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UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
FORT WORTH DIVISION
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FOR TRANSPARENCY ,
ET AL .,
Plaintiff s,
v.
No. 4:2 2-cv-0915-P
FOOD AND DRUG ADMINISTRATION ,
Defendant.
ORDER
“Democracy dies behind closed doors.” Detroit Free Press v. Ashcroft ,
303 F.3d 681 ( 6th Cir. 2022). To help prevent that from happening,
Congress enacted t he Freedom of Information Act (“FOIA”). It allows the
public access to agency records upon request. But if an agency
improperly denies a request , courts may order the agency to release the
records sought. In this case, Plaintiffs filed a FOIA request for the
documents the Food and Drug Administration (“FDA”) relied on to
license two COVID -19 vaccines: (1) Pfizer’s 12 to 15 -year-olds vaccine
and (2) Moderna’s adult vaccine. Because the FDA improperly denied
Plaintiffs ’ request , the Court ORDERS the FDA to produce all
documents relating to the two vaccines by June 31, 2025.
BACKGROUND
This is Plaintiff Public Health and Medical Professional for
Transparency’s ( “PHMPT” ) second case involving a FOIA request
submitted to the FDA for documents related to COVID -19 vaccines . In
the first case, PHMPT ’s expedited FOIA request sought the documents
related to the FDA ’s licens ing of Pfizer ’s COVID -19 vaccine for those
over 15 years old . See Pub. Health & Med. Pros. for Transparency v.
FDA , No. 4:21 -CV-1058 -P, 2022 WL 90237, at *1 (N.D. Tex. Jan. 6, 2022)
(Pittman, J.). Because t he FDA denied PHMPT’s FOIA request, PHMPT Case 4:22-cv-00915-P Document 31 Filed 05/09/23 Page 1 of 4 PageID 325
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sued to obtain the documents . Id. And after the Parties failed to agree
on a production schedule, t his Court held that PHMPT was entitled to
expedited processing and ordered the FDA to produce the expected
450,000 pages at a rate of 55,000 per month . Id. at *1 . The Parties later
agreed to modify the rate of production. But the expected end date for
producing all documents —November 1, 2022—remained unchanged .1
Plaintiffs PHMPT and Patrick and Stephanie de Garay2 now seek a
production schedule for the documents the FDA relied on to license Pfizer’s COVID -19 vaccine for 12 to 15 -year- olds and Moderna’s COVID -
19 vaccine for adults . As in the first case, the FDA denied Plaintiffs
expedited F OIA request, and the Parties have failed to agree on a
production schedule . The Court thus held a conference with the Parties
to determine whether Plaintiffs are entitled to expedited processing and ,
if so, an appropriate production schedule .
LEGAL STANDARD
FOIA generally gives citizens the right to access federal agency
records . See 5 U.S.C. § 552 . To do so , a person m ust submit a request to
a federal agency describing the records sought . § 552(a)(3)(A). Generally,
federal agencies process these requests on a first -in/first -out basis. See
Open Am. v. Watergate Special Prosecution Force, 547 F.2d 605, 616 (D.C. Cir. 1976) . Sometimes, however, agencies must expedite the
processing of certain requests —cutting all non- expedited requests in
line.
See Daily Caller v. U.S. Dep’ t of State , 152 F. Supp. 3d 1, 8 (D.D.C.
2015) . If an agency denies a request for expedited processing under
FOIA, the decision is subject to immediate judicial review .
§ 552(a)(6)(E)(iii). District courts have “jurisdiction to enjoin the agency
from withholding agency records and to order the production of any
1 Under the rate of production ordered by the Court and later modified by the
Parties, all documents were set to be produced by November 1, 2022. Because the
450,000- page estimation provided by the FDA, however, is nowhere close to the
number of actual do cuments —1.2 million —only 64% of the total documents have been
produced.
