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IN THE UNITED STATES DISTRICT COURTFOR THE NORTHERN DISTRICT OF TEXASFORT WORTH DIVISIONPUBLIC HEALTH AND MEDICALPROFESSIONALS FOR TRANSPARENCY
andCivil Action No. 4:22-cv-915-P

PATRICK AND STEPHANIE DE GARAY,
Plaintiffs,
v.

U.S. FOOD AND DRUG
ADMINISTRATION,
Defendant.
DECLARATION OF SARAH B. KOTLER
I, Sarah B. Kotler, declare as follows:1.

I am the Director of the Division of Freedom of Information (“DFOI”), Office of

the Executive Secretariat, Office of the Commissioner, Food and Drug Administration (“FDA” or“the agency”), United States Department of Health and Human Services (“HHS”), in Rockville,
Maryland.
2.

I have held the position of Director of DFOI since January 2015. Prior to becoming

Director, I served as Acting Director of DFOI from November through December 2014, after theformer Director of DFOI retired. I previously served as DFOI’s Deputy Director and Denial &Appeals Officer from September 2013 through October 2014; and as Denials & Appeals Officer
from March 2007 through August 2013.
3.

As both Deputy Director and Director, I have had supervisory 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

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Information Act (FOIA), 5 U.S.C. § 552. See 21 C.F.R. § 20.40. In addition, DFOI is responsible
for FDA’s FOIA reporting to HHS and the U.S. Department of Justice, consulting with otherfederal agencies regarding FOIA requests, agency-wide FOIA training, and expedited processing,among other functions. DFOI processes about 25% of all FOIA requests received by FDA; theother 75% are processed by the FOIA reviewers within FDA’s other components.
4.

As part of my duties, I coordinate 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 pursuant to applicable law, including provisions of the FOIA, 5
U.S.C. § 552. I am also aware of the workload obligations 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 provide an overview of FDA’s procedures forhandling FOIA requests, FOIA workloads across the agency, and FDA’s ability to process the
FOIA requests at issue in this proceeding made by Public Health and Medical Professionals forTransparency (“PHMPT”) and Stephanie and Patrick de Garay (collectively, “Plaintiffs”). Thisdeclaration also documents the agency’s basis for denying Plaintiffs’ requests for expedited
processing.
7.

As explained below, Plaintiffs’ FOIA requests did not satisfy the standard forexpedited processing because they did not establish an urgent need to inform the public about
federal government activities. Further, Plaintiffs’ proposed production schedule is not feasible-2-

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given that, among other things, FDA cannot reallocate resources from other components of theagency. Since the beginning of the COVID-19 pandemic, the number of FOIA requests
submitted to FDA has significantly increased, as has their complexity and the amount ofsubsequent FOIA litigation. Because of these factors and the agency’s existing FOIA and nonFOIA workload, other FDA components cannot assist the Center for Biologics Evaluation andResearch (“CBER”) in attempting to satisfy Plaintiffs’ proposed production schedule without
diverting significant resources away from the processing of other FOIA requests that are also inlitigation, requests that are ahead of Plaintiffs’ requests, and other non-FOIA record requests.
This would adversely impact the agency’s ability to meet stipulated document processing
deadlines and prejudice other important pending requests at the expense of overall transparency
and the agency’s public health mission.
FDA’S GENERAL PROCEDURE FOR INCOMING FOIA REQUESTS
8.

Under FDA’s regulations, DFOI is the office responsible for FDA’s compliancewith FOIA. See 21 C.F.R. §§ 20.30, 20.40. When DFOI receives an electronic FOIA request, it
generates a control number that begins with four digits reflecting the calendar year in which therequest was received, followed by a number reflecting 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 forindividuals 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,-3-

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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 request 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 imminent threat to the life or physical safety of anindividual”; or (2) a request is made by “a person primarily engaged in disseminating information”
and there is a demonstrated “urgency to inform the public concerning actual or alleged Federal
Government activity.” Id. DFOI reviews requests to determine whether expedited processing isappropriate and sends a letter to the requester documenting its determination. In accordance with
21 C.F.R. § 20.44, requests that have been granted expedited processing are processed as soon aspracticable, on a first-in, first-out basis based on the date of receipt.
10.

