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FDA Refuses To Change Anti-Ivermectin Statements After Court Ruling

FDA Refuses To Change Anti-Ivermectin Statements After Court Ruling

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Anti-ivermectin…

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FDA Refuses To Change Anti-Ivermectin Statements After Court Ruling

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

Anti-ivermectin statements made by the FDA are not being changed, even after an appeals court ruled against the agency.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)

The U.S. Food and Drug Administration (FDA) is refusing to change its statements against ivermectin, even after a court said it acted outside of its authority when it told people to stop using it to treat COVID-19.

The U.S. appeals court said that the FDA's statements, including one telling people to "stop" using ivermectin as a COVID-19 treatment, went beyond the authority conferred on the agency by Congress.

“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 Sept. 1 ruling.

Two weeks later, FDA social media posts and a key webpage remain unchanged.

That includes an Aug. 21, 2021, Twitter post, on the social media site since renamed X, that hyperlinked to a FDA webpage and stated: "You are not a horse. You are not a cow. Seriously, y'all. Stop it."

The page has not been updated either. It says people "should not use ivermectin to treat or prevent COVID-19."

The appeals court did not order the FDA to take any action and remanded the case to a lower court for consideration on standing.

But Dr. Robert Apter, the lead plaintiff in the case that led to the ruling, said that the FDA should still take action.

"From an ethical point of view, the FDA has been told not to do what they are doing. They have an ethical and moral obligation to follow the court’s directive and stop giving advice against using effective repurposed drugs for early treatment of COVID," Dr. Apter told The Epoch Times in a message.

The FDA declined to comment.

"The FDA does not comment on possible, pending, or ongoing litigation," a spokesperson told The Epoch Times via email.

In a statement after the ruling was handed down, the agency noted that ivermectin is approved by the FDA but for other uses. The FDA "has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use," the agency said.

"Health care professionals generally may choose to prescribe an approved human drug for an unapproved use when they judge that the unapproved use is medically appropriate for an individual patient," it added.

Such prescriptions are known as off-label prescriptions and are common in the United States.

Another FDA page may have been removed in the wake of the ruling. That page said, in part: "Q: Should I take ivermectin to prevent or treat COVID-19? A: No."

Archives show it was still up as of this year but it's unclear exactly when it was taken down.

Ruling

In the ruling, a U.S. Court of Appeals for the Fifth Circuit panel found in favor of Drs. Apter, Mary Talley Bowden, and Paul Marik, overturning a previous decision.

The doctors sued the FDA in 2022 over its anti-ivermectin statements, arguing the agency was illegally interfering with their practice of medicine.

While the Federal Food, Drug, and Cosmetic Act enables the FDA to inform consumers, it does not let the agency give medical advise, Jared Kelson, an attorney representing the doctors, told the panel during oral arguments.

U.S. District Judge Jeffrey Brown had ruled against the plaintiffs, finding the FDA acted within the authority conferred by the act.

The panel disagreed.

"FDA never points to any authority that allows it to issue recommendations or give medical advice," Judge Willett wrote. “Nothing in the act’s plain text authorizes FDA to issue medical advice or recommendations,” he also said.

"The decision is pretty clear that the FDA is not a physician, and that while it might have authority to inform the public, it can't endorse particular treatments or advise on how to approach any specific illness," Mr. Kelson told The Epoch Times.

He declined to comment on whether the FDA should update its statements.

The appeals court decision trumps the previous ruling, but the panel also sent the case back to Judge Brown.

The FDA had asked the appeals court to dismiss the case based on lack of standing. The court said it chose not to decide on the standing issue.

"We see greater wisdom in remanding for the district court to address standing and any other jurisdictional issues in the first instance," the panel said. "We express no view on those issues, and instead we trust their initial determination to the district court’s sound judgment."

That means Judge Brown will take up the case again, but that his ruling on standing could be overturned.

The government could also appeal the recent appeals court ruling. That appeal would go to the U.S. Supreme Court. The U.S. Department of Justice, which is representing the FDA, did not respond to a request for comment.

Tyler Durden Sun, 09/17/2023 - 22:15

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International

As yen weakens and interest peaks, Bank of Japan balances on a policy precipice

Quick Take The Bank of Japan (BOJ) stands at a critical juncture, striving to maintain a delicate balance amid a changing economic landscape. Recent data…

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Quick Take

The Bank of Japan (BOJ) stands at a critical juncture, striving to maintain a delicate balance amid a changing economic landscape. Recent data shows that the 10-year yield, which the BOJ has endeavored to keep below 1%, has touched 0.8, a peak unseen since 2013. Simultaneously, the BOJ has labored not to let the Yen weaken, yet it continues to be pressured as it drops further against the US dollar, crossing the 150 mark for the first time in over a year.

There is burgeoning speculation about possible BOJ interventions in these market movements. As the central bank continues to uphold negative interest rates, a shift towards positive rates might become inevitable in the foreseeable future. It’s a precarious fulcrum of financial strategies that the BOJ is balancing on, with market tempests stirring on one side and the stability of the national currency on the other.

This scenario highlights the intricate dynamics of monetary policies and the profound impact they can have on both national and global economies. A closer look at the situation illuminates the complexities in the BOJ’s policy decisions and the broader implications on the financial landscape.

JPY: (Source: Trading View)

The post As yen weakens and interest peaks, Bank of Japan balances on a policy precipice appeared first on CryptoSlate.

