FDA memorandum supporting motion to modify scheduling order — PHMPT v. FDA

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U.S. District Court for the Northern District of Texas · No. 4:21-cv-01058-P · Doc. 37 · 2022-01-18 · Docket on CourtListener

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A memorandum supporting the FDA's motion to partially modify the scheduling order in Public Health and Medical Professionals for Transparency v. United States Food and Drug Administration, No. 4:21-cv-01058-P, in the U.S. District Court for the Northern District of Texas, filed January 18, 2022 as Document 37. The memorandum asks that the January 6, 2022 order's rate of 55,000 pages every 30 days be reduced to 10,000 pages per month for the first two 30-day periods after the January 31, 2022 production. The 55,000 pages per month rate would resume with the production due May 2, 2022. It states that FDA has begun hiring a minimum of 15 full-time contractors at a cost of some $3 million, is advertising eight temporary detail positions, and has asked Pfizer-BioNTech to identify parts of the biologics license application not containing Exemption 4 material. The document is 12 pages.

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IN THE UNITED STATES DISTRICT COURT 
FOR THE NORTHERN DISTRICT OF TEXAS 
____________________________________ 
 
 
 
 
 
 
) 
PUBLIC HEALTH AND MEDICAL  
) 
PROFESSIONALS FOR 
 
 
) 
TRANSPARENCY,  
 
  
) 
) 
Plaintiff, 
 
) 
) 
v. 
 
 
 
)  
Civil Action No. 4:21-cv-01058-P 
) 
UNITED STATES FOOD AND DRUG 
) 
ADMINISTRATION, 
 
 
) 
) 
Defendant. 
 
) 
___________________________________  ) 
 
 
 
MEMORANDUM IN SUPPORT OF DEFENDANT’S MOTION TO PARTIALLY 
MODIFY SCHEDULING ORDER 
 
INTRODUCTION 
Defendant U.S. Food and Drug Administration (“FDA”) respectfully moves the Court to 
partially modify its January 6, 2022 Scheduling Order (“January 6 Order” or “Order”), Dkt. No. 
35. As the Court itself has acknowledged, the processing rate of 55,000 pages every 30 days1 
established by the Order is “unprecedented,” id. at 3—and FDA is, in turn, undertaking 
extraordinary and unprecedented steps to marshal every possible resource available to it, in its 
best efforts to comply, while also meeting production schedules in other FOIA litigation and 
continuing to process the thousands of other FOIA requests currently pending with FDA. 
However, as explained in detail below, and in the attached supporting declarations, the most 
                                                          
1 For ease of reference, FDA will occasionally refer herein to this as the “monthly rate” 
established by the January 6 Order.  
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impactful of FDA’s interventions—including, inter alia, the agency’s plan to hire contractors, 
advertise agency-wide for voluntary detail assignments, and work with Pfizer-BioNTech, as 
appropriate, to speed the agency’s review will, of necessity, require some amount of lead time to 
operationalize. Accordingly, FDA respectfully requests that the January 6 Order be modified to 
provide that—for only the first two 30-day periods following FDA’s scheduled January 31, 2022 
production—FDA’s monthly quota be adjusted to 10,000 pages per month. FDA would use this 
period to “stand up” the extraordinary resources that will be required to bring full compliance 
with the Order within the realm of possibility—while still processing records at a rate on par 
with the most extreme processing rates that Plaintiff cited in its briefing. See Dkt. No. 26 p. 23 
(Plaintiff’s second brief in advance of the scheduling conference, listing outlier cases—the 
fastest of which is less than half the rate set by the January 6 Order). Under FDA’s proposed 
modification, at the conclusion of this interim “stand up” period, i.e., beginning with the FDA’s 
production due on May 2, 2022,2 the full 55,000-pages-per-month processing rate ordered by the 
Court would then apply, until production is complete. 
As the below-described agency actions make clear, FDA is doing everything within its 
ability to attempt to comply with the January 6 Order. However, the unavoidable reality for FDA 
is that, until additional resources are in place, full compliance with the January 6 Order is not 
feasible. Even with the additional and unprecedented resources that FDA is actively marshalling, 
compliance with the Court’s order will present extraordinary challenges. Accordingly, FDA 
respectfully submits that the relatively modest modification it requests is both necessary, and in 
                                                          
