Court filing

PHMPT's combined opposition and cross-motion for summary judgment — PHMPT v. FDA

Record facts

Court	U.S. District Court for the Northern District of Texas
Filed	2024-11-07

U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 95 · 2024-11-07 · Docket on CourtListener

Summary

Plaintiff's combined memorandum opposing the Food and Drug Administration's motion for summary judgment and supporting its own cross-motion, No. 4:21-cv-01058-P, filed November 7, 2024 as Document 95 in the U.S. District Court for the Northern District of Texas. The plaintiff, Public Health and Medical Professionals for Transparency, seeks records under a Freedom of Information Act request submitted August 27, 2021 for all data and information for the Pfizer COVID-19 vaccine enumerated in 21 C.F.R. § 601.51(e). It argues the agency withheld an EUA file of approximately one million pages that is responsive to the request, and asks the court to order production no later than February 20, 2025. The facts section recounts that the vaccine was approved August 23, 2021 and that the agency represented production complete on November 1, 2023 with 1,187,147 pages processed.

Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used

Full text

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS

PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY,

Plaintiff,

UNITED STATES FOOD AND DRUG
ADMINISTRATION,

Defendant.

Civil Action No. 4:21-cv-01058-P

PLAINTIFF’S COMBINED MEMORANDUM IN OPPOSITION TO DEFENDANT’S
MOTION FOR SUMMARY JUDGMENT AND IN SUPPORT OF PLAINTIFF’S
CROSS-MOTION FOR SUMMARY JUDGMENT
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 1 of 27 PageID 2444

TABLE OF CONTENTS
TABLE OF AUTHORITIES ........................................................................................................... ii
INTRODUCTION .......................................................................................................................... 1
FACTS ............................................................................................................................................ 3
LEGAL STANDARD ....................................................................................................................11
ARGUMENT ................................................................................................................................ 12
I. Plaintiff’s FOIA Request Must Be Construed Liberally and the Scope Includes
the EUA File ..................................................................................................................... 15
II. Even If the Appropriate Focus Is on the Definition of “Biological Product File,”
the EUA File Is Still Responsive ...................................................................................... 20
III. The EUA File Is Critical to PHMPT’s Goals and to the American Public ....................... 21
CONCLUSION ............................................................................................................................. 22
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 2 of 27 PageID 2445

TABLE OF AUTHORITIES
Cases
Anderson v. Liberty Lobby, Inc.,
477 U.S. 242 (1986) ...................................................................................................................11

Batton v. Evers,
598 F.3d 169 (5th Cir. 2010) .................................................................................................... 13

Celotex Corp. v. Catrett,
477 U.S. 317 (1986) ...................................................................................................................11

Conservation Force v. Ashe,
979 F. Supp. 2d 90 (D.D.C. 2013) ............................................................................................ 13

Corel Corp. v. U.S.,
165 F. Supp. 2d 1 (D.D.C. 2001) .............................................................................................. 12

Defs. of Wildlife v. United States Border Patrol,
623 F. Supp. 2d 83 (D.D.C. 2009) ............................................................................................ 12

Esch v. Yeutter,
876 F.2d 976 (D.C. Cir. 1989)................................................................................................... 12

Fed. Labor Relations Auth. v. United States Dept’ of Treasury,
884 F.2d 1446 (D.C. Cir. 1989)................................................................................................. 21

Hemenway v. Hughes,
601 F. Supp. 1002 (D.D.C. 1985); ............................................................................................ 13

Inst. for Justice v. IRS,
941 F.3d 567 (D.C. Cir. 2019)............................................................................................. 13, 18

Media Research Ctr. v. U.S. Dep’t of Just.,
818 F. Supp. 2d 131 (D.D.C. 2011) ...........................................................................................11

Nat’l Sec. Counselors v. CIA,
849 F. Supp. 2d 6 (D.D.C. 2012) .............................................................................................. 13

Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 3 of 27 PageID 2446

iii

PHMPT v. FDA,
22-cv-00915 (N.D. Tex.)……………………………………………………………………..5, 6

Rodriguez v. DOD,
236 F. Supp. 3d 26 (D.D.C. 2017) ............................................................................................ 13

SafeCard Servs., Inc. v. SEC,
926 F.2d 1197 (D.C. Cir. 1991) ................................................................................................. 14

Schrecker v. DOJ,
349 F.3d 657 (D.C. Cir. 2003)................................................................................................... 14

Steinberg v. U.S. Dep’t of Justice,
23 F.3d 548 (D.C. Cir. 1994)..................................................................................................... 13

Valencia-Lucena v. United States Coast Guard,
180 F.3d 325 (D.C. Cir. 1999)................................................................................................... 12

Wallick v. Agric. Mktg. Serv.,
281 F. Supp. 3d 56 (D.D.C. 2017) ............................................................................................ 13

Weisberg v. U.S. Dep’t of Justice,
227 U.S. App. D.C. 253, 705 F.2d 1344 (D.C. Cir. 1983) ........................................................ 12

Weisberg v. U.S. Dep’t of Justice,
745 F.2d 1476 (D.C. Cir. 1984)................................................................................................. 13
Statutes
21 C.F.R. § 601.51(a) ............................................................................................................. passim

21 C.F.R. § 601.51(e) ............................................................................................................. passim

21 C.F.R. § 601.51(g) .......................................................................................................... 9, 19, 20

FED. R. CIV. P. 56 (a) ....................................................................................................................11

PROJECT BIOSHIELD ACT OF 2004, 108 P.L. 276, 118 Stat. 835 ............................................ 9

Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 4 of 27 PageID 2447

Public Health and Medical Professionals for Transparency (“PHMPT” or “Plaintiff”)
respectfully submits this Opposition to the Food and Drug Administration’s (“FDA”) Motion for
Summary Judgment and in Support of PHMPT’s Cross-Motion for Summary Judgment. This
matter concerns a Freedom of Information Act (“FOIA”) request submitted by PHMPT to FDA
seeking copies of all data and information for Pfizer’s COVID-19 Vaccine (the “Pfizer Vaccine”),
licensed for those 16 years of age and older.
INTRODUCTION
The sole issue before the Court is an easy, clear-cut one: FDA, understanding full well from
the outset that Plaintiff is seeking all records in FDA’s possession concerning and leading up to the
licensure of the Pfizer Vaccine, secretly withheld from Plaintiff an entire “EUA file”1 containing
approximately one million pages of responsive and critical records. This file contains the data that
support FDA’s decision to initially grant authorization and then licensure for the Pfizer Vaccine
and to begin the world’s largest vaccination campaign in history. There was only one clinical trial
for one product, the Pfizer Vaccine, and around half the data and records related to that trial have
been produced while the other half of the data and records remains hidden in the EUA file. This
makes it impossible to properly analyze the clinical trial FDA relied upon to license this product,
continuing FDA’s refusal to simply provide transparency.
Only due to a specific document in a separate litigation, and through emails with opposing
counsel in that separate litigation, was the existence of the EUA file first disclosed. FDA is well
aware that this is the file that Plaintiff seeks yet mentions it in only one paragraph in its nearly 20-
page brief (Defendant’s Brief in Support of Motion for Summary Judgment, Dkt. 91, hereinafter
“Def. Brief,” at 15) and in only one nearly identical paragraph of the Declaration of Suzann Burk

1 “EUA” means emergency use authorization.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 5 of 27 PageID 2448

(“Burk Decl.”) ¶ 42 of Defendant’s App’x 013 (“Def. App’x __”). Instead of confronting the sole
adequacy of search issue head-on, FDA attempts to distract with voluminous and sometimes
irrelevant details about the records it did search for and produce. However, FDA is not permitted
to unilaterally narrow requests or cherry-pick responsive documents regardless of the number of
those cherry-picked documents and has, thus, failed to meet its statutory obligations under FOIA.
To be clear, Plaintiff seeks the EUA file as part of its FOIA request so that independent
researchers can adequately evaluate the Pfizer Vaccine. Therefore, it is again worth stressing that
there was only one clinical trial that FDA relied upon to license the Pfizer Vaccine. The data for
this one trial is split between the EUA file (from an earlier point in time) and the remainder of what
has already been produced (submitted to FDA by Pfizer at a later point in time). As PHMPT’s
scientists have repeatedly advised, and more recently bemoaned, they cannot do any real analysis
with only half the data from this one trial for this one product. They need it all.
Since the independent researchers and scientists within PHMPT (and without) cannot
conduct the analyses they need to conduct without this EUA file, we would be remiss if we did not
make abundantly clear that this FOIA request is currently the only vehicle by which the American
public will obtain access to these records. Pfizer (and Moderna) are not even considering requests
for their data for at least 2 years post-trial, if ever. Whether they ever make this data available to
the public is at their sole discretion. Perhaps revealing Pfizer’s intent, its COVID-19 vaccine
clinical trial study listing on the clinicaltrials.gov website states: “Plan to Share Individual
Participant Data (IPD)? No.”2 The same American public who was convinced, coerced, and
mandated to receive this product by their government deserve to see what the government saw and
to know what the government knew. Simply because time has passed, the importance of these

2 https://clinicaltrials.gov/study/NCT04368728#more-information (emphasis added).
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 6 of 27 PageID 2449

records and what they reveal about the government’s actions has not lessened, and nor should the
urgency with which they are released to the public. In fact, FDA’s effort to stonewall their release
should only serve as a stark reminder of why FOIA exists in the first place.
Unfortunately, from the outset of this FOIA request, FDA, to the extent it could, has sought
to obfuscate, delay, evade, and object to the release of the records at issue, and a part of this plan
has clearly been to hide the existence of the “EUA file” until continuing that ruse became
impossible. This conduct sadly continues to thwart the release of records to which the American
public is entitled. FDA’s lack of transparency and violations of FOIA should not be permitted and,
thus, Plaintiff moves for summary judgment and an order from this Court that FDA produce the
“EUA file” and any other responsive records forthwith.
FACTS
Procedural History
Plaintiff recognizes that the Court is familiar with the procedural history in this case and
will therefore only recite those portions most critical for the instant motion.
On August 23, 2021, FDA approved the Pfizer-BioNTech COVID-19 Vaccine, marketed
as Comirnaty, (the “Pfizer Vaccine”) for individuals 16 years of age and older.
Four days later, on August 27, 2021, Plaintiff submitted its FOIA request for “All data and
information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)3 with the exception of

3 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following
information shall be made available for immediate disclosure absent extraordinary circumstances:
“(1) All safety and effectiveness data and information. (2) A protocol for a test or study . . . . (3)
Adverse reaction reports, product experience reports, consumer complaints, and other similar data
and information . . . . (4) A list of all active ingredients and any inactive ingredients . . . . (5) An
assay method or other analytical method . . . . (6) All correspondence and written summaries of
oral discussions relating to the biological product file . . . . (7) All records showing the
manufacturer’s testing of a particular lot . . . . (8) All records showing the testing of and action on
a particular lot by the [FDA]."
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 7 of 27 PageID 2450

