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UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF TEXAS
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,
Plaintiff,
-against -
FOOD AND DRUG ADMINISTRATION,
Defendant.
Civil Action No. 4:21- cv-01058- P
OPPOSITION TO FDA’S REQUEST FOR AT LEAST 75 YEARS TO RELEASE
PFIZER’S BLA DOCUMENTS
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TABLE OF CONTENTS
TABLE OF AUTHORITIES ..................................................................................................... III
PRELIMINARY STATEMENT ................................................................................................. 1
ARGUMENT ................................................................................................................................. 4
I. THE FDA ASKS THE COURT TO GIVE IT OVER 75 YEARS TO PROCESS THE
FULL REQUEST ............................................................................................................. 4
II. FEDERAL LAW REQUIRES THE FDA TO “IMMEDIATELY RELEASE” THE
REQUESTED DOCUMENTS ........................................................................................ 6
III. FOIA DEMANDS THE FDA TIMELY PRODUCE THE DOCUMENTS ................... 8
A. FOIA Requires Productions to Be Made “Promptly” and Expedited Requests
Such as the One at Issue Here Must be Completed “as Soon as Practicable” .............. 8
B. Claimed Need for Redactions is Overblown ........................................................ 16
C. The FDA Failed to Comply with FOIA’s “Due Diligence” Requirement ............ 18
CONCLUSION ........................................................................................................................... 19
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TABLE OF AUTHORITIES
Cases
Brennan Ctr. for Justice at New York Univ. School of Law v. United States Dept. of State ,
300 F. Supp. 3d 540 (S.D.N.Y. 2018) ....................................................................................... 11
Brennan Ctr. for Justice at NYU School of Law v Dept. of Commerce ,
498 F. Supp. 3d 87 (D.D.C. 2020) ................................................................................ 10, 11, 12
Clemente v Fed. Bur. of Investigation,
71 F. Supp. 3d 262 (D.D.C. 2014) ............................................................................................ 16
Diocesan Migrant & Refugee Services, Inc. v United States Immigration and Customs Enf't ,
EP-19-CV-00236- FM, 2021 WL 289548 (W.D. Tex. Jan. 28, 2021) ...................................... 12
Edmonds v F.B.I.,
No. 02- 1294 (ESH), 2002 WL 32539613 (D.D.C. Dec. 3, 2002) ............................................ 11
Elec. Privacy Info. Ctr. v. Dept. of Justice ,
416 F. Supp. 2d 30 (D.D.C. 2006) ............................................................................ 9, 10, 12, 16
Long v U.S. I.R.S.,
693 F.2d 907 (9th Cir 1982) ..................................................................................................... 16
Open Socy. Justice Initiative v Cent. Intelligence Agency,
399 F. Supp. 3d 161 (S.D.N.Y. 2019) ................................................................................. 12, 13
Payne Enterprises, Inc. v United States ,
837 F.2d 486 (D.C. Cir. 1988) .............................................................................................. 9, 16
Statutes
21 C.F.R § 20.63(b) ................................................................................................................ 16, 17
21 C.F.R. § 20.44 (c)(2) -(3) ............................................................................................................ 9
21 C.F.R. § 601.51 (d)(2) ................................................................................................................ 7
21 C.F.R. § 601.51(e) ........................................................................................................ 5, 6, 7, 19
21 C.F.R. § 601.51(e). ..................................................................................................................... 5
5 U.S.C. § 552 (a)(6)(E)(iii)...................................................................................................... 8, 11
5 U.S.C. § 552 (a)(6)(E)(v) ............................................................................................................. 9 Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 3 of 26 PageID 1429Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 3 of 26 PageID 1429
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5 U.S.C. § 552(a)(3) ........................................................................................................................ 8
5 U.S.C. § 552(a)(6)(C) ................................................................................................................ 18
Other Authorities
1974 U.S. Code Cong. & Admin. News ......................................................................................... 9
H.R. Rep. No. 93–876 (1974) ......................................................................................................... 9 Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 4 of 26 PageID 1430Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 4 of 26 PageID 1430
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Plaintiff, Public Health and Medical Professionals for Transparency (“ PHMPT ”), by and
through its attorneys, Siri & Glimstad LLP, respectfully submits this brief in opposition to the
FDA’s request for at least 75 years to release documents submitted by Pfizer Inc. (“ Pfizer ”) to the
U.S. Food and Drug Administration (the “ FDA”) to license its COVID -19 vaccine (the “Pfizer
vaccine” ).
PRELIMINARY STATEMENT
Defendant, incredibly, focuses its opening brief on the idea that fairness requires it to take
decades to produce the Pfizer vaccine licensure documents . Fairness? Fairness would be giving
millions of Americans who are mandated to receive this liability -free vaccine today assurance
regarding the FDA’s review by allowing independent scientists access to the same data the FDA
reviewed, without making them wait decades. Fairness would be allowing Americans injured by
the vaccine today, who cannot sue Pfizer or anyone else for the harm , hope that independent
scientists with access to that data can more readily develop treatments f or their ailments. Fairness
would be our federal health authorities allocat ing more than one person spending a few hours each
month to review Pfizer’s documents for public disclosure after having given Pfizer over $17 billion
of taxpayer money to develop and market the product. Fairness would be releasing the documents
so that independent scientists can have this data to assist in addressing serious issues of waning
immunity, diminished efficacy, vaccine -immunity evading variants, etc. Fairness would be
producing documents that the American taxpayers paid for while those same people are still alive,
not decades after most are dead. That would be fairness to the American people.
