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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF TEXAS
FORT WORTH DIVISION
PUBLIC HEALTH AND MEDICAL
PROFESSIONALS FO R TRANSPARENCY
and
PATRICK AND STEPHANIE DE GARAY,
Plaintiffs, v.
U.S. FOOD AND DRUG
ADMINISTRATION,
Defendant.
Civil Action No. 4:22-cv-915-P
DECLARATION OF SARAH B. KOTLER
I, Sarah B. Kotler, declare as follows:
1. I am the Director of the Di vision of Freedom of Inform ation (“DFOI”), Office of
the Executive Secretariat, Office of the Commissioner, Food and Drug Administration (“FDA” or “the agency”), United States Department of Hea lth and Human Services (“HHS”), in Rockville,
Maryland.
2. I have held the position of Director of DFOI since January 201 5. Prior to becoming
Director, I served as Acting Director of DFOI from November through December 2014, after the
former Director of DFOI retired. I previously served as DFOI’s Deputy Director and Denial &
Appeals Officer from September 2013 through Oct ober 2014; and as Denials & Appeals Officer
from March 2007 through August 2013.
3. As both Deputy Director and Director, I have had superv isory authority over DFOI,
which serves as FDA’s official point of receipt for all requests for records under the Freedom of Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 1 of 24 PageID 284
-2- Information Act (FOIA), 5 U.S.C. § 552. See 21 C.F.R. § 20.40. In add ition, DFOI is responsible
for FDA’s FOIA reporting to HHS and the U.S. Department of Ju stice, consulting with other
federal agencies regarding FOIA requests, agency-wide FOIA tr aining, and expedi ted processing,
among other functions. DF OI processes about 25% of all FOIA requests received by FDA; the
other 75% are processed by the FOIA revi ewers within FDA’s other components.
4. As part of my duties, I c oordinate FDA’s processing of FOIA requests that relate
to the novel coronavirus known as SARS-CoV-2, also known by the disease it causes, COVID-19.
Due to the nature of my official duties, I am familiar with the procedures followed by FDA in
responding to requests for records pur suant to applicable law, incl uding provisions of the FOIA, 5
U.S.C. § 552. I am also aware of the workload obligati ons of offices that process FOIA requests
across the agency.
5. The statements contained in this declaration are based upon my personal
knowledge, upon information I have learned in my official capacity, and upon conclusions I
reached based on that knowledge or information.
6. The purpose of this declaration is to provi de an overview of FDA’s procedures for
handling FOIA requests, FOIA wo rkloads across the agency, and FDA’s ability to process the
FOIA requests at issue in this proceeding made by Public Health and Medical Professionals for
Transparency (“PHMPT”) and Stephanie and Patrick de Garay (collectively, “Plaintiffs”). This
declaration also documents the agency’s basis for denying Plaintiffs’ requests for expedited
processing.
7. As explained below, Plaintiffs’ FOIA re quests did not satisfy the standard for
expedited processing because they did not establis h an urgent need to inform the public about
federal government activities. Further, Plainti ffs’ proposed production sche dule is not feasible Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 2 of 24 PageID 285
-3- given that, among other things, FDA cannot reallo cate resources from othe r components of the
agency. Since the beginning of the COVI D-19 pandemic, the number of FOIA requests
submitted to FDA has significan tly increased, as has their complexity and the amount of
subsequent FOIA litigation. Because of these factors and the agency’s existing FOIA and non-
FOIA workload, other FDA components cannot assi st the Center for Biologics Evaluation and
Research (“CBER”) in attempti ng to satisfy Plaintiffs’ propos ed production schedule without
diverting significant resources away from the processing of other FO IA requests that are also in
litigation, requests that are ahead of Plaintiffs’ requests, and ot her non-FOIA record requests.
This would adversely impact the agency’s abil ity to meet stipulated document processing
deadlines and prejudice other im portant pending requests at the e xpense of overall transparency
and the agency’s publ ic health mission.
FDA’S GENERAL PROCEDURE FOR INCOMING FOIA REQUESTS
8. Under FDA’s regulations, DFOI is the of fice responsible for FDA’s compliance
with FOIA. See 21 C.F.R. §§ 20.30, 20.40. When DFOI receiv es an electronic FOIA request, it
generates a control number that be gins with four digits reflecti ng the calendar year in which the
request was received, followed by a number reflec ting the sequential count of FOIA requests
received by DFOI to date in that particular calendar year. Plaintiff PHMPT’s request filed on February 23, 2022 related to Moderna’s COVID-19 vaccine was the 1,614th FOIA request
received by FDA in fiscal year (“FY”) 2022 and thus has the control number “2022-1614.”
