ORDER 2022 01 06

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer Court Documents

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Document text

UNITED STATES DISTRICT COURT  
FOR THE NORTHERN DISTRICT OF TEXAS  
FORT WORTH DIVISION  
 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR TRANSPARENCY ,  
 
Plaintiff,   
  
v. 
 No. 4:2 1-cv-1058-P 
FOOD AND DRUG ADMINISTRATION ,  
 
Defendant.   
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 t he 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 
 
1Surprisingly , the FDA did not send a n agency  representative to the scheduling 
conference.   
2151 CONG. REC. S1521 ( daily ed. Feb. 16, 2005) (statement of Sen. John Cornyn).   Case 4:21-cv-01058-P   Document 35   Filed 01/06/22    Page 1 of 4   PageID 1715Case 4:21-cv-01058-P   Document 35   Filed 01/06/22    Page 1 of 4   PageID 1715
 
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 knowledge gives.”3 John F. Kennedy l ikewise 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 
admi nistrative 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 Jus t. 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 re quest 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 America n 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. 
 
3Letter from J ames  Madison to W.T. Barry (August 4, 1822), in 9 WRITINGS OF 
JAMES MADISON  103 (S. Hunt ed., 1910).  
4John F. Kennedy, Remarks on the 20th Anniversary of the Voice of America (Feb. 
26, 1962).  
5America After 9/11: Freedom Preserved or Freedom Lost?: Hearing Before the S. 
Comm. on the Judiciary , 108th Cong. 302 (2003).  Case 4:21-cv-01058-P   Document 35   Filed 01/06/22    Page 2 of 4   PageID 1716Case 4:21-cv-01058-P   Document 35   Filed 01/06/22    Page 2 of 4   PageID 1716
 
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 Accordingly, t he 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 ne cessary . 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 (2n d 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’ argument s, 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 . Case 4:21-cv-01058-P   Document 35   Filed 01/06/22    Page 3 of 4   PageID 1717Case 4:21-cv-01058-P   Document 35   Filed 01/06/22    Page 3 of 4   PageID 1717
 
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 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 .  
 
6Although the Court does not decide w hether 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.  
 
Mark T. Pittman  
UNITED STATES DISTRICT JUDGE  
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