All of the FDA’s griping about fairness come s down to one thing, and one thing alone : it
has not sufficiently staffed its FOIA office to properly meet its legal obligations to respond to the
request s it receives . In passing FOIA , Congress made the policy decision that it wanted to en sure Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 5 of 26 PageID 1431Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 5 of 26 PageID 1431
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transparency , and it knew that transparency delayed is transparency denied, therefore it require d
agencies like the FDA to produce documents as soon as practicable where the request qualifies for
expedited processing. That is the FDA’s legal obligation: to promptly produce records . The FDA
is not permitted to thwart Congress’ policy choice by understaffing its FOIA response office.
Numerous cases show how other agencies, when dealing with a production that is eligible for
expedited processing, have transferred staff, or hired more sta ff, in order to promptly comply with
its statutory obligations. Here, for the reasons explained in PHMPT’s opening brief, the instant
FOIA request is the prime example of one that requires expedited processing, and as a result, the
FDA cannot be heard to claim that it has too few people to meet its statutory obligations.
Law journal articles, ABA publications, and legal decisions all reflect a document review
rate of at least 50 pages per hour per reviewer, and often far more, for reviewing documents for
production in litigation – where those reviewers are also searching the documents for relevance,
responsiveness, privilege, hot documents, confidentiality designations, attorney- eyes only
designation, trade secrets, certain personal information, coding by c ategory, etc. Those are tasks
far more complex than called for here. For the simpler task of reviewing for only personally
identifiable information and trade secrets under FOIA, assuming a low average of 50 pages per
hour per person, even to review the hundreds of thousands of pages the FDA estimates, the agency
would need just 19 reviewers to work full time for 12 weeks to review and produce these
documents – which is a tiny fraction of its approximately 18,000 employees or, if it outsources the
review as is common in litigation reviews, a mere rounding error in its approximately $6.5 billion
budget and an even smaller rounding e rror of the over $17 billion given by the federal government
to Pfizer . Plaintiff, in fact, obtained a quote from the e -discove ry company BIA dated December
10, 2021 to conduct this precise review of 400,000 pages. BIA concluded that the review could Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 6 of 26 PageID 1432Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 6 of 26 PageID 1432
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be completed in a period of 6- 8 weeks with 10 reviewers and 1 team leader for a total price tag of
approximately $132,000. ( App000634 ¶ 5.) The FDA should be directed to do precisely that.
It should do what everyone else in this country must do – follow the requirements of federal law .
Companies do not get to delay paying taxes because they don’t have enough tax personnel.
They don’t get to avoid complying with environmental regulations because they don’t have enough
compliance officers. They don’t get to avoid responding to a U.S. Attorney’s subpoena because
they don’t have enough staff to review the documents. T hey must follow the law , and so must
federal agencies . And here the law says “promptly” and “as soon as practicable,” and the
regulation says , “immediately available.” All of this statutory and regulatory language is intended
to ensure transparency. These requirements are utterly defeated if the documents are not produced
forthwith. Waiting for transparency until almost everyone alive today i s dead makes a mockery
of FOIA and of the promise of transparency.
Showing just how misguided the FDA is in its approach, i n its brief and declaration in
support of same, the FDA ignores all the arguments made by P laintiff with regard to fairness in
the pa rties’ First Joint R eport and Second Joint Report. (Dkt 18 ¶ 15; Dkt 20 ¶¶ 2-3.) It ignores
the incredible unfairness to the American people to not have access to the Pfizer documents.
Instead, the FDA repeatedly discusses in its motion papers what is fair to the vaccine
sponsor, meaning Pfizer, and “the interests of the vaccine sponsor .” (Dkt 18 ¶ 15; Dkt 20 ¶ 2.)
Putting aside that this is not a real concern in this case, if Pfizer is concerned about its trade secrets,
then it has more than sufficie nt resources to perform the necessary review and inform the FDA
what it believes should be withheld from disclosure in a timely manner . This is not a novel concept
as other FOIA matter s have been resolved in this manner wherein the FDA has adopted redacti ons
proposed by the creator of the documents based on the company’s representations that the Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 7 of 26 PageID 1433Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 7 of 26 PageID 1433
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documents covered confidential commercial information that would cause harm if disclosed. In
fact, if Pfizer spent just .01% of the $17 billion in taxpayer money it received from the federal
government for its liability -free mandated product, it could complete this review in less than a
week. At a minimum, Pfizer’s interests must be viewed through the lens of its obligation to the
American people who are underwrit ing its profits for a product the government has marketed for
Pfizer, given immunity from harm, and mandated American take under penalty of exclusion from
civil society.
The FDA also says it is unfair to other pending FOIA request ers to prioritize this re quest .
First, since this request qualifies for expedited processing, it must by statute take priority over all
other requestors. Second, any unfairness to other requestors is outweighed by the interest of
millions of Americans who are being a ffected by t he Pfizer vaccine in having independent
scientists review the Pfizer data. Third, a ny unfairness falls squarely on the shoulders of the FDA
for choosing, even now during a pandemic, to only have 10 people in its FOIA office (only 8 of
whom with experience) despite a budget of over $6.5 billion and over 18,000 employees.
Regardless of whether the FDA has made FOIA or transparency a priority, it is an obligation
imposed by law and one that must be upheld by the courts despite any claimed hardship it may
impose. For the hardship suffered by the American people in the alternative far outweighs any felt
by the agency.