2 Thirty days from March 31, 2022 is April 30, 2022—which, this year, falls on a Saturday. 
Pursuant to Fed. R. Civ. P. 6(a)(1)(C), this production will thus be due on Monday, May 2, 2022.  
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the public interest, in that it will afford FDA an adequate opportunity to gather, and 
operationalize, resources necessary to achieve compliance with the Court’s Order. 
ARGUMENT 
I. 
Modification of the January 6 Order Is Necessary to Afford FDA a Period in 
which to “Stand Up” Unprecedented and Extraordinary Operations  
 
A. 
FDA’s Efforts to Channel Every Possible, Available Resource 
As previewed above, FDA is not requesting additional time in order to spin its wheels, or 
to merely assess its options to attempt to achieve compliance with the unprecedented processing 
rate ordered by the Court. To the contrary, and as set forth in the Second Declaration of Suzann 
Burk (“Second Burk Declaration”), although FDA received the Court’s January 6 Order only 
seven business days prior to the filing of the instant motion, the agency is already making its best 
efforts to comply, and is acting with maximal urgency to assemble every possible resource 
available to it, as well as those not yet available to it. Specifically, FDA is actively taking the 
following—and wholly unprecedented—steps: 
• 
Hiring Contractors. FDA has initiated—at the anticipated cost of some $3 
million dollars—the process of putting in place the contract and hiring a minimum of 15 full-
time contractors to assist with processing responsive records. 2d Burk Decl. ¶¶ 6, 22 (APPX004,  
009). FDA anticipates that, of this total, 11 contractors will assist with processing those records 
that do not require review for trade secret or confidential commercial information, and the 
remaining four contractors will have additional experience that will allow them to assist with 
processing more complex records. In addition to reviewing and redacting responsive records, the 
contractors will assist with certain administrative, but often time-consuming, steps required for 
final production, such as, inter alia, finalizing redactions and applying Bates numbers. Id. ¶ 6 
(APPX004). FDA expects that, once these contract staff have been hired and trained, they will 
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significantly expand FDA’s capacity to process the records at issue in this case. Id. ¶ 7 
(APPX004). 
• 
Although FDA is prepared to undertake the significant cost of these contractor 
positions—and is moving forward as expeditiously as it can to finalize and implement the 
relevant contract(s)—the unavoidable reality is that this process cannot occur overnight. Before 
the contractors can begin their work, and thus contribute to FDA’s efforts to comply with the 
January 6 Order, FDA must first advertise for these positions, select appropriate contract staff 
members, and train selected workers so that they can meaningfully contribute to the review and 
production process. Id. ¶ 7 (APPX004); see also Declaration of Sarah B. Kotler (“Kotler Decl.”), 
Dkt. No. No. 30, ¶ 22.  
• 
Details for FDA Staff. Separately, FDA’s Center for Biologics Evaluation and 
Research (“CBER”)3 is preparing to publish an agency-wide advertisement for eight temporary 
“detail” positions dedicated to processing the records at issue in this suit. 2d Burk Decl. ¶ 8 
(APPX005). These details will reallocate resources currently devoted to other, important FDA 
work to the agency’s efforts to comply with the January 6 Order. As with the contract staff 
described above, however, there will—of necessity—be some lag time before the detailees are 
able to begin contributing to this project. CBER is working to obtain the requisite approvals to 
publish the advertisements, and anticipates that they will post by approximately February 1, 
2022. As with the contractors (and, indeed, any similar hiring or recruitment process in any 
workplace), CBER will need to allow time for applicants to respond to the posting, and will then 
need to both select detailees from the applicant pool, and provide the selected detailees with the 
                                                          
