Summary: Court orders FDA to release 55,000 pages per day - instead of the 500 pages per day that the FDA had offered (a process which would have taken 75 years to complete). Now will be faster.

What is not clear is how much of the released pages will be redacted (i.e. blacked out to censor information).

Given that the US govt has guaranteed sales and profits to Pfizer - for the sale and use of it's vaccine - there should be some expectation of transparency from Pfizer, even if it means some loss of control over proprietary information.

 

 

Source - as seen on Twitter:

https://twitter.com/AaronSiriSG/status/1479230040630251520

Aaron Siri

I am pleased to report a federal judge rejected the FDA's request to produce the Pfizer Covid vaccine data at 500 pages per month and instead ordered a rate of 55,000 pages per month! Everyone should read the Judge's excellent 3-page decision available at

https://aaronsiri.substack.com/p/instead-of-fdas-requested-500-pages?justPublished=true

https://twitter.com/Stockache/status/1479248643353939975

So instead of 70+ year's it should only take 8 months-1 year now for full data. Haha I hope pfizer gets screwed with some type of lawsuit not like it matters. They falsify data many other times to make like $ 30 billion and after lawsuit pay 5billion in fines. Still a $25m profit

 

 

News coverage:

https://www.ntd.com/judge-gives-fda-just-over-8-months-to-produce-pfizers-safety-data_724236.html

Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data US

Mimi Nguyen Ly

Jan 6, 2022

 

 

Article by Attorney Aaron Siri:

https://aaronsiri.substack.com/p/instead-of-fdas-requested-500-pages?justPublished=true

INSTEAD OF FDA’S REQUESTED 500 PAGES PER MONTH, COURT ORDERS FDA TO PRODUCE PFIZER COVID-19 DATA AT RATE OF 55,000 PAGES PER MONTH!

A great win for transparency that removes a stranglehold "health" authorities have had on data independent scientists need to offer solutions and address serious issues with the vaccine program.

Aaron Siri

Jan 7, 2022

 

On behalf of a client, my firm requested that the FDA produce all the data submitted by Pfizer to license its Covid-19 vaccine. The FDA asked the Court for permission to only be required to produce at a rate of 500 pages per month, which would have taken over 75 years to produce all the documents.

I am pleased to report that a federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month!

This is a great win for transparency and removes one of the strangleholds federal “health” authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission.

Links: https://www.healthline.com/health-news/states-with-high-vaccination-rates-can-still-experience-covid-19-surges-heres-why

https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine

https://fortune.com/2021/11/26/omicron-south-africa-covid-variant-vaccine-resistant-pandemic/

https://www.cdc.gov/media/releases/2021/s0730-mmwr-covid-19.html

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.

In ordering the release of the documents in a timely manner, the Judge recognized that the release of this data is of paramount public importance and should be one of the FDA’s highest priorities. He then aptly quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy” and John F. Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”

The following is the full text of the Judge’s order, a copy of which is also available here.

Link: https://www.sirillp.com/wp-content/uploads/2022/01/ORDER_2022_01_06-9e24e298ae561d16d68a3950ab57077b.pdf

UNITED STATES DISTRICT COURT

PHMPT, Plaintiff v. FDA, Defendant, No. 4:21-cv-1058-P

ORDER

This case involves the Freedom of Information Act (“FOIA”). Specifically, at issue is Plaintiff’s FOIA request seeking “[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Events Reporting System” from the Food and Drug Administration (“FDA”). See ECF No. 1. As has become standard, the Parties failed to agree to a mutually acceptable production schedule; instead, they submitted dueling production schedules for this Court’s consideration. Accordingly, the Court held a conference with the Parties to determine an appropriate production schedule.[1] See ECF Nos. 21, 34.

“Open government is fundamentally an American issue” – it is neither a Republican nor a Democrat issue.[2] As James Madison wrote, “[a] popular Government, without popular information, or the means of acquiring it, is but a Prologue to a Farce or a Tragedy; or, perhaps, both. Knowledge will forever govern ignorance: And a people who mean to be their own Governors, must arm themselves with the power which knowledge gives.”[3] John F. Kennedy likewise recognized that “a nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”[4] And, particularly appropriate in this case, John McCain (correctly) noted that “[e]xcessive administrative secrecy . . . feeds conspiracy theories and reduces the public’s confidence in the government.”[5]

Echoing these sentiments, “[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society.” NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). “FOIA was [therefore] enacted to ‘pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.’” Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep’t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And “Congress has long recognized that ‘information is often useful only if it is timely’ and that, therefore ‘excessive delay by the agency in its response is often tantamount to denial.’” Open Soc’y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)). When needed, a court “may use its equitable powers to require an agency to process documents according to a court-imposed timeline.” Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014).

