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FDA Allows Shorter Reviews for New Drug Approvals if they Promote “National Priorities” Like Operation Warp Speed Did – Iran War Updates

Dr. Jay Bhattacharya, director of the NIH, Robert F. Kennedy Jr, Secretary of HHS, Dr. Marty Makary, U.S. FDA Commissioner.

by Brian Shilhavy
Editor, Health Impact News

While HHS Secretary Kennedy has promised more rigorous study of drugs using higher standards and returning to the “Gold Standard of Medical Research” before they are approved, his FDA is doing the exact opposite.

In a Press Release today from the FDA, Commissioner Dr. Marty Makary announced that they were now going to begin offering “vouchers” to “companies supporting U.S. national interests” for new drugs being introduced to the market, and that voucher will shorten the drug company’s review time from approximately 10-12 months to only 1-2 months.

FDA NEWS RELEASE: FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests

Excerpts:

The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans.

The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.

The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H.

Source [1].

In a recently published JAMA medical journal article [2], the FDA Commissioner said he wanted to copy the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

From the Associated Press [3]:

Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to “challenge assumptions” and rethink procedures.

In a medical journal commentary [4] published last week, Makary suggested the agency could conduct “rapid or instant reviews,” pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.

For the new program, the FDA will issue a limited number of “national priority vouchers” to companies “aligned with U.S. national priorities,” the agency said in a statement.

The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.

Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews.

Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.

Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness.

Such trials are generally considered the gold standard of medical research. (Full Article [3].)

This announcement should not be too surprising, given that Mr. Kennedy stated publicly that he supported Operation Warp Speed under Trump 1.0, and would do so again. (Source [5].)

This new policy by the FDA eliminates the need to invoke a “national health crisis emergency” as Trump did with the PREP Act back in 2020.

Now he can just choose which drug companies he wants to give federal funds to so they can rush their products to market, and basically use the American public as the third phase of the drug trials to see how many people these new “novel” drugs injure and kill, before making adjustments.

What a financial boom to Big Pharma!

MAKE BIG PHARMA RICH AGAIN! (as in the good ole days of Operation Warp Speed…)

Related:

COVID Shots Now Only Recommended for Sick Children and Pregnant Women while Still Available for Everyone [6]

More headline news from our Telegram Channel [7] today.

The whole rationale being put forward by Trump and the MAGA Zionists for entering this war, is because Iran is building a nuclear bomb, and we cannot let them do that.

But they have been saying this for over 30 years now. Also, other countries that do have nuclear bombs, particularly Pakistan, have promised to help Iran if they were attacked with nuclear weapons.

Then there is Tulsi Gabbard, Trump’s Director of National Intelligence, who testified before Congress in March that Iran was NOT developing a nuclear bomb.

A CNN reporter asked Trump about this today, and his response has gone viral on Telegram.

Trump threatens Iran’s leader, demands ‘unconditional surrender’

From CNBC [8]:

President Donald Trump on Tuesday warned Iranian leader Ali Khamenei that he is an “easy target” and that “our patience is wearing thin,” before demanding Tehran surrender in its conflict against Israel.

“We know exactly where the so-called ‘Supreme Leader’ is hiding,” Trump wrote on Truth Social.

“He is an easy target, but is safe there – We are not going to take him out (kill!), at least not for now,” he wrote.

“But we don’t want missiles shot at civilians, or American soldiers. Our patience is wearing thin.”

Trump added in a subsequent post: “UNCONDITIONAL SURRENDER!”

Typical Zionist logic by Trump: We can bomb you and your civilians and start a war, but don’t you dare bomb us back and endanger our military and civilians.

This is all about regime change now, it would seem. They appear to want to put Iranian Zionist Reza Pahlavi into power.

Top photo left to right: Israeli Intelligence Minister Gila Gamliel, Yasmine Pahlavi, Reza Pahlavi – Crown Prince of Iran in exile, Sara Netanyahu, and Israeli Prime Minister Benjamin Netanyahu on June 6, 2023. Bottom photo: Reza Pahlavi Crown Prince of Iran at wailing wall in Jerusalem in 2023.