publicly available reports on the Vaccine Adverse Events Reporting System4” and sought
expedited processing.
After FDA denied expedited processing, Plaintiff sued on September 16, 2021. The parties
then briefed the timing of the production wherein Plaintiff sought an expedited production and
FDA sought at least 75 years to produce the then-undisclosed volume of records.
During the litigation, FDA was not forthcoming about the number of pages responsive to
the request. In November 2021, that number was originally cited as approximately 329,000 pages.
(Dkt. 18, Dkt 22.) In December 2021, Plaintiff advised the Court that FDA had clarified that in
addition to that previous number, there were another “approximately 39,000 pages” of BLA
“supplements, amendments, and product correspondence,” plus “tens of thousands of additional
pages” of “records that may be supportive of the BLA,” plus at least 126 data files. Plaintiff’s best
estimate of the volume of responsive pages at that time was 451,000 pages. (Dkt. 31.) On January
6, 2022, the Court issued its Order calling for production of 55,000 pages a month starting on
March 1, 2022, which was presumably based on the 450,000 pages representation as it would have
meant production would be complete by the end of that calendar year. (Dkt. 35.) Months later, in
March 2023, Plaintiff informed the Court that while it had expected only around 450,000 pages,
FDA had produced 779,206 as of that date and said there were still about 372,000 additional pages.
(Dkt. 67.) It turns out that FDA knew at least a year earlier than that, by March 2022, that there
were at least 1.2 million pages to review. Plaintiff did not learn this from FDA, but from a separate
FOIA request submitted by Plaintiff which produced a contract between FDA and a third-party

4 For the avoidance of doubt, this request includes but is not limited to all of the data and
information in the biological product file, as defined in 21 C.F.R. § 601.51(a), 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.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 8 of 27 PageID 2451

document reviewing company. (PHMPT v. FDA, 22-cv-00915 (N.D. Tex.) (“PHMPT 2”), Dkt. 28
at 1, April 12, 2023.) While FDA knew the volume it intended to produce by March 2022, it was
never transparent about this fact with Plaintiff or the Court.
FDA produced documents monthly and on November 1, 2023, it represented that
production was complete with a total of 1,187,147 pages processed. At that time, there was
confusion among PHMPT’s members as to certain data that was expected and needed but not
received.5
On March 13, 2024, after conferring with members of PHMPT who are involved in
analyzing the records produced, undersigned counsel sent a letter to FDA challenging the adequacy
of the search. That letter listed seven categories of the most pressing records that PHMPT was still
seeking that are needed in order to carry out crucial analyses and that PHMPT expected it would
have received as part of the production as the records would have been in FDA’s possession. (See
Appendix, Declaration of Elizabeth A. Brehm (hereinafter “Brehm Decl.”), Exhibit A, App’x 003-
141.) Note that at the time this letter was sent, PHMPT was not aware of any “EUA file” and
assumed all records about the product’s clinical trial would be contained within the product’s file
at FDA.
Prior to that letter, on January 2, 2024, FDA represented that production of the Pfizer 12-
15-year-old portion of the PHMPT 2 request was complete.6 (Brehm Decl., Exhibit B, App’x 142-
144.) The deGarays, plaintiffs in the PHMPT 2 case, identified that their daughter’s case report

5 As an important example, the production contained PDFs with tables that were submitted with
the biologics license application, and it also contained the underlying data for those PDFs/tables.
The production similarly contained PDFs with tables that were submitted earlier on in the clinical
trial with Pfizer’s request for emergency use authorization, yet the data underlying those
PDFs/tables was not produced. Thus, PHMPT cannot replicate those tables.
6 The production of Moderna records is still ongoing.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 9 of 27 PageID 2452

form (“CRF”) had not been produced despite FDA’s claim that production was complete. Thus,
on April 23, 2024, following emails with defense counsel, Plaintiff’s counsel formally requested
that the CRF be produced in PHMPT 2. (Brehm Decl., Exhibit C, App’x 145-146.) On April 24,
2024, counsel for FDA in PHMPT 2 represented, for the very first time in either of the litigations,
that there was something called an “EUA file” and that the CRF for the deGarays’ daughter was in
that file. FDA claimed the EUA file is separate from the “biological product file” and therefore
was not responsive to Plaintiff’s request and so it was not produced. (Brehm Decl., Exhibit D,
App’x 147-149.) That was the first time Plaintiff was made aware of the existence of an “EUA
file.”7
On July 17, 2024, FDA responded to PHMPT’s adequacy of search letter, referencing for
the first time in this litigation the existence of an “EUA file.” (Brehm Decl., Exhibit E, App’x 150-
155.) FDA’s letter, however, is unclear as to whether FDA does not have the seven categories of
documents PHMPT asserts were missing from the production or if it does have the records but
refuses to disclose them because they are in the newly identified “EUA file” which FDA deems
“non-responsive” to the request. In conversations with FDA’s counsel subsequent to this letter
exchange, Plaintiff has learned that there are approximately one million pages of records related
to the Pfizer Vaccine and its clinical trial in this EUA folder, none of which FDA has disclosed.
This EUA file is the file PHMPT seeks and that FDA continues to withhold – meaning,
more than 3 years and 2 months have passed since the clinical trial documents were requested, and

7 In PHMPT 2, the parties subsequently met and conferred about this issue, but FDA asserted this
was not ripe to raise with the Court yet as production continues for Moderna. Counsel agreed in
good faith to submit a separate FOIA to obtain the CRF but did not waive the argument that the
CRF is responsive to the original request, which can be raised later in that litigation.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 10 of 27 PageID 2453

Plaintiff has received only half the records for the clinical trial Pfizer conducted and which it
submitted to FDA to obtain a license for its COVID-19 vaccine.
Pfizer Vaccine Background and Relevant Regulation
The EUA file was plainly part of PHMPT’s request for “All data and information for the
Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e).”8 The regulation cited within the request, 21
C.F.R. § 601.51, is an FDA regulation that deals with the “confidentiality of data and information
in applications for biologics licenses.” The regulation was enacted in 1974.9
At the time it was enacted, the federal register read as follows:
[A] biologic must be licensed by the Food and Drug Administration
before it may lawfully be shipped in interstate commerce.10 Unlike
the regulation of human and animal drugs, all biological
products are required to undergo clinical testing in order to
demonstrate safety, purity, potency, and effectiveness prior to
licensing, regardless whether other versions of the same product
are already marketed or standards for the product have been
adopted by rule making. Indeed, many of the existing standards
require specific clinical testing before approval will be granted. This
is required because all biological products are to some extent
different and thus each must be separately proved safe, pure, potent,

