Order on FOIA production schedule — Phmpt v. FDA (N.D. Tex.)

Record facts

UNITED STATES DISTRICT COURT · No. 4:22-cv-00915-P · Doc. 38 · 2023-06-12 · 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, 
ET AL., 
 
Plaintiffs, 
 
 
v. 
 
No. 4:22-cv-0915-P 
FOOD AND DRUG ADMINISTRATION, 
 
Defendant. 
 
ORDER 
In May 2023, the Court ordered the Food and Drug Administration 
(“FDA”) to produce all documents related to the approval of Pfizer’s 12 
to 15-year-olds COVID-19 vaccine and Moderna’s adult COVID-19 
vaccine by June 30, 2025. The Court also ordered the Parties to meet 
and confer about a mutually acceptable production schedule of those 
documents—roughly 4.5 million documents in total. But the Parties 
failed to agree on a production schedule and submitted dueling 
schedules for this Court’s consideration. Having considered the Parties 
proposed production schedules, arguments in support, and applicable 
law, the Court ORDERS the following: 
1. The FDA must produce all documents related to Pfizer’s 12 to 15-
year-olds COVID-19 vaccine by January 2, 2024, on a rolling 
basis at a rate no fewer than (1) 35,000 pages per month in July, 
August, and September 2023, (2) 55,000 pages per month in 
October and November 2023, and (3) 180,000 pages per month 
thereafter. 
2. The FDA must produce all documents related to Moderna’s adult 
COVID-19 vaccine by June 30, 2025, at a rate no less than 75,000 
pages per month in January 2024 and 180,000 pages per month 
thereafter. 
3. The FDA’s rolling productions are due on the first business day of 
each month. 
Case 4:22-cv-00915-P   Document 38   Filed 06/12/23    Page 1 of 3   PageID 413

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4. The FDA can “bank” any processed pages it produces in excess of 
its monthly quota. 
5. If the FDA asserts any privilege, exemption, or exclusion as to 
any responsive record or portion of it, the FDA must—concurrent 
with each production required by this Order—produce a redacted 
version of the record, redacting only those portions to which the 
privilege, exemption, or exclusion is asserted. 
6. The Parties must submit a Joint Status Report detailing the 
progress of the rolling production by September 1, 2023, and 
every 90 days thereafter.  
The chart below illustrates the minimum rate of production for the two 
vaccines mentioned above and Pfizer’s 16+ COVID-19 vaccine1 based on 
the expected number of documents set to be produced: 
           Minimum # of Documents to be Produced 
 
Pfizer’s 
16+ 
Vaccine 
Pfizer’s 
12-15 
Vaccine 
Moderna’s 
Adult 
Vaccine 
Total 
July 3, 2023 
55,000 
35,000 
0 
90,000 
Aug. 1, 2023 
55,000 
35,000 
0 
90,000 
Sept. 1, 2023 
55,000 
35,000 
0 
90,000 
Oct. 2, 2023 
55,000 
55,000 
0 
110,000 
Nov. 1, 2023 
55,000 
55,000 
0 
110,000 
Dec. 1, 2023 
 02 
180,000 
0 
180,000 
Jan. 2, 2024 
0 
 105,0003 
75,000 
180,000 
Feb. 1, 2024 
0 
0 
180,000 
180,000 
1st business 
day of every 
month 
thereafter 
0 
0 
180,000 
180,000 
 
1 See Pub. Health & Med. Pros. for Transparency v. FDA, No. 4:21-CV-1058-P, 2022 
WL 90237 (N.D. Tex. Jan. 6, 2022) (Pittman, J.). 
2 This assumes that all documents related to Pfizer’s 16+ vaccine have been 
produced. If not, the FDA must continue to produce at least 55,000 pages per month 
until completion.  
3 This number reflects the expected number of documents remaining at that time. 
All documents—regardless of the actual number remaining at that time—must be 
produced by January 2, 2024. 
Case 4:22-cv-00915-P   Document 38   Filed 06/12/23    Page 2 of 3   PageID 414

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SO ORDERED on this 12th day of June 2023. 
 
Mark T. Pittman 
UNITED STATES DISTRICT JUDGE 
Case 4:22-cv-00915-P   Document 38   Filed 06/12/23    Page 3 of 3   PageID 415

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