Memorandum Opinion — ICAN v. FDA, No. 25-823 (D.D.C. Oct. 16, 2025)

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UNITED STATES DISTRICT COURT · No. 1:25-cv-00823-JEB · Doc. 22 · 2025-10-16 · Docket on CourtListener

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UNITED STATES DISTRICT COURT 
FOR THE DISTRICT OF COLUMBIA 
 
 
INFORMED CONSENT ACTION 
NETWORK, 
 
Plaintiff, 
 
 
v. 
Civil Action No. 25-823 (JEB) 
FOOD AND DRUG ADMINISTRATION, 
et al., 
 
Defendants. 
 
 
 
MEMORANDUM OPINION 
 
Plaintiff Informed Consent Action Network brought this action against the Food and 
Drug Administration and the United States Department of Health and Human Services, seeking 
records it had previously requested under the Freedom of Information Act.  Defendants now 
move to stay proceedings in this case for eighteen months.  Because they face unforeseeable and 
unprecedented demands for records imposed by a district court in Texas and by Plaintiff itself, 
the Court will grant the Motion.  
I. 
Background  
On December 31, 2019, ICAN submitted a FOIA request to the FDA seeking every email 
communication from calendar year 2019 among federal employees of the Center for Biologics 
Evaluation and Research (CBER) Office of Vaccines Research and Review that included or 
concerned certain individuals or topics.  See ECF No. 1 (Compl.), ¶ 6; see also ECF Nos. 1-1–6 
(FOIA requests).  By 2025, the FDA had neither produced records responsive to the request nor 
issued a final determination under 5 U.S.C. § 552(a)(6)(A)(i) stating whether it would comply 
with the request.  See Compl., ¶ 12.  ICAN then sued FDA and HHS, seeking to compel the 
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agencies’ compliance with FOIA.  Id. at 1.  Defendants have now filed a Motion to Stay 
proceedings, contending that they face unprecedented demands under FOIA and, despite ongoing 
hiring and training efforts, are unable to keep up with requests.  See ECF Nos. 15 (Mot. Stay), 
15-1 (Mem. Supp.) at 2.  They also point to their requests for stays in thirteen other FOIA cases 
in this district, which courts have granted.  See Mem. Supp. at 8–9, 8 n.3 (listing cases).   
II. 
Legal Standard 
When an agency receives a request for records under FOIA, it shall determine within 20 
working days “whether to comply with such request.”  5 U.S.C. § 552(a)(6)(A)(i).  “Upon any 
determination by an agency to comply with a request for records, the records shall be made 
promptly available to such person making such request.”  Id., § 552(a)(6)(C)(i).  But “[i]f the 
Government can show exceptional circumstances exist and that the agency is exercising due 
diligence in responding to the request, the court may . . . allow the agency additional time to 
complete its review of the records.”  Id.; see also Open Am. v. Watergate Special Prosecution 
Force, 547 F.2d 605, 616 (D.C. Cir. 1976) (when exceptional circumstances and due diligence 
are shown, “the time limits . . . in subsection (6)(A) become not mandatory but directory”).  
“Exceptional circumstances” include those “created by a virtual deluge of requests” that “have 
prevented the agency from completing its review of the records sought.”  Open Am., 547 F.2d at 
610.  Agencies can demonstrate due diligence by reallocating staff to address increased FOIA 
needs, splitting requests into “simple” and “complex” tracks, and hiring new staff as their 
budgets permit.  Democracy Forward Found. v. Dep’t of Just., 354 F. Supp. 3d 55, 61–62 
(D.D.C. 2018).   
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III. 
Analysis 
A. 
Jurisdiction 
ICAN’s opening argument is that FOIA does not permit the Court to stay such an action.  
See ECF No. 17 (Resp.) at 8–11.  Plaintiff agrees that when "the Government can show 
exceptional circumstances exist and that the agency is exercising due diligence in responding to 
the request," FOIA authorizes the court to "retain jurisdiction and allow the agency additional 
time to complete its review of the records."  Id. at 8–9 (quoting 5 U.S.C. § 552(a)(6)(A)(i)).  It 
then focuses solely on the words “retain jurisdiction,” arguing that the statutory phrase does not 
permit courts to “grant a stay, suspend proceedings, or excuse compliance” with FOIA.  Id. at 9.  
