Memorandum Opinion and Order — PHMPT v. FDA

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UNITED STATES DISTRICT COURT · No. 4:21-cv-01058-P · Doc. 101 · 2024-12-06 · Docket on CourtListener

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UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
FORT WORTH DIVISION 
 
PUBLIC HEALTH AND MEDICAL 
PROFESSIONALS FOR 
TRANSPARENCY,  
Plaintiff,  
 
v. 
No. 4:21-cv-01058-P
FOOD AND DRUG ADMINISTRATION, 
Defendant. 
 
 
MEMORANDUM OPINION AND ORDER 
 
      Before the Court are Defendant Food and Drug Administration (the 
“FDA”)’s Motion for Summary Judgment (ECF No. 90) and Plaintiff 
Public Health and Medical Professionals for Transparency (“Plaintiff”)’s 
Cross-Motion for Summary Judgment (ECF No. 93). Having considered 
the briefing, evidence, and applicable legal authorities, the Court 
concludes that the FDA’s Motion is DENIED and Plaintiff’s Cross-
Motion is GRANTED.  
BACKGROUND 
      On August 23, 2021, the FDA approved the Pfizer-BioNTech COVID-
19 Vaccine (the “Pfizer Vaccine”) for individuals sixteen years of age and 
older. Four days later, Plaintiff submitted a Freedom of Information Act 
(“FOIA”) request with the FDA for “[a]ll data and information for the 
Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) with the exception 
of publicly available reports on the Vaccine Adverse Events Reporting 
System.” In addition, Plaintiff’s request included a footnote specifying 
that “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 . . . .” After the FDA denied Plaintiff’s 
request for expedited processing, Plaintiff filed this lawsuit on 
September 16, 2021. On January 6, 2022, after being informed that the 
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FDA sought at up-to seventy-five years to produce the documents, the 
Court put the Parties on an expedited document production schedule 
which was partially modified on February 2, 2022. Since then, the FDA 
has produced some 1,200,874 pages of responsive records. The Parties 
now dispute the sufficiency of the FDA’s search, and each moves the 
Court to grant summary judgment in their favor.   
      Vaccines are regulated as biological products under the Public 
Health Service Act (“PHSA”) and as drugs under the Federal Food, 
Drug, and Cosmetic Act (“FDCA”). See 42 U.S.C. § 262(i)(1); see also 21 
U.S.C. § 321(g)(1)(B). Vaccines are approved for marketing through 
applications known as Biologics License Applications (“BLA”). See 42 
U.S.C. § 262(a).  
      A sponsor of a biological product—such as a vaccine—generally 
begins the process of studying an investigational product by performing 
a variety of laboratory tests on it, including certain safety tests in 
animals. See ECF No. 92 at 5; see also 21 C.F.R. Part 58. The sponsor’s 
focus at this stage is to collect the data and information necessary to 
establish that the investigational product will not expose humans to 
unreasonable risks when used in limited, early-stage clinical studies. 
ECF No. 92 at 5. However, before the investigational biological product 
may be administered to human subjects, the sponsor must first submit 
an investigational new drug application (“IND”) to the FDA. See 21 
C.F.R § 312.20; see generally 21 U.S.C. § 355(i); 42 U.S.C. § 262(a)(3); 21 
C.F.R. Part 312. In general, an IND application contains the: (1) results 
of the laboratory and animal tests that have been performed, gathered, 
and submitted by the sponsor; (2) manufacturing information for the 
investigational biological product; and (3) sponsor’s plans for testing the 
investigational biological product on human subjects. See generally 21 
C.F.R. § 312.23.  
      Tests conducted in human beings are called “clinical trials.” The 
FDA’s medical and scientific reviewers evaluate the data submitted in 
the IND, including the proposed clinical trial protocols. See ECF No. 92 
at 6. If the reviewers determine, from the evidence, that the biological 
product does not pose an unreasonable or significant risk of illness or 
injury to human subjects and, if there are no other problems with the 
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submission that cause the agency to identify the need for a clinical hold, 
the agency will allow the clinical trial to proceed. Id. Given that an IND 
is submitted during the investigational stage of drug development, IND 
files may contain data and information regarding formulations, dosages, 
or uses that differ from those that are ultimately licensed. Id.  
      In a subsequent stage of the development process, sponsors may 
submit to the FDA a formal application for licensing (i.e., marketing 
approval), which is called a BLA. See 42 U.S.C. § 262(a)(1)(A). BLAs 
include various information and data, including: (1) nonclinical and 
clinical data; (2) information about manufacturing methods and 
locations; (3) data establishing stability of the product through the 
dating period; (4) summaries of results from tests performed on the lots 
of representative samples of the product; and (5) mockups of the labels, 
enclosures, medication guide if proposed, and containers as applicable. 
See 21 C.F.R. § 601.2(a). Pursuant to the PHSA, the FDA approves a 
BLA if the applicant has demonstrated that: (1) the vaccine is “safe, 
pure, and potent;” and (2) the facility in which the vaccine is produced 
