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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 sc hedules 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. Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 1 of 12 PageID 1723Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 1 of 12 PageID 1723
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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 w ill, of necessity, require some amount of lead time to
operationalize. Accordingly, FDA re spectfully requests that the January 6 Order be modified to
provide that —for only the first two 30 -day periods following FDA ’s schedu led January 31, 2022
production—FDA ’s monthly quota be adjusted to 10,000 pages per mont h. 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 process ing 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 i s 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, u ntil additional resources are in place, f ull complian ce 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 ne cessary , 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. Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 2 of 12 PageID 1724Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 2 of 12 PageID 1724
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the public inter est, in that it will afford FDA an adequate opportunity to gather, and
operationalize, resources necessary to achieve compliance with t he Court ’s Order.
ARGUMENT
I. Modific ation 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 urgen cy 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, 1 1 contractors will as sist 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
process ing more complex records. I n addition to reviewing and reda cting responsive records, the
contract ors will assist with certain administrative , but often time -consuming, steps required for
final production, such as, inter alia , finalizing redactions and applying Bates num bers. Id. ¶ 6
(APPX004) . FDA expects that, once these contract staff have been hired and trained, they will Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 3 of 12 PageID 1725Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 3 of 12 PageID 1725
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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 o f 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. B efore
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 meanin gfully contribute to t he review and
production process. Id. ¶ 7 (APPX004) ; see also Declaration of Sarah B. Kotler (“ Kotler Decl. ”),
Dkt. No. No. 30, ¶ 22.
• Details for FDA Staf f. 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 re allocate resources currently devoted to other, importa nt 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 beg in contributing to this project. CBER is working to obtain the requisite approvals to
publish the advertisements , and anticipates that they will post by a pproximately 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 ap plicant pool, and provide the selected detailees w ith the
3 As explained in prior filings, CBER is the FDA division that maint ains the records at issue in
this suit. Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 4 of 12 PageID 1726Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 4 of 12 PageID 1726
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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 b egin working at full capacity . Id. ¶ 9
(APPX 005); 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 r eview and redaction of records re lated 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, t hese reassigned staff members will r equire
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 obliga tions 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 matte r. Under such an arrangement, CBER would
temporarily reduce its production obligation to zero in that case, so as to allow CBER ALFOI Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 5 of 12 PageID 1727Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 5 of 12 PageID 1727
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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 Pfize r-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 presen ce 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 expe rience. 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.” Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 6 of 12 PageID 1728Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 6 of 12 PageID 1728
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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 th e 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 Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 7 of 12 PageID 1729Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 7 of 12 PageID 1729
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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 candi dates 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 extan t
March 1, 2022 deadline to make a first initial production of 55,000 pages. Id. ¶ 19 (APPX 008).
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 (APPX 007). Further, FDA is actively
assessing additional potential ways in which the agency may properly enlist and work with Pfizer -BioNTech to speed up the ultimat e resolution of this matter. Id. ¶ 15 (APPX 007). 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 compl y 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 (APPX 009). 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 Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 8 of 12 PageID 1730Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 8 of 12 PageID 1730
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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 ( (APPX 003, 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 prior itize 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 (APPX 009). 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 t o 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
Januar y 6 Order cannot be replicated in other FOIA cases, either presently or in the future. See
id. ¶ 25 ( APPX 010). Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 9 of 12 PageID 1731Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 9 of 12 PageID 1731
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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 p ersonal 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) (“FOI A expressly recognizes that ‘ important interests [a re] served by [its]
exemptions,’ and ‘ [t]hose exempti ons 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 ca tegories of information that FOIA exempt s 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) (APPX 015-019); id. at ¶ 13 ( APPX 018-109) (noting, in
particular, that “[i]den tification of commercially sensitive information in a biologics license
application” … “requires … specialized expertise” not typically implicated in a privat e
commercial dispute).
In sum, FDA is actively taking extraordinary measures to marshal every possible
resource, and to make every possible ef fort 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 aff ord the agency a reasonable—and
limited —interim period of two months to put the above -described operations in place, while still Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 10 of 12 PageID 1732Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 10 of 12 PageID 1732
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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 m odification 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 quot a 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 Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 11 of 12 PageID 1733Case 4:21-cv-01058-P Document 37 Filed 01/18/22 Page 11 of 12 PageID 1733
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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: [email protected]
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