8 The request, in its entirety, also said, “with the exception of publicly available reports on the
Vaccine Adverse Events Reporting System” and it contained two footnotes. The first footnote
quoted the language of 21 CFR § 601.51(e). The second footnote, importantly, said, “For the
avoidance of doubt, this request includes but is not limited to all of the data and information
in the biological product file, as defined in 21 C.F.R. § 601.51(a), 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.” PHMPT was making clear that it wanted all records about the
Pfizer vaccine (“not limited to all of the data and information in the biological product file”) except
publicly available VAERS data.
9 Although it has been amended since 1974, none of the amendments have been substantive. See
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601/subpart-F/section-601.51
(showing amendments that address changes of addresses or of names of agency branches or that
clarify that persons wishing to request the information shall submit a request under the Freedom
of Information Act).
10 Note that this recognizes licensure as the only way a biologic “may lawfully be shipped in
interstate commerce.” That is because, as explained further infra, emergency use authorization did
not exist at the time and was therefore not an avenue for a biologic to be lawfully in use.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 11 of 27 PageID 2454

and effective. Although, like an approved NDA, a license to
manufacture a particular biologic is a private license that is
applicable only to a single manufacturer, a biologics license is
under no circumstances granted by the Food and Drug
Administration to a second manufacturer based upon published
or otherwise publicly available data and information on another
manufacturer’s version of the same product. Under section 351
of the Public Health Service Act, biologics never become “old
drugs’’ and cannot be marketed solely on the basis of an existing
product standard published in the Federal Register. There is no such
thing as a “me-too” biologic.

Thus, the regulatory scheme for biologics is quite different from the
methods by which new drugs and antibiotic drugs are controlled …

Accordingly, the Commissioner concludes that the safety and
effectiveness data for a biologic regulated under section 351 of
the Public Health Service Act is not properly classified as a trade
secret. Such data afford no competitive advantage because,
unlike the situation with new drugs, no competitor can utilize it
to gain approval for his product. Moreover, since such data are
routinely published in the scientific literature, they do not fall within
the confidential commercial information exemption…

Because there was not a concern for competitive advantage as there might be with drugs,
FDA adopted the regulation – cited by PHMPT in its FOIA request – that mandates transparency
of the data related to biological products (vaccines), including data about their clinical testing.
The definition of “biological product file” within the relevant regulation is:
For purposes of this section the biological product file includes all
data and information submitted with or incorporated by
reference in any application for a biologics license, IND’s
incorporated into any such application, master files, and other
related submissions. The availability for public disclosure of any
record in the biological product file shall be handled in accordance
with the provisions of this section.

21 CFR § 601.51(a).
To be sure, the term “emergency use authorization” or “EUA” does not appear within the
definition of a “biological product file.” That is because the regulation was drafted in 1972 and
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 12 of 27 PageID 2455

enacted in 1974 – decades before “emergency use authorization” existed. Emergency use
authorization was brought about in July 2004 as part of the “Project BioShield Act of 2004”11
Thus, it could not have been specified within the regulation. Instead, the regulation uses a catch-
all phrase (“and other related submissions”) to capture additional data related to the biological
product.
Reinforcing that the definition of “biological product file” is meant to include all data about
the product, and crucial to the issue before the Court, 21 CFR § 601.51(g) states: “For purposes of
this regulation, safety and effectiveness data include all studies and tests of a biological
product on animals and humans and all studies and tests on the drug for identity, stability,
purity, potency, and bioavailability.” 21 CFR § 601.51(g) (emphasis added).
There was only one set of studies/testing done on this product at the pre-clinical (animal
testing) and clinical (Phase I trial, one Phase II trial, and one Phase III trials) testing stages. The
study is described by Pfizer as follows:
[A] Phase 1/2/3, randomized, placebo-controlled, observer-blind,
dose-finding, vaccine candidate-selection, and efficacy study in
healthy individuals.

The study consists of 2 parts: Phase 1: to identify preferred vaccine
candidate(s) and dose level(s); Phase 2/3: an expanded cohort and
efficacy part.

The study will evaluate the safety, tolerability, and immunogenicity
of 3 different SARS-CoV-2 RNA vaccine candidates against
COVID-19 and the efficacy of 1 candidate:
•
As a 2-dose (separated by 21 days) schedule;

11
PROJECT
BIOSHIELD ACT
OF
2004,
108
P.L.
276,
118
STAT.
835. https://
www.congress.gov/108/plaws/publ276/PLAW-108publ276.pdf. President George W. Bush signed
the Act into law to improve medical countermeasures protecting Americans against a chemical,
biological, radiological, or nuclear attack. Part of the Act “[ga]ve FDA the ability to make
promising treatments quickly available in emergency situations – this tightly controlled new
authority will enable access to the best available treatments in the event of a crisis.”
https://georgewbush-whitehouse.archives.gov/infocus/bioshield/index.html.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 13 of 27 PageID 2456

•
At various different dose levels in Phase 1;
•
As a booster;
•
In 3 age groups (Phase 1: 18 to 55 years of age, 65 to 85
years of age; Phase 2/3: ≥12 years of age [stratified as 12-
15, 16-55 or >55 years of age]).

The candidate selected for efficacy evaluation in Phase 2/3 is
BNT162b2 at a dose of 30 µg.

