Posted on 01/15/2024 7:29:10 PM PST by SeekAndFind
The U.S. Food and Drug Administration (FDA) is seeking to persuade a federal court to dismiss a lawsuit challenging its repeated advisories against using ivermectin to treat COVID-19.
The FDA in a sealed motion asked the U.S. District Court for the Southern District of Texas to dismiss the suit, which was brought by three doctors who allege the FDA’s warnings were illegal.
The late 2023 motion was sealed because exhibits the government cited “include confidential information” from a separate legal proceeding, according to a government brief.
Government lawyers said they would file redacted versions of the motion for public perusal but still have not done so.
Attorneys for the doctors said on Jan. 12 that the court should reject the government’s fresh bid to throw out the case.
“The FDA exceeded its authority by repeatedly issuing public directives not to use ivermectin for COVID-19, even though the drug remains fully approved for human use,” they wrote.
One of the directives said: “You are not a horse. Stop it with the #Ivermectin. It’s not authorized for treating #COVID.”
The government motion came after an appeals court found the FDA likely overstepped its authority with the warnings.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ’stop' taking medicine,” U.S. Circuit Judge Don Willett, an appointee of former President Donald Trump, wrote in the ruling.
The appeals court remanded the case back to U.S. District Judge Jeffrey Brown, who said in 2022 that the doctors failed to prove their allegations.
The FDA in the sealed motion asked Judge Brown, another appointee of President Trump, to dismiss the case.
According to lawyers for the doctors, the FDA’s motion includes arguments that claim the plaintiffs have not suffered injuries that are traceable to the FDA, and that cannot be remedied by a ruling in favor of the plaintiffs.
“The FDA is wrong,” the lawyers said. “Plaintiffs have suffered interference with their practice of medicine and the doctor-patient relationship, economic harm, reputational harm, and increased exposure to malpractice liability, and have been subject to disciplinary proceedings and forced resignations, all of which clearly trace to the FDA’s campaign against ivermectin and would be remedied by equitable relief.”
The Federal Food, Drug, and Cosmetic Act enables the FDA to authorize or approve drugs for a specific use but doctors are free to prescribe cleared drugs for other purposes, in what’s known as “off-label” prescribing. The law does not grant authority to the FDA to regulate off-label use.
The plaintiffs include Dr. Robert Apter, who was investigated by medical boards in two states for prescribing ivermectin to treat COVID-19. The referrals to the boards include some of the FDA’s warnings against using the drug as a COVID-19 treatment.
The FDA’s position in seeking a dismissal stems in part from the negative actions against the plaintiffs being taken by third parties such as pharmacies, according to a description of the sealed motion. It was quoted as saying that the referrals “are not fairly traceable” to the FDA’s statements.
An exhibit included by the FDA, however, showed one of the referrals came from a pharmacist who cited FDA documents as a reason for “increased scrutiny” with regard to ivermectin prescriptions. The pharmacist wrote that Dr. Apter would not provide a “valid medical reason” for the ivermectin prescription and was thus engaging in “inappropriate prescribing.”
“The FDA is the common thread through all of [the] plaintiffs’ injuries, which began only after the FDA embarked on its campaign to stop the use of ivermectin for COVID-19 and which often involve explicit invocation of the FDA’s directives and recommendations,” the plaintiffs’ lawyers said.
They are seeking an order that would force the FDA to rescind or amend its warnings. That would remove the justification of the parties that have taken negative actions against the plaintiffs, the lawyers added.
Ping for your interest
Malinformation (information which is true but inconvenient to the ruling class) must be outlawed!
FDA is EVIL ... of course they’re asking this TX Fed court to drop this case!
I pray they will NOT!!
These good docs deserve justice.....actual justice, not XiDen/BigPharma/DS INjustice.
Thx for the ping.
AFAIK, The Philippine armed forces distributed ivermectin to its members without prescription or restriction.
This lawsuit looks like a bunch of grandstanding.
A warning is not a regulation.
While ivermectin may be approved for treating parasites, it is not approved for treating viruses. Viruses and parasites are as different biologically as airplanes are different from kitchen blenders.
The FDA can and does warn against claiming that a substance has specific therapeutic properties that it does not have. The FDA issues warning against these kinds of claims all the time.
This lawsuit will go nowhere.
Dissolve the FDA.
Fire every employee!
So parasites cannot spread viruses?
Let’s not bicker and argue over who killed who... right???
FDA will be in a bind since ivermectin has been in use as a anti cancer drug and for high blood pressure since at least 2019.
Ivermectin is over the counter in many countries. It thwarted Covid in utter pradesh, india.
To hell with the FDA, we’re on our own. I can do the math for the proper dosage. I got Ivermectin when I needed it for COVID and I’ll get Fenbendazole if I need it for cancer.
Ivermectin, ‘Wonder drug’ from Japan: the human use perspective Feb. 10, 2011 - ncbi.nlm.nih.govDiscovered in the late-1970s, the pioneering drug ivermectin, a dihydro derivative of avermectin—originating solely from a single microorganism isolated at the Kitasato Intitute, Tokyo, Japan from Japanese soil—has had an immeasurably beneficial impact in improving the lives and welfare of billions of people throughout the world.
(snip)
There are few drugs that can seriously lay claim to the title of ‘Wonder drug’, penicillin and aspirin being two that have perhaps had greatest beneficial impact on the health and wellbeing of Mankind. But ivermectin can also be considered alongside those worthy contenders, based on its versatility, safety and the beneficial impact that it has had, and continues to have, worldwide—especially on hundreds of millions of the world’s poorest people.
Get stuffed troll.
Doctors prescribe stuff for off-label use all the time.
The FDA ad said “Y’all are not a horse” — implying clearly that Ivermectin is only for horses.
Despite the discoverer getting the 2015 Nobel Prize in Medicine for discovering Ivermectin.
So the FDA was making the fraudulent claims.
Oh wait — you do, too.
Like the idea that eating food exposes the nuclei of your cells to the same mRNA as the jabs do.
Troll.
Seems to have greatly helped me in 2021
Gov’t “guidance” was used as a rationale for local gov’ts and other orgs. to impose fascist bans and lockdowns.
Sick it is.
You have it wrong.
Ivermectin was effective. the Covid Jab was not.
The messages from all the medical oversight groups involved in this know they did it for the money.
My 94 year old father was diagnosed with Covid (from the longer covid test). Local doctor prescribed 3mg Ivermectin 4X per day for 3 days. On 4th day he no longer had symptoms.
There are many more things done to the medical profession during the Covid Insanity.
AG Paxton has filed a case against Pfizer.
You have failed.
You do not know and cannot provide a number for how many lives were saved because of the vaccinations.
All you do know are numbers of deaths said to be vax related
Not here to argue with anyone about numbers. It is pointless. This will all eventually be exposed.
I never mentioned numbers.
I know for a fact that HCQ, Querctin, and Ivermectin were effective in treating the disease. Nations who used Ivermectin quickly saw the numbers of deaths drop and the number of hospitalized citizens dropped.
It will be 10 years before the damage by the mRNA treatment is clear.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.