ARGUMENT
I. THE FDA ASKS THE COURT TO GIVE IT OVER 75 YEARS TO PROCESS
THE FULL R EQUEST
The FDA initially disclosed that responding to the instant FOIA request would involve
producing 329,000+ pages . As stated in PHMPT’s opening brief, at the FDA’s proposed 500
pages per month, it would take 54 years and 10 months to process the instant request. The FDA Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 8 of 26 PageID 1434Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 8 of 26 PageID 1434
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has since clarified its estimated pages and , with its revised figures, the FDA’s current production
schedule will require at least 75 years to complete.
The FDA has clarified that , in addition to the previously estimate, the r esponse includes
another “approximately 39,000 pages” of BLA “ supplements, amendments, and product
correspondence” (App000633 ¶ 3), plus “tens of thousands of additional pages” of “records that
may be supportive of the BLA” ( Id.), plus at least 126 data fi les from Pfizer, many of which the
FDA says have over ten thousand rows. (Dkt. No. 22 p. 3.) The FDA states it would like to treat
twenty rows in each data file as one page for its monthly production quota . (Dkt. No. 22 p. 9 n.6.)
The page counts incre ased because the agency initially inappropriately limited the scope of
Plaintiff’s request without any agreement from Plaintiff. Now they have chosen to provide a more
accurate page count based on the initial, plainly worded request seeking all documents enumerated
in 21 C.F.R. § 601.51(e) . However, the FDA has so far refused to provide a more precise count
of the “tens of thousands of additional pages” or the total rows in all spreadsheets. (App000633
¶¶ 3-4.) Instead, the agency argues that Plaintiff’s request is overly broad – despite it asking for
precisely what is enumerat ed in 21 C.F.R. § 601.51(e) , nothing more. In fact, Plaintiff excluded
from the documents any of those already made public via the Vaccine Adverse Event Reporting
System. The scope of Plain tiff’s request is clear and has been consistent ; any misinterpretation or
one-sided narrowing of same is on the FDA’s part.
The FDA’s 20 lines per page estimate is ridiculous in terms of estimating how long it will
take to review a spreadsheet. The reaso n why data is put in a spreadsheet is so that different types
of data can be easily identified and separated by column s. If there is either personally identifiable
or trade secret information in a column which needs redact ion, which as explained below is
unlikely, then the FDA can identify same and, as already proposed by Plaintiff, the parties can Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 9 of 26 PageID 1435Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 9 of 26 PageID 1435
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discuss redacting the entire column. In that case, a line -by-line review is unnecessary or at the
very least can be performed very quickly.
Putting aside that 20 rows per page is an inflated estimate of the time to review , at an
average of 12,000 rows per data file, at the FDA’s proposed 20 rows per page, the 126 data files
adds around 75,000 additional pages. (Dkt. No. 22 pp. 3, 9 n.6.) And assuming the FDA’s
amorphous “tens of thousands of additional pages” amounts to 20,000 additional pages, then the
grand total appears to be at least 451,000 pages. This is the best estimate Plaintiff has at this time .
Even assuming the FDA produces the 12,000 pages it claims it will produce by the end of
January, that still leaves at least 439,000 pages to be produced. This number pales in comparison
to the millions of pages regularly produced in commercial litigations . Nevertheless, at the rate of
500 pages per month proposed by the FDA, the agency is asking that this Court give it at least 75
years to produce all the documents. The average life expectancy in the United States in 2020 was
77.8 years. ( App000634 ¶ 6.) Thus, the FDA is asking this Court to wait until almost everyone
alive today is dead to produce documents that are supposed to be “immediately released” after
approval.
II. FEDERAL LAW REQUIRES T HE FDA TO “IMMEDIATELY RELEASE” THE
REQUESTED DOCUMENTS
Federal regulation requires that upon licensure of a vaccine, the agency is to make “the
biological product file … immediately available for public disclosure.” 21 C.F.R. § 601.51(e) . The
FDA obviously adopted this regulation w hen it still believed in transparency, accountability, and
open government. That it has retreated from these positions does not mean it can ignore the same
federal laws every American must follow.
The FDA previously argued that this regulation creates no right for the public to obtain
these documents, rather it merely allows the agency to produce what are otherwise private Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 10 of 26 PageID 1436Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 10 of 26 PageID 1436
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documents. However, that argument is belied by the language of the regulation itself . The request
here seeks the information listed in 21 C.F.R. § 601.51(e) . Directly above section (e) is another
section that concerns obtaining documents. That section, section (d), provides t hat the “FDA will
make available to the public upon request” other documents concerning pre -licensure applications,
and that “[p]ersons wishing to request this information shall submit a request under the Freedom
of Information Act [FOIA]. ” 21 C.F.R. § 601.51 (d)(2) . In stark contrast, paragraph (e) says
nothing about a member of the public needing to make a FOIA request. Rather, it enumerates that
the information that must be made “immediately available” to the public upon licensure . This
difference reflect s that paragraph (e) obligates the FDA , separate and apart from FOIA, to make
those documents (i.e., the documents sought in the current request) “immediately available” just
as it says.
This is also plain from the fact that p aragraph (e) also sets its own standard as to what
information should be redacted. For example, (e)(2) provides that the FDA is to make the study’s
“protocol” immediately public unless it contains “ trade secrets and confidential commercial or
financial information.” Similarly, (e)(3) provides that “[a]dverse reaction reports” and “product
experience reports” are to be made immediately available “after deletion of … names and any
information that would identify the person using the product.” If section (e) was not in tending to
create a right separate and apart from FOIA, there is no need for these redundant redaction
obligations. Hence, this again further makes plain that the disclosure obligation under 21 C.F.R.