It further contends that granting a stay would “eliminate[] judicial oversight,” although it cites no 
authority for that proposition or its crabbed interpretation of FOIA’s requirements.  Id.     
This unsupported statutory reading, moreover, runs headlong into a wall of textual 
evidence and precedent.  On its face, the statute permits courts to “allow the agency additional 
time to complete its review of the records” upon a showing of exceptional circumstances and due 
diligence.  See 5 U.S.C. § 552(a)(6)(C)(i).  A different statutory provision excuses certain 
consequences for an agency’s failure to comply with standard time limits if “a court has 
determined that exceptional circumstances exist,” as defined in subparagraph (C), “for the length 
of time provided by the court order.”  Id., § 552(a)(4)(A)(viii)(II)(cc).  The statute thus clearly 
contemplates that courts may order stays in FOIA litigation proceedings upon a finding of 
exceptional circumstances, as that would be the mechanism by which agencies would receive 
additional time to respond. 
Indeed, Plaintiff’s own account of a court’s role while it “retains jurisdiction” over a 
FOIA case is consistent with the stay that Defendants seek.  ICAN argues that the statute 
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“contemplates active judicial supervision, continued progress, and court-ordered accountability,” 
Resp. at 9 — all of which still occur, albeit in more attenuated fashion, when a stay is in place.  
Courts granting a stay motion can require status reports and respond to a party’s motion to end 
the stay as facts on the ground change, preserving their supervisory and accountability functions.  
See, e.g., ICAN v. FDA, 2024 WL 4836405, at *2 (D.D.C. Nov. 20, 2024) (shortening agency’s 
requested stay from eighteen months to eight); ICAN v. FDA, 2025 WL 2480080, at *2 (D.D.C. 
Aug. 28, 2025) (imposing six-month stay and ordering status conference “to discuss whether the 
stay should be extended or lifted”).  Nothing in Plaintiff’s characterization precludes a judicial 
stay of proceedings. 
Longstanding precedent in this Circuit confirms the propriety of a stay.  In Open 
America, the D.C. Circuit held that subparagraph (C) permits courts to “excuse the Government 
from the rigid time limits of subparagraphs (A) and (B).”  547 F.2d at 612.  The Open America 
court further concluded that this “safety valve” made sense given Congress’s decision to 
“appropriate[] no additional resources whatsoever” for the implementation of its recent FOIA 
amendments.  Id.  And Congress, far from “reject[ing]” the holding in Open America, Resp. at 
14, appeared to accept it in its 1996 amendments.  See H.R. Rep. No. 104-795, at 24 (1996) 
(noting amendments were “consistent with the holding of Open America” and “would clarify 
that routine, predictable agency backlogs . . . do not constitute exceptional circumstances”); S. 
Rep. No. 104-272, at 17 (1996) (when exceptional circumstances are found, “FOIA does not 
limit the additional time permitted”).  Later D.C. Circuit decisions continued to characterize 
subparagraph (C) as authorizing courts to extend agencies’ FOIA deadlines during litigation in 
response to exceptional circumstances.  See, e.g., Citizens for Responsibility & Ethics in Wash. 
v. Fed. Elec. Comm’n, 711 F.3d 180, 185 (D.C. Cir. 2013) (noting that while agency’s failure to 
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make a determination satisfies requester’s exhaustion requirement, “[o]nce in court . . . the 
agency may further extend its response time if it demonstrates ‘exceptional circumstances’ to the 
court”).  Plaintiff offers no evidence to rebut these unified sources. 
Even if, as Plaintiff asserts, “Open America should be abandoned or narrowly confined,” 
Resp. at 11 (formatting altered), this Court has no authority to reinterpret a statute contrary to 
existing circuit precedent.  As have dozens of other courts, it thus proceeds to the merits of 
Defendants’ Motion to Stay. 
B. 
Section 552(a)(6)(C)(i) Stay 
It is beyond dispute that “timely disclosure of information of potential public interest was 
among Congress’s central aims in enacting FOIA.”  Daily Caller v. U.S. Dep’t of State, 152 F. 
Supp. