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.
✔️ Boost your immune system with Nutraceutical by Dr. Zev Zelenko
✔️ Beat supply chain issues and future pharmaceutical tyranny with 5 Antibiotics Delivered to Your Home
✔️ Be ready to help yourself and your family with the World’s Best Med Kit
“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.
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. 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.
Yes, We Need Your Help
I hate being “that guy” who asks people to donate because I think our conservative news network is so crucial, but here I am…
When I left my cushy corporate job in 2017, I did so knowing that my family would have to make sacrifices. But I couldn’t continue to watch the nation slip into oblivion and was inspired by President Trump’s willingness to fight the good fight even at his own personal expense. What I didn’t realize then is that conservative media would be so heavily attacked, canceled, and defunded that the sacrifices would be extreme.
Many in this nation are struggling right now even though we weren’t struggling just a few years ago. I’m not alone. But I wake up every morning and operate the sites we’ve been able to build because there’s really no other choice. I refuse to be beholden to Big Tech like so many other conservative news outlets, which is why you won’t see Google ads here. With that said, it’s often challenging to pay the bills and it’s even harder to expand so we can get the America First message out to a wider audience.
The economic downturn has forced me to make a plea for help. Between cancel culture, lockdowns, and diminishing ad revenue, we need financial assistance in order to continue to spread the truth. We ask all who have the means, please donate through our Giving Fuel. Your generosity is what keeps these sites running and allows us to expand our reach so the truth can get to the masses. We’ve had great success in growing but we know we can do more with your assistance.
We currently operate:
- NOQ Report
- Conservative Playlist
- Uncanceled News
- Based Underground
- Five other conservative news sites
I would even be willing to entertain investments and partnerships at this stage. I’ve turned them down in the past because editorial purity is extremely important. I’ll turn them down again if anyone wants us to start supporting RINOs or avoid “taboo” topics like voter fraud, vaccines, or transgender supremacy. But I’d talk to fellow America First patriots who want to help any (or all) of our 10 news sites. Hit me up at jdrucker (at) substack (dot) com if you’re interested.
For those who have the means and just want to help keep the mission of spreading a conservative, Christian message to the nation, please consider a generous donation.
All ORIGINAL content on this site is © 2021 NOQ Report. All REPUBLISHED content has received direct or implied permission for reproduction.
With that said, our content may be reproduced and distributed as long as it has a link to the original source and the author is credited prominently. We don’t mind you using our content as long as you help out by giving us credit with a prominent link. If you feel like giving us a tip for the content, we will not object!
JD Rucker – EIC