PHMPT’s request filed on August 8, 2022 related to Pfizer-BioNTech’s COVID-19 vaccine for
individuals between the ages of 12-15 years old was the 5,812th FOIA request in FY 2022 (FOIA
Control # 2022-5812), and Plaintiffs Stephanie and Patrick de Garay’s request filed on August 22, Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 3 of 24 PageID 286
-4- 2022 related to Pfizer-BioNTech’s COVID-19 vaccine for individuals between the ages of 12-15
years old, was the 6,129th FOIA request in FY 2022 (FOIA Control # 2022-6129).
9. FDA expedites processing of a FOIA reque st when the requester demonstrates a
“compelling need” and in other cases determined by the agency. See 5 U.S.C. § 552(a)(6)(E). A
“compelling need” exists when: (1) a failure to obtain requested records on an expedited basis
could reasonably be expected to pose “an imminen t threat to the life or physical safety of an
individual”; or (2) a request is made by “a person primarily engage d in disseminating information”
and there is a demonstrated “urg ency to inform the public concer ning actual or alleged Federal
Government activity.” Id. DFOI reviews requests to deter mine whether expedite d processing is
appropriate and sends a letter to the requester documenti ng its determination. In accordan ce with
21 C.F.R. § 20.44, requests that have been granted expedited processing are processed as soon as
practicable, on a first-in, first-out basi s based on the date of receipt.
10. FDA’s FOIA program is decentralized be cause of the agency’s size, the large
number of records generated during the course of agency business, and the different components
within FDA. After a FOIA reque st is received and logged by DFOI , the request is assigned to the
FDA component reasonably likely to possess responsive records, whic h then processes the request.
FOIA reviewers within the as signed component process poten tially responsiv e records and
determine whether they should be re leased in full, redacted in part , or withheld in their entirety
under any applicable FOIA exemption or ot her statutory or re gulatory provision.
FDA’S PUBLICATION OF INFORMAT ION REGARDING THE SPIKEVAX AND
COMIRNATY VACCINES
11. In an effort to inform the public about its work related to the COVID-19 vaccines,
FDA has published an abundance of relevant informa tion. As relevant to the instant matter, this
includes the most important safe ty and efficacy information a bout Moderna’s Spikevax vaccine, Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 4 of 24 PageID 287
-5- Pfizer-BioNTech’s Comirnaty vaccine, and the s upplemental approval of the Comirnaty vaccine
for use in individuals ag es 12-to-15 years old.
12. FDA features the latest in formation about the agency’s COVID-19 response on the
homepage of its website, https://www.fda.gov. For example, the homepage currently prominently
features “COVID-19 Bivalent Vaccine Boosters,” which takes the user to a page with numerous
links to information about the authorization of bivalent vaccine boosters from Moderna and Pfizer,
https://www.fda.gov/emergency-preparedness-and -response/coronavirus-di sease-2019-covid-19/
covid-19-bivalent-vaccine-boosters.
13. From there, among other places, the user can access a main link titled “Coronavirus
Disease 2019 (COVID-19)” which takes the user to a collection of linked webpages about FDA’s
COVID-19 response from January 2020 up to the latest developments. The linked webpages
provide information about COVID-19 vaccines, em ergency use authorizations, personal protective
equipment, FDA guidance documents, Frequently Asked Questions, and resources for health
professionals, among other things. FD A, Coronavirus Disease 2019 (COVID-19),
https://www.fda.gov/emergency-preparedness-a nd-response/counterterrorism-and-emerging-
threats/coronavirus- disease-2019-covid-19.
14. From that main COVID-19 page, the us er can access webpages about specific
COVID-19 vaccines.
15. Information About the Spikevax Vaccine: A Moderna-specific webpage
provides updated information about the Spikevax vaccine and Moderna’s bivalent booster vaccine.
Moderna’s COVID-19 Vaccines, at https://www. fda.gov/emergency-preparedness-and-response/
coronavirus-disease-2019-covid-19 /moderna-covid-19-vaccines. That page contains links to a
variety of important info rmation about the Sp ikevax vaccine (and its bi valent booster), organized Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 5 of 24 PageID 288
-6- into the following categories designed to make each topic accessible to th e public and healthcare
providers:
a) Spikevax Information : This section provides package inserts, the Summary Basis for
Regulatory Action, Frequently Asked Questio ns (FAQs), an Approval Letter, and an
additional link to information on the Centers for Disease Control (CDC) website. These
materials were all updated in 2022. b) Moderna Fact Sheets (English) and FAQs : This section includes “Health Care
Provider Materials” with updated fact sheets and letters for heal thcare providers that
describe the primary series a nd bivalent boosters for the Spik evax vaccine, organized by
date and vaccine recipient group. The most recent updates were added to Fact Sheets on
December 8, 2022. This section also includes “Recipient and Caregiver Materials” with
fact sheets describing primary se ries and bivalent booster vaccin es and an FAQ. The fact
sheets were last updated on December 8, 2022.
