Pfizer unable to postpone the release of its internal documents

Pfizer will not be able to postpone the release of its internal documents on the vaccine until 2076, as they previously wanted. The FDA (FDA) must provide hundreds of thousands of pages over the next six months, the judge ruled in the final court decision.

Case 4:21-cv-01058-P Document 56 Filed 02/02/22 Page 1 of 2 PageID 2149

UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF TEXAS FORT WORTH DIVISION

Plaintiff,
v. No. 4:21-cv-1058-P FOOD AND DRUG ADMINISTRATION,

Defendant.

ORDER

Before the Court is Defendant Food and Drug Administration’s Motion to Partially Modify Scheduling Order (“Motion”). ECF No. 36. Also before the Court is a Joint Status Report that articulates the Parties’ agreed production schedule. ECF No. 55. Having considered the Joint Status Report, the Court will adopt the Parties’ agreed-upon terms; the Motion is therefore GRANTED in part.

In accordance with the Parties’ agreed production schedule detailed in the Joint Status Report, the Court ORDERS that:

1. TheFoodandDrugAdministration’s(“FDA”)rollingproductions will each be due on the first business day of each month, instead of once every thirty days.
2. TheFDAwillproduce10,000pagesforthefirsttwoproductions, which will be due on or before March 1 and April 1, 2022.
3. The FDA will produce 80,000 pages on or before May 2, June 1, and July 1, 2022; 70,000 pages on or before August 1, 2022; and then 55,000 pages on or before the first business day of each month thereafter.
4. TheFDAcan“bank”anyprocessedpagesinexcessofitsmonthly quota, such that, for example, if the FDA produces 90,000 pages in May 2022 (or 65,000 pages in September 2022), it would bank 10,000 pages. Then, in a subsequent month, if the FDA is unable to produce the full amount of pages required, it can apply the banked pages toward its quota for that month.

PUBLIC HEALTH AND MEDICAL

PROFESSIONALS FOR TRANSPARENCY,

Case 4:21-cv-01058-P Document 56 Filed 02/02/22 Page 2 of 2 PageID 2150

5. For the SAS files that duplicate the data in CRF files, the FDA will count every 40 rows as one page instead of every 20 rows as one page.

SO ORDERED on this 2nd day of February, 2022.

Mark T. Pittman
UNITED STATES DISTRICT JUDGE

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