Participants who originally received placebo will be offered the
opportunity to receive BNT162b2 at defined points as part of the
study.12

Thus, there were not separate studies or clinical trials for the “EUA” biological product
versus the licensed biological product; there was animal testing and there was a clinical trial for
the sole biologic product file at issue in this request: the Pfizer Vaccine. Pfizer first submitted data
to FDA on November 20, 2020, seeking emergency use authorization for its COVID-19 vaccine.13
This submission occurred as the clinical trial was ongoing. The EUA was granted just twenty-two
days later on December 11, 2020 (a process that typically takes at least 6-10 months). About 5.5
months later, on May 7, 2021, Pfizer started another rolling submission seeking licensure for the
same COVID-19 vaccine.14 This submission added to the clinical trial data that Pfizer had
previously submitted for the EUA.
In FDA’s own words to the public at the time it granted licensure to the Pfizer Vaccine:
For Comirnaty [Pfizer Vaccine], the BLA builds on the extensive
data and information previously submitted that supported the
EUA, such as preclinical and clinical data and information, as well
as details of the manufacturing process, vaccine testing results to
ensure vaccine quality, and inspections of the sites where the vaccine
is made… The first EUA, issued Dec. 11, for the Pfizer-BioNTech

12 https://clinicaltrials.gov/study/NCT04368728.
13
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-
emergency-use-authorization. Pfizer Press Release, November 20, 2020
14
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-
rolling-submission-biologics. Pfizer Press Release, May 7, 2021.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 14 of 27 PageID 2457

COVID-19 Vaccine for individuals 16 years of age and older
was based on safety and effectiveness data from a randomized,
controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA
reviewed updated data from the clinical trial which supported
the EUA and included a longer duration of follow-up in a larger
clinical trial population.15

It is clear that all of the data submitted leading up to FDA’s decision to license the product,
including any EUA data, is within the scope of the FOIA request.
LEGAL STANDARD
A movant is granted summary judgment “if the movant shows that there is no genuine
dispute as to any material fact.” FED. R. CIV. P. 56 (a). A material fact is a fact that “might affect
the outcome of the suit under the governing law.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,
248 (1986). A genuine dispute arises “if the evidence is such that a reasonable jury could return a
verdict for the nonmoving party.” Id.
“The moving party bears the burden of demonstrating [the] absence of a genuine issue of
material fact in dispute.” Media Research Ctr. v. U.S. Dep’t of Just., 818 F. Supp. 2d 131, 136
(D.D.C. 2011) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986)). An agency moving
for summary judgment must prove that “it has fully discharged its obligations under the FOIA,
after the underlying facts and the inferences to be drawn from them are construed in the light most
favorable to the FOIA requester.” Id. at 137.
Generally, courts limit their review to the information contained within the administrative
record; however, the D.C. Circuit has held that supplemental evidence may be properly admitted:
(1) when agency action is not adequately explained in the record
before the court; (2) when the agency failed to consider factors
which are relevant to its final decision; (3) when an agency

15
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
(emphasis added). FDA News Release, August 23, 2021.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 15 of 27 PageID 2458

considered evidence which it failed to include in the record; (4)
when a case is so complex that a court needs more evidence to
enable it to understand the issues clearly; (5) in cases where
evidence arising after the agency action shows whether the decision
was correct or not; (6) in cases where agencies are sued for a failure
to take action; (7) in cases arising under the National Environmental
Policy Act; and (8) in cases where relief is at issue, especially at the
preliminary injunction stage.
Esch v. Yeutter, 876 F.2d 976, 991 (D.C. Cir. 1989) (footnote omitted). “Put another way,
[c]ourts admit outside evidence primarily as a means of requiring an agency to explicate its own
reasoning when the record is unclear.” Corel Corp. v. U.S., 165 F. Supp. 2d 12, 31 (D.D.C. 2001)
(internal quotation marks omitted); see Brehm Decl., App’x 1-155.
ARGUMENT
PHMPT is entitled to summary judgment because there are no genuine issues of material
fact. Conversely, FDA is not entitled to summary judgment because FDA has not proved, and
cannot prove, it has fully discharged its obligations under FOIA. FDA did not conduct an adequate
search and did not conduct the search in good faith. FDA has not advanced any logical, coherent
reason as to why the EUA file does not fit the statutory definitions of the materials that must be
released to the public. The EUA file concerning Pfizer’s Vaccine is responsive to Plaintiff’s request
and Plaintiff therefore requests that the records within the file be produced with production
complete no later than February 20, 2025.
“To meet its burden to show that no genuine issue of material fact exists, with the facts
viewed in the light most favorable to the requester, the agency must demonstrate that it has
conducted a ‘search reasonably calculated to uncover all relevant documents.’” Weisberg v. U.S.
Dep’t of Justice, 745 F.2d 1476, 1485 (D.C. Cir. 1984) (quoting Weisberg v. U.S. Dep’t of Justice,
227 U.S. App. D.C. 253, 705 F.2d 1344, 1350-51 (D.C. Cir. 1983)) (emphasis added); see also
Valencia-Lucena v. United States Coast Guard, 180 F.3d 325 (D.C. Cir. 1999); Defs. of Wildlife v.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 16 of 27 PageID 2459

