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 Children's Health Defense

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(Children’s Health Defense) – U.S. Food and Drug Administration (FDA) officials skipped the start of oral arguments Tuesday as a federal district court weighed whether the agency can take 75 years to fully release documents on Pfizer’s Comirnaty COVID vaccine, according to a lawyer representing plaintiffs who sued the FDA for the documents.

A U.S. Department of Justice lawyer representing the FDA told the U.S. District Court for the Northern District of Texas the agency will produce more than 329,000 related documents as fast as it can, while safeguarding personally identifiable information and Pfizer trade secrets.

Public Health and Medical Professionals for Transparency (PHMPT), the group behind the Freedom of Information Act (FOIA) request and subsequent lawsuit, is seeking safety and effectiveness data, adverse reaction reports and a list of active and inactive vaccine ingredients.

PHMPT is a group of more than 30 scientists, medical professionals, international public health professionals and journalists. The group’s lawsuit argues the FDA is overestimating the time needed and understaffing the job.

“Assuming a low average of 50 pages per hour per person, even to review the hundreds of thousands of pages the FDA estimates, the agency would need just 19 reviewers to work full-time for 12 weeks to review and produce these documents — which is a tiny fraction of its approximately 18,000 employees,” said PHMPT in a legal brief filed Monday.

The day before oral arguments, the FDA released 14 document files, the largest file including 2,030 pages. PHMPT posted an updated list which shows documents released since Nov. 17.

FOIA does not mandate any particular processing schedule, only that the agency process requests “as soon as practicable,” the FDA said in a legal brief filed Monday.

“The bottom-line issue still remains what processing schedule is ‘practicable’ for the agency,” the FDA said.

At the agency’s proposed rate of 500 documents per month, the last documents would be released in 2096.

A quote from Business Intelligence Associates, an e-discovery company, estimated 400,000 pages could be produced within six to eight weeks at a cost of $132,000, according to PHMPT.

PHMPT wants the FDA documents released within 108 days. That’s the same amount of time the FDA spent reviewing the responsive documents for “the far more intricate task” of licensing Pfizer’s vaccine, the group said in its lawsuit.

Attorney Aaron Siri, who represents PHMPT, said:

“Americans must routinely produce documents, pay fines, and otherwise expend resources to comply with the law. Courts don’t inquire as to the ability or financial resources to comply with the law — they must comply.

“In fact, it would be laughable if a billionaire defendant came before a court and claimed poverty to escape making a document production, but that is the FDA’s position.”

The FDA budget for fiscal year 2019 was $6.1 billion.

In the FDA’s 64-page briefing, the agency argued it needed the full 75 years to redact and release the documents out of “fairness” to other FOIA requesters.

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PETITION: Resist Biden's Vaccine Mandate
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It's official: Joe Biden has announced that his Administration will be forcing COVID vaccinations on nearly 1/3rd of American citizens, blatantly disregarding the personal objections of millions of people and moving America ever closer towards a medical dictatorship.

We cannot stand for this unprecedented overreach, and we will not submit to Biden's tyrannical public coercion efforts.

Please SIGN this urgent petition informing the President that you will NOT comply with these unconstitutional vaccine mandate orders issued by the Biden Administration, and that elected officials should act in their capacity to block these intrusive demands.

On Thursday, September 9th, Joe Biden announced the latest round of federal orders meant to further coerce large swaths of the public into getting the COVID vaccine -- many against their will.

While the legal standing of these measures is, at best, dubious, the Biden Administration appears more ready than ever to gut our individual rights and practically erase medical autonomy in our country.

This latest escalation in overreach was announced via a televised speech in which Biden outlined a new "six-point plan" that includes far more than just six avenues to achieve mass medical compliance.

Among the most egregious new federal mandates are the following:

  • A requirement that all private businesses employing more than 100 people mandate their workers get the Covid-19 vaccine or submit to weekly testing (to be implemented by way of a new Department of Labor rule)
  • A requirement that all federal employees and federal contractors get the COVID vaccine
  • A requirement that all healthcare workers in facilities that receive reimbursement from Medicare and/or Medicaid (an estimated 17 million) get the Covid-19 vaccine without an alternative testing option
  • A requirement that all Head Start teachers get the COVID vaccine
  • A federal effort to lobby states to implement vaccine mandates for all school employees, and require regular testing of all students and school staff
  • A federal effort to lobby entertainment venues to require proof of vaccination or testing in order to grant entry to the public
  • A continuation of mask mandates on all federal properties and during interstate travel (i.e. planes, trains, buses)

All in all, these new vaccine mandates, which will go into effect within the coming weeks, will affect an estimated 100 million American workers -- 2/3rds of the entire workforce!

And, according to an administration official, violations of these unconstitutional requirements could result in fines of up to $14,000.

While this is clearly a political ploy on the part of the Joe Biden and his team of power-hungry Washington insiders to shift the focus from their disastrous withdrawal from Afghanistan, the American public knows better: After nearly a year and a half's worth of arbitrary, ever-changing, and unconstitutional government mandates in response to the COVID outbreak, it was always a given that the Biden Administration would ramp things up even further when it behooved them.

And now, it would seem that time has officially come.

"This is not about freedom or personal choice," Biden uttered in his remarks, confirming his administration's blatant dismissal of all Americans' right(s) to accept or decline the experimental Covid-19 vaccine.

This is a stunning reversal from Biden's declaration last December that "I don’t think [the vaccine] should be mandatory, I wouldn’t demand it to be mandatory."

In fact, Biden even confirmed his intention to flout states' rights in the process, warning that "If these governors won’t help us beat the pandemic I’ll use my power as president to get them out of the way."

These are not the words of an "empathetic" leader; these are the words of an aspiring dictator. And, for the time being, the only way to stop Joe Biden's tyranny is through mass noncompliance.

As we've said from the beginning, science, basic logic, and common sense should dictate policy regarding COVID and the Delta variant.

But Joe Biden and the federal government have long abandoned those principles throughout this crisis, culminating into this disturbing yet inevitable flurry of intrusive vaccine mandates that use people's jobs, individual autonomy, and livelihood as leverage.

This assault on our individual rights, private businesses, and American workers cannot be tolerated, and the easiest way to combat these unlawful orders is to just say NO.

Please SIGN and SHARE this most important petition letting Joe Biden know that you will NOT comply with the unconstitutional medical demands being made by this administration, and that action should be taken to block any intrusive action against working Americans and private employers.

Thank you!

FOR MORE INFORMATION:

'Biden announces vaccine requirements for private businesses, impacting tens of millions of Americans': https://www.lifesitenews.com/news/breaking-biden-announces-vaccine-requirements-for-private-businesses-impacting-tens-of-millions-of-workers/

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PHMPT defined fairness differently in its responding brief:

“Fairness would be giving millions of Americans who are mandated to receive this liability-free vaccine today assurance regarding the FDA’s review by allowing independent scientists access to the same data the FDA reviewed, without making them wait decades.

“Fairness would be allowing Americans injured by the vaccine today, who cannot sue Pfizer or anyone else for the harm, hope that independent scientists with access to that data can more readily develop treatments for their ailments.

“Fairness would be our federal health authorities allocating more than one person spending a few hours each month to review Pfizer’s documents for public disclosure after having given Pfizer over $17 billion of taxpayer money to develop and market the product.

“That would be fair to the American people.”

Siri noted that no decision has been made by the court and that a transcript of this week’s hearing should be released soon.

U.S. Rep. Ralph Norman (R-S.C.) earlier this month introduced a bill that would force the FDA to release them in 100 days.

© December 17, 2021. Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

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