They have been planning to install him back into the head of Iran for years now. Then Iran will become an ally once again, as they were until 1979.

Let’s see if this happens. I imagine that China and Russia might have something to say about this.

Largest Russian Strikes In Months Hit Ukrainian Capital, Killing 15 & Wounding Over 100

Meanwhile, Putin is taking advantage of the Middle East distraction and making his move on Kiev.

From ZeroHedge News [9]:

Russia overnight unleashed one of its largest and sustained attacks on the Ukrainian capital of Kyiv in recent months, resulting in 15 people killed and over one hundred wounded.

The assault, which lasted some ten hours, involved a coordinated barrage of drones, ballistic, and cruise missiles – and severely impacted residential areas, including a direct hit on a nine-story apartment building in the city’s Solomyanskyi district.

Strikes so far against Israel just a warning, punitive operations to follow: Iran’s top general

From PressTV in Iran [10]:

“The Zionist regime, in an act of aggression disguised as military goals, has attacked the people of Iran—women, children and the elderly. Ignoring all recognized international laws, and continuing the killing of some 300 journalists in Gaza and Lebanon, it has now launched a savage assault on the media professionals of the Islamic Republic of Iran Broadcasting to silence the voice of truth.

The great nation of Iran, as history shows, has never bowed to any aggression, and, while standing firm against this savage act, will make the Zionist regime pay for its crimes, God willing.

By God’s power, the martyrdom of our dear compatriots, scientists and commanders of the armed forces will only strengthen our resolve to carry out a punishing reprisal.

Thus far, the IRGC Aerospace Force and the Air Defense Headquarters, at the front line with support from the Army, the IRGC, the Law-Enforcement Command and the Ministry of Defense, have—by God’s grace—inflicted heavy blows on the enemy by striking sensitive and vital targets.

However, the operations conducted so far have only been a warning for deterrence; the punitive operation will be carried out shortly.

We therefore strongly warn the residents of the occupied territories, especially Tel Aviv and Haifa, to leave these areas to save their lives and not sacrifice themselves to Netanyahu’s animalistic desires.

Let the free peoples of the world rest assured: the great nation of Iran, led by its armed forces, will avenge the blood of the martyrs—God willing, by His power.”

In inaugural address, Trump said U.S. measure of success is ‘the wars we never get into’

From the Washington Post [11]:

As President Donald Trump weighs U.S. military involvement in Iran, several of his top allies, including conservative pundit Tucker Carlson, have urged Trump to stay out of the war — with some pointing to his promise of being an anti-war president.

“We will measure our success not only by the battles we win but also by the wars that we end — and perhaps most importantly, the wars we never get into,” Trump said in his inaugural address in January.

“My proudest legacy will be that of a peacemaker and unifier. That’s what I want to be: a peacemaker and a unifier,” he said. “Our power will stop all wars and bring a new spirit of unity to a world that has been angry, violent and totally unpredictable.”

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This article was written by Human Superior Intelligence (HSI) [13]

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The Bewitching of America with the Evil Eye and the Mark of the Beast [16]

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Jesus Christ’s Opposition to the Jewish State: Lessons for Today [17]

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Distinguishing True Prophets from False Prophets in These Evil Modern Times [18]

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Who Controls the World? by Dr. A. True Ott [19]

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Exposing the Christian Zionism Cult [20]

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Insider Exposes Freemasonry as the World’s Oldest Secret Religion and the Luciferian Plans for The New World Order [21]

Identifying the Luciferian Globalists Implementing the New World Order – Who are the “Jews”? [22]

[22]

The Brain Myth: Your Intellect and Thoughts Originate in Your Heart, Not Your Brain [23]

[23]

Fact Check: “Christianity” and the Christian Religion is NOT Found in the Bible – The Person Jesus Christ Is [24]

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[25]

The Satanic Roots to Modern Medicine – The Mark of the Beast? [26]

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Medicine: Idolatry in the Twenty First Century – 8-Year-Old Article More Relevant Today than the Day it was Written [27]

[27]

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