is room to say, “they just broke loose”! It’s actually pretty clever for an enemy to be doing.
However, if good ole USA is doing this, it’s not clever; just plain stupid and annoying.
BondGirl
Yesterday
When a govt is at war with their own citizens, yet no one realizes it. Look up! The sky has become a crime scene daily as unmarked military planes with evil pilots dumping chemicals on you. That is called chemical warfare.. and for the love of money, our own are doing this to us.It is a multi vector attack: poisoning of the food, water and air supply, hijacking of the "healthcare" system, and now we are under siege as our infrastructure gets destroyed. and most in office now have NO OATH of OFFICE or FRAUD OATHS
Madm0j0
Yesterday
Excellent time to get stocked up. A lotta products flow on that river. All the way to the Mississippi!😕

Including a “lot” for defense!
gravedigergary
Yesterday
Sad but the plain truth. Communists in office, killing the USA and Canada.
gravedigergary
Yesterday
Sadly true, but most still call us conspiracy theorists and nut cases, while the world and North America burn.
Mattyc
Yesterday
Wish they would target the railways as well at the same time as the boats.
Paybacks are a cummin' for 200 years of regime changes and countless wars
against countless countries. Pretty hard to feel any sympathy when we know the reason behind these events. Representitives from 180 countries are here now for the express purpose of payback time for skanky yanky stan. Thanks to stinkfingur.
Yet everyone seems to be shocked when people FINALLY stand up to this country.
Aint so exceptional no more obviously.
Adster
Yesterday
Asymmetric warfare
Rok
Yesterday
The USA has so many enemies now I can't say who is behind this.

Iran?
China?
Ukraine, for being pissed we stopped or slowed done support?
Libtards commies in this country
space aliens
or maybe the beginning of God's judgments. Those with eye to see will get this.

I can tell you this: no matter who, I blame the US Gov for allowing them into this country and open borders. Not having a clue who is inside.
Eyez2C
Yesterday
"Allowed into this country?" More like invited, supported & encouraged. Then, there's the Migration Compact signed by the 3 North American countries....all 3 are guilty.
SignaltoNoise
Yesterday
Quoting Rok:
The USA has so many enemies now I can't say who is behind this.

Iran?
China?
Ukraine, for being pissed we stopped or slowed done support?
Libtards commies in this country
space aliens
or maybe the beginning of God's judgments. Those with eye to see will get this.

I can tell you this: no matter who, I blame the US Gov for allowing them into this country and open borders. Not having a clue who is inside.

It's all one temple with many branch plants also known as governments.
gravedigergary
Yesterday
Well said. Im a vet, and American Legion member, but ashamed of our stinking government .
ronberry65
Yesterday
they will blame white right wing, pro gun, pro life, christian extremists AKA average mericans!
Paul Lambert
Yesterday
That's how we can know that such are NOT responsible for all of this.
gravedigergary
Yesterday
Of course.
WilliamtheResolute
Yesterday
On alert my ass...there are dozens of tows for these barges going up and down the river all the time...call an emergency, have them park their loads and round up the loose barges.
Witness
Yesterday
Ah. Good to know. Thanks.
Jefferson
Yesterday
I remember back in Alabama in the '90's I would go climb onto parked barges on the Black Warrior River and jump from one to the other and hang out, fishing off them. I'm sure I was trespassing but it was a lot of fun. They were just tied to trees and to each other with big ropes. I'm sure the flooding was a factor, but yeah maybe somebody cut them loose.
JEWallace
Yesterday
The energy you put out into the world whether it be negative or positive, returns to its source.

Under this divine principle, severe destruction is forthcoming for both Israel and the United States.

Since Genocide in Gaza is heavily focused upon by humanity, Israel shall suffer first and foremost.

When Israel is demolished, the energy will then be transferred to its main supporter 🇺🇸.

I admire and respect “Divine Law”.

There are repercussions for committing evil deeds.
Plowboy
Yesterday
NONSENSE! The Lord Jesus Christ was righteous (i.e. sinless) and it got him nailed to a tree!
Johann Gambolputty
Yesterday
If he was sinless, then when he said "Let he who is without sin cast the first stone" why didn't he throw the stone?

That was an admission of sin right there.
Sludgehammer
Yesterday
Rumor has it he liked the jailbait.
Witness
Yesterday
Ummm. That was God’s plan all along. He didn’t just get caught and killed by evil men.

Isaiah 53:10 “Yet it pleased the Lord to bruise him; he hath put him to grief: when thou shalt make his soul an offering for sin, he shall see his seed, he shall prolong his days, and the pleasure of the Lord shall prosper in his hand. 11 He shall see of the travail of his soul, and shall be satisfied: by his knowledge shall my righteous servant justify many; for he shall bear their iniquities.”
HawkHollar
Yesterday
That river is stupid high now and cant hold anymore water. 5' to 8'ft above the barge tie offs. Maybe thats why? Weather warfare again?
Marm
Yesterday
This is normal for Pittsburgh under flood conditions. Nothing new here. Not every event is a conspiracy.
linmarie
Yesterday
Perhaps not. But you must admit it’s very suspicious given the Baltimore & NYC incidents.
Something doesn’t smell right….
gravedigergary
Yesterday
Right
Marm
Yesterday
I'm from Pittsburgh, this happens when there is heavy flooding on the rivers. Look back in history. Nearly an annual occurrence.
LindaL23
Yesterday
Quoting Marm:
I'm from Pittsburgh, this happens when there is heavy flooding on the rivers. Look back in history. Nearly an annual occurrence.

Then why have they not done anything to prevent this kind of thing from occuring every time the river rises? Also, it is not like they did not know the river levels were rising and to get most of the barges down river or moored better. Just plain stupidity, or planned.
DocHolliday
Yesterday
Under Bush Israeli mafia had threatened to do terror acts if they didn't get their way from the US cooperation.
Free Route 66
Yesterday
The river is very high and flooding due to alot of rain in Ohio and Pennsylvania.
Lexy
Yesterday
OBidens let in 4 million total strangers amongst them 100 thousand innocent bowing Chinese. For all we know its some of them. Quite the set up.
mtw1128
Yesterday
Taking us down, without firing a shot.
R.H. Smith
Yesterday
What a demeaning job it must be to be a Main Stream Journalist - to be in a constant state of printing lies fed to you from the CIA. Not one word throughout all of them about our failed Transportation Sec. Peaty or terrorism. Both are at play and it doesn't take much Logic to come to that conclusion.
OVERCOMER
Yesterday
IMHO, only the beginning!!!!!! We need to be guarding the electric grid, etc. It does not take an EMP to cripple large areas of this country!!!!
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