Court Rejects FDA’s Request to Produce Pfizer Covid-19 Data at a Rate of 500 Pages Per Month. Judge Orders FDA to Produce Data at Rate of 55,000 Pages Per Month

A federal judge has rejected a request by the U.S. Food and Drug Administration (FDA) to produce data related to Pfizer’s Covid-19 drug, Comirnaty, at a rate of 500 pages per month.

Instead, the judge ordered the FDA to produce the information at a rate of 55,000 pages per month.

The Background…

In August of 2021, the non-profit organization Public Health and Medical Professionals for Transparency (PHMPT) sued the FDA for data and information submitted to the FDA by Pfizer to license its Covid-19 vaccine, Comirnaty.

In response, the FDA requested to produce the data at a rate of 500 pages per month. At this rate, it would take approximately 55 years to produce the paginated data, and another 20 years to produce any non-paginated data. In sum, the FDA wanted roughly 253 times the original 108 days it used to conduct “an intensive review” to approve Comirnaty in the first place.  

The Order…

The four-page Order denying the FDA’s proffered timeline was issued by Judge Mark Pittman of the U.S. District Court for the Northern District of Texas Fort Worth Division.

Judge Pittman noted that both parties submitted dueling production schedules for the release of the data, at which point he scheduled a conference to discuss moving forward. “Surprisingly,” he noted in his Order, “the FDA did not send an agency representative to the scheduling conference.”

Despite the FDA’s lack of representation, Judge Pitman acknowledged that a fast-paced release of the documents might strain the FDA’s resources. However, he suggested that the most important matter to the FDA currently is probably the pandemic, Pfizer’s vaccine, the vaccine rollout, and “making sure that the American public is assured that this was not … rushed on behalf of the United States…”

“The basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.”

Order, page 2, quoting NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977)

Judge Pitman noted that “stale information is of little value” and ordered the following four points:

1. The FDA shall produce the “more than 12,000 pages” articulated in its own proposal, see ECF No. 29 at 24, on or before January 31, 2022.

2. The FDA shall produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.

3. To the extent the FDA asserts any privilege, exemption, or exclusion as to any responsive record or portion thereof, FDA shall, concurrent with each production required by this Order, produce a redacted version of the record, redacting only those portions as to which privilege, exemption, or exclusion is asserted.

4. The Parties shall submit a Joint Status Report detailing the progress of the rolling production by April 1, 2022, and every 90 days thereafter.

Impact…

Aaron Siri, the managing partner of Siri & Glimstad whose firm represented PHMPT, has heralded the decision as “a great win for transparency.”

“No person should ever be coerced to engage in an unwanted medical procedure.  And while it is bad enough the government violated this basic liberty right by mandating the Covid-19 vaccine, the government also wanted to hide the data by waiting to fully produce what it relied upon to license this product until almost every American alive today is dead.  That form of governance is destructive to liberty and antithetical to the openness required in a democratic society.”

Aaron Siri writing for Injecting Freedom

Under the judge’s order, the data is set to be fully released within a time span of approximately 8 months. Utilizing this data, Mr. Siri claims that interested parties may now focus on analyzing why the vaccines have issues of waning immunity, why certain variants have evaded vaccine immunity, and why (as the Center for Disease Control (CDC) confirmed) vaccines fail to prevent transmission.

I would add, that there are those who will be very interested to study what might be the trigger point for a myriad of reported adverse side effects. As of January 9, 2022, the CDC’s Vaccine Adverse Event Reporting System (VAERS) has recorded 715,857 adverse events. Meanwhile, the World Health Organization’s (WHO’s) comparable system VigiAccess has recorded 2,947,999 adverse events. The records indicate cases of vaccine-induced abscesses, various heart disorders, spinal cord issues, spontaneous abortions, blood clots, and many other diseases, including deaths.

Given that the Supreme Court is currently debating the wisdom of a mandatory vaccine regime for American workers, transparency could not come at a better time.

Post by: CJ Fisher

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