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>>19480286

'FDA is not a Physician': Federal Appeals Court Sides with Doctors on Ivermectin for COVID-19

Dr. Mary Talley Bowden 'thrilled" the 5th Circuit rules that her lawsuit against the agency can continue

Emily Miller

Sep 2, 2023

A federal appeals court on Friday gave three doctors the green light to pursue their lawsuit against the Food and Drug Administration (FDA) over using ivermectin off-label to treat COVID-19.

“It’s been David v Goliath from the start of this pandemic, and it’s finally a small win for David,” Dr. Mary Talley Bowden, one of the plaintiffs, told me Friday. “But there’s still a lot more work to do.” Bowden writes Day 8

.

This is the fifth part of the series on this case. Catch up and get the original sources: lawsuit filed (June 2022), federal district court hearing (Nov. 2022), lawsuit dismissed and appealed (Dec. 2022) and 5th Circuit Appeal hearing (Aug. 2023)

Just weeks after hearing the case, the 5th Circuit reversed a district court’s dismissal on the grounds that the FDA has sovereign immunity. (The decision is at the bottom for paid subscribers to read.)

The ruling was written by U.S. Circuit Judge Don Willett, a Pres. Donald Trump appointee. He pointed to the FDA’s social media posts (below) about ivermectin that made it seem the medication was for farm animals.

The judge wrote:

FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.

Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.

Judge Willett also wrote that the social media messaging “traveled widely across legacy and online media.” He wrote:

Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.

Dr. Bowden said that she and her co-plaintiffs Dr. Paul E. Marik and Dr. Robert L. Apter are “thrilled with the decision which recognizes the FDA is not a doctor and does not have the authority to issue medical advice.”

During the hearing before the three-judge panel, Judge Jennifer Walker Elrod pressed the FDA’s lawyer hard on whether the agency’s social media posts were “commands.”

Finally, the FDA lawyer conceded, “FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.”

The doctors filed the suit in June 2022 for interfering with both their authority to prescribe an approved medication and the doctor-patient relationship.

“The court rejected the government’s attempt to assert sovereign immunity and avoid any accountability for its illegal actions, allowing our case to proceed,” Bowden said. “We look forward to continuing the fight.”

https://www.emilypostnews.com/p/fda-is-not-a-physician-federal-appeals

>>19480286

BOOM! 'Court revives doctors' lawsuit saying FDA overstepped its authority with anti-ivermectin campaign'; “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse

denounce, or advise,” Judge Don Willett wrote for a panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts were misguided, wrong

Dr. Paul Alexander

Sep 2, 2023

A federal appeals court Friday revived a lawsuit by three doctors who say the Food and Drug Administration overstepped its authority in a campaign against treating COVID-19 with the anti-parasite drug ivermectin.

Ivermectin is commonly used to treat parasites in livestock. It can also be prescribed for humans and it has been championed by some conservatives as a treatment for COVID-19. The FDA has not approved ivermectin as a COVID-19 treatment because studies have not proven it is effective.

The agency did not immediately respond to requests for comment.

Friday's ruling from a panel of three judges on the 5th U.S. Circuit Court of Appeal in New Orleans focused on various aspects of an FDA campaign against ivermectin as a COVID-19 treatment.

The ruling acknowledged FDA's receiving reports of some people requiring hospitalization after self-medicating with ivermectin intended for livestock. But the ruling said the campaign — which at times featured the slogan “You are not a horse!” — too often left out that the drug is sometimes prescribed for humans.

The doctors can proceed with their lawsuit contending that the FDA's campaign exceeded the agency's authority under federal law, the ruling said.

“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” Judge Don Willett wrote for a panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

https://news.yahoo.com/court-revives-doctors-lawsuit-saying-232441458.html

https://palexander.substack.com/p/boom-court-revives-doctors-lawsuit

>>19480286

FDA ruled against by a federal court over anti-ivermectin messaging

"FDA can inform, but it has identified no authority allowing it to recommend consumers 'stop' taking medicine," the ruling reads.

A federal court ruled on Friday that the U.S. Food and Drug Administration (FDA) likely abused its authority when it used anti-ivermectin messaging to get Americans to not use it to treat COVID-19.

"FDA can inform, but it has identified no authority allowing it to recommend consumers 'stop' taking medicine," U.S. Circuit Judge Don Willett wrote in the ruling, according to The Epoch Times.