§ 601.51(e) is separa te and apart from FOIA.
The Court should, therefore, respectfully require the FDA to abide by its own regulations,
just as all Americans must abide by the FDA’s regulations, and “immediately disclose” all the
information required to be immediately disclo sed under 21 C.F.R. § 601.51(e) . Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 11 of 26 PageID 1437Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 11 of 26 PageID 1437
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III. FOIA DEMANDS THE FDA TIMELY PRODUCE THE DOCUMENTS
The FDA also has a separate duty to disclose the documents requested under FOIA.
A. FOIA REQUIRES PRODUCTIONS TO BE MADE “PROMPTLY” AND
EXPEDITED REQUESTS SUCH AS THE ONE A T ISSUE HERE MUST BE
COMP LETED “AS SOON AS PRACTICABLE”
The FDA explains how it must take incredible care to abide by the statutory requirements
to redact any information required by FOIA. That it must safeguard Pfizer’s trade secrets by
conducting a line -by-line, word- by-word review which will take decades because no shortcuts can
be taken. That it must exactingly abide by the FOIA’s redaction requirements. Taking the FDA
at its word that the FOIA obligations must be strictly followed, the FDA must also give as much
or more gravity to the primary requirement under FOIA – that it “shall make the records promptly
available to any person” and that, when as here, a request qualifie s for expedited processing, it is
to be produced at even greater haste “ as soon as practicable.” 5 U.S.C. § 552(a)(3), 5 U.S.C.
§ 552 (a)(6)(E)(iii) (emphasis added). Congress made plain in FOIA that when there is an
“urgency to inform the public concerning actual or alleged Federal Government activity,”
expedited processing beyond the routine “promptly” requirement is demanded. There frankly
could not be an i nstance that more squarely falls into the criteria for expedited processing. At issue
is a product for which the government has granted immunity to liability, has mandated millions of
Americans to receive, has given Pfizer millions of dollars for, and was approved within 108 days.
What Plaintiff seeks is to review the documents the government relied upon in its action of
licensing this product for the public’s use. T here is , therefore, a dire urgency for the public to have
full transparency and review of the FDA’s quintessential government activity of licensing Pfizer’s
COVID- 19 vaccine. Id. But still, where th is need for expedited processing is crystal clear , the
FDA shockingly appears to argue that this threshold is not met . Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 12 of 26 PageID 1438Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 12 of 26 PageID 1438
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Incredibly, the FDA justifies asking for decades to produce documents by noting that FOIA
does not have “a specific timeframe for the release of records.” (Dkt. No. 22 p. 2.) Putting aside
the elementary school understanding of the word “promptly” and “a s soon as practicable,” and the
purpose of FOIA, courts have made clear that, “ Congress recognized that delay in complying
with FOIA requests is ‘ tantamount to denial.’ ” Elec. Privacy Info. Ctr. v. Dept. of Justice , 416 F .
Supp. 2d 30, 40 ( D.D.C. 2006) (quoting H.R. Rep. No. 93–876, at 6 (1974) , 1974 U.S. Code Cong.
& Admin. News , pp. 6267, 6271) . Likewise, t he D.C. Circuit , the circuit with the most experience
concerning FOIA, has “acknowledged that ‘ stale information is of little value. ’” Id. (quoting
Payne Enterprises, Inc. v United States , 837 F .2d 486, 494 (D.C. Cir. 1988 )). That is why “[t]he
1996 amendments to FOIA creating the statutory right to expedition in certain cases ‘ underlined
Congress ’ recognition of the value in hastening release of certain information. ’” Id. (quoting
Edmonds v F.B.I., 417 F .3d 1319, 1324 ( D.C. Cir. 2005)).
As shown in PHMPT’s complaint and in its opening brief, its instant FOIA r equest is
exactly the type of request that Congress had in mind for expedited processing under the FOIA
statue. 5 U.S.C. § 552 (a)(6)(E)(v); 21 C .F.R. § 20.44 (c)(2) -(3). PHMPT is unquestionably an
organization engaged in the dissemination of information. (Dkt. No. 1 ¶ 4; Dkt. No. 26 p. 14.)
The FDA has not challenged this fact. All the documents sought in the FOIA request are urgently
needed to allow independent scientists to review the FDA’s work and to provide assurance to the
public that the liability -free vaccine they are being mandated to receive has truly passed the most
rigorous review possible. (Dkt. No. 16 pp. 14-16.) Politicians, academics, and the scientific
community all agree on this point. ( Id.) Additionally, not only are the documents sought central
to the largest media story of our time – the fight against COVID -19 and the vaccines deployed in
that fight – but as shown, the FDA’s claim that it would require decades to produce documents has Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 13 of 26 PageID 1439Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 13 of 26 PageID 1439
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itself generated substantial media attention. (Dkt. No. 26 p. 16); see also Brennan Ctr. for Justice
at NYU School of Law v Dept. of Commerce , 498 F . Supp. 3d 87, 97 (D.D.C. 2020) (requiring
expedited processing of a FOIA request because the 2020 Census had generated substantial media
attention and there was a need to establish the integrity of the Census). Furthermore, the need for
this information will be lost if all the documents are not promptly produced because people and
governments are making decisions regarding the Pfizer vaccine now, not in 75 years. (Dkt. No. 26
pp. 17- 19.)
