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

FDA Should Need Only ‘12 Weeks’ to Release Pfizer Data, Not 75 Years
The Liberty Beacon / This article was posted by TLB Staff

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

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.

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.

••••

The above article (FDA Should Need Only ‘12 Weeks’ to Release Pfizer Data, Not 75 Years, Plaintiff Calculates) was originally published on The Defender and is re-published here by ‘contribution’ with attribution to the author Seth Hancock , and The Defender.

Image/Photo Credit: Pfizer Logo in Featured image (top) – Public Domain (featured image from original article)

About the Author: Seth Hancock is a freelance reporter for The Defender. He has worked in journalism professionally for over 15 years, primarily in local news for a community newspaper, Examiner Publications, in Bartlett, IL. He is also a contributor for The Liberty Loft. Seth has a B.A. in journalism from Western Illinois University.

Urgent: 3 Ways to Help Stop Biden’s Vaccine Mandates

ORDER TODAY: Robert F. Kennedy, Jr.’s New Book — ‘The Real Anthony Fauci’

••••

Read more articles about COVID Vaccines

••••

Read articles by: Children’s Health Defense Team

••••

TLB Editors Note: TLB highly recommends you click on the image (the Defender) below, visit this great website, and do whatever you can to help see this vital forum succeed … for the sake of our children !!!

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. CHD is planning many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured. Your support is essential to CHD’s successful mission.

••••

Click on image below to visit site:

••••

••••

Stay tuned to …

TLB%20Radio%20Network%207.jpg

••••

The Liberty Beacon Project is now expanding at a near exponential rate, and for this we are grateful and excited! But we must also be practical. For 7 years we have not asked for any donations, and have built this project with our own funds as we grew. We are now experiencing ever increasing growing pains due to the large number of websites and projects we represent. So we have just installed donation buttons on our websites and ask that you consider this when you visit them. Nothing is too small. We thank you for all your support and your considerations … (TLB)

••••

Comment Policy: As a privately owned web site, we reserve the right to remove comments that contain spam, advertising, vulgarity, threats of violence, racism, or personal/abusive attacks on other users. This also applies to trolling, the use of more than one alias, or just intentional mischief. Enforcement of this policy is at the discretion of this websites administrators. Repeat offenders may be blocked or permanently banned without prior warning.

••••

Disclaimer: TLB websites contain copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available to our readers under the provisions of “fair use” in an effort to advance a better understanding of political, health, economic and social issues. The material on this site is distributed without profit to those who have expressed a prior interest in receiving it for research and educational purposes. If you wish to use copyrighted material for purposes other than “fair use” you must request permission from the copyright owner.

••••

Disclaimer: The information and opinions shared are for informational purposes only including, but not limited to, text, graphics, images and other material are not intended as medical advice or instruction. Nothing mentioned is intended to be a substitute for professional medical advice, diagnosis or treatment.

Original Article: https://www.thelibertybeacon.com/fda-should-need-only-12-weeks-to-release-pfizer-data-not-75-years/

Support Truth11.com

$1 Per Month or make a Donation

Thank you for helping support independent media


About this entry