FDA’s FOIA program is decentralized because 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 request is received and logged by DFOI, the request is assigned to the
FDA component reasonably likely to possess responsive records, which then processes the request.
FOIA reviewers within the assigned component process potentially responsive records anddetermine whether they should be released in full, redacted in part, or withheld in their entirety
under any applicable FOIA exemption or other statutory or regulatory provision.
FDA’S PUBLICATION OF INFORMATION 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 information. As relevant to the instant matter, thisincludes the most important safety and efficacy information about Moderna’s Spikevax vaccine,-4-Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23

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Pfizer-BioNTech’s Comirnaty vaccine, and the supplemental approval of the Comirnaty vaccine
for use in individuals ages 12-to-15 years old.
12.

FDA features the latest information 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-disease-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, emergency use authorizations, personal protective
equipment, FDA guidance documents, Frequently Asked Questions, and resources for healthprofessionals, among other things.

FDA, Coronavirus Disease 2019 (COVID-19),https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emergingthreats/coronavirus-disease-2019-covid-19.
14.

From that main COVID-19 page, the user 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 avariety of important information about the Spikevax vaccine (and its bivalent booster), organized-5-

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into the following categories designed to make each topic accessible to the public and healthcare
providers:a) Spikevax Information: This section provides package inserts, the Summary Basis forRegulatory Action, Frequently Asked Questions (FAQs), an Approval Letter, and an
additional link to information on the Centers for Disease Control (CDC) website. Thesematerials 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 healthcare providers that
describe the primary series and bivalent boosters for the Spikevax vaccine, organized bydate 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” withfact sheets describing primary series and bivalent booster vaccines 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 addendums 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/media/163937/download) and letter ofauthorization (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 about Spikevax, press
conference links, and press releases beginning in December of 2020. More recently, thisincludes two Advisory Committee webcasts from June of 2022 totaling more than 15 hours-6-

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https://youtu.be/Ixm4UmldTGQ

andhttps://youtu.be/

GbNpaZeDPiA).
e) Translations: To ensure public accessibility, the webpage also includes translations ofcertain Spikevax information in multiple languages.
16.

The “Spikevax Information” section includes a link to another webpage providing

detailed regulatory documents that explain the basis for Spikevax’s approval, found athttps://www.fda.gov/vaccines-blood-biologics/spikevax.

This page contains the “Action

Package” for Spikevax, comprising hundreds of pages of materials that the agency expects are themost useful to the public in understanding FDA’s approval decision. It includes the Clinical
Review Memorandum (which provides information about individual clinical trials, safety andefficacy, and risk-benefit considerations and recommendations, 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 History, Letters, Reviews, and Related Documents” for Spikevax.
The zip file (at https://www.fda.gov/media/156343/download) provides, among other things,
Statistical Reviews, Toxicology Review, Benefit-Risk Assessment Review, Pharmacovigilance
Plan Review, and Chemistry-Manufacturing Controls Review. The documents in the Action
Package thus provide valuable summaries of the information and data submitted by Moderna, as
well as FDA’s assessment, which together explain FDA’s decision to license the Spikevax vaccine.
17.

Information about the Comirnaty Vaccine: Similarly, a Pfizer-specific webpage

provides focused and updated information about the Comirnaty vaccine and its bivalent booster
vaccine.

Pfizer-BioNTech

COVID-19

Vaccines,

athttps://www.fda.gov/emergency-

preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19vaccines. Among other things, that page contains links to important information about the-7-Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23

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Comirnaty vaccine, FDA’s approval of its use in individuals 12 through 15 years of age, and thebivalent booster.
18.

The information is organized into the following categories designed to make each

topic readily accessible to the public and healthcare providers.
a) Comirnaty Information: This section provides package inserts, regulatory information,
Frequently Asked Questions (FAQs), and additional links to information on the Centers
for Disease Control (CDC) website. Among other things, the package inserts dated July 8,2022, provide information about clinical trials and adverse reaction frequency in study
participants of different ages, including participants 12 through 15 years of age. See
Package Insert (purple cap), at https://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 healthcare providers that
describe the primary series and bivalent boosters for the Comirnaty vaccine, organized bydate 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 andolder. 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 and 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 Committee Meeting information,
beginning in December of 2020. The most recent updates include a decision memorandum-8-

Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23(https://www.fda.gov/media/163895/download)