c) Moderna COVID-19 Vaccine Regulatory Information : This section provides
decision memoranda and adde ndums to memoranda, letters, and Advisory Committee
Meeting information, beginning in December of 2020. The most recent updates include a
decision memorandum (https://www.fda.gov/me dia/163937/download) and letter of
authorization (https://www.fda.gov/media/ 144636/download) added on December 8,
2022. d) Media Materials and Webcasts : This section provides webcasts of FDA’s Vaccines
and Related Biological Products Advisory Committee meetings a bout Spikevax, press
conference links, and press releases beginning in December of 2020. More recently, this
includes two Advisory Committe e webcasts from June of 202 2 totaling more than 15 hours Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 6 of 24 PageID 289
-7- of discussion (found at https://youtu.be/Ixm4UmldTGQ and https://youtu.be/
GbNpaZeDPiA ).
e) Translations : To ensure public accessibility, the we bpage also includes translations of
certain Spikevax informati on in multiple languages.
16. The “Spikevax Information” section incl udes a link to anothe r webpage providing
detailed regulatory documents that explain the basis for Spikevax ’s approval, found at
https://www.fda.gov/vaccines-blood-biologics/spi kevax. This page contains the “Action
Package” for Spikevax, comprising hundreds of pages of materials that the agency expects are the
most useful to the public in understanding FDA’ s approval decision. It includes the Clinical
Review Memorandum (which provide s information about individual clinical trials, safety and
efficacy, and risk-benefit considerations and re commendations, among other things), Package
Inserts, Approval Letter, and the Summary Basis for Regulatory Action, as well as a link to a zip
file containing the “Approval Hi story, Letters, Reviews, and Rela ted Documents” for Spikevax.
The zip file (at https://www.fda.gov/media/ 156343/download) provides, among other things,
Statistical Reviews, Toxicology Review, Benefi t-Risk Assessment Revi ew, Pharmacovigilance
Plan Review, and Chemistry-Ma nufacturing Controls Review. The documents in the Action
Package thus provide valuable summaries of the information and data sub mitted by Moderna, as
well as FDA’s assessment, which toge ther explain FDA’s decision to license the Spikevax vaccine.
17. Information about th e Comirnaty Vaccine: Similarly, a Pfizer-specific webpage
provides focused and updated information about th e Comirnaty vaccine and its bivalent booster
vaccine. Pfizer-BioNTech COVID-19 Vacci nes, at https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-dis ease-2019-covid-19/pfizer -biontech-covid-19-
vaccines. Among other things, that page contai ns links to important information about the Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 7 of 24 PageID 290
-8- Comirnaty vaccine, FDA’s approval of its use in individuals 12 through 15 years of age, and the
bivalent booster.
18. The information is organized into the fo llowing categories de signed to make each
topic readily accessible to the publ ic and healthcare providers.
a) Comirnaty Information : This section provides package inserts, regulatory information,
Frequently Asked Questions (FAQs), and addi tional links to information on the Centers
for Disease Control (CDC) webs ite. Among other thi ngs, the package inserts dated July 8,
2022, provide information about clinical tria ls and adverse reaction frequency in study
participants of different ages, including participants 12 through 15 years of age. See
Package Insert (purple cap), at http s://www.fda.gov/media/151707/download; Package
Insert (gray cap), at https ://www.fda.gov/media/154834/download.
b) Pfizer-BioNTech Fact Sheets (English) and FAQs : This section includes “Health Care
Provider Materials” with updated fact sheets and letters for heal thcare providers that
describe the primary series a nd bivalent boosters for the Co mirnaty vaccine, organized by
date and vaccine recipient group. The most recent document was a Fact Sheet updated on
December 22, 2022, describing the primary series vaccine for those 12 years of age and
older. See Fact Sheet, at https://www.fda.gov/media/153713/download . This section also
includes “Recipient and Caregiver Materials” with fact sheets describing primary series
and bivalent booster vaccines an d an FAQ. The fact sheets were last updated on December
8, 2022, including a fact sheet for the vaccine recipient group 12 years of age and older.
c) Pfizer-BioNTech Regulatory Information : This section provides 35 documents
comprising decision memoranda, letters, and Advisory Com mittee Meeting information,
beginning in December of 2020. The most rece nt updates include a decision memorandum Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 8 of 24 PageID 291
-9- (https://www.fda.gov/media/163895/download) and letter of authorization
(https://www.fda.gov/media/150386/download) added on December 8, 2022, and a letter
granting EUA Amendment (https://www.fd a.gov/media/164184/download) added on
December 22, 2022. d) Media Materials and Webcasts : This section provides 28 records comprised of
webcasts of FDA’s Vaccines and Related Biological Products Advisory Committee
meetings, press conference links, and press re leases, beginning in December of 2020, with
the most recent update being a press release on December 8, 2022
(https://www.fda.gov/news-events/press-a nnouncements/coronavi rus-covid-19-update-
fda-authorizes-updated-bi valent-covid-19-vaccines- children-down-6-months ).
e) Translations : To ensure public accessibility, the we bpage also includes translations of
certain information in multiple languages.