3 As explained in prior filings, CBER is the FDA division that maintains the records at issue in 
this suit. 
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requisite training. CBER does not expect that agency staff selected for these details will have the 
requisite experience and training to immediately begin working at full capacity. Id. ¶ 9 
(APPX005); see also Kotler Decl. ¶ 22. 
• 
Reassignment of Staff within CBER’s OCOD. Third—and in recognition that 
the above-described efforts will take some time to ramp up—CBER has already reallocated 
CBER resources and staff in order to prioritize FDA’s efforts to comply with the January 6 
Order. First, within CBER’s Access Litigation and Freedom of Information Branch (“ALFOI”), 
approximately five and a half of CBER’s ten “full-time equivalents” are, as of the date of this 
filing, dedicated to the review and redaction of records related to this litigation. 2d Burk Decl. ¶ 
10 (APPX005). 
Second, the Division of Disclosure and Oversight Management (“DDOM”) has also 
already obtained the temporary reassignment of five additional staff members from other 
divisions of CBER’s Office of Communication Outreach and Development (“OCOD”)—the 
CBER office within which DDOM is situated—to assist ALFOI with processing Plaintiff’s 
request, in the interim in which the above-described efforts are being ramped up. However, as 
with other additional personnel described above, these reassigned staff members will require 
training before they can work at full capacity on this project. Id. ¶ 11 (APPX006). 
• 
Assistance with Other Litigation Deadlines.  As discussed in prior filings, FDA 
has disclosure obligations in several other FOIA suits implicating CBER. In at least one case, 
where CBER had agreed to contribute 450 pages per month toward FDA’s overall (and court-
ordered) production quota, CBER has asked other agency components to take on extra work to 
allow CBER to devote more resources to this matter. Under such an arrangement, CBER would 
temporarily reduce its production obligation to zero in that case, so as to allow CBER ALFOI 
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staff that would otherwise have been working on that production to devote more time to this 
production. Id. ¶ 12 (APPX006). 
• 
Working with Vaccine Sponsors to Identify Records that Do Not Contain 
Exemption 4 Material.  FDA has also reached out to Comirnaty4 sponsors Pfizer-BioNTech to 
seek its assistance, initially, in identifying sections of the biologics license application (“BLA”) 
that do not contain any trade secret or confidential commercial information subject to FOIA 
Exemption 4. Once Pfizer-BioNTech has identified those sections (which FDA has requested that 
it do by February 1, 2022), FDA will be able to streamline its disclosure review with respect to 
this subset of records. Specifically, although FDA will still need to review the identified records 
for other types of information protected by the FOIA Exemptions (most notably, Exemption 6, 
which protects the privacy interests of clinical trial participants), it will not need to review this 
particular subset of records for the presence of trade secret or confidential commercial 
information. Id. ¶¶ 13-14 (APPX006-007). 
As discussed in the earlier-filed Kotler Declaration, reviewing BLA files for trade secret 
and confidential commercial information requires specialized training and experience. See Kotler 
Decl. ¶ 24. Thus, by eliminating the need to review what FDA anticipates will be a large subset 
of the BLA for information protected under Exemption 4, FDA will be able to assign less 
experienced staff to work on this subset of records—thus freeing up more experienced staff to 
focus on the more complex portions of the records at issue. Id. ¶ 14 (APPX007). 
In addition, FDA is actively assessing other potential ways in which it can request that 
the sponsors assist with streamlining the processing of the records at issue in this suit. Id. ¶ 15 
(APPX007). 
                                                          
4 Comirnaty is the product name for what is colloquially referred to as the “Pfizer vaccine.”  
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B. 
FDA’s Unprecedented Measures Will Take Time to Operationalize, Come at 
Considerable Cost to Other Critical Agency Missions, and Represent the 
Agency’s Maximal Possible Efforts 
 