meets standards designed to assure that the vaccine continues to be 
safe, pure, and potent. 42 U.S.C. § 262(a)(2)(C)(i). The applicant must 
also consent to inspection of the manufacturing facility. Id. § 
262(a)(2)(C)(ii).  
      If the FDA determines that the BLA meets the statutory and 
regulatory requirements, the FDA will issue a biologics license for the 
product, authorizing the sponsor of that particular BLA to market that 
new product. See 21 C.F.R. § 601.4(a). IND and BLA files continue to be 
maintained following initial licensure of a product, and sponsors may 
continue to make submissions to the relevant file. ECF No. 92 at 6.  For 
example, clinical trial data for formulations, dosages, or uses that differ 
from the licensed vaccine could be submitted to the IND file; and certain 
post-licensure submissions for the licensed vaccine would be submitted 
to the BLA file. Id.  
     In addition to BLAs, as part of the “Project BioShield Act of 2004,” 
Congress granted the FDA the ability to grant “Emergency Use 
Authorization” (“EUA”) to certain medical products—such as vaccines—
during public health emergencies. The purpose of the act is to allow the 
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“use of unapproved medical products . . . in an emergency to diagnose, 
treat, or prevent serious or life-threatening diseases or conditions when 
certain statutory criteria have been met.” See Emergency Use 
Authorization 
for 
Vaccines 
Explained, 
U.S. 
Food 
and 
Drug 
Administration (Nov. 20, 2020), https://www.fda.gov/vaccines-blood-
biologics/vaccines/emergency-use-authorization-vaccines-explained.  As 
a result, the level of scrutiny afforded to a vaccine seeking EUA approval 
varies significantly from what is considered normal for FDA approval. 
The standards for FDA approval vary depending on the type of medical 
product at issue; devices rarely require clinical trials, whereas drugs and 
biologics usually require randomized clinical trials proving safety and 
efficacy. See Diana Zuckerman, Emergency Use Authorizations (EUAs) 
Versus FDA Approval: Implications for COVID-19 and Public Health, 
(June 
2021) 
https://pmc.ncbi.nlm.nih.gov/articles/PMC8101583/. 
Generally, EUA applications require data supporting—not proving—
safety and effectiveness, with lower standards and faster reviews than 
normal FDA approval. Id. While it is normal for EUA standards to vary 
from those required for FDA approval the “EUA standards for COVID-
19 products varied considerably” and, in some cases, did “not require[] 
any FDA review of safety or efficacy.” Id.  
LEGAL STANDARD 
Summary judgment is appropriate when “there is no genuine 
dispute as to any material fact” and the moving party “is entitled to 
judgment as a matter of law.” FED. R. CIV. P. 56(a). A dispute is 
“genuine” if the evidence presented would allow a reasonable jury to 
return a verdict for the non-moving party. Anderson v. Liberty Lobby, 
Inc., 477 U.S. 242, 248 (1986). A fact is “material” if it would affect the 
case’s outcome. Id. Generally, the “substantive law will identify which 
facts are material,” and “[f]actual disputes that are irrelevant or 
unnecessary will not be counted.” Id.    
      Under Fifth Circuit law, an agency may demonstrate the adequacy 
of its search by showing that it used “methods which can be reasonably 
expected to produce the information requested.” Batton v. Evers, 598 
F.3d 169, 176 (5th Cir. 2010) (quoting Oglesby v. U.S. Dep’t of Army, 920 
F.2d 57, 68 (D.C. Cir. 1990)). The issue “is not whether there might exist 
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any other documents possibly responsive to the request, but rather 
whether the search for those documents was adequate.” Weisberg v. U.S. 
Dep’t of Justice, 745 F.2d 1476, 1485 (D.C. Cir. 1984) (emphasis in 
original). To demonstrate the adequacy of its search, the agency may 
submit affidavits or declarations explaining the scope and method of the 
search in reasonable detail and in a nonconclusory fashion. Brown v. 
F.B.I., 873 F. Supp. 2d 388, 399 (D.D.C. 2012) (citing Steinberg v. DOJ, 
23 F.3d 548, 551 (D.C. Cir. 1994)). These documents “are afforded a 
presumption of good faith, which cannot be rebutted by purely 
speculative claims about the existence and discoverability of other 
documents.” Id. (citing SafeCard Servs., Inc. v. SEC, 926 F.2d 1197, 
1200 (D.C.Cir.1991)). Additionally, in making a determination a 
“district court must analyze all underlying facts and inferences in the 
light most favorable to the FOIA requester.” Freedom Coal. of Drs. for 
Choice v. Centers for Disease Control & Prevention, No. 2:23-CV-102-Z, 
2024 WL 69084, at *5 (N.D. Tex. Jan. 5, 2024) (quoting Ayuda, Inc. v. 
Fed. Tr. Comm’n, 70 F. Supp. 3d 247, 259 (D.D.C. 2014)).  
ANALYSIS 
      The briefing of the Parties makes clear that there is only one issue 
remaining in this case—whether the EUA file is responsive to Plaintiff’s 
FOIA request and must be produced. For the reasons set out below, the 
Court finds that it is. 
      As discussed above, Plaintiff’s FOIA request states: “All data and 
information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e) 
with the exception of publicly available reports on the Vaccine Adverse 
Events Reporting System.” See, e.g., ECF No. 1-1 at 2. Plaintiff’s request 
also contained two footnotes providing:  
      (1) “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 