19. The “Comirnaty Information” section incl udes a link to another webpage providing
detailed regulatory documents that explain the basis for Comirnaty ’s approval, found at
https://www.fda.gov/vaccines-blood- biologics/comirnaty. This page contains the “Action
Package” for Comirnaty, comprising hundreds of pages of materials that the agency expects are
the most useful to the public in understanding FDA’s approval deci sion. It includes the Clinical
Review Memorandum (which provides information a bout clinical trials safety and efficacy, and
risk-benefit considerations a nd recommendations, among other things), the Statistical Review,
Approval Letters, and the Summary Basis for Regul atory Action, as well as a link to a zip file
containing the “Approval History, Letters, Reviews, and Related Documents” for the Comirnaty
vaccine. The documents in the Action Packag e thus provide valuable summaries of the
information and data submitted by Pfizer-BioNTech that FDA reviewed and assessed in Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 9 of 24 PageID 292
-10- determining whether to approve licensure for the v accine and its subsequent use for individuals 12
through 15 years of age.
20. Additionally, a database of adverse event report data is continually updated by the
Centers for Disease Control (CDC), found at https://www.cdc.gov/vaccin esafety/ensuringsafety/
monitoring/.
21. FDA continues to regularly update its we bsite to provide th e most current and
relevant information about COVID-19 to the public as soon as possible.
FDA’S PROCESSING OF PLAINTIFFS’ REQUESTS
22. Collectively, Plaintiffs submitted three FOIA requests to FDA:
a) First Request: On February 23, 2022, Plaintiff PH MPT submitted a request seeking
expedited processing of “[a]ll data and info rmation for the Modern a Vaccine enumerated
in 21 C.F.R. § 601.51(e), with the exception of publicly available reports on the Vaccine
Adverse Events Reporting System [‘VAERS’]” (citation omitted). FDA assigned this
request control number 2022-1614 (hereafter, “Fir st Request”). Complaint, Ex. 1.
b) Second Request : On August 8, 2022, Plaintiff PHMPT submitted a request seeking
expedited processing of “[a]ll data and information for the 12 -15-Year-Old Pfizer Vaccine
enumerated in 21 C.F.R. § 601.51(e), with the exception of publicly available reports on
[VAERS]” and excluding “any da ta and information responsiv e to and being produced in
FOIA Control # 2021-5683 (previously made on behalf of PHMPT)” (citation omitted).
FDA assigned this request control numbe r 2022-5812 (hereafter, “Second Request”).
Complaint, Ex. 5. c) Third Request : On August 22, 2022, Plaintiffs Stephanie and Patrick de Garay
submitted a request materially identical to Plaintiff PHMPT’s A ugust 8, 2022 request. Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 10 of 24 PageID 293
-11- FDA assigned this request control number 2022-6129 (hereafter, “Third Request”).
Complaint, Ex 8. 23. As written, Plaintiffs’ requests are extremel y broad and would require the agency’s
careful review of millions of pages of records a nd data files in the Biol ogic Product Files (“BPFs”)
for the Spikevax vaccine and the ages 12 through 15 years indication for the Comirnaty vaccine (hereafter, the “Comirnaty indication”) to determin e which information is available for release to
the public under 21 C.F.R. § 601.51(e).
24. I assigned Plaintiffs’ requests to CBE R for processing because they sought
information—BPF records—in CBER’s custody. CBER’s processing of Pl aintiffs’ requests is
described in more detail in the Beth Brockner-Ryan Declaration (B rockner-Ryan Decl. ¶¶ 32-34).
REQUESTS FOR EXPEDITED PROCESSING
25. I reviewed Plaintiffs’ requests for expe dited processing and determined that
Plaintiffs did not satisfy the requirements for expedited pro cessing on any request. Complaint,
Exs. 2, 6, and 8.
26. I found that Plaintiffs did not demons trate a compelling need under 5 U.S.C.
§ 552(a)(6)(E), in substantial part because large amounts of inform ation have already been made
available to the public about the Spikevax and Comirnaty vaccines and related FDA activities. A
compelling need exists when: (1) A failure to obt ain requested records on an expedited basis could
reasonably be expected to pose an imminent threat to the life or physical safety of an individual; or (2) With respect to a request made by a person primarily engaged in diss eminating information,
there is a demonstrated urgenc y to inform the public concerni ng actual or alleged Federal
Government activity. 5 U.S.C. § 552(a)(6)(E)(v). Department of Justice guidance advises
agencies to “carefully” assess the merits of expe dited processing requests “[b]ecause the granting Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 11 of 24 PageID 294
-12- of a request for expedition necessarily works to th e direct disadvantage of other FOIA requesters.”
DOJ, FOIA Update: OIP Guidance: When to Expedite FOIA Requests ,
https://www.justice.gov/oip/blog/foia-update-o ip-guidance-when-expedite-foia-requests .
