{"id":2327,"date":"2023-08-12T07:35:52","date_gmt":"2023-08-12T07:35:52","guid":{"rendered":"https:\/\/highspeedjob.com\/?p=2327"},"modified":"2023-08-12T07:50:58","modified_gmt":"2023-08-12T07:50:58","slug":"fda-drops-bombshell-new-guidance-ivermectin-can-be-prescribed-to-treat-covid-19","status":"publish","type":"post","link":"https:\/\/highspeedjob.com\/fda-drops-bombshell-new-guidance-ivermectin-can-be-prescribed-to-treat-covid-19\/","title":{"rendered":"FDA Drops Bombshell New Guidance: Ivermectin Can Be Prescribed To Treat Covid-19"},"content":{"rendered":"

Doctors have the authority to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) announced in court this week. The FDA is also attempting to re-write history, claiming in court that they never told Americans to stop taking ivermectin to treat Covid-19.<\/p>\n

\u201cFDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,\u201d Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.<\/p>\n

Epoch Times reports: The government is defending the FDA\u2019s repeated exhortations to people to not take ivermectin for COVID-19, including a post that said \u201cStop it.\u201d<\/p>\n

The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements.<\/p>\n

A federal judge dismissed the case in 2022, prompting an appeal.<\/p>\n

\u201cThe fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,\u201d Jared Kelson, representing the doctors, told the appeals court.<\/p>\n

The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter:<\/p>\n

\u201cYou are not a horse. You are not a cow. Seriously, y\u2019all. Stop it.\u201d<\/p>\n

The post, which linked to an FDA page that says people shouldn\u2019t use ivermectin to prevent or treat COVID-19, went viral.<\/p>\n

In other statements, the FDA said that ivermectin \u201cisn\u2019t authorized or approved to treat COVID-19\u201d and \u201cQ: Should I take ivermectin to prevent or treat COVID-19? A: No.\u201d<\/p>\n

Command or Not<\/h3>\n

\u201cFDA 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,\u201d Ms. Honold said.<\/p>\n

A version of the drug for animals is available, but ivermectin is approved by the FDA for human use against diseases caused by parasites.<\/p>\n

Ms. Honold said that the FDA didn\u2019t purport to require anyone to do anything or to prohibit anyone from doing anything.<\/p>\n

\u201cWhat about when it said, \u2018No, stop it\u2019?\u201d Circuit Judge Jennifer Walker Elrod, on the panel that is hearing the appeal, asked.<\/p>\n

\u201cWhy isn\u2019t that a command? If you were in English class, they would say that was a command.\u201d<\/p>\n

Ms. Honold described the statements as \u201cmerely quips.\u201d<\/p>\n

\u201cCan you answer the question, please? Is that a command, \u2018Stop it\u2019?\u201d Judge Elrod asked.<\/p>\n

\u201cIn some contexts, those words could be construed as a command,\u201d Ms. Honold said.<\/p>\n

\u201cBut 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.\u201d<\/p>\n

The statements \u201cdon\u2019t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose\u201d 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.<\/p>\n

\u201cFDA 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,\u201d she said.<\/p>\n

Judge Elrod is on the panel with Circuit Judges Edith Brown Clement and Don Willett. All three were appointed under President Donald Trump.<\/p>\n

Federal Law<\/h3>\n

The plaintiffs are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA\u2019s statements, including being terminated over efforts to prescribe ivermectin to patients.<\/p>\n

Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.<\/p>\n

Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.<\/p>\n

\u201cThis is something the FDA has never been able to do. And it\u2019s a bright line,\u201d he told the court, adding later:<\/p>\n

\u201cThe clearest examples of where they have gone over the line are when they say things like, \u2018You are not a horse, you are not a cow. Seriously, y\u2019all. Stop it.\u2019\u201d<\/p>\n

Judges indicated they agree that the FDA lacks the power to give medical advice; Judge Clement said, \u201cYou\u2019re not authorized to give medical advice.\u201d<\/p>\n

\n

You are not a horse. You are not a cow. Seriously, y’all. Stop it. https:\/\/t.co\/TWb75xYEY4<\/a><\/p>\n

\u2014 U.S. FDA (@US_FDA) August 21, 2021<\/a><\/p><\/blockquote>\n