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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];” and 
      (2) “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.”  
Id. 
      While the Parties debate numerous theories regarding the 
responsiveness of the EUA, the Court’s analysis begins and ends with 
whether it was “submitted with or incorporated by reference” in the 
BLA. The FDA argues that the EUA file does not fall within Plaintiff’s 
FOIA request because the BLA and EUA are separate applications that 
are subject to different standards and, thus, a FOIA request for one does 
not necessitate production of the other. ECF No. 97 at 3–11. While the 
FDA is correct that the two applications are distinct, it is evident to the 
Court that in this case, the EUA is disclosable data as requested by 
Plaintiff and defined in 21 C.F.R. § 601.51. Section 601.51 provides that 
“all data and information submitted with or incorporated by reference 
in any [BLA],” as well as “other related submissions” must be disclosed. 
Id. at § 601.51(a). Further, Section 601.51 provides that “[f]or the 
purposes of this regulation, safety and effectiveness data include[s] 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.” Id. at § 601.51(g) (emphasis added). 
      In an August 23, 2021 press release, the FDA stated, inter alia: 
      For all vaccines, the FDA evaluates data and 
information included in the manufacturer’s submission of 
a biologics license application (BLA). A BLA is a 
comprehensive document that is submitted to the agency 
providing very specific requirements. For [the Pfizer 
Vaccine], the BLA builds on the extensive data and 
information previously submitted that supported the 
EUA, such as preclinical and clinical data and 
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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 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. . 
. .  
FDA Approves first COVID-19 Vaccine: Approval Signifies Key 
Achievement for Public Health, U.S. Food & Drug Administration (Aug. 
23, 2021), https://www.fda.gov/news-events/press-announcements/fda-
approves-first-covid-19-vaccine (emphasis added) (hereinafter the “FDA 
Statement”). 
      The FDA argues that its statement is insufficient to establish that 
the “data and information” from the EUA was “submitted with or 
incorporated by reference” in the Pfizer Vaccine’s BLA because “the 
language merely alludes to the EUA file, and does not specifically 
identify any particular records from the EUA file that a reviewer 
intended to incorporate into their review of the BLA.” ECF No. 98 at 6.  
Similarly, the FDA argues that the EUA is does not fall within the 
definition of “other related submissions.” The Court disagrees.  
      In support of its argument that the EUA file was not incorporated 
by reference, the FDA cites to Morley v. CIA, 508 F.3d 1108 (D.C. Cir. 
2007). In Morley, a journalist was seeking records related to the John F. 
Kennedy assassination. Id. at 113. As relevant here, the court held that 
the CIA was not required to search for and produce “records referenced 
in the responsive documents.” Id. at 1121. The FDA relies on this case 
for the proposition that “mere reference to other files does not establish 
the existence of documents that are relevant to appellant’s FOIA 
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request.” Id. (quoting Steinberg v. U.S. Department of Justice, 23 F.3d 
548, 552 (D.C. Cir. 1994)). 
This case is easily distinguishable. Here, the FDA’s statement 
provides that the BLA builds on the EUA’s “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.” FDA Statement. It further states that the 
BLA “updated data from the clinical trial which supported the EUA.” Id. 
The FDA’s statement evidences the fact that the EUA was not “mere[ly] 
reference[d]” in the BLA but that the BLA incorporated and relied 
heavily on the EUA. Thus, the Court finds that at a minimum, the EUA 
is an “other related submission” with regard to the BLA. Additionally, 
however, the EUA is responsive to Plaintiff’s FOIA request under 
Section 601.51(a) as it was “submitted with or incorporated by reference” 
in the Pfizer Vaccine’s BLA. Either way, the EUA must be produced. 
Therefore, it is ORDERED that Plaintiff’s Cross-Motion for Summary 
Judgment is GRANTED, and the FDA’s Motion for Summary Judgment 
is DENIED.   
 
 
 
 
 
 
 
 
 
 
 
 
 
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CONCLUSION 
 
“The liberties of a people never were, nor ever will be, secure, when 
the transactions of their rulers may be concealed from them.” Jonathan 
Elliot, The Debates in the Several State Conventions on the Adoption of 
the Federal Constitution, as Recommended by the General Convention at 
Philadelphia in 1787, at 169–70 (ed. 1881) (statement of Patrick Henry). 
The Covid-19 pandemic is long passed and so has any legitimate reason 
for concealing from the American people the information relied upon by 
the government in approving the Pfizer Vaccine.     
For the reasons set out above, Plaintiff’s Cross-Motion for Summary 
Judgment is GRANTED, and the FDA’s Motion for Summary Judgment 
is DENIED. It is ORDERED that the FDA shall produce the responsive 
EUA file on or before June 30, 2025.  
SO ORDERED on this 6th day of December 2024. 
 
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