FDA

FDA Asks the Court to Delay First 55,000 Page Production Until May and Pfizer Moves to Intervene in the Lawsuit

By Aaron Siri   January 27, 2022

pfizer

As explained in prior posts, in a lawsuit seeking all of the documents the FDA relied upon to license Pfizer’s COVID-19 vaccine, a federal judge shot down the FDA’s requested rate of 500 pages per month and instead ordered the FDA to produce at the rate of 55,000 pages per month starting on March 1. 

Since the government has trillions of dollars of our money, it is putting it to good use by fighting to assure that the public has the least amount of transparency possible.  To that end, it has now asked the Court to make the public wait until May for it to start producing 55,000 pages per month and, even then, claims it may not be able to meet this rate. 

The FDA’s excuse?  As explained in the brief opposing the FDA’s request, the FDA’s defense effectively amounts to claiming that the 11 document reviewers it has already assigned and the 17 additional reviewers being onboarded are only capable of reading at the speed of preschoolers. 

Meanwhile…

As the FDA tries to obtain months of delay, guess who just showed upon in the lawsuit?  Yep, Pfizer.  And it is represented by a global chair and team from a law firm with thousands of lawyers.  Pfizer’s legal bill will likely be multiple times what it would cost the FDA to simply hire a private document review company to review, redact, and produce the documents at issue.  Within weeks, if not days.

Pfizer is coming in as a third party.  But Pfizer assures the Court it is here to help expedite production of the documents.  Sure it is!  Where was Pfizer before the Court ordered the 55,000 pages per month?  Right, doing what it normally does: letting the government work on its behalf – like the way the government mandates, promotes, and defends Pfizer’s product. 

But the government did not please Pfizer this time and so here it comes, likely looking for a second bite at the apple.  Of course the FDA consented to Pfizer appearing.  You can read the response my firm filed to Pfizer’s motion , as well as all of the other relevant recent filings in the link provided below. 

Read more: FDA Asks the Court to Delay First 55,000 Page Production Until May and Pfizer Moves to Intervene in the Lawsuit

FDA Asks Federal Judge to Grant it Until the Year 2076 to Fully Release Pfizer’s COVID-19 Vaccine Data

The fed gov’t shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its product. But won’t let you see the data supporting its safety/efficacy. Who does the gov’t work for?

By Aaron Siri | Published 17 November 2021

FDA Approved

The FDA has asked a federal judge to make the public wait until the year 2076 to disclose all of the data and information it relied upon to license Pfizer’s COVID-19 vaccine. That is not a typo. It wants 55 years to produce this information to the public.

As explained in a prior article, the FDA repeatedly promised “full transparency” with regard to Covid-19 vaccines, including reaffirming “the FDA’s commitment to transparency” when licensing Pfizer’s COVID-19 vaccine.

With that promise in mind, in August and immediately following approval of the vaccine, more than 30 academics, professors, and scientists from this country’s most prestigious universities requested the data and information submitted to the FDA by Pfizer to license its COVID-19 vaccine.

The FDA’s response?  It produced nothing. So, in September, my firm filed a lawsuit against the FDA on behalf of this group to demand this information. To date, almost three months after it licensed Pfizer’s vaccine, the FDA still has not released a single page. Not one.

Instead, two days ago, the FDA asked a federal judge to give it until 2076 to fully produce this information. The FDA asked the judge to let it produce the 329,000+ pages of documents Pfizer provided to the FDA to license its vaccine at the rate of 500 pages per month, which means its production would not be completed earlier than 2076. The FDA’s promise of transparency is, to put it mildly, a pile of illusions.

It took the FDA precisely 108 days from when Pfizer started producing the records for licensure (on May 7, 2021) to when the FDA licensed the Pfizer vaccine (on August 23, 2021). Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure. While it can conduct that intense review of Pfizer’s documents in 108 days, it now asks for over 20,000 days to make these documents available to the public.

So, let’s get this straight. The federal government shields Pfizer from liability. Gives it billions of dollars. Makes Americans take its product. But won’t let you see the data supporting its product’s safety and efficacy. Who does the government work for?

The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure. Everyone who wants to get vaccinated and boosted should be free to do so.  But nobody should be coerced by the government to partake in any medical procedure. Certainly not one where the government wants to hide the full information relied upon for its licensure until the year 2076!

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