Here, the Court recognizes the “unduly burdensome” challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as expressed at the scheduling conference, there may not be a “more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . .” ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance.

“[S]tale information is of little value.” Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore concludes that the expeditious completion of Plaintiff’s request is not only practicable, but necessary. See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371, 378 (S.D.N.Y. Aug. 15, 2007) (“[I]t is the compelling need for such public understanding that drives the urgency of the request.”). To that end, the Court further concludes that the production rate, as detailed below, appropriately balances the need for unprecedented urgency in processing this request with the FDA’s concerns regarding the burdens of production. See Halpern v. FBI, 181 F.3d 279, 284–85 (2nd Cir. 1991) (“[FOIA] emphasizes a preference for the fullest possible agency disclosure of such information consistent with a responsible balancing of competing concerns . . . .”).

Accordingly, having considered the Parties’ arguments, filings in support, and the applicable law, the Court ORDERS that:

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.[6]

SO ORDERED on this 6th day of January, 2022.

[1] Surprisingly, the FDA did not send an agency representative to the scheduling conference.

[2] 151 CONG. REC. S1521 (daily ed. Feb. 16, 2005) (statement of Sen. John Cornyn).

[3] Letter from James Madison to W.T. Barry (August 4, 1822), in 9 WRITINGS OF JAMES MADISON 103 (S. Hunt ed., 1910).

[4] John F. Kennedy, Remarks on the 20th Anniversary of the Voice of America (Feb. 26, 1962).

[5] America After 9/11: Freedom Preserved or Freedom Lost?: Hearing Before the S. Comm. on the Judiciary, 108th Cong. 302 (2003).

[6] Although the Court does not decide whether the FDA correctly denied Plaintiff’s request for expedited processing, the issue is not moot. Should the Parties seek to file motions for summary judgment, the Court will take up the issue then.

 

 

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References:

https://aaronsiri.substack.com/p/cdc-admits-crushing-rights-of-naturally

CDC Admits Crushing Rights of Naturally Immune Without Proof They Transmit the Virus

After formal demand, the CDC concedes it does not have proof of a single instance of a naturally immune individual spreading the virus.

Aaron Siri

Nov 12, 2021

 

https://aaronsiri.substack.com/p/fda-asks-federal-judge-to-grant-it

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?

Aaron Siri

Nov 17, 2021

 

https://twitter.com/akheriaty/status/1461407823821037568?t=5PlRGx4zHKSIeI3dxT06fQ&s=19

Aaron Kheriaty, MD

I submitted this FOIA request to the FDA: they now claim it will take them 55 years to release the data on which Pfizer's vaccine approval was based, though it only took them 108 days to review this data for the approval process. New heights of absurdity.

 

https://www.israelnationalnews.com/News/News.aspx/317161

FDA asks for 55 years to release data on Pfizer's COVID vaccine

The FDA promised "full transparency" due to "tremendous public interest" in a drug that it approved after studying the data for just 108 days.

Y Rabinovitz

Nov 18 , 2021

 

https://www.reuters.com/legal/government/wait-what-fda-wants-55-years-process-foia-request-over-vaccine-data-2021-11-18/

Wait what? FDA wants 55 years to process FOIA request over vaccine data

By Jenna Greene

November 19, 2021

 

https://aaronsiri.substack.com/p/fda-produces-the-first-91-pages-of

FDA Produces the First 91+ pages of Documents from Pfizer’s COVID-19 Vaccine File

Only 54 years, 11 months to go…

Aaron Siri

Nov 20, 2021

 

https://www.reddit.com/r/scienceuncensored/comments/r6up93 Pfizer ordered by court to release documents of vaccine adverse events

Dec 2, 2021

 

https://aaronsiri.substack.com/p/fda-doubles-down-asks-federal-judge

FDA Doubles Down: Asks Federal Judge to Grant it Until at Least the Year 2096 to Fully Release Pfizer’s COVID-19 Vaccine Data

The fed gov’t gives Pfizer billions in taxpayer money + makes Americans take its product + won’t let Americans sue for harm + shields disclosure of its licensure documents = 1984

Aaron Siri

Dec 7, 2021