An agency like the FDA cannot satisfy Congress’ expedited processing requirements solely
by giving the FOIA request prompt administrative attention, or by giving priority to only the first
12,000 pages that PHMPT was seeking by November 17 in order to conduct a quick initial
assessment. Elec. Privacy Info. Ctr., 416 F . Supp. 2d at 41 (holding that, where a request i s entitled
to expedited processing, the agency must produce documents in a timely manner). “ What matters
… is … when the documents are actually released. ” Id. Notably, the FDA’s brief is misleading
as to the course of communications between the parties. It makes it appear as if Plaintiff agreed
to some initial list of documents to the exclusion of others when, in reality , the list provided, with
a request the FDA produce by November 17, 2021, was merely intended to get an initial sense of
what was in th e product file so that Plaintiff c ould create a priority list for the entire production to
occur over a 30 -day period and, later, its compromise position of no more than 108 days. The
FDA knows that this information is useless in conducting an independent review and was merely
intended to get an overview , yet treats it as if it’s providing something valuable by the end of
January when in reality is well aware that all this has done is create a two -month delay without
adding value to the public. See full exchange between counsel included at App000633 ¶ 2. As
such, the FDA cannot possibly claim that releasing a small subset of the documents when pressed Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 14 of 26 PageID 1440Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 14 of 26 PageID 1440
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or the universe of responsive documents over the course of 75 years meets its statutory obligation
to “process” the FOIA r equest “ as soon as pr acticable.” 5 U.S.C. § 552 (a)(6)(E) (iii).
Absent from the FDA’s arguments is any acknowledgement of the declarant scientists and
researchers’ explanations that until the entire universe of documents is produced, Plaintiff will not
be able to conduct a proper review to evaluate the government’s licensure of the product at issue .
“Attempting to recreate analyses on efficacy or safety without all the relevant data – data already
limited by the short time period of the [Pfizer vaccine] trials – would prove useless.” (Dkt. No. 26
p. 16.) Instead of acknowledging this issue , the FDA repeatedly demand s that Plaintiff narrow its
request to target only a subset or subsets of the entire biologic product file , ignoring the fact that
all of the data is necessary in order to conduct an adequate analysis .
Nor can the FDA claim that it must take decades to process PHMPT’s request because it
received 329 other pending FOIA requests before PHMPT ’s request. (Dkt. No. 22 p. 11.) This is
a specious claim given that , “[p]rocessing expedited FOIA cases takes precedence over processing
other non- expedited FOIA cases .” Brennan Ctr. for Justice at New York Univ. School of Law v .
United States Dept. of State , 300 F . Supp. 3d 540, 549 ( S.D.N.Y. 2018) ; Brennan Ctr ., 498 F .
Supp. 3d at 100-01 (stating that because the request qualified for expedited processing the agency
needed to move the request to the front of the line of requests to be processed); Edmonds v F.B.I.,
No. 02-1294 (ESH), 2002 WL 32539613, at *2 ( D.D.C. Dec. 3, 2002) (same). Simply put, the
“hardship on other FOIA requesters is not a bar to relief ” where the Court finds that expedited
processing is warranted because the “s ubstantial interests ” of PHMPT in obtaining the requested
documents regarding the Pfizer vaccine “outweigh the hardship to Defendant [] and other
requesters .” Brennan Ctr ., 498 F Supp 3d at 103 (internal quotations omitted); see also Ctr. for Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 15 of 26 PageID 1441Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 15 of 26 PageID 1441
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Pub. Integrity , 411 F . Supp. 3d at 14 (noting that FOIA requests often overlap and that processing
of documents for one FOIA requests will assist in responding to other similar requests).
Moreover, the FDA’s obligations do not st op at simply putting PHMPT at the head of the
line. Elec. Privacy Info. Ctr. , 416 F . Supp. 2d at 41. Expedited processing means that the agency
is required to actually produce the documents as soon as practicable. Id. “Unless the requests are
processed [i.e., the documents are produced] without delay, [PHMPT’s] right to expedition will be
lost.” Id.; see also Brennan Ctr., 498 F . Supp. 3d at 103 (finding that where the requestor had
proven it was entitled to expedited processing, it was “ entitled to expedited processing by a date
certain ”); Open Socy. Justice Initiative v Cent. Intelligence Agency, 399 F. Supp. 3d 161, 167
(S.D.N.Y. 2019) (focusing on the actual date of production after noting that meeting the date would
put the request in priority over other request s).
Respect fully, “[t]he Court cannot ‘simply ... take at face value an agency ’s determination
that more time is necessary. ’” Brennan Ctr., 498 F . Supp. 3d at 100 (quoting Elec. Privacy Info.
Ctr. v Dept. of Justice , 416 F . Supp. 2d at 37 ). The obligations under FOIA mus t be honored and
hence, the FDA should review for information that needs redaction, but it must at the same time
conduct that review in a manner that results in the documents being produced “ as soon as
practicable.” Brennan Ctr., 498 F . Supp. 3d at 103 (finding that, even though “ inadvertent release
of exempted documents ” was a concern, that concern was not so great as to warrant dramatically
slower production); Diocesan Migrant & Refugee Services, Inc. v United States Immigration and
Customs Enf't , EP-19-CV-00236- FM, 2021 WL 289548, at *4 ( W.D. Tex. Jan. 28, 2021) (noting
that ICE had diverted resources and re -assigned 30% of its FOIA st aff to first line review, and then
10-15 attorneys to spend half of every work day doing second line review in order to meet the
court’s expedited deadlines). Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 16 of 26 PageID 1442Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 16 of 26 PageID 1442
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PHMPT is also willing to crowdsource sufficient funds for the FDA to hire contract
attorneys to r eview the documents and produce them in less than 30 days . If the FDA would accept
that help, it can produce these funds forthwith. However, the agency has declined this offer stating
that “non- federal personnel…cannot perform federal work .” (App000633 ¶ 4.) This claim rings
hollow. When the FDA review ed Pfizer ’s application to license its vaccine, the agency received
at least $2,875,842 directly from Pfizer to expedite the licensing review . (App000634 ¶ 7.) As
such, it is clear that the FDA’s unprecedented quick approval time for Pfizer’s vaccine was in
many ways directly underwritten by Pfizer. (App000634 ¶ 8.) If the agency will now refuse to
accept funds from Plaintiff to produce to the American people expeditiously the same documents
it reviewed , then that decision makes crystal clear whose interests it really is serving.