As described above and in the Second Burk Declaration, FDA is actively and 
expeditiously responding to the unprecedented processing rate established by the January 6 
Order by undertaking unprecedented measures, in a good faith effort to achieve full compliance. 
Initially, FDA is taking immediate, temporary measures to increase its processing capabilities to 
the maximal extent possible, in the short term. Specifically, between devoting approximately five 
and a half out of the ten employees currently employed by AFLOI solely to the processing of the 
relevant records, and temporarily re-assigning five other agency employees to assist with these 
efforts until additional staff can be brought on, FDA has immediately allocated the equivalent of 
nearly 11 full-time staff to this project. This re-allocation of resources is itself unprecedented 
within the agency, and will allow FDA to meet its proposed production quota of 10,000 pages 
per month for each of the first two months following the agency’s scheduled January 31, 2022 
production—a rate that is on par with the most extreme processing cited in Plaintiff’s briefing. 
See First Declaration of Suzann Burk, Dkt. No. 23, ¶ 31 (estimating that if each of ALFOI’s 10 
staff members devoted all of their working hours solely to this production, they would be 
expected to produce 25,410 pages in 11 weeks, which translates to approximately 10,000 pages 
per month); Dkt. No. 26 p. 23 (Plaintiff’s second brief in advance of the scheduling conference, 
collecting outlier cases).   
However, in order to make compliance with the unprecedented processing rate entered by 
the Court even possible, FDA recognizes that it must muster additional—and extraordinary—
resources. As described in detail above, FDA is moving swiftly to do so, most notably by 
preparing to onboard a total of 23 additional contractor and agency staff to this project, and by 
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requesting that Pfizer-BioNTech assist FDA by, initially, identifying those portions of the BLA 
that do not need to be reviewed for trade secret or confidential commercial information. See 2d 
Burk Decl. ¶¶ 6-9, 13-15 (APPX004-007). But notwithstanding that FDA is pressing forward 
with these efforts with maximal speed, the unavoidable reality is that some minimal threshold 
period of time is necessary for these endeavors to be fully operationalized, and to bear fruit. With 
respect to the additional staffing, FDA must advertise the positions, select qualified candidates, 
bring the selected candidates on board, and train them so that they can contribute to CBER’s 
production efforts. Id. ¶¶ 7, 9 (APPX004-005). As a result, very few, if any, of the additional 
individuals needed for the FDA to achieve full compliance will be in place before the extant 
March 1, 2022 deadline to make a first initial production of 55,000 pages. Id. ¶ 19 (APPX008). 
Similarly, FDA expects that, once the sponsors have identified to the agency those portions of 
the BLA that do not need to be reviewed for Exemption 4 material, the agency will be able to 
streamline its review of that subset of the records. Id. ¶ 14 (APPX007). Further, FDA is actively 
assessing additional potential ways in which the agency may properly enlist and work with 
Pfizer-BioNTech to speed up the ultimate resolution of this matter. Id. ¶ 15 (APPX007). Again, 
however, while these efforts are actively underway, they will, unavoidably, take some time to 
bear tangible results.  
It also bears emphasizing that, while FDA is making every possible effort to comply with 
the terms of the January 6 Order, the above-described measures far exceed what the agency 
considers tenable for the processing a single FOIA request, and, in fact, represent the absolute 
maximum efforts FDA can apply to this matter. Id. ¶ 21 (APPX009). Initially, while precise 
numbers are not yet available, CBER estimates that its plan to hire at least 15 contract staff will 
cost at least 3 million dollars—and, factoring in CBER’s other above-described efforts, CBER 
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presently estimates that the total cost of its efforts to comply with the order will come to a 
cumulative total of $4 to $5 million dollars. Id. ¶¶ 4, 22 ((APPX003, 009) These expenditures 
must, necessarily, come at the expense of other crucial public health operations, such as, inter 
alia, assessing new medical products and treatments, inspecting FDA-regulated establishments, 
and purchasing laboratory equipment to run analytical testing. Id. ¶ 22 (APPX009). Further, the 
Court’s direction for CBER to prioritize this FOIA case above all others will—again, of 
necessity—require FDA to allocate resources away from the processing of the hundreds of other 
FOIA requests that are currently pending before CBER, many of which also seek information 
related to COVID-19. Id. ¶ 23 (APPX009). While these FOIA requesters are not before this 
Court, the reallocation of resources away from processing their requests will be a direct 
consequence of the Court’s Order.  
Similarly, the reallocation of resources from other FDA components will also come with 
tradeoffs for the agency overall. As explained above, CBER has obtained the temporary 
reassignment of five OCOD employees, and it may in the future seek additional similar 
reassignments from other FDA disclosure offices in order to meet the exigencies created by the 
Court’s Order. These diversions of resources will, necessarily, detract from the output of these 
other disclosure offices, as will the reallocation of eight agency employees through the detail 
assignments described above. For these reasons—which is to say, because the FDA has a broad 
public health mandate, but limited resources with which to accomplish its many crucial 
missions—FDA emphasizes that the extraordinary measures it is undertaking in response to the 
January 6 Order cannot be replicated in other FOIA cases, either presently or in the future. See 
id. ¶ 25 (APPX010).   
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Finally, while the agency recognizes the public interest in the public disclosure of the 
records here at issue, FDA must also ensure that the personal information of clinical trial 
participants, as well any trade secret or commercially confidential information contained within 
the records, is protected from disclosure. See Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 
2356, 2366 (2019) (“FOIA expressly recognizes that ‘important interests [are] served by [its] 
exemptions,’ and ‘[t]hose exemptions are as much a part of [FOIA’s] purpose[s and policies] as 
the [statute’s disclosure] requirement.’” (brackets in original) (quoting FBI v. Abramson, 456 
U.S. 615, 630–631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018))). 
While FDA is putting every available resource at its disposal into its efforts to achieve 
compliance with the Court’s Order, it cannot achieve speed at the expense of its competing 
obligation to protect the categories of information that FOIA exempts from disclosure. Ensuring 
that such information is fully and properly redacted will, unavoidably, limit the speed with which 
FDA can act. See generally the attached Declaration of Douglas Weinfield (explaining why 
FDA’s FOIA reviews are often more time-intensive document reviews than those in garden-
variety private commercial litigation) (APPX015-019); id. at ¶ 13 (APPX018-109) (noting, in 
particular, that “[i]dentification of commercially sensitive information in a biologics license 
application” … “requires … specialized expertise” not typically implicated in a private 
commercial dispute).  
In sum, FDA is actively taking extraordinary measures to marshal every possible 
resource, and to make every possible effort to comply with the Court’s Order. But because 
operationalizing these resources will require an upfront investment of time, FDA respectfully 
requests that the Court modify its Order, in part, so as to afford the agency a reasonable—and 
limited—interim period of two months to put the above-described operations in place, while still 
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meeting monthly production quotas of 10,000 pages. For all of the reasons set forth above, FDA 
respectfully submits that this modification is both necessary to afford the agency a practical 
opportunity to achieve compliance with the Court’s Order, while simultaneously fulfilling its 
statutory duty to protect the sensitive personal and commercial information contained within the 
records here at issue. 
CONCLUSION 
For the foregoing reasons, FDA respectfully requests that the Court modify its January 6 
Order so as to provide that, for the first two 30-day periods following FDA’s scheduled January 
31, 2022 production, FDA’s monthly quota be adjusted to 10,000 pages per month. Following 
this initial two-month “stand up” period, FDA would then be required to process 55,000 pages 
per month, beginning with its May 2, 2022, production until such time as production is complete. 
 
