On Tuesday, a lawyer representing U.S. Food and Drug Administration (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, often referred to as the ‘Wonder Drug’ for off-label use in treating 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.
“We’re suing the FDA for lying to the public about ivermectin,” said Dr. Bowden.
Claims were made that the initial article misrepresented the law by stating the FDA’s official stance against Ivermectin use without mentioning that doctors were allowed to administer the medicine.
U.S. law is cited in the complaint, including the provision that the FDA “may not interfere with the authority of a health care provider to prescribe or administer any legally marked device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
The Gateway Pundit reported that 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.
However, the statement from the lawyer contradicted to 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 that says, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
You are not a horse. You are not a cow. Seriously, y’all. Stop it. https://t.co/TWb75xYEY4
— U.S. FDA (@US_FDA) August 21, 2021
Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19. https://t.co/TWb75xYEY4
— U.S. FDA (@US_FDA) April 26, 2022
On Tuesday, Doctors Mary Talley Bowden, Paul Marik, & Robert Apter appeared in the Fifth Circuit Court of Appeals as part of their lawsuit.
“The FDA is not your doctor. Yesterday we took them to court to remind them of that,” Dr. Bowden wrote Wednesday.
“A pharmacist cites CDC and US FDA as why she will continue to deny filling prescriptions for ivermectin. On Tuesday, the FDA’s attorney declared the FDA has no problem with doctors prescribing ivermectin off-label. It’s time for them to make a formal announcement and set the record straight,” Bowden wrote on Thursday.
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.
More from Epoch Times:
“What about when it said, ‘No, stop it’?” Circuit Judge Jennifer Walker Elrod, on the panel that is hearing the appeal, asked. “Why isn’t that a command? If you were in English class, they would say that was a command.”
Ms. Honold described the statements as “merely quips.”
“Can you answer the question, please? Is that a command, ‘Stop it’?” Judge Elrod asked.
“In some contexts, those words could be construed as a command,” Ms. Honold said. “But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command.”
The statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose” Ms. Honold said. She noted that the FDA, along with the statements, said that people should consult their health care providers about COVID-19 treatments and that they could take medicine if it was prescribed by the provider.
“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” she said.
1) FDA Attorney Ashley Cheung Honold Now Says Doctors Did Have the Right to Prescribe Ivermectin Off-Label for COVID-19
“Here FDA was not regulating the off-label use of drugs…The FDA explicitly recognizes that doctors do have the authority to prescribe Ivermectin to treat… pic.twitter.com/o7EFT05vDC
— Chief Nerd (@TheChiefNerd) August 8, 2023
Honold claimed that the FDA had “sovereign immunity” and is therefore immune from liability for false or misleading statements.
2) FDA Attorney Ashley Cheung Honold Says the FDA Has ‘Sovereign Immunity’ and Cannot Be Held Responsible for Misleading Statements
“If the FDA is merely making information statements, they do have sovereign immunity” pic.twitter.com/K9TIFzkJdA
— Chief Nerd (@TheChiefNerd) August 8, 2023
Honold claimed that the FDA possesses the authority to give medical advice.
3) FDA Attorney Ashley Cheung Honold Says the FDA Does Have the Power to Issue Medical Advice
JUDGE: “Does it matter whether they are scientific views or not…or whether they are just views?”
HONOLD: “There’s nothing in the multiple sources of authority that I cited that… pic.twitter.com/WSUDDPyUUp
— Chief Nerd (@TheChiefNerd) August 8, 2023
Honold asserted that even if the FDA’s statements on Ivermectin were misleading, the agency isn’t accountable for doctors losing their positions.
4) FDA Attorney Ashley Cheung Honold Says Even if FDA Statements on Ivermectin Were Partially Misleading, the Agency Is Not Responsible for Doctors Losing Their Jobs
“Even if this court concluded that the parts of the statement that said ‘Stop It’ were unlawful, the remaining… pic.twitter.com/kG1D4kYtXe
— Chief Nerd (@TheChiefNerd) August 8, 2023
In an admission, Honold asserted that the FDA ‘held accountable by the political process’, emphasizing that agency leaders are accountable through the political process, and it’s not the judiciary’s job to verify the FDA’s scientific claims.”
“The public can elect its government officials and FDA…have politically accountable heads of the agency who are held accountable by the political process. It’s not the role of the courts to fact-check the FDA’s scientific statements.”
5) In the Most Disturbing Admission, FDA Attorney Ashley Cheung Honold Says the FDA is ‘Held Accountable by the Political Process’
“The public can elect its government officials and FDA…have politically accountable heads of the agency who are held accountable by the political… pic.twitter.com/RP4YY0ZUHy
— Chief Nerd (@TheChiefNerd) August 8, 2023
There have now been 99 Ivermectin COVID-19 controlled studies that show a 62% improvement in COVID patients.
The post FDA Lawyer Admits Doctors Can Prescribe Ivermectin for COVID-19, Claims FDA Has “Sovereign Immunity” Against Liability for False or Misleading Statements (VIDEO) appeared first on The Gateway Pundit.