It is embarrassing that our federal health agency gave Pfizer billions of taxpayer dollars ,
mandated Americans take its product, eliminate d their ability to sue Pfizer for harms from this
product, and then cr ies it is unfair to Pfizer if the y have to produce these documents without a
word -by-word review. Truly shameful. The pandemic is spiraling out of control and basic
freedoms are receding i n all directions. The solution is not for Plaintiff and the American people
to wait until most people alive today are dead for the documents to be produced. Rather it is for
the FDA to assign a few dozen of its 18,000+ employees or use a tiny rounding er ror fraction of
its over $6.5 billion budget t o hire professional document reviewers to get this done in less than
30 days, or at most Plaintiff’s compromise position of no more than 108 days. Or it can allocate
just .01% of the $17 billion the federal ex ecutive has given Pfizer which would be sufficient to
hire enough contract attorneys to review and produce these documents in less than a week. See
Open Socy. Justice Initiative , 399 F . Supp. 3d at 169 (directing expedited production “ even if Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 17 of 26 PageID 1443Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 17 of 26 PageID 1443
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meeting this demand calls upon DOD to augment, temporarily or permanently, its review
resources, human and/or technological ”).
Plaintiff’s request for production within 108 days is justified. If the FDA was able to
review the universe of documents thoroughly enough to confirm and analyze Pfizer’s data and
conclusions, then certainly the agency can review the same universe looking only for the rare
occurrence of trade secrets or personally identifying inf ormation. The FDA claims that Pfizer
“submitted data to FDA on a rolling basis, even in advance of the formal BLA submission,
meaning the substantive data review occurred over a l onger period than the 108 days.” (Dkt. No.
23 ¶ 35.) But Pfizer in a press release dated May 7, 2021, titled “Pfizer and BioNTech initiated
the BLA by submitting the nonclinical and clinical data needed to support licensure…” of its
COVID- 19 vaccine anno unced that the “[d]ata to support the BLA will be submitted by the
companies to the FDA on a rolling basis over the coming weeks, with a request for Priority
Review .” (App000634 ¶ 9) (emphasis added) . Meaning, Pfizer began its rolling submission on
May 7 , 2021 and the vaccine was licensed on August 23, 2021, a total of 108 days from initial
submission to licensure.
The only reason that the documents cannot be produced promptly is that the FDA has
chosen to not properly allocate the resources to perform the required work. The FDA has
repeatedly stated that the licensure of a COVID -19 vaccine and addressing the pandem ic via same
is its highest priority. T his same branch of government reflected this priority by allocat ing enough
resources to prioritize development, production, authorization, distribution, promotion, and
licensing of the vaccine. It should now allocate adequate resources to transparency related to this
vaccine. Releasing these documents is directly in line with this priority. It should act accordingly. Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 18 of 26 PageID 1444Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 18 of 26 PageID 1444
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Corporations with a small fraction of the FDA’s employees and resources must comply
with all forms o f statutory obligations. A company cannot claim that it only has 10 people in its
accounting and tax department s and hence need s another 75 years to review its records in order to
pay its taxes. But when it comes to the FDA’s statutory obligation, the agency proposes to devote
the equivalent of one person reviewing a few hours a month (even at its thumb- twiddling 8- minute -
per-page rate) for the next 75+ years to fulfill its statutory obligation to produce these urgent
records “as soon as practicable.” It is a truly absurd position.
Putting this into perspective, private law firms manage to review and produce hundreds of
thousands of pages per month in litigation when review ing for far more than just the disclosure
exemptions listed in FOIA, but also for relevance, responsiveness, privilege, hot documents, trade
secrets, confidentiality designation, attorney- eyes only designation, coding by category, coding by
request number, coding for second level reviews, certain personal information, etc. Law journal
articles, ABA publications, and caselaw all reflect that at least 50 pages per hour, and often far
more pages per hour, can be manually reviewed for this far more complex and involved review
than the one required by FOIA, which here the Defendant submits only requires reviewing for
trade secrets and personally identifiable information. ( App000634 ¶ 10 – App000635 ¶ 13.) At
this rate, it would take one reviewer just 10 hours to view the 500 pages that the FDA wants to
produce in a month. Even at the FDA’s ridiculous rate of 8 minutes per page, it would only take
one reviewer 66 hours per month to review 500 pages. FDA also does not acknowledge the
growing availability of artificial intelligence capable of almost completely automating pr ivilege
review. (App000635 ¶ 14.)
At bottom, the FDA does not treat its transparency obligations under FOIA to produce “ as
soon as practicable ” as an actual statutory requirement. It instead just pays lip service to the Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 19 of 26 PageID 1445Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 19 of 26 PageID 1445
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concept by saying that the “FDA is committed to transparency” but then does nothing to ensure
that transparency. (Dkt. No. 18 ¶ 15.) “[M] erely paying lip service to [PHMPT’s] statutory right
does not negate the harm that results from the agency’ s failure to actually expedite its pr ocessing.”
