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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.

Comments   

# LyingForrest Mosby 2022-11-23 19:26
Bastards
# They are pure evilModSquad 2022-11-23 02:05
Must Watch! "DIED SUDDENLY"
https://rumble.com/v1wac7i-world-premier-died-suddenly.html
# It Must Be...Getsum 2022-11-22 23:48
It must be "Report another website's story and not give them credit day".

This is the third story today jacked from another website. See Link:

https://citizenfreepress.com/breaking/fda-lies-in-court-we-never-told-anyone-not-to-take-ivermectin/

If you notice, while reading the link above, in the world of reporting it IS OK to do this, but you MUST ALWAYS give credit to the original poster/originator of said story...that does not happen here for some reason. Probably because the majority of these sites are FREE and this one is a subscription based for some stories. In academia it's called plagiarism and one can be immediately expelled for taking credit for another's work. It looks bad, to say the very least.
+1 # #RECOMMENDEDKathrynM 2022-11-21 22:08
In California, in 1990's, medical doctors who are also lawyers, worked directly with professional liability insurance companies, malpractice insurers, to petition the California medical board to change the language when doctors write their "orders". Ca medical board accepted the change of language from "DR's ORDERS" to "recommendations" along with counseling and discussion. The entire coding system required a change to accommodate new language.

I worked as a forensic accounts receivable specialist from 1985-2007 and noticed the language switch when I was reviewing a sub specialist's medical records. It read very suspiciously to me and I spoke w/the Dr about it. He stated, it was to play cya for all the OB Dr's getting sued for the avalanche of medical malpractice claims the malpractice companies didn't want to pay out. So the insurance lobby petitioned the medical board of CA to overhaul professional medical language from "DOCTORS ORDERS" to "recommendations" with counseling and discussion requiring 15 whole minutes to let shitty doctors off the financial hook for malpractice claims.

Enter the opioid crisis. The term "recommendation" was hijacked again by the Dea to throttle all doctors who prescribed opioids. All drs prescribing opioids were immediately placed into Medicare / Medicaid review. Yes, it did get lots of bad doctors out of the pill mills. But that could have been easily accomplished by simply busting those bad doctors when the dea got their monthly report. Instead, the federal government was given open season on an entire sub speciality. Good doctors were bankrupted defending themselves and even some jailed for writing prescriptions. Had doctors never allowed the ama to manipulate their professional language responsibilities they never would have subverted an entire professional group of ppl.

The most educated and highly trained amongst all the educated were subverted again with the "Affordable Care Act". It completely changed new admissions into college entrance exams to medical school, mcat. They removed serious pre med requirements and began integrating the new diversity bs and the medical profession was gone. The final nail was to vilify any doctor who refused to be controlled by gov entities. What we are witnessing today. The free doctors must be crushed to keep the drones under control.
+1 # RE: FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a Recommendationdavidbeaton 2022-11-21 13:17
Yet you could not fill an ivermectin prescription if you went to a pharmacy like CVS, Walgreens, etc. Only the small local pharmacies would fill the ivermectin prescription.
# do the oppositePSKYWAY 2022-11-21 10:17
of what the gov says
+8 # Ivermectin worked for us.shirley5520 2022-11-21 02:05
On the first of this year, my husband and I had Covid 19. I order my meds from India and had Ivermectin and Hydroxycholquin at the time. We immediately started taking both meds, and within 2-3 days we were both over Covid. No one will convince me that these drugs don't work for Covid. I also keep a variety of antibiotics just in case something happens and we don't have a doctor available. I refuse to be a victin.
+10 # RE: FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a RecommendationErfman 2022-11-20 21:01
It's funny how they say it was only a suggestion, after the fact.

They also villainized hydroxy chloroquine and drug stores wouldn't fill legitimate prescriptions for it.

The fact that ivermectin was used for horses was the only reason people could get their hands on it.

The real truth was they didn't want real safe and effective remedies, they had an experimental gene therapy and lockdowns before the election they wanted to push therefore standard treatments could not be allowed.

...and they are not done yet. They want to massively reduce the population... Especially the retirees.
# Partially Correct...Getsum 2022-11-22 23:58
For the "Vaccine" to be approved for Emergency Use Authorization (EUA), there could not be another treatment that was effective against the virus.

By demonizing both common drugs as ineffective, they were able to get their coveted EUA which included the ability to NOT be able to get sued if (and in this case) WHEN it went wrong.

Why/how logical and intelligent people would sign their rights away to receive a rushed/unproven experimental shot is beyond imagination. The NWO must be laughing themselves to sleep at night at how easy a second holocaust could be...by a German, Klaus Schwab, no less. Who would have thought? And people who did this to themselves are STILL defending them! You can't make this stuff up!
+2 # FDAfaithman 2022-11-20 19:50
F-ing dumb a’s
+1 # █▓▒░ "recommendation" ░▒▓█Palehorse 2022-11-20 19:04
|

To have expected anything else would have been stupid.