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andletterofauthorization(https://www.fda.gov/media/150386/download) added on December 8, 2022, and a letter
granting EUA Amendment (https://www.fda.gov/media/164184/download) added on
December 22, 2022.
d) Media Materials and Webcasts: This section provides 28 records comprised ofwebcasts of FDA’s Vaccines and Related Biological Products Advisory Committee
meetings, press conference links, and press releases, beginning in December of 2020, with
the

most

recentupdate

being

a

press

releaseon

December

8,2022(https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-updatefda-authorizes-updated-bivalent-covid-19-vaccines-children-down-6-months).
e) Translations: To ensure public accessibility, the webpage also includes translations ofcertain information in multiple languages.
19.

The “Comirnaty Information” section includes a link to another webpage providing

detailed regulatory documents that explain the basis for Comirnaty’s approval, found athttps://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 decision. It includes the Clinical
Review Memorandum (which provides information about clinical trials safety and efficacy, andrisk-benefit considerations and recommendations, among other things), the Statistical Review,
Approval Letters, and the Summary Basis for Regulatory Action, as well as a link to a zip filecontaining the “Approval History, Letters, Reviews, and Related Documents” for the Comirnaty
vaccine.

The documents in the Action Package thus provide valuable summaries of theinformation and data submitted by Pfizer-BioNTech that FDA reviewed and assessed in-9-Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23

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determining whether to approve licensure for the vaccine 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 theCenters for Disease Control (CDC), found at https://www.cdc.gov/vaccinesafety/ensuringsafety/
monitoring/.
21.

FDA continues to regularly update its website to provide the most current andrelevant 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 PHMPT submitted a request seeking
expedited processing of “[a]ll data and information for the Moderna 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 thisrequest control number 2022-1614 (hereafter, “First 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 data and information responsive to and being produced in
FOIA Control # 2021-5683 (previously made on behalf of PHMPT)” (citation omitted).
FDA assigned this request control number 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 August 8, 2022 request.

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FDA assigned this request control number 2022-6129 (hereafter, “Third Request”).
Complaint, Ex 8.
23.

As written, Plaintiffs’ requests are extremely broad and would require the agency’s

careful review of millions of pages of records and data files in the Biologic Product Files (“BPFs”)
for the Spikevax vaccine and the ages 12 through 15 years indication for the Comirnaty vaccine(hereafter, the “Comirnaty indication”) to determine which information is available for release to
the public under 21 C.F.R. § 601.51(e).
24.

I assigned Plaintiffs’ requests to CBER for processing because they sought

information—BPF records—in CBER’s custody. CBER’s processing of Plaintiffs’ requests is
described in more detail in the Beth Brockner-Ryan Declaration (Brockner-Ryan Decl. ¶¶ 32-34).
REQUESTS FOR EXPEDITED PROCESSING
25.

I reviewed Plaintiffs’ requests for expedited processing and determined that

Plaintiffs did not satisfy the requirements for expedited processing on any request. Complaint,
Exs. 2, 6, and 8.
26.

I found that Plaintiffs did not demonstrate a compelling need under 5 U.S.C.

§ 552(a)(6)(E), in substantial part because large amounts of information have already been madeavailable to the public about the Spikevax and Comirnaty vaccines and related FDA activities. A
compelling need exists when: (1) A failure to obtain 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 disseminating information,
there is a demonstrated urgency to inform the public concerning 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 expedited processing requests “[b]ecause the granting-11-

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of a request for expedition necessarily works to the direct disadvantage of other FOIA requesters.”
DOJ,

FOIA

Update:OIP

Guidance:

When

to

Expedite

FOIA

Requests,

https://www.justice.gov/oip/blog/foia-update-oip-guidance-when-expedite-foia-requests.
27.

First, I found that Plaintiffs’ requests did not contain any basis to conclude that a

failure to obtain records on an expedited basis would pose a threat to any individual. As a result,
I concluded that Plaintiffs had not satisfied the first criterion for expedited processing. Second, I
determined that Plaintiffs had not established an urgency to inform the public concerning actual or
alleged Federal Government activity, also largely because there is a significant amount of
information already available to Plaintiffs and the public concerning 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 argued that PHMPT was primarily
engaged in disseminating information and that it was urgent to release the records underlying
licensure of Spikevax because of “widespread 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.”
29.