The ruling was sent back to the lower court where it will be reconsidered.

“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” the ruling reads.

Three doctors sued the agency over its statements on ivermectin, arguing the agency can't intervene on what doctors prescribe their patients.

Plaintiff Mary Talley Bowen celebrated the Sept. 1 ruling on social media.

“A small win, or at least a step forward, in a monumental battle to protect the doctor-patient relationship from government tyranny,” she wrote on X, the platform previously called Twitter. “ONWARD!”

https://justthenews.com/government/courts-law/fda-ruled-against-federal-court-over-anti-ivermectin-messaging

>>19480286

Federal Court Rules FDA Abused Its Authority with Anti-Ivermectin Messaging to Americans: “FDA is Not a Physician”

In a landmark ruling on September 1, a federal court stated that the U.S. Food and Drug Administration (FDA) abused its authority under federal law when it advised Americans to “stop” using the drug Ivermectin as a treatment for COVID-19.

The Gateway Pundit previously reported that a group of doctors had filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) over the agencies’ unlawful attempts to block the use of Ivermectin in treating COVID-19.

The lawsuit, filed in the U.S. Southern District of Texas in Galveston, argues that the FDA has overstepped its authority and unjustifiably interfered with their medical practice.

The plaintiffs, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, are contesting the FDA’s portrayal of Ivermectin as dangerous for human consumption. They note that the FDA has approved Ivermectin for human use since 1996 for a variety of diseases. However, they allege that with the advent of the COVID-19 pandemic, the FDA began releasing documents and social media posts discouraging the use of the anti-viral drug for COVID-19 treatment.

During a hearing last year, the agency’s lawyers argued that the FDA was only giving advice and it was not mandatory when it told people to “stop” taking Ivermectin for COVID-19.

“The cited statements were not directives,” said Isaac Belfer, one of the lawyers. “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.”

“They use informal language, that is true… It’s conversational but not mandatory,” he continued.

The statement from the lawyer contradicted the FDA’s social media post, stating, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19″ and another tweet says, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Both posts were linked to FDA’s website with the title, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”

Last month, the lawyer representing the FDA clarified the agency’s stance on the use of Ivermectin for treating COVID-19 patients. The lawyer confirmed that doctors have the authority to prescribe the drug for off-label use in treating COVID-19.

During the oral argument, Ashley Cheung Honold, a Department of Justice lawyer representing the FDA stated that the agency “explicitly recognizes” that doctors do have the authority to administer Ivermectin to treat COVID.

“”FDA explicitly recognizes that doctors do have the authority to prescribe Ivermectin to treat COVID,” said Honold.

“FDA made these statements in response to multiple reports of consumers being hospitalized, after self-medicating with Ivermectin intended for horses, which is available for purchase over the counter without the need for prescription,” Honold said.

On Friday, September 1, U.S. Circuit Judge Don Willett stated in his written ruling, “FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”

According to the court’s decision, the three physicians can now pursue legal action, arguing that the FDA’s campaign went beyond the scope of the agency’s jurisdiction as defined by federal legislation.

“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” Judge Don Willett wrote for a panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.”

>>19480522

“FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise,” Judge Don Willett wrote for a panel that also included Jennifer Walker Elrod and Edith Brown Clement. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to. As such, the Doctors can use the APA to assert their ultra vires claims against the Agencies and the Officials.”

In the ruling, Judge Willett wrote, “Left unmentioned in most of that messaging: Ivermectin also comes in a human version. And while the human version of Ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose.”

He added, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”

In a statement to Epoch Times, Dr. Mary Talley Bowden said, “The FDA misled the public into thinking it has more authority than it does. This decision confirms that the FDA is not your doctor and has no authority to tell doctors how to practice medicine.”

It can be recalled that Houston Methodist launched an investigation into Bowden and suspended her for defying health authorities and exercising free speech.

The hospital excoriated Bowden for “using her social media accounts to express her personal opinions about the COVID-19 vaccine and treatments,” NBC News reports. The suspension barred the physician from admitting or treating patients at the hospital.

Bowden repeatedly warned that it is “wrong” to mandate the experimental mRNA vaccines and continuously touted Ivermectin as a safe and effective treatment amid threats from public health officials against prescribing the drug.

Bowden was forced to resign. In her resignation letter, Bowden doubled down on the efficacy of Ivermectin.