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Poland, Austria, & Czechia Introduce Temporary Border-Checks With Slovakia To Curb Illegal Migration

Poland, Austria, & Czechia Introduce Temporary Border-Checks With Slovakia To Curb Illegal Migration

Authored by Thomas Brooke via Remix…

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Poland, Austria, & Czechia Introduce Temporary Border-Checks With Slovakia To Curb Illegal Migration

Authored by Thomas Brooke via Remix News,

Poland, Austria and Czechia will all introduce random checks at the countries’ borders with Slovakia from midnight on Wednesday following an influx of illegal immigration.

Temporary checks will be conducted along the length of the border for an initial 10-day period until Oct. 13.

They will focus specifically on road and railway border crossings, although, pedestrians and cyclists may also be asked for documentation. Anyone within the vicinity of the border may be requested to identify themselves.

“The numbers of illegal migrants to the EU are starting to grow again,” said Czech Prime Minister Petr Fiala following the announcement. “We don’t take the situation lightly.”

“Citizens need a valid passport or identity card to cross the border,” the Czech Interior Ministry added.

The Czech policy would also be adopted by neighboring Austria, the country’s Interior Minister Gerhard Karner confirmed.

Poland had already announced its intention to reintroduce checks on the Slovak border with the number of migrants along the Balkans migration route continuing to surge. Prime Minister Mateusz Morawiecki said last week he was “instructing Minister of Interior Mariusz Kamiński to check on buses, coaches, and cars crossing the border when it is suspected there could be illegal migrants on board.”

“In recent weeks, we detected and detained 551 illegal migrants at the border with Slovakia. This situation causes us to take decisive action,” Kaminski added.

Slovak caretaker Prime Minister Ludovit Odor acknowledged the growing issue of illegal migration in his country but insisted that the problem needs a European solution rather than individual nations restricting border access.

He claimed that the decision by the three neighboring countries had been fueled by the Polish government, which is involved in a tightly contested election campaign, with Poles heading to voting booths on Oct. 15.

“The whole thing has been triggered by Poland, where an election will soon take place, and the Czech Republic has joined in,” Odor said.

Slovakia revealed last month that the number of illegal migrants detained by its authorities this year had soared nine-fold to over 27,000. The majority of detainees comprise young men from the Middle East using the Balkan migratory route through Serbia as they seek to migrate to northwestern Europe.

The winner of Sunday’s general election in Slovakia, former Prime Minister Robert Fico, has vowed to tackle the issue more robustly by promising to reintroduce border checks with neighboring Hungary.

“It will not be a pretty picture,” Fico told journalists as he threatened to use force to dispel illegal migrants detected on Slovak territory.

Tyler Durden Wed, 10/04/2023 - 02:00

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International

EU Wants To Pay Off Hungary To The Tune Of €13BN So Orban Doesn’t Veto Ukraine Aid

EU Wants To Pay Off Hungary To The Tune Of €13BN So Orban Doesn’t Veto Ukraine Aid

Hungary’s Viktor Orbán has long been an opponent of…

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EU Wants To Pay Off Hungary To The Tune Of €13BN So Orban Doesn't Veto Ukraine Aid

Hungary's Viktor Orbán has long been an opponent of the mainstay of EU policy on Ukraine, having also persistently criticized Kiev for discrimination against Hungarian minorities, and demanding that a 2017 law restricting the use of minority languages be changed. He's also refused to ratify Sweden's entry into NATO.

Orbán has further throughout the conflict stood against policies which escalate against Moscow, and has constantly warned against stumbling into a WW3 scenario involving direct NATO-Russia clash. He told Tucker Carlson in a recent interview that "the Third World War сould be knocking on our door so we have to be very careful." With Budapest having been a consistent thorn in the side of the EU, Brussels now wants to pay the Hungarians off.

AFP/Getty Images

"The European Commission is preparing to unfreeze around €13 billion in funds for Hungary to try to avoid Prime Minister Viktor Orbán vetoing EU aid for Ukraine, in a move likely to draw criticism from the European Parliament," Politico reports Tuesday.

"The Commission needs the unanimous backing of the bloc's 27 countries for an update to the EU’s long-term budget, which includes a €50 billion funding pot for Ukraine," the report adds.

Akin to what's currently going down in Washington with a group of Republicans holding up Ukraine funding, Brussels may soon have its own Ukraine aid blockage problem. EU aid for Kiev which was previously approved runs out in December, hence the urgency for EU leadership in wanting to push through a new package.

A week ago, Orbán gave a speech declaring Hungary will no longer support Ukraine in any way unless certain significant policies are changed both in Kiev and in the European Union.

He stressed in the words given before parliament that "Hungary is doing everything for peace" but that "unfortunately the Russian-Ukrainian war continues, tens of thousands of people are victims." Thus, he continued, "Diplomats must take control back from the hands of the soldiers, otherwise it will be in vain for women to wait for their sons and fathers and husbands to come home."

The Hungarian leader has stood against ratcheting Western sanctions on Moscow, instead choosing to maintain a generally positive diplomatic relationship with the Kremlin.

He also a week ago charged that Kiev and its backers have cheated Budapest by "Ukrainian grain dumping" into his country. He had also laid out, per The Hill:

... that he was protesting a 2017 law in Ukraine that limits ethnic Hungarians from speaking their own language, particularly in schools and said Hungary would not support Ukraine on international issues "until the previous laws are restored."

Needless to say EU officials are panicking, and are readying a lucrative quid pro quo with Hungary (based on freeing frozen funds related to the prior years' so-called "rule of law" punitive measures"), so that EU aid to Ukraine doesn't get blocked at a crucial moment that Washington funding is drying up.

Tyler Durden Wed, 10/04/2023 - 02:45

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