United States Border Patrol, 623 F. Supp. 2d 83, 91 (D.D.C. 2009). The standard of reasonableness
“depends, not surprisingly, upon the facts of each case.” Weisberg, 745 F.2d at 1485. Notably,
FOIA obligates agencies to conduct searches in good faith. Steinberg v. U.S. Dep’t of Justice, 23
F.3d 548, 551 (D.C. Cir. 1994) (quoting Weisberg v. U.S. Dep’t of Justice, 745 F.2d 1476, 1485
(D.C. Cir. 1984)).
To determine whether a search for responsive records was adequate, a court must first
determine the scope of the documents the plaintiff requested. Wallick v. Agric. Mktg. Serv., 281 F.
Supp. 3d 56, 66 (D.D.C. 2017). It has long been established that an agency has a duty to construe
FOIA requests liberally. See Hemenway v. Hughes, 601 F. Supp. 1002, 1005 (D.D.C. 1985);
Conservation Force v. Ashe, 979 F. Supp. 2d 90, 101-02 (D.D.C. 2013); Rodriguez v. DOD, 236 F.
Supp. 3d 26, 36-38 (D.D.C. 2017). Thus, an agency has a duty under FOIA to select the
interpretation that would likely yield the greatest number of responsive documents. Conservation
Force, 979 F. Supp. 2d at 102-03; Nat’l Sec. Counselors v. CIA, 849 F. Supp. 2d 6, 12 (D.D.C.
2012). “Technical precision” is not required in FOIA requests, “and a request certainly should not
fail where the agency knew or should have known what the requester was seeking all along.” Inst.
for Justice v. IRS, 941 F.3d 567, 572 (D.C. Cir. 2019).
FDA cites Batton v. Evers, 598 F.3d 169, 176 (5th Cir. 2010) to argue that “[t]he issue is
not whether other documents may exist, but rather whether the search for undisclosed documents
was adequate.” (Def. Brief at 9.) But Batton is not helpful to FDA here. In Batton, the plaintiff
asserted that “other documents may exist that were not located in the search.” Batton, 169 F.3d at
176. Here, Plaintiff knows that other documents exist because FDA knew and eventually disclosed
that they exist. And so, as the Batton court held, the question is whether the search for the
undisclosed documents was adequate. Here, FDA’s search was by definition inadequate given that
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 17 of 27 PageID 2460

FDA knows precisely where the records are and how to find them – yet, it did not conduct a search
for them at all. In its brief, FDA explains: “The agency tracks EUA records in BIRAMS, and the
IRA number associated with Pfizer’s COVID-19 vaccine EUA file is 27034.” (Def. Brief at 15.)
Note that BIRAMS is also where FDA successfully searched for and pulled IND-related records
from. (See Def. Brief at 13.) FDA purposefully overlooked the EUA file and interpreted the FOIA
request in the most narrow, inartful reading possible to avoid producing known records.
SafeCard Servs., Inc. v. SEC, 926 F.2d 1197 (D.C. Cir. 1991) also does not support FDA’s
argument. FDA asserts that its affidavit should be “accorded a presumption of good faith, which
cannot be rebutted by ‘purely speculative claims about the existence and discoverability of other
documents.’” (Def. Brief at 9.) But again, Plaintiff is not speculating about the existence and
discoverability of other documents. FDA has confirmed a file of one million pages exists and
knows precisely where that file is; there is no speculation needed.
Similarly, FDA cites numerous cases in an attempt to tell the Court that it should not
interfere with the agency’s administrative judgment in conducting its search. (See Def. Brief at
10.) But all of these cases presume that the agency has searched every reasonable place it would
expect documents to be and yet the plaintiff challenges the search arguing there may be additional
documents that were not disclosed or additional alternative methods the government should have
applied. For example, in Schrecker v. DOJ, 349 F.3d 657, 662 (D.C. Cir. 2003), the court talks of
the “agency’s rate of success in unearthing the information sought.” Id. at 662; Def. Brief at 10.
Here, again, there is no need to “unearth” anything here. FDA was fully aware that Plaintiff wanted
all records related to the Pfizer Vaccine. FDA knows there is an EUA file as well as a “biological
product file” and so did not need to “unearth” anything. This is not a case where the Court can
conclude that FDA did the best it could and while, yes, there may be other documents that exist
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 18 of 27 PageID 2461

somewhere, we cannot expect the agency to check everywhere. Instead, this is a case where the
FDA has a known file, filled with one million pages, about the sole product at issue that it has
never disclosed to Plaintiff or to this Court throughout the entire production. A presumption of
good faith in this circumstance would be inappropriate.
I.
Plaintiff’s FOIA Request Must Be Construed Liberally and the Scope Includes the
EUA File
Here, FDA knew all along what PHMPT was after: all data FDA has concerning the Pfizer
Vaccine that was licensed mere days before PHMPT submitted its request. Despite knowing this,
FDA admits that when it received Plaintiff’s request, it “[i]nitially …interpreted Plaintiff’s FOIA
Request as a ‘request for all publicly releasable information in the original biologics license
application submitted by BioNTech-Pfizer for the Comirnaty vaccine.’” (Burk Decl. at 7-8, Def.
App’x 007-008 (emphasis added).) This, of course, was already an impermissible narrowing of
Plaintiff’s request with no explanation provided by the agency as to why it would unilaterally
narrow an otherwise clear request. Throughout the parties’ meet and confer calls from early on in
the litigation, in the voluminous briefing submitted to the Court,16 and during the Court hearings,17

16 See, e.g., Complaint (Dkt. 1 ¶ 21) (citing government claims the Pfizer Vaccine is ‘safe and
effective’ made “prior to FDA approval”); id. ¶¶ 24-25 (citing article by member of PHMPT dated
August 23, 2021 when “FDA [was on] the verge of granting a marketing license” to Pfizer
discussing the inadequate EUA data and no reported data past March 13, 2021); id. ¶ 47 (making
clear PHMPT seeks “full disclosure of the data and information underlying the FDA’s conclusion
that the Pfizer Vaccine is ‘safe and effective.’”); Joint Status Report dated November 15, 2021
(Dkt. 20) (“Until the entire body of documents provided by Pfizer to the FDA are made available,
an appropriate analysis by the independent scientists that are members of Plaintiff is not
possible.”); Plaintiff’s Brief dated December 7, 2021 (Dkt. 26) (quoting President Biden talking
about the need for “all of it” [the vaccine data] to be made “available to other experts across the
nation so they can look and see, so there’s a consensus this is a safe vaccine” and quoting fifteen
U.S. Senators calling for “full transparency throughout the review and authorization process is []
essential…”)
17 See Transcript of December 14, 2021 hearing at 49 (Dkt. 34) (“In terms of the scope of
documents. As the doctors have made very clear, unless they have all the data, the entire
production, they can't do a proper review. If even one data set is missing, they don’t know if
their analysis is correct. In terms of the actual scope that was requested. As I pointed out, I believe
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 19 of 27 PageID 2462