27. First, I found that Plaintiffs’ requests di d not contain any basis to conclude that a
failure to obtain records on an ex pedited basis would pose a threat to any individual. As a result,
I concluded that Plaintiffs had not satisfied the first criterion for expedi ted processing. Second, I
determined that Plaintiffs had not established an urgency to in form the public concerning actual or
alleged Federal Government activ ity, also largely be cause there is a significant amount of
information already available to Plaintiffs and the public conc erning FDA’s activities surrounding
the Spikevax and Comirnaty vaccines.
28. On June 1, 2022, Plaintiff PHMPT appealed the Agency’s denial of expedited
processing of the First Request. See Complaint, Ex. 3. Plaintiff ar gued that PHMPT was primarily
engaged in disseminating informat ion and that it was urgent to release the records underlying
licensure of Spikevax because of “widespr ead and ongoing public debate” about Spikevax,
“invasive policy decisions” like COVID-19 vaccine mandates, and a “lack of disclosure regarding
the determination of the products [sic ] safety and effectiveness.” Id.
29. As discussed above, FDA has published a si gnificant amount of in formation related
to the Spikevax and Comirnaty vaccines on its website on an ongoing basis. The documents posted
by the agency currently contai n, among other things, FDA revi ew memoranda, which include
summaries of safety and effectiveness data, as well as FDA reviewers’ analyses of them.
Moreover, the CDC also maintains a website with additional information about ingredients and
analyses of safety and effec tiveness, among other things, for both Spikevax and Comirnaty. See
CDC, Overview of COVID-19 Vaccines, https://www.cdc.gov/coronavirus/2019-ncov/Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 12 of 24 PageID 295
-13- vaccines/different-vaccines/overv iew-COVID-19-vaccines.html. CDC also provides the public
with access to its WONDER database , which contains adverse event report data collected through
the U.S. Vaccine Adverse Event Reporting System. See CDC, How to Access VAERS Data
through VAERS WONDER System , https://www.cdc.gov/vaccin esafety/ensuringsafety/
monitoring/vaers/access-VAERS-data .html. As a result, the public has access to a large amount
of information about the vaccine, particularly gov ernment actions related to the vaccine’s approval
as well as on-going advers e event information.
30. The fact that people may have differing opinions about a cert ain FDA-regulated
product does not create “urgency” within the meaning of the expe dited processing standard –
especially in light of the amount of information, and cons idering that the most relevant information
for health care provider s and consumers has been, published on FDA’s website. Nor does the fact
that certain individuals may be administered a certain pr oduct. FDA approves medical products
regularly in the course of agency business. It is not unheard of for those ap provals to be the subject
of controversy, and there are almost always peopl e who are administered th e products shortly after
approval. Such a situation cannot be deemed to cr eate an urgent need for the agency to expedite
its review and processing of the millions of pages of records and data files at issue here, especially
when the agency routinely publishes summaries of safety and efficacy in formation on its website
(as it did here). If Plaintiffs’ view became th e standard, a great number of FDA’s FOIA requests
would qualify for expedited processing, and reque sters with non-expedited requests would have
their wait times extended – possibl y significantly. Thus, Plaintif fs’ claims that their requests
would fulfill an urgent demand is not supported, and I denied the re quests for expedite d processing.
Complaint, Exs. 2, 6, and 8. Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 13 of 24 PageID 296
-14- ALLOCATION OF AGENCY RESOURCES
31. As detailed in the Brockner-Ryan Decl aration (¶¶ 23-28), CBE R’s FOIA resources
are currently stretched to their maximum capacity due to marshaling its resources to comply with
this Court’s production order in PHMPT v. FDA , No. 4:21-CV-1058 (“PHMPT 1 ”). And FDA
cannot reallocate resources from other agency functi ons or components to he lp process Plaintiffs’
requests. Performing disclosure reviews is a speci alized skill that requires training and expertise
that the vast majority of FDA staff does not ha ve. It is not reasonable to expect that a
microbiologist who perfor ms laboratory assays, a pharmacist who reviews drug applications, a
badging office employee who issues credentials, or a mail room clerk who organizes mail can
simply begin performing di sclosure review without significant training. Moreover, it would be
contrary to FDA’s public health mission to pull staff of f reviewing cancer treat ment applications
or building counterfeit medication investigations to have them c onduct work for which they are
untrained and unqualified.
32. Further, FOIA administration is an unfunded mandate—that is, it is not a separate
“line item” category in legislative appropriations for the agency, and thus FOIA operations must
be funded from general budgetary appropriations. See, e.g. , DOJ, FOIA Update: FOIA Affected
by Budget Constraints , https://www.justice.gov/oip/blog/ foia-update-foia -affected-budget-
constraints . Accordingly, when the agency receives more FOIA requests, it cannot hire more
employees with specific FOIA funding.
