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FDA Should Need Only ‘12 Weeks’ to Release Pfizer Data, Not 75 Years, Plaintiff Calculates

The nonprofit group suing the U.S. Food and Drug Administration for the release of documents related to the approval of Pfizer’s Comirnaty vaccine calculated it should take the agency only 12 weeks with 19 reviewers working full-time to review and produce the documents.

by Seth Hancock
December 18, 2021
0 0
FDA Should Need Only ‘12 Weeks’ to Release Pfizer Data, Not 75 Years, Plaintiff Calculates

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.

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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.

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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. 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.

© 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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Most “Conservative” News Outlets Are on the Big Tech Teat

Not long ago, conservative media was not beholden to anyone. Today, most sites are stuck on the Big Tech gravy train.

I’ll keep this short. The rise of Pandemic Panic Theater, massive voter fraud, and other “taboo” topics have neutered a majority of conservative news sites. You’ll notice they are very careful about what topics they tackle. Sure, they’ll attack Critical Race Theory, Antifa, and the Biden-Harris regime, but you won’t see them going after George Soros, Bill Gates, the World Economic Forum, or the Deep State, among others.

The reason is simple. They are beholden to Big Tech, and Big Tech doesn’t allow certain topics to be discussed or they’ll cut you off. Far too many conservative news outlets rely on Google, Facebook, and Twitter for the bulk of their traffic. They depend on big checks from Google ads to keep the sites running. I don’t necessarily hold it against them. We all do what we need to do to survive. I just wish more would do like we have, which is to cut out Big Tech altogether.

We don’t get Google checks. We don’t have Facebook or Twitter buttons on our stories. We don’t have a YouTube Channel (banned), an Instagram profile (never made one), or a TikTok (no thanks, CCP). We’re not perfect, but we’re doing everything we can to not owe anything to anyone… other than our readers. We owe YOU the truth. We owe YOU the facts that others won’t reveal about topics that others won’t tackle. And we owe America, this great land that allows us to take hold of these opportunities.

Like I said, I don’t hold other conservative sites under too much scrutiny over their choices. It’s easy for people to point fingers when we’re not the ones paying their bills or supporting their families. I just wish there were more who would make the bold move. Today, only a handful of other major conservative news outlets have broken free from the Big Tech teat. Of course, we need help.

The best way you can help us grow and continue to bring proper news and opinions to the people is by donating. We appreciate everything, whether a dollar or $10,000. Anything brings us closer to a point of stability when we can hire writers, editors, and support staff to make the America First message louder. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal or Bitcoin as well. Bitcoin: 3A1ELVhGgrwrypwTJhPwnaTVGmuqyQrMB8

Our network is currently comprised of six sites:

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We are also building partnerships with great conservative sites like The Liberty Daily and The Epoch Times to advance the message as loudly as possible, and we’re always looking for others with which to partner.

Some of our content is spread across multiple sites. Other pieces of content are unique. We write most of what we post but we also draw from those willing to allow us to share their quality articles, videos, and podcasts. We collect the best content from fellow conservative sites that give us permission to republish them. We’re not ego-driven; I’d much rather post a properly attributed story written by experts like Dr. Joseph Mercola or Natural News than rewrite it like so many outlets like to do. We’re not here to take credit. We’re here to spread the truth.

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We know we could make a lot more money if we sold out like so many “conservative” publications out there. You won’t find Google ads on our site for a reason. Yes, they’re lucrative, but I don’t like getting paid by minions of Satan (I don’t like Google very much if you couldn’t tell).

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Why We “Moderate” a Commentor’s First Post

Tags: Children's Health DefenseCoronavirusCovid-19FDALedePfizerPHMPTTop StoryVaccines
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  • Zola Holt says:
    December 18, 2021 at 6:39 pm

    No way they’re letting that data out before Mid-Terms!
    75 years will ensure that all malefactors will be long dead before the revelations, the only acceptable answer.

    Reply
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