PHMPT was consistent and clear: with regard to the Pfizer Vaccine, PHMPT wanted to know what
the government knew, see what the government had seen, and make that data publicly available so
that independent researchers and scientists could run their own analyses to try to replicate what
the government did or disprove the government’s conclusions at the time it licensed the product.
But throughout the processing of this request, FDA has attempted to impermissibly narrow the
request and interpret it in the most restrictive way possible so as to produce the fewest number of
responsive records.
To obtain the records, PHMPT clearly requested “All data and information for the Pfizer
Vaccine enumerated in 21 C.F.R. § 601.51(e)18 with the exception of publicly available reports on
the Vaccine Adverse Events Reporting System.19”

earlier, this FOIA request is for the precise scope of documents that the Code of Federal
Regulations, that the FDA’s own regulations say, should be made immediately available after
licensure”) (emphasis added); Transcript of January 28, 2022 hearing at 82 (Dkt. 58) (“as the group
I represent has pointed out, until they get all the documents at issue here, particularly the
underlying data sets, they can’t do a proper analysis because missing even one data set could
throw off any analysis they do.”) (emphasis added).
18 21 C.F.R. § 601.51(e) provides that after a biological product is licensed, the following
information shall be made available for immediate disclosure absent extraordinary circumstances:
“(1) All safety and effectiveness data and information. (2) A protocol for a test or study . . . . (3)
Adverse reaction reports, product experience reports, consumer complaints, and other similar data
and information . . . . (4) A list of all active ingredients and any inactive ingredients . . . . (5) An
assay method or other analytical method . . . . (6) All correspondence and written summaries of
oral discussions relating to the biological product file . . . . (7) All records showing the
manufacturer’s testing of a particular lot . . . . (8) All records showing the testing of and action on
a particular lot by the [FDA].”
19 For the avoidance of doubt, this request includes but is not limited to all of the data and
information in the biological product file, as defined in 21 C.F.R. § 601.51(a), 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.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 20 of 27 PageID 2463

The relevant parts of the regulation referenced in the request read as follows:
20
Thus, the request language captures the EUA file now at issue.

20 https://www.ecfr.gov/current/title-21/chapter-I/subchapter-F/part-601/subpart-F/section-601.51
(excerpted to show only relevant sections of the regulation).
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 21 of 27 PageID 2464

The request focuses on 21 C.F.R. § 601.51(e) which enumerates categories of “data and
information in the biological product file” including, but not limited to, “all safety and
effectiveness data and information.” See image above.
Contrary to its obligation to construe this request liberally and to interpret it in the way that
would yield the greatest number of responsive documents, understanding full well what Plaintiff
was seeking, FDA puts its head in the sand, pretending to not understand what Plaintiff was
seeking. It instead points to the definition of “biological product file” in subsection (a) of the
regulation and then uses the definition as a restriction on the records it claims it was obligated to
search. This argument must fail for at least three reasons.
First, because FDA knew what PHMPT was seeking, those records should have been
disclosed. Period. A requester does not need to be precise and does not need to expressly name
every record it seeks nor the location of where the records might be. FDA, as the government
agency in control of the records, must take its understanding of the FOIA requester’s goal and, in
good faith, search for and produce those responsive records. See Inst. For Justice v. IRS, 941 F.3d
567, 572 (D.C. Cir. 2019) (“We do not require technical precision in FOIA requests, and a request
certainly should not fail where the agency knew or should have known what the requester was
seeking all along…Nor do we require a requester to know anything about where or how the
agency stores those [records].” (emphasis added)).
Second, as noted supra, the regulation was enacted in 1974, decades before an “emergency
use authorization” was created in 2004. Thus, the regulation’s definition that the agency hyper-
focuses on does not expressly provide an analogous path to licensure and only considers the
application for a biologics license.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 22 of 27 PageID 2465

Third, and fatal to FDA’s purposeful narrow reading of the request, subsection (g) of the
regulation cited by Plaintiff defines the very “safety and effectiveness data” expressly and precisely
requested by Plaintiff: “For purposes of this regulation, safety and effectiveness data include all
studies and tests of a biological product on animals and humans and all studies and tests on
the drug for identity, stability, purity, potency, and bioavailability.” 21 C.F.R. § 601.51(g) (emphasis
added), see image above. The data within the EUA file that FDA is refusing to disclose is data
about the same product for which it released the other 1.2 million pages. It is data about the same
non-clinical (animal) studies and about the same clinical trial. To be sure, without the data in the
EUA file, there would have been no licensure. In other words, the biologics license application
was an extension of the request for emergency use authorization – the BLA data continued the
already-submitted data from an earlier timepoint in the same trial. In FDA’s own words: “[T]he
BLA builds on the extensive data and information previously submitted that supported the
EUA...”21 The BLA, therefore, all rests on the EUA date; they are completely related and
intertwined.
All of the data submitted by Pfizer to FDA in order to, first, obtain emergency use
authorization and, subsequently, licensure, are responsive to PHMPT’s request for “all data and
information for the Pfizer Vaccine” which includes “all safety and effectiveness data and
information,” which is defined as “all studies and tests of a biological product on animals and
humans…” To argue otherwise is to ask this Court to suspend reality.