33. Moreover, even when the agency can allo cate new monetary res ources to hire new
disclosure staff or contractors, it takes substantia l time to recruit and hire new staff, bring them on
board, and provide them with the necessary training to become competent to perform disclosure
reviews. FDA estimates that it takes approximat ely two years to fully train a new disclosure Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 14 of 24 PageID 297
-15- reviewer. In the meantime, experienced reviewers are needed to closely s upervise and review their
work – thus decreasing the amount of time that experienced reviewers can spend reviewing
records. Indeed, as explained in the Brockner- Ryan Declaration (¶ 28), CBER staff continue to
expend significant time on supervision and review of newly hired contractors on the PHMPT 1
production matter. As a result, it is not reasonable to expect that FDA will be able to respond to
Plaintiffs’ requests more quickly by allocating non-disclosure resour ces. In fact, to do so would
significantly impede FDA’s public safety role.
34. Moreover, as discussed in more detail in the following section, it is not feasible for
the agency to reallocate its existing disclosure resources in components outside of CBER to work
on Plaintiffs’ reques ts because other FDA components’ disclo sure staff are already over-extended
by existing disclosure obligations, many of which concern products or issu es similarly important
to public health. For example, the Center for Devices and Radiologi cal Health, among other
things, is processing requests related to COVID- 19 test kits; the Center for Drug Evaluation and
Research, among other things, is processing requests relate d to COVID-19 pharmaceutical
treatments; the Center for Food Sa fety and Applied Nutrition, am ong other things, is processing
requests related to infant formula; the Center for Veterinary Medicine , among other things, is
processing requests related to animal drugs; the Ce nter for Tobacco Products, among other things,
is processing requests related to electronic nicotine delivery systems, colloquially known as e-
cigarettes and their co mponents; the Office of Regulatory Affairs, among other things, is
processing requests related to th eir inspections of regulated i ndustry; and the Office of the
Commissioner, among other things, is processing re quests related to its administrative priorities
and responsibilities. Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 15 of 24 PageID 298
-16- PROCESSING WORKLOAD OF DISCLOSU RE OFFICES OUTSIDE OF CBER
35. As an initial matter, the disclosure offi ce of each FDA component has its own
specialized responsibilities and expe rtise. Thus, although all disclosu re staff will be familiar with
statutory requirements of FOIA and FDA’s disclosure regulations, staff from different centers will
be trained to review informatio n regularly generated within th at center. For example, CBER
reviewers are familiar with the types of informat ion regularly contained in BLAs and are trained
to identify information that may be exempt from disclosure in those types of files; CBER reviewers
would not be familiar with the t ypes of records commonly processe d by other parts of the agency,
such as premarket tobacco product applications or food additive pe titions. The converse is also
true; reviewers in FDA’s Center for Food Safety and Applied Nutrition (“ CFSAN”) are familiar
with records regularly generated within CFSAN bu t would not have the same expertise as a CBER
reviewer when looking at a BLA. Thus, even di sclosure staff within the agency should not be
considered interchangeable.
36. Further, on March 13, 2020, the President de clared a national emergency due to the
ongoing COVID-19 pandemic. Since the beginni ng of this emergency, FDA has been flooded
with FOIA requests related to the pandemic.
37. Specifically, in fiscal year 2022, F DA received approximately 8,529 FOIA
requests, many of which are directly related to COVID-19. Complicati ng matters, many recent
FOIA requests are more complex an d are expected to take longer to process than typical FOIA
requests received prior to the beginning of the COVID-19 pandemic. Many requests for
information related to COVID-19 require colla boration among federal ag encies because they
involve records (such as emails) th at may have originated in other agencies. Department of Justice
guidance advises federal agencies to consult with the originating ag ency for disclosure Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 16 of 24 PageID 299
-17- determinations. DOJ, FOIA Update: OIP Guidance: Referral and Consultation Procedures ,
https://www.justice.gov/oip/blog/f oia-update-oip-guidance-referr al-and-consultation-procedures .
As a result, FDA regularly collaborates with ot her federal agencies, such as CDC, the National
Institutes of Health, and the De partment of Health and Human Se rvices, about records responsive
to requests. These consultations add both time and complication to the process for responding to
FOIA requests.
38. Coupled with the increased number a nd complexity of requests, FDA has
experienced an unprecedented increase in FOIA litigation in recent years. Between calendar years
2018 and 2020, the number of FOIA lawsuits filed against FDA gr ew by approximately 200%. In
2022, FDA received 26 new FOIA lawsuits. Curre ntly, FDA is involved in approximately 52
active FOIA litigations. Significantly, 20 of t hose FOIA lawsuits involve COVID-19 records—
thus, there are now nearly as many FOIA litigatio ns involving COVID-19 as there were total FOIA
litigations brought in 2022.
39. At the review and redaction phase, certai n FDA components have had to shift some
of their FOIA reviewers from re sponding to FOIA requests in th e normal course to almost
exclusively processing FOIA request s in litigation. This diversion of staff resources to respond to
ever increasing litigation and imp ending court deadlines means that fewer initial FOIA requests
are being processed, and at a slower pace, which is causing even more litigation.