“I have worked hard to provide early treatment for victims of COVID-19. My efforts have been successful. I have treated more than 200 COVID-19 patients, including many with co-morbidities, and none of these patients have required hospitalization. This is a testament to the success of my treatment methods,” she wrote. “Throughout this pandemic, there has been no FDA-approved treatment for COVID. Therefore I have done my best to care for patients and save lives in the absence of a clear scientific consensus.”

“Early treatment must still be part of any strategy for patient care. That is why physicians and hospitals should pay more attention to medications such as Ivermectin, which significant research and my clinical experience indicate is effective,” she continued. “I have decided to part ways with Houston Methodist because of the accusation that I have been spreading “dangerous information.” This is false and defamatory. I do not spread misinformation, and my opinions are supported by science. There is substantial evidence for the efficacy of Ivermectin in treating COVID-19, and no evidence for serious or fatal side effects associated with the doses used to treat COVID-19.”

There have now been 99 Ivermectin COVID-19 controlled studies that show a 62% improvement in COVID patients.

https://www.thegatewaypundit.com/2023/09/federal-court-rules-fda-abused-its-authority-anti/

Court smacks down FDA's ivermectin warnings: 'FDA is not a doctor'

An appeals court has replied to the FDA's 2021 warnings about using ivermectin to treat Covid, "You are not a horse."

"FDA is not a doctor," writes the court. Later in the court decision, four appellate judges write, "FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to."

FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.

Fifth Circuit Court Decision

The court decision is a major victory for Dr. Mary Tally Bowden and two others who sued the FDA; FDA Commissioner Dr. Robert Califf; and its parent agency, HHS. The plaintiffs argued that the FDA overstepped its authority in warding people away from a drug that they say had proven to work for Covid.

Bowden says the FDA propaganda about ivermectin interfered with her ability to help patients, and destroyed her reputation. The FDA's smear of ivermectin was heavily used against medical professionals who chose to prescribe ivermectin, was widely circulated uncritically on social media and on the news, and was cited by medical boards and court filings against prescribing physicians.

In a series of now-infamous tweets, FDA implied ivermectin was dangerous, and that it was intended only for horses and other animals. The appellate judges noted that FDA failed to acknowledge that a safe and effective human form of the medicine has been in use for decades.

On the heels of the government and other vaccine industry interests attacking ivermectin, WalMart and many other pharmacies refused to fill legal prescriptions for the drug and, instead, heavily promoted the experimental vaccines that turned out to be ineffective at preventing Covid infection or transmission.

A number of cases stemming from government actions during the height of the Covid pandemic are now working their way through court. Decisions in these cases may serve as precedents if and when CDC, FDA and other public health officials and medical interests attempt a repeat of broad, restrictive measures that were frequently accompanied by false information.

On Full Measure, we reported on a couple who said they were very ill and desperate, and felt compelled to use the horse version of ivermectin when their local pharmacies wouldn't fill prescriptions for human version. They say they believe ivermectin was crucial in helping them get better. Watch that report here.

The government and vaccine industry interests gave much the same treatment to another inexpensive drug, hydroychloroquine, after President Trump said it should be tried. Watch that report here.

Read the ivermectin court decision or download it below.

https://sharylattkisson.com/wp-content/uploads/2023/09/668573027-Fifth-Circuit-Decision-Against-FDA-in-Apter-Case-1.pdf

https://sharylattkisson.com/2023/09/read-court-smacks-down-fdas-ivermectin-warnings-fda-is-not-a-doctor

>>19480390

whats notable about it?

>>19480636

I dont fucking care

fuck off

filturd

NOTABLES ARE NOT ENDORSEMENTS

>>19480286

#23925

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>>19480510 'FDA is not a Physician': Federal Appeals Court Sides with Doctors on Ivermectin for COVID-19

>>19480515 BOOM! 'Court revives doctors' lawsuit saying FDA overstepped its authority with anti-ivermectin campaign'; “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse

>>19480519 FDA ruled against by a federal court over anti-ivermectin messaging

>>19480522 Federal Court Rules FDA Abused Its Authority with Anti-Ivermectin Messaging to Americans: “FDA is Not a Physician”

>>19480535 Court smacks down FDA's ivermectin warnings: 'FDA is not a doctor'

Anonymous ID: befd01 Sept. 2, 2023, 8:20 p.m. No.19480687 🗄️.is 🔗kun >>0691

>>19480675

havent finished getting down the bread..

want to bake

call the ball