by Zachary Stieber
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
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
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
horses, y'all. Ivermectin may be trending, but it still isn't
authorized or approved to treat COVID-19."
In a separate page,
"Q: Should I
take Ivermectin to prevent or treat COVID-19?
interfered with the doctors' practice of medicine, violating the
laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit
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.
an attorney representing the plaintiffs, told the court during the
hearing that that informal claim,
explain the language they actually used: 'Stop it. Stop it with
The FDA's actions,
that this is not an acceptable way to treat these patients," he
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...
forced to resign from his positions because he
couldn't prescribe Ivermectin due to the FDA's statements, the suit
The government has
moved to dismiss the complaint, asserting plaintiffs lack standing
because the injuries cannot be traced back to the FDA.
Dr. Paul Marik
in Kissimmee, Fla. on Oct. 14, 2022.
(The Epoch Times)
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.
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.
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.
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
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
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...