The court have ruled against the FDA in a sensational case which witnessed a judge rejecting FDA vaccine data request. The motion was set forward so that the vaccine companies could submit the vaccine test result documents at a rate which was akin to providing no data at all, but the ruling of the court have now forced their hands.
A federal judge has dismissed the FDA’s proposal for only 500 pages per month of statistics supplied by Pfizer in order to license its Covid-19 vaccine, instead ordering 55,000 pages per month. It will take little over eight months for the world to view what ‘s beneath the bonnet, presuming there are around 450,000 pages.
Our firm sought that the FDA release all of Pfizer’s data submitted in order to licence its Covid-19 vaccine on behalf of a client. The FDA requested authorization from the Court to only be compelled to disclose 500 pages every month, which would have needed over 75 years to deliver all of the papers.
I’m delighted to inform that a federal judge has flatly dismissed the FDA’s motion and has mandated the agency to disclose all records at a rate of 55,000 pages per month!
This is a significant victory for transparency, as it breaks one of the federal “health” authorities’ monopolies on statistics deemed necessary for independent scientists to offer remedies and address significant issues with the present vaccine program, such as waning immunity, variants evading vaccine immunity, and the fact that immunization need not prevent transmission, as the CDC has confirmed.
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No one should ever be forced to undergo a medical procedure they don’t desire. Although it is unfortunate enough that the administration infringed on this core liberty right by requiring the Covid-19 vaccination, the government also sought to keep the data hidden by delaying the complete release of the data that it depended on to license the drug until practically every American currently alive had died. That type of government is harmful to liberty and incompatible with the transparency necessary in a functioning democracy.
The Judge acknowledged that the publication of this research is of extreme public significance and should be one of the FDA’s top priorities when he ordered the materials to be released in a timely manner. He then directly quoted James Madison, who said that 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, who said 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 complete text of the Judge’s order can be found below, with a copy also accessible here.
UNITED STATES DISTRICT COURT
PHMPT, Plaintiff v. FDA, Defendant, No. 4:21-cv-1058-P
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. See ECF Nos. 21, 34.
“Open government is fundamentally an American issue” – it is neither a Republican nor a Democrat issue. 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.” 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.” 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.”
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.
SO ORDERED on this 6th day of January, 2022.
 Surprisingly, the FDA did not send an agency representative to the scheduling conference.  151 CONG. REC. S1521 (daily ed. Feb. 16, 2005) (statement of Sen. John Cornyn).  Letter from James Madison to W.T. Barry (August 4, 1822), in 9 WRITINGS OF JAMES MADISON 103 (S. Hunt ed., 1910).  John F. Kennedy, Remarks on the 20th Anniversary of the Voice of America (Feb. 26, 1962).  America After 9/11: Freedom Preserved or Freedom Lost?: Hearing Before the S. Comm. on the Judiciary, 108th Cong. 302 (2003).  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.