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UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF TEXASFORT WORTH DIVISIONPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCY,ET AL.,
Plaintiffs,v.

No. 4:22-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 the Freedom of Information Act (“FOIA”). It allows thepublic access to agency records upon request. But if an agency
improperly denies a request, courts may order the agency to release therecords sought. In this case, Plaintiffs filed a FOIA request for thedocuments the Food and Drug Administration (“FDA”) relied on tolicense two COVID-19 vaccines: (1) Pfizer’s 12 to 15-year-olds vaccineand (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.

BACKGROUNDThis is Plaintiff Public Health and Medical Professional forTransparency’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 licensing of Pfizer’s COVID-19 vaccine for thoseover 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 the FDA denied PHMPT’s FOIA request, PHMPTCase 4:22-cv-00915-P Document 31 Filed 05/09/23

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sued to obtain the documents. Id. And after the Parties failed to agree
on a production schedule, this Court held that PHMPT was entitled toexpedited 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. 1Plaintiffs PHMPT and Patrick and Stephanie de Garay 2 now seek aproduction schedule for the documents the FDA relied on to license
Pfizer’s COVID-19 vaccine for 12 to 15-year-olds and Moderna’s COVID19 vaccine for adults. As in the first case, the FDA denied Plaintiffs
expedited FOIA 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 must submit a request toa federal agency describing the records sought. § 552(a)(3)(A). Generally,federal agencies process these requests on a first-in/first-out basis. SeeOpen Am. v. Watergate Special Prosecution Force, 547 F.2d 605, 616(D.C. Cir. 1976). Sometimes, however, agencies must expedite theprocessing of certain requests—cutting all non-expedited requests inline. 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 underFOIA, 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 theParties, all documents were set to be produced by November 1, 2022. Because the450,000-page estimation provided by the FDA, however, is nowhere close to thenumber of actual documents—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.

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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, theappropriate production schedule for the documents sought.

A. Expedited Processing
Plaintiffs contend that the FDA wrongfully denied their request forexpedited 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 anindividual” 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 andinformation 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 toeradicate COVID-19, and continued government and private efforts toenforce these vaccines. 3 The FDA’s own regulations also recognize thisurgency—“[a]fter a license has been issued, the following data andinformation in the biological product file are immediately available forpublic 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 instrumentof conspiracy, ought never to be the system of regular government.” See The Oxford
Handbook of Public Accountability 275 (2014). Indeed, conspiracies flourish where
information is not transparent. And they often expand with great harm beyond theirinitial target. As such, this information is not only necessary for the good of ourAmerican medical system, but also for the health of our society at large.

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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 recordssought.” Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270, 275(D.D.C. 2012). So courts have “broad discretion” to determine areasonable 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 the Court recognizes the limited resources thatthe FDA has dedicated to FOIA requests, the number of resources anagency dedicates to such requests does not dictate the bounds of anindividual’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 “staleinformation 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 asmuch time as possible to comply, the Court ORDERS the FDA toproduce all data and information relating to the approval of the twovaccines by June 31, 2025.

CONCLUSIONThe Court recognizes the burden the FDA faces in releasing thedocuments by the abovementioned date and thus ORDERS the Parties
to meet and confer and submit a joint production rate that maximallyreduces this burden by May 23, 2023.
SO ORDERED on this 9th day of May 2023.

Mark T. Pittman
UNITED STATES DISTRICT JUDGE4