Elec. Privacy Info. Ctr., 416 F . Supp. 2d at 41 (internal quotations omitted, emphasis in original).
In the end, w hether the FDA values or is “committed” to transparency is irrelevant, Congress gave
it a statutory obligation to produce expedited productions “ as soon as practicable” and the Court
must hold the agency to abide by that obligation – just as every other American must abide by
federal statutes. Payne Enterprises, Inc. v Unit ed States , 837 F .2d 486, 494 (D.C. Cir. 1988)
(“‘unreasonable delays in disclosing non- exempt documents violate the intent and purpose of the
FOIA, and the courts have a duty to prevent these abuses .’” (quoting Long v U.S. I.R.S., 693 F .2d
907, 910 ( 9th Cir 1982) )); Clemente v Fed. Bur. of Invest igation, 71 F . Supp . 3d 262, 269 ( D.D.C.
2014) (quoting Payne and concluding that a “ court therefore may use its equitable powers to
require the agency to process documents according to a court -imposed timeline ”).
For these reasons, a ny partial adoption of the FDA’s current production proposal will not
result in a prompt or immediate result for the American public and so should be rejected by this
Court. That w ill instead result in a piecemeal, foot- dragging schedule for which the parties will
undoubtedly need repeated Court intervention to settle.
B. CLAIMED NEED FOR REDACTI ONS IS O VERBLOWN
It is also simply untrue that the review the FDA argues it must conduct i s as arduous as it
claims. The FDA claims it must review for two categories of information: personal information
that constitutes “a clearly unwarranted invasion of privacy” and trade secrets. (Dkt. No. 22 at 2.)
As for personally identifiable information, this information has already been redacted by Pfizer
before submission because that is what is required by the FDA regulations. 21 C.F.R § 20.63(b) .
(“The names and other information which would identify patients or research subjects should be Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 20 of 26 PageID 1446Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 20 of 26 PageID 1446
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deleted from any record before it is submitted to the Food and Drug Administration.”) . This likely
explains why, when the FDA reviewed the two data file s it produced to Plaintiff, the FDA found
“that there was no exempt material in the data files” and hence “made no deletion or reductions in
those files.” (Dkt. No. 22 at 6.)
As for trade secrets, the FDA’s regul ations state that Pfizer was to designate trade secrets
within its documents before submitting its documents or seek redactions in a “ reasonable time
thereafter.” 21 C.F.R § 20.63(b) . (“A person who submits records to the Government may
designate part or all of the information in such records as exempt from disclosure under exemption
4 of the Freedom of Information Act. The person may make this designation either at the time the
records are submitted to the Government or within a reasonable time thereafter. The designation
must be in writing. … Any such designation will expire 10 years after the records were submitted
to the Government.”) In any event, most of the information submitted by Pfizer was clinical trial
information – not trade secrets. It is deidentified patient level data.
As an example of how a rbitrary and capricious the FDA acts regarding trade secret
redactions, the FDA placed on its website its clinical trial review i t conducted for the Pfizer vaccine
which included an ingredient list for this product . One of the ingredients was redacted. Our firm
submitted a FOIA request on behalf of a client to have that redaction lifted. ( App000635 ¶ 15.)
When it was finally lif ted, it turned out that the redacted ingredient was “water for injection”
(App000635 ¶ 16.) Literally “water.”
The Court should respectfully not let the FDA play this same type of game here –
pretending it must carefully review word- by-word to redact in formation and then finding
something to redact to justify its review, when in reality almost everything submitted by Pfizer,
without any review needed, will plainly not include trade secrets (e.g., the hundreds of thousands Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 21 of 26 PageID 1447Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 21 of 26 PageID 1447
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of pages of patient level data) . In any event, Pfizer has already had an opportunity to designate
any information it feels rises to the level of proprietary information.
If Pfizer has not already done so, t he FDA can put the responsibility of designating
information exempt from disclosure on Pfizer. Pfizer knows these documents and data inside and
out. Pfizer has the responsibility to protect clinical trial participants’ personally identifying
information. Pfizer holds the interest in protecting trade secret information. Pfizer undoubtedly
has the resources – as it expects to make $36 billion in sales on its COVID -19 vaccine this year
alone (App000635 ¶ 17 ) – and the ability to promptly designate information it believes is exempt
from disclosure and so, if the FDA cannot do so in an adequate period of time, the agency should
notify Pfizer that it plans to produce the documents in full and lay the burden at Pfizer’s feet to
object to same.
C. THE FDA FAIL ED TO COMPLY WITH FOIA’S “DUE DILIGENCE”
REQUIREMENT
An agency must show due diligence in responding to the request, even in situations where
it is able to show exceptional circumstances exist for not being able to otherwise comply with
statutory time frames. See 5 U.S.C. § 552(a)(6)(C). Here, the FDA has failed to show due
diligence. Despite more than three months elapsing since Plaintiff’s FOIA request was made,
more than two months of communication through the parties’ counsel, and t he agency’s own
regulation which calls for these records to be made “immediately available” to the public, the
agency has failed to do, inter alia , the following:
1. Provide a full index of the biological product file requested;
2. Provide a full index of the bi ologic license application within that file;
3. Provide approximate page counts/line counts for each portion of the biological product
file;
4. Identify any documents or categories of documents which do not or are not expected
to contain any exempt information;
5. Produce any documents that do not contain any exempt information; Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 22 of 26 PageID 1448Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 22 of 26 PageID 1448
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6. Identify any documents or categories of documents which are expected to contain any
exempt information;
7. Disclose any column headers for the data files so that the parties can discuss which
columns may need review for potential redactions;
8. Confer with Plaintiff, proactively, about redactions or withholdings that may be needed
to expedite that review now and to avoid disputes about redactions post -production;
9. Inform Plaintiff whether Pfi zer has already designated information it believes is exempt
from disclosure as proprietary trade secrets.