21
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine.
FDA News Release, August 23, 2021.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 23 of 27 PageID 2466

II.
Even If the Appropriate Focus Is on the Definition of “Biological Product File,” the
EUA File Is Still Responsive
FDA takes the position that the request must be read only literally and as narrowly as
possible and, in so doing, it ignores subsection (g) of 21 C.F.R. § 601.51 and only looks to
subsection (a) to govern its search parameters. This violates the agency’s duties under FOIA.
However, even if a technical reading of subsection (a) and the definition of “biological product
file” is appropriate to determine the scope of the agency’s search, Plaintiff still prevails.
Subsection (a)’s definition of biological product file (which FDA cannot and does not argue
is excluded from Plaintiff’s request) has at least two provisions which would encompass the EUA
file.
First, the definition “includes all data and information submitted with or incorporated by
reference in any application for a biologics license.” The EUA file is and must be incorporated by
reference in the biologics license. Again, as stated above, there was only one clinical trial for the
Pfizer Vaccine. This is not a scenario where there was one product and one clinical trial that was
submitted for EUA and then a separate product, with a separate clinical trial, then submitted for a
license: it is the same product, tested in the same trial. The biologics license application built upon
the foundation set by the prior request for emergency use authorization submitted to FDA.
Evidencing this is that FDA’s BLA Clinical Review Memorandum states “Supportive information
from EUA 27034/0 and clinical study protocols reviewed under IND 19736 were also referenced
during the review cycle.”22 This shows that when FDA was reviewing Pfizer’s application for a
biologics license, it reviewed information from both the EUA and IND files. Thus, the EUA files
were part of the review conducted by FDA in issuing licensure and so they are ipso facto part of

22 FDA’s BLA Clinical Review Memorandum, dated August 23, 2021 at 20, available at
https://www.fda.gov/media/152256/download?attachment.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 24 of 27 PageID 2467

the overall biological product file.
Second, the definition “includes … other related submissions.” Although the regulation at
the time could not name “emergency use” submissions, given it did not yet exist, a plain reading
of the regulation’s definition lists everything else related to the biological product and makes clear
that it meant to capture all submissions related to the biological product (listing all data existing at
the time of enactment and “and other related submissions”). The “biological product file” is, after
all, FDA’s file about the biologic product. Again: same product for EUA and BLA, same trial. To
argue that the emergency use authorization data is not “related to” the biological product file or to
the application for the biologics license is nonsensical.
III.
The EUA File Is Critical to PHMPT’s Goals and to the American Public
Plaintiff is under no duty to proffer a reason why it seeks these records, other than to
demonstrate that the records reveal information about our government’s actions. See Fed. Labor
Relations Auth. v. United States Dept’ of Treasury, 884 F.2d 1446, 1451 (D.C. Cir. 1989) (“[U]nder
FOIA the disclosure interest must be measured in terms of its relation to FOIA’s central purpose -
- to ensure that the Government’s activities be opened to the sharp eye of public scrutiny.” (internal
citations omitted)). These records unquestionably meet that criterion. However, it is important to
note that there are multiple groups, some at major universities, as well as individuals working with
the data being disclosed through this FOIA.
Some of those individuals have published books and articles,23 in addition to other writings
about the data, but various major university scientists and other scientific groups have yet to

23 See, e.g., https://www.statnews.com/2020/12/17/did-the-fda-understaff-its-review-of-the-
pfizer-biontech-vaccine/; https://www.amazon.com/DailyClout-Documents-Analysis-Volunteers-
Reports-ebook/dp/B0BSK6LV5D?asc_source=01J4MHGGSBVSF6AFQ9RRJ9VTCE&tag=
snxs21-20; https://www.amazon.com/Pfizer-Papers-Pfizers-Against-Humanity-ebook/dp/B0CNQ
GVDKB?asc_source=01J4MHGGSBVSF6AFQ9RRJ9VTCE&tag=snxs21-20.
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 25 of 27 PageID 2468

publish as they are still waiting on all datasets. They still, all these years later, cannot move forward
and replicate what the government reviewed to license this product without the data that they now
know is in an “EUA file.” They have made clear that this is the only route likely ever to obtain
these data.
Nearly four years have passed since Pfizer applied for emergency use authorization from
FDA. Since that time, approximately 80% of Americans have received a dose of a COVID-19
vaccine. Many of them were mandated to do so, either at the time of the emergency use
authorization or at the time of licensure. All of them have funded the government’s actions with
regards to these products. They deserve today, no less than they did throughout the last four years,
transparency. FDA cannot be allowed to continue to withhold data about this product by playing
games and violating FOIA, which it has done since the inception of this FOIA request and which
it continues to do to date.
CONCLUSION
For the foregoing reasons, the Court should deny FDA’s motion for summary judgment,
grant PHMPT’s cross-motion for summary judgment, and order FDA to disclose, forthwith, the
non-exempt portions of all remaining responsive records including the “EUA file,” with production
to be complete no later than February 20, 2025.
Dated: November 7, 2024

SIRI & GLIMSTAD LLP
/s/ Elizabeth A. Brehm
Aaron Siri
Elizabeth A. Brehm
745 Fifth Avenue, Suite 500
New York, NY 10151
Tel: (888) 747-4529
ebrehm@sirillp.com

Attorney for Plaintiff
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 26 of 27 PageID 2469

CERTIFICATE OF SERVICE
I hereby certify that on November 7, 2024, I electronically transmitted the foregoing to the
parties and the clerk of court for the United States District Court for the Northern District of Texas
using the CM/ECF filing system.
/s/ Elizabeth A. Brehm
Elizabeth A. Brehm
Case 4:21-cv-01058-P Document 95 Filed 11/07/24 Page 27 of 27 PageID 2470

File and source

File: gov.uscourts.txnd.353278.95.0.pdf
Size: 981,924 bytes
SHA-256: 47c8060845eeda33150e2ddc73a1d5b666e5db6b2702b31c32b0239cb5124a45
Our copy: gov.uscourts.txnd.353278.95.0.pdf
Original: archive.org

PHMPT's combined opposition and cross-motion for summary judgment — PHMPT v. FDA

Record facts

Summary

Full text

File and source

Related records