2 Patrick and Stephanie de Garay’s daughter was part of the clinical trial to license
Pfizer’s COVID -19 vaccine for 12- to 15 -year-olds. Directly after her second shot, she
was rushed to the emergency room and now requires a wheelchair and a feeding tube
for daily life . Case 4:22-cv-00915-P Document 31 Filed 05/09/23 Page 2 of 4 PageID 326
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agency records improperly withheld. ” 5 U.S.C. § 552(a)(4)(B) . These
determinations are made de novo. See Bloomberg, L.P. v. FDA , 500 F.
Supp. 2d 371, 374 (S.D.N.Y. 2007) .
ANALYSIS
This case presents two issues. First , whether the FDA erroneously
denied Plaintiffs’ request for expedited processing. Second , the
appropriate production schedule for the documents sought.
A. Expedited Processing
Plaintiffs contend that the FDA wrongfully denied their request for
expedited processing . A requestor is entitled to expedited processing if
they show a compelling need. § 552(a)(3)(6) (E)(i)(I). A need is compelling
if there is (1) “an imminent threat to the life or physical safety of an
individual” or (2) for “a person primarily engaged in disseminating
information, urgency to inform the public concerning actual or alleged
Federal Government activity.” Id. This case falls under the second
definition.
First , PHMPT has shown —and Defendants do not dispute —that it
“exists for the sole purpose of disseminating to the public the data and
information in the biological product files for each of the COVID -19
Vaccines .” ECF No. 1 at 21. Second , Plaintiffs have shown an urgent
need to inform the public about the health and safety of the COVID -19
vaccines based on the massive push to vaccinate, persistent effort to
eradicate C OVID -19, and continued government and private efforts to
enforce these vaccines .3 The FDA’s own regulations also recognize this
urgency —“[a]fter a license has been issued, the following data and
information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown: (1) All
safety and effectiveness data and information . . . .” 21 C.F.R. § 601.51(e).
3 As political theorist Jeremy Bentham once said , “[s]ecrecy, being an instrument
of conspiracy, ought never to be the system of regular government. ” See The Oxford
Handbook of Public Accountability 275 (2014). Indeed, conspirac ies flourish where
information is not transparent . And they often expand with great harm beyond their
initial target. As such, this information is not only necessary f or the good of our
American medical system , but also for the health of our society at large. Case 4:22-cv-00915-P Document 31 Filed 05/09/23 Page 3 of 4 PageID 327
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Because Plaintiffs have shown a compelling need, the FDA
wrongfully denied their request for expedited processing.
B. Production Schedule
The Court must next determine the appropriate production schedule.
FOIA “does not assign any particular time frame to release of the records
sought.” Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270, 275
(D.D.C. 2012). So courts have “ broad discretion ” to determine a
reasonable processing schedule. Colbert v. FDA, No. 16 -1790, 2018 WL
6299966, at *1 (D.D.C. 2014).
Defendants propose a production schedule that would take at least
23.5 years. And while t he Court recognizes the limited resources that
the FDA has dedicated to FOIA requests , the number of resources an
agency dedicates to such requests does not dictate the bounds of an
individual’s FOIA rights. See Open America , 547 F.2d at 621 (Leventhal,
J., concurring ). Instead, the Court must ensure that the fullest possible
disclosure of the information sought is timely provided—as “stale
information is of little value.” Payne Enters., Inc. v. United States, 837
F.2d 486, 494 (D.C. Cir. 1988). To do so and provide the FDA with as
much time as possible to comply, the Court O RDERS the FDA to
produce all data and information relating to the approval of the two
vaccines by June 31, 2025.
CONCLUSION
The Court recognizes the burden the FDA faces in releasing the
documents by the abovementioned date and thus ORDERS the Parties
to meet and confer and submit a j oint production rate that maximally
reduces this burden by May 23, 2023.
SO ORDERED on this 9 th day of May 2023 .
Mark T. Pittman
UNITED STATES DISTRICT JUDGE
Case 4:22-cv-00915-P Document 31 Filed 05/09/23 Page 4 of 4 PageID 328