Instead, and only in response to specific prompting from Plaintiff, the agency has provided
fractured and incomplete information regarding the volume of the responsive documents, has
offered no information about redactions other than the general claim that redactions are needed
and take time and resources to apply, and has provided only two tiny limited, piecemeal
productions which are useless in isola tion. The agency’s actions fall far short of due diligence and
have already violated its own regulation calling for these precise records to be made “immediately
available” after licensure. In fact, the FDA could have performed the basic due diligence ne eded
to provide almost all of foregoing information in less time than it took for it to draft the 19 -page
declaration filed in this action.
CONCLUSION
The FDA, so focused on its concern for Pfizer’s purported trade secrets, simply ignores its
obligations to make “immediately available” the requested documents under 21 C.F.R. § 601.51(e )
as well as the entire purpose of FOIA – transparency – and its obligat ion to produce requested
documents “ as soon as practicable.” All of these obligations are frustrated unless the requested
documents are produced forthwith. Issues regarding waning immunity, need for boosters, vaccine
immunity driving variants, and a host of others, need independent scientists to have transparency
into the FDA’s process today. Not 75 years from now. And without all the data, a proper analysis
of the data cannot be done. Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 23 of 26 PageID 1449Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 23 of 26 PageID 1449
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Transparency is also urgently needed here because millions of Americans are being
mandated to receive this product under penalty of exclusion from work, school , the military , and
everyday life in society . It is unconscionable that the FDA would not immediately assign sufficient
personnel or resources to review these documents and release them to the public . It is in fact
shocking that the agency did not anticipate this demand for these documents and had not done so
prior to Plaintiff’s request . Instead, prior to today and s ince the vaccine was licensed, the FDA
has produced a total of 339 pages and two tiny data files . That is an average of producing 3 pages
per day since Plaintiff submitted its request on August 27, 2021. Any other documentation
released by federal health authorities regarding Pfizer’s vaccine were documents generated by the
government and were not Pfize r’s documents which is what Plaintiff seeks to review. The whole
purpose of FOIA and expedited treatment is to review government conduct.
True to form, and despite the passage of 112 days since licensure, the agency incredibl y
tells the Court in its pap ers that it still does not know how many pages are in the BLA file for
Pfizer’s vaccine, can’t determine how many rows are in the 126 data files it identified, can’t figure
out which documents may be easily produced, can’t disclose whether the documents we re already
deidentified by Pfizer, can’t provide a full index of the documents, can’t determine even how well
its existing 10 reviewers can work since two of them are newer, etc. But there are two things the
FDA is certain about : it is certain it can igno re the FOIA obligation to produce these documents
“as soon as practicable ” and it is certain it must put its obligation to redact trade secrets on Pfizer’s
behalf above the American peoples’ right and need to see these documents .
But the FDA seeks to ass ure the Court that its choice to ignore its disclosure obligations is
fine because when it reviewed the Pfizer data the agency “marshaled ” all available resources to
ensur e that the public had access to “life -saving products ” as soon as possible. (Dkt. No. 20 ¶ 2.) Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 24 of 26 PageID 1450Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 24 of 26 PageID 1450
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That is precisely the issue at hand. The public is entitled to have independent scientists review the
data underlying the federal government’s decisions regarding this mandatory and liability- free
COVID- 19 vaccine. The FDA is essentially sayi ng, “trust us , we know what we are doing, no one
else needs to check our work.” However, Congress made the policy decision decades ago that the
American people may trust their government, but they also get to verify that trust through rigorous
transparency.
The issue here is simply one of resources and for this issue, the FDA should be directed to
produce at least the same speed it took to license the product given the importance of timely
production, the obligation to “promptly” produce under FOIA to assure transparency , and the
regulation calling for these documents to be “immediately available” to the public following
licensure. The FDA should not be above the law. Nor should it be permitted to get away with its
unconscionable approach and position with regard to disclosing Pfizer’s documents for
independent review.
For the foregoing reasons, during the upcoming scheduling conference, the Court should
order the FDA to produce all documents responsive to the PHMPT ’s FOIA Request on or before
March 3, 2022, which is 108 days from the parties Second Joint Report to the Court. Whether the
FDA or Pfizer reviews the documents for proposed redactions i s not of concern for Plaintiff and
should not affect the requested production date of March 3, 2022.
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Dated: December 13, 2021
SIRI & GLIMSTAD LLP
__________________________
Aaron Siri , NY Bar No. 4321790
Elizabeth A. Brehm, NY Bar No. 4660353
Gabrielle G. Palmer, CO Bar No. 48948
200 Park Avenue
New York, New York 10166
Tel: (212) 532- 1091
Fax: (646) 417- 5967
[email protected]
[email protected]
[email protected]
HOWIE LAW, PC
John Howie
Texas Bar Number: 24027239
2608 Hibernia Street
Dallas, Texas 75204
Tel: (214) 622- 6340
[email protected]
Attorneys for Plaintiff
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