40. In addition to FOIA, FDA also ha s numerous other document processing
obligations, including those arising from subpoe nas; discovery requests in non-FOIA litigations;
oversight requests from Congress; requests from domestic and fore ign regulatory bodies; and other
statutory disclosure mandates. In some agency o ffices, the same staff that handles FOIA requests
also handles these other disclosure projects, as they rely on similar di sclosure skills. As a result, it Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 17 of 24 PageID 300
-18- would not be feasible for FDA to shift resour ces from other disclosure offices to help CBER
process Plaintiffs’ requests. In the following paragraphs, I discuss the current workload of various
FDA components.1
Center for Drug Evaluation and Research (“CDER”) 41. As of February 28, 2023, CDER is re sponsible for processing 987 pending FOIA
requests, of which approximately 48 are related to COVID-19. This is a significant increase in
pending requests compared to past years. The following chart illustrates the numbers of pending
requests in CDER’s FOIA queue on February 28 of the previous five calendar years, showing a
marked increase in the numbers of requests beginning in 2021.
Figure 1: Pending FOIA Requests in CDER as of February 28 of each year from 2019 to 2023.
42. In addition to processing FOIA requests, CDER is also responsible for processing
other document requests made by Congress; the U. S. Government Accountability Office; foreign,
state, and local governments; a nd other federal agencies. Alt hough these requests are not made
1 I do not include a discussion of CBER’s workload because that information is discussed in the
Brockner-Ryan Declaration. See Brockner-Ryan Decl. ¶¶ 18-22.
564597 614882987
2019 2020 2021 2022 2023CDER: 5‐Year History of
Pending FOIA Request NumbersCase 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 18 of 24 PageID 301
-19- under FOIA and are not processed in CDER’s FOIA tracks, they are processed by CDER’s FOIA
reviewers because of the similar nature of the work to FOIA processing and the need for
consistency in reviewing and redacting responses to information requests. Responding to these
non-FOIA requests requires a corresponding decrease in reviewers’ time available to respond to
FOIA requests. For example, in recent years, CDER has been required to devote time to producing
tens of thousands of pages in response to requests from foreign regul atory authorities for
documents regarding FDA inspections of foreign drug manufacturers, and in response to requests
from the Department of Justice re lated to its investigations of pharmaceutical companies. CDER
also has other statutory disclosure oblig ations under the Food a nd Drug Administration
Amendments Act of 2007, which requires that New Molecular/Biological Entity (NM/BE) action
packages be published on CDER’s web page with in 30 days of approva l. In 2022 and the
beginning of 2023, CDER reviewed and redacted 37 NM/BE action packages, each of which
typically contains thous ands of pages.
Office of the Commissioner (“OC”)
43. As of February 28, 2023, OC has 378 pe nding FOIA requests. After 2020, OC
experienced a significant increase in FOIA re quests, with the number approximately doubling
between 2020 and 2021.
44. Prior to May 2022, OC had one full-time em ployee (“FTE”) devoted to processing
of FOIA requests for records originating in OC , at times (since the fall of 2020), aided by short-
term detailees for 90-120 day peri ods. In 2022, due to its increasi ng backlog – particularly as it
pertains to FOIA litigation – OC added a second FTE and part-time assistance from others on my
team at DFOI (which division resi des in OC) and was thus able to slightly decrease its FOIA queue.
However, the number of pending FO IA requests, even after more than doubling the FTEs working Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 19 of 24 PageID 302
-20- on these requests, remains far above pre-pandemic numbers. Indeed, desp ite my other duties,
including management of my division, I have al so been assisting with FOIA review for COVID
requests in OC, as well as keep ing the non-COVID OC FOIA workload moving. OC is currently
involved in 6 active litigation ma tters. The following chart illu strates the number of pending
requests in OC’s FOIA queue as of February 28 of the previous five calendar years.
Figure 2: Pending FOIA Requests in OC as of February 28 of each year from 2019 to 2023.
Center for Devices and Radi ological Health (“CDRH”)
45. As of February 28, 2023, CDRH has 1, 852 pending FOIA requests, approximately
145 of which are related to COVID-19. The follo wing chart illustrates the length of CDRH’s
FOIA queue as of February 28 of each calendar year. Although CDRH’s queue has not changed
as dramatically as other FDA components, it remains the longest queue in the agency.
144218457469
378
2019 2020 2021 2022 2023OC: 5‐Year History of
Pending FOIA Request NumbersCase 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 20 of 24 PageID 303
-21-
Figure 3: Pending FOIA Requests in CDRH as of February 28 of each year from 2019 to 2023.