Dated: January 18, 2022 
 
 
Respectfully submitted, 
 
 
 
 
 
 
BRIAN M. BOYNTON 
 
 
 
 
 
 
Acting Assistant Attorney General 
 
 
 
 
 
 
Civil Division 
 
 
 
 
 
  
 
 
 
 
ELIZABETH J. SHAPIRO  
 
 
 
 
 
 
Deputy Director  
 
 
 
 
 
 
Federal Programs Branch 
 
 
  
 
 
 
 
 
 
/s/ Antonia Konkoly 
 
 
 
ANTONIA KONKOLY 
Trial Attorney 
United States Department of Justice 
Civil Division, Federal Programs Branch 
1100 L Street, N.W. 
Room 11110 
Washington, D.C. 20005 
Tel: (202) 514-2395 
Email: antonia.konkoly@usdoj.gov 
 
Counsel for Defendant 
 
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CERTIFICATE OF SERVICE 
 
 
I hereby certify that on January 18, 2022, I electronically transmitted the foregoing to the 
parties and the clerk of court for the United States District Court for the Northern District of 
Texas using the CM/ECF filing system. 
 
/s/ Antonia Konkoly 
 
 
 
ANTONIA KONKOLY 
Trial Attorney 
United States Department of Justice 
Civil Division, Federal Programs Branch 
1100 L Street, N.W. 
Room 11110 
Washington, D.C. 20005 
Tel: (202) 514-2395 
Email: antonia.konkoly@usdoj.gov 
 
 
 
 
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