+10 # RE: FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a RecommendationWilliamtheResolute 2022-11-20 16:51
Don't piss on my leg and tell me it's raining...I'm done with gaslighting Leftards.
+2 # Piss on my legTurnercom1 2022-11-20 18:27
To funny bro. Laughed my ads off.
+7 # This is liar, er I mean lawyer BS.wardoc 2022-11-20 15:29
When the FDA speaks, its taken as a directive, whether mandatory or not. And they know it. I know this to be absolutely true, having 38 years in medical practice in hospitals, clinics and military related settings. Also medical boards take anything the FDA says as gospel and they punish doctors who who follow FDA directives, whether, a recommendation or not.
+3 # they punish doctors who DON'T follow FDAwardoc 2022-11-20 15:31
sorry, typo.
+1 # There is an edit button...FewThereBe 2022-11-20 16:18
---

FYI: There is an edit button at the bottom-left of any comment that you make.

There will be 3 icons/buttons on any of our own comments vs. only 2 for anyone else's comments.
+4 # RE: FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a Recommendationsandymc 2022-11-20 15:08
Time to put them down...Like the Dogs they are,,,.They are too sick to continue..
+5 # MURDERING SCUMjoe@tittiger.com 2022-11-20 15:05
.
MURDERING SCUM is my only thought here.

Lots of them need to swing from the gallows.

FWIW I took my "horse paste" this month....
Whatever is going on you can't get Ivermectin at the local feed store now for months.
+1 # RE: MURDERING SCUMNda 2022-11-20 22:45
This country is done. I hate liars.


Quoting joe@tittiger.com:
.
MURDERING SCUM is my only thought here.

Lots of them need to swing from the gallows.

FWIW I took my "horse paste" this month....
Whatever is going on you can't get Ivermectin at the local feed store now for months.
+10 # Ivermectin was developed for humans before horses.paulattahoe 2022-11-20 15:03
The "horse paste" works so well that I had to hide it so non-vaxxed people around us would order their own.

We fired our "board-certified" doctor over an argument involving Ivermectin. The liberal idiot insisted the jab was mandatory. I jumped back on the doc hard in the office, and the whole place heard the argument before I walked out.
+12 # IVERMECTINzoochman 2022-11-20 15:02
It's only your imagination that the FDA and the government were advocating vaccines and against ivermectin. Fauci and Gates are war criminals and should be immediately found and arrested.
# RE: FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a RecommendationRealAmericanPride 2022-11-20 14:47
I’m a all paste and no horse kind of guy.
+8 # Recommendations only?gpfla 2022-11-20 14:44
If ivermectin was only not recommend, was the recommendation justification for my order being confiscated by customs?
+5 # RE: Recommendations only?FewThereBe 2022-11-20 16:23
---

I believe U.S. Post Offices could also open/inspect for IVM.
# RE: Recommendations only?mjc 2022-11-20 14:52
Quoting gpfla:
If ivermectin was only not recommend, was the recommendation justification for my order being confiscated by customs?


No, that would not be justification for seizure.

However, did you not file your Form 987987 stroke 3 (figuratively) and wait for both Customs and FDA approval (litterally)? Your supplier? If 'no' or 'unknown' (realistically.....no).....then Customs will seize the prescription drugs if they find them....


https://www.fda.gov/industry/fda-basics-industry/what-must-i-do-import-human-drug-product-has-been-approved-fda-us

"An FDA approved drug is one which is subject to an FDA approved application: New Drug Application (NDA), Abbreviated New Drug Application (ANDA) or Biologics License Application (BLA). Unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval.

All foreign drug establishments whose products are imported or offered for import into the United States are required to register their establishment with FDA and list all of their drug products in commercial distribution in the United States (See FAQ: If I am required to register my drug facility and list my drug product, how do I proceed? For more details)

To ensure that FDA is notified of all regulated products imported into the United States, the importer, or his/her representative, must file an entry notice and an entry bond with Customs pending a decision regarding the admissibility of the product. FDA inspection and enforcement procedures for imports rely on coordination with Customs. FDA is notified by Customs of the product’s entry and makes a decision as to its admissibility."
+6 # RE: FDA Says Telling People NOT TO TAKE Ivermectin for COVID-19 Was Just a Recommendationebelfer52 2022-11-20 14:42
What a crap statement. The fda is certainly sidestepping its responsibility. They shadow banned it. Pharmacies to avoid trouble with the fda refused to fill prescriptions of it then quit even carrying it to avoid angry patients. Easy to say sorry it's not in stock than no u can't have it. Hospitals and courts refused to use or allow it even in dying patients based on the statements of the fda. And worse is doctors believed it and still believe its horse medicine. And some states are still persecuting any physician willing to use it. One of the safest drugs in existence and a proven reduction in covid deaths of 92 percent and it's still almost impossible to get, but sorry we never meant u cant use it.. ..
# ebelfer52shirley5520 2022-11-21 11:52
Your statement is sad but true; that is why I keep my stash of meds that I buy from India. So many people don't realize that the Rx meds they get from their local pharmacy are from India.
# Sidestepping its responsibility389rivka@gmail.com 2022-11-20 15:42
FDA version of the highly popular “DC Two-step”.


*sarc

 

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