46. Other than FOIA requests, CDRH’s FOIA Office is also responsible for responding
to subpoenas and non-FOIA record requests made by Congress; foreign, state, and local
governments; and other federal agencies. Re sponding to these non-FOIA requests requires a
corresponding decrease in reviewers’ time available to respond to FOIA requests. For example,
within the past four years alone, CDRH has b een required to devote time to producing hundreds
of thousands of pages of documents in response to requests from other fede ral agencies related to
their investigation of medical device companies. Furthermore, since 2018, CDRH has responded
to numerous federal subpoenas, with quick turnarounds for producti ons that have required CDRH
reviewers to stop processing FOIA requests to respond to these subpoenas. In 2022, one
voluminous subpoena alone yielded hundr eds of thousands of pages.
Other FDA Components 47. The components highlighted above are not outliers. Other FDA components have
significant queues, some of which have grown due to increased workloads related to COVID-19.
Across the Office of Regulatory Affairs and its subcomponents/field offices , the total number of
22712331
1927 19431852
2019 2020 2021 2022 2023CDRH: 5‐year History of
Pending FOIA Request NumbersCase 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 21 of 24 PageID 304
-22- pending FOIA requests has increased markedly from 162 in February 2021 to 409 in February
2023—more than doubling in just two years.
48. Although largely unrelated to the COVI D-19 pandemic, FDA’s Center for
Veterinary Medicine has also s een its number of pending requests jump from 56 in February 2020
to 150 in February 2023. FDA’s Center for Food Safety and Applied Nutrition and Center for
Tobacco Products have not encountered the same influx of COVID-19 FOIA requests, so their
FOIA queues have remained fairly steady. But th ey currently maintain queues in the 100 to 150
range, so their resources are fully consumed with their standard responsibilities, which also include
non-FOIA disclosure projects, su ch as Privacy Act requests.
49. Based on all of the information above, none of FDA’s other disclosure offices are
able to assume the burden of taking on a significant role in the review of CBER records responsive
to Plaintiffs’ requests without co mpromising their ability to keep up with their own disclosure
review responsibilities, especially considering that these staff are not specifically trained to review
the records at issue in this case.
EFFORTS TO REDUCE BACKLOGS
50. FDA’s FOIA offices have taken numerous steps to reduce b acklogs and improve
processing time. Specifically, FDA’s FOIA office s are recruiting and hiring new employees where
funding allows; proactively posting online frequently requested documents to reduce the need for
new FOIA requests; training FOIA employees to handle types of records within their component
that they do not typically handle to assist with complex track request s; evaluating requests daily in
order to shift them to experien ced redactors as needed; and, wher e possible, proactively contacting
FOIA requesters to negotiate the sc ope of requests to in order to produce records more quickly.
As noted in the Brockner-Ryan Declaration (¶ 26), since February 2022, CBER has hired 9.5 Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 22 of 24 PageID 305
-23- contractors (9 full-time and 1 part -time) to assist with FOIA pr ocessing and was recently approved
to hire and train 6 new full-time disclo sure staff for conti nued processing for PHMPT 1 and to
address its backlog due to the resources already devoted to PHMPT 1 .
51. Moreover, starting in Janu ary 2022, CDER has brought on 7 additional employees
(comprised of 6 brand-new FDA employees and 1 employee return ing to CDER from the Office
of Regulatory Affairs) to assi st with FOIA processing. Simil arly, CDRH completed a business
process improvement review of its FOIA progr am in October 2019, which included identifying
hiring needs; updating workflows, processes, and procedures; training reviewers; and additional
tracking of FOIA requests. Between Sept ember and December 2019, CDRH acquired a multi-
year contract that currently provi des 11 contractors to a ssist in reducing FOIA backlogs and hired
additional full-time reviewers to process FOIA requests and other disclosure tasks.
CONCLUSION
52. In sum, FDA is committed to transparency in all aspects of its work, especially its
response to the COVID-19 pandemic. The agency has provided, and continues to provide, an
abundant amount of information to the public about the Spikevax and Comirnaty vaccines. FDA
has also taken reasonable steps to assist Plainti ffs with providing a more targeted FOIA request,
as discussed in greater detail in the Brockner-Ryan Decl aration (¶¶ 33-35). Bu t Plaintiffs’ requests
do not satisfy the statutory standa rd for granting expedited processi ng. Further, gi ven the limited
number of FDA staff available to perform disclosure reviews and the heavy workload FDA’s
disclosure offices are facing, it would be unduly bur densome for FDA to rea llocate resources from
agency components outside of CBER. If required to do so, FDA’ s ability to perform its other
agency functions, including res ponding to other record requests, would likely be impaired. Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 23 of 24 PageID 306
-24- Pursuant to 28 U.S.C. § 1746, I declare under the penalty of perjury th at the foregoing is
true and correct.
Executed on March 31, 2023.
_____________________ SARAH B. KOTLER Director of Divi sion of Freedom of Information
Office of the Executive Secretariat Food and Drug Administration U.S. Department of Health and Human Services Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 24 of 24 PageID 307