Id.

As discussed above, FDA has published a significant amount of information related

to the Spikevax and Comirnaty vaccines on its website on an ongoing basis. The documents posted
by the agency currently contain, among other things, FDA review 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 andanalyses of safety and effectiveness, among other things, for both Spikevax and Comirnaty. See
CDC,

Overview

of

COVID-19

Vaccines,-12-

https://www.cdc.gov/coronavirus/2019-ncov/

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vaccines/different-vaccines/overview-COVID-19-vaccines.html. CDC also provides the publicwith access to its WONDER database, which contains adverse event report data collected throughthe U.S. Vaccine Adverse Event Reporting System. See CDC, How to Access VAERS Datathrough

VAERS

WONDER

System,https://www.cdc.gov/vaccinesafety/ensuringsafety/

monitoring/vaers/access-VAERS-data.html. As a result, the public has access to a large amountof information about the vaccine, particularly government actions related to the vaccine’s approval
as well as on-going adverse event information.
30.

The fact that people may have differing opinions about a certain FDA-regulated

product does not create “urgency” within the meaning of the expedited processing standard –especially in light of the amount of information, and considering that the most relevant information
for health care providers and consumers has been, published on FDA’s website. Nor does the factthat certain individuals may be administered a certain product. FDA approves medical products
regularly in the course of agency business. It is not unheard of for those approvals to be the subjectof controversy, and there are almost always people who are administered the products shortly after
approval. Such a situation cannot be deemed to create 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, especiallywhen the agency routinely publishes summaries of safety and efficacy information on its website(as it did here). If Plaintiffs’ view became the standard, a great number of FDA’s FOIA requests
would qualify for expedited processing, and requesters with non-expedited requests would havetheir wait times extended – possibly significantly. Thus, Plaintiffs’ claims that their requests
would fulfill an urgent demand is not supported, and I denied the requests for expedited processing.
Complaint, Exs. 2, 6, and 8.

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ALLOCATION OF AGENCY RESOURCES
31.

As detailed in the Brockner-Ryan Declaration (¶¶ 23-28), CBER’s FOIA resources

are currently stretched to their maximum capacity due to marshaling its resources to comply withthis Court’s production order in PHMPT v. FDA, No. 4:21-CV-1058 (“PHMPT 1”). And FDA
cannot reallocate resources from other agency functions or components to help process Plaintiffs’
requests. Performing disclosure reviews is a specialized skill that requires training and expertisethat the vast majority of FDA staff does not have.

It is not reasonable to expect that a

microbiologist who performs laboratory assays, a pharmacist who reviews drug applications, abadging office employee who issues credentials, or a mail room clerk who organizes mail cansimply begin performing disclosure review without significant training. Moreover, it would becontrary to FDA’s public health mission to pull staff off reviewing cancer treatment applications
or building counterfeit medication investigations to have them conduct 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 mustbe funded from general budgetary appropriations. See, e.g., DOJ, FOIA Update: FOIA AffectedbyBudgetConstraints,

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 allocate new monetary resources to hire new

disclosure staff or contractors, it takes substantial time to recruit and hire new staff, bring them onboard, and provide them with the necessary training to become competent to perform disclosure
reviews. FDA estimates that it takes approximately two years to fully train a new disclosure-14-

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reviewer. In the meantime, experienced reviewers are needed to closely supervise and review theirwork – 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 resources. 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 forthe agency to reallocate its existing disclosure resources in components outside of CBER to workon Plaintiffs’ requests because other FDA components’ disclosure staff are already over-extended
by existing disclosure obligations, many of which concern products or issues similarly importantto public health. For example, the Center for Devices and Radiological Health, among otherthings, is processing requests related to COVID-19 test kits; the Center for Drug Evaluation andResearch, among other things, is processing requests related to COVID-19 pharmaceuticaltreatments; the Center for Food Safety and Applied Nutrition, among other things, is processing
requests related to infant formula; the Center for Veterinary Medicine, among other things, isprocessing requests related to animal drugs; the Center for Tobacco Products, among other things,
is processing requests related to electronic nicotine delivery systems, colloquially known as ecigarettes and their components; the Office of Regulatory Affairs, among other things, isprocessing requests related to their inspections of regulated industry; and the Office of theCommissioner, among other things, is processing requests related to its administrative priorities
and responsibilities.

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PROCESSING WORKLOAD OF DISCLOSURE OFFICES OUTSIDE OF CBER
35.

As an initial matter, the disclosure office of each FDA component has its own

specialized responsibilities and expertise. Thus, although all disclosure staff will be familiar withstatutory requirements of FOIA and FDA’s disclosure regulations, staff from different centers willbe trained to review information regularly generated within that center. For example, CBER
reviewers are familiar with the types of information 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 types of records commonly processed by other parts of the agency,such as premarket tobacco product applications or food additive petitions. 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 but would not have the same expertise as a CBER
reviewer when looking at a BLA. Thus, even disclosure staff within the agency should not be
considered interchangeable.
36.

Further, on March 13, 2020, the President declared a national emergency due to theongoing COVID-19 pandemic. Since the beginning of this emergency, FDA has been flooded
with FOIA requests related to the pandemic.
37.

Specifically, in fiscal year 2022, FDA received approximately 8,529 FOIA

requests, many of which are directly related to COVID-19. Complicating matters, many recent
FOIA requests are more complex and 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 collaboration among federal agencies because they
involve records (such as emails) that may have originated in other agencies. Department of Justiceguidance advises federal agencies to consult with the originating agency for disclosure-16-

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determinations. DOJ, FOIA Update: OIP Guidance: Referral and Consultation Procedures,https://www.justice.gov/oip/blog/foia-update-oip-guidance-referral-and-consultation-procedures.
As a result, FDA regularly collaborates with other federal agencies, such as CDC, the National
Institutes of Health, and the Department of Health and Human Services, 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 and 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 grew by approximately 200%. In
2022, FDA received 26 new FOIA lawsuits. Currently, FDA is involved in approximately 52
active FOIA litigations. Significantly, 20 of those FOIA lawsuits involve COVID-19 records—
thus, there are now nearly as many FOIA litigations involving COVID-19 as there were total FOIA
litigations brought in 2022.
39.

At the review and redaction phase, certain FDA components have had to shift someof their FOIA reviewers from responding to FOIA requests in the normal course to almost
exclusively processing FOIA requests in litigation. This diversion of staff resources to respond toever increasing litigation and impending 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 has numerous other document processing

obligations, including those arising from subpoenas; discovery requests in non-FOIA litigations;oversight requests from Congress; requests from domestic and foreign regulatory bodies; and otherstatutory disclosure mandates. In some agency offices, the same staff that handles FOIA requests
also handles these other disclosure projects, as they rely on similar disclosure skills. As a result, it-17-

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would not be feasible for FDA to shift resources 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 responsible for processing 987 pending FOIA

requests, of which approximately 48 are related to COVID-19. This is a significant increase inpending 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 amarked increase in the numbers of requests beginning in 2021.

CDER: 5‐Year History ofPending FOIA Request Numbers
987
882

564

597

614

2019

2020

2021

2022

2023

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; and other federal agencies. Although these requests are not made1

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.
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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 forconsistency 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 regulatory authorities for
documents regarding FDA inspections of foreign drug manufacturers, and in response to requests
from the Department of Justice related to its investigations of pharmaceutical companies. CDER
also has other statutory disclosure obligations under the Food and Drug Administration
Amendments Act of 2007, which requires that New Molecular/Biological Entity (NM/BE) action
packages be published on CDER’s web page within 30 days of approval. In 2022 and the
beginning of 2023, CDER reviewed and redacted 37 NM/BE action packages, each of which
typically contains thousands of pages.
Office of the Commissioner (“OC”)
43.

As of February 28, 2023, OC has 378 pending FOIA requests. After 2020, OC

experienced a significant increase in FOIA requests, with the number approximately doubling
between 2020 and 2021.
44.

Prior to May 2022, OC had one full-time employee (“FTE”) devoted to processingof FOIA requests for records originating in OC, at times (since the fall of 2020), aided by shortterm detailees for 90-120 day periods. In 2022, due to its increasing backlog – particularly as it
pertains to FOIA litigation – OC added a second FTE and part-time assistance from others on myteam at DFOI (which division resides in OC) and was thus able to slightly decrease its FOIA queue.
However, the number of pending FOIA requests, even after more than doubling the FTEs working-19-Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23

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on these requests, remains far above pre-pandemic numbers. Indeed, despite my other duties,
including management of my division, I have also been assisting with FOIA review for COVID
requests in OC, as well as keeping the non-COVID OC FOIA workload moving. OC is currently
involved in 6 active litigation matters. The following chart illustrates the number of pending
requests in OC’s FOIA queue as of February 28 of the previous five calendar years.

OC: 5‐Year History ofPending FOIA Request Numbers
457

469
378

218
144

2019

2020

2021

2022

2023

Figure 2: Pending FOIA Requests in OC as of February 28 of each year from 2019 to 2023.
Center for Devices and Radiological 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 following 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.

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CDRH: 5‐year History ofPending FOIA Request Numbers
2271

2019

2331

2020

1927

1943

1852

2021

2022

2023

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. Responding to these non-FOIA requests requires acorresponding decrease in reviewers’ time available to respond to FOIA requests. For example,
within the past four years alone, CDRH has been required to devote time to producing hundredsof thousands of pages of documents in response to requests from other federal agencies related totheir investigation of medical device companies. Furthermore, since 2018, CDRH has responded
to numerous federal subpoenas, with quick turnarounds for productions that have required CDRH
reviewers to stop processing FOIA requests to respond to these subpoenas.

In 2022, one

voluminous subpoena alone yielded hundreds of thousands of pages.
Other FDA Components
47.

The components highlighted above are not outliers. Other FDA components havesignificant 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-21-

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pending FOIA requests has increased markedly from 162 in February 2021 to 409 in February2023—more than doubling in just two years.
48.

Although largely unrelated to the COVID-19 pandemic, FDA’s Center for

Veterinary Medicine has also seen 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 they 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, such as Privacy Act requests.
49.

Based on all of the information above, none of FDA’s other disclosure offices areable to assume the burden of taking on a significant role in the review of CBER records responsive
to Plaintiffs’ requests without compromising 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 backlogs and improve

processing time. Specifically, FDA’s FOIA offices 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 requests; evaluating requests daily inorder to shift them to experienced redactors as needed; and, where possible, proactively contacting
FOIA requesters to negotiate the scope of requests to in order to produce records more quickly.
As noted in the Brockner-Ryan Declaration (¶ 26), since February 2022, CBER has hired 9.5-22-Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23

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contractors (9 full-time and 1 part-time) to assist with FOIA processing and was recently approved
to hire and train 6 new full-time disclosure staff for continued processing for PHMPT 1 and toaddress its backlog due to the resources already devoted to PHMPT 1.
51.

Moreover, starting in January 2022, CDER has brought on 7 additional employees(comprised of 6 brand-new FDA employees and 1 employee returning to CDER from the Officeof Regulatory Affairs) to assist with FOIA processing. Similarly, CDRH completed a businessprocess improvement review of its FOIA program in October 2019, which included identifying
hiring needs; updating workflows, processes, and procedures; training reviewers; and additional
tracking of FOIA requests. Between September and December 2019, CDRH acquired a multiyear contract that currently provides 11 contractors to assist in reducing FOIA backlogs and hired
additional full-time reviewers to process FOIA requests and other disclosure tasks.
CONCLUSION52.

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, anabundant amount of information to the public about the Spikevax and Comirnaty vaccines. FDA
has also taken reasonable steps to assist Plaintiffs with providing a more targeted FOIA request,
as discussed in greater detail in the Brockner-Ryan Declaration (¶¶ 33-35). But Plaintiffs’ requests
do not satisfy the statutory standard for granting expedited processing. Further, given 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 burdensome for FDA to reallocate resources fromagency components outside of CBER. If required to do so, FDA’s ability to perform its otheragency functions, including responding to other record requests, would likely be impaired.

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Pursuant to 28 U.S.C. § 1746, I declare under the penalty of perjury that the foregoing istrue and correct.
Executed on March 31, 2023.

signed by
Sarah B. Digitally
Sarah B. Kotler -S
Date: 2023.03.31
Kotler-S
08:39:30 -04'00'_____________________

SARAH B. KOTLER
Director of Division of Freedom of Information
Office of the Executive Secretariat
Food and Drug Administration
U.S. Department of Health and Human Services-24-