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

Summary

An order, Document 56 in Public Health and Medical Professionals for Transparency v. Food and Drug Administration, No. 4:21-cv-1058-P, U.S. District Court for the Northern District of Texas, filed February 2, 2022. The order grants in part the FDA's Motion to Partially Modify Scheduling Order and adopts the production schedule the parties agreed to in a Joint Status Report. It orders the FDA to produce 10,000 pages for the first two productions, due on or before March 1 and April 1, 2022, and 80,000 pages on or before May 2, June 1, and July 1, 2022. It also lets the FDA apply processed pages above a monthly quota to later months, and the name of Mark T. Pittman, United States District Judge, appears below the order.

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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-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. The Food and Drug Administration’s (“FDA”) rolling productions 
will each be due on the first business day of each month, instead 
of once every thirty days. 
2. The FDA will produce 10,000 pages for the first two productions, 
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. The FDA can “bank” any processed pages in excess of its monthly 
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.  
Case 4:21-cv-01058-P   Document 56   Filed 02/02/22    Page 1 of 2   PageID 2149
Case 4:21-cv-01058-P   Document 56   Filed 02/02/22    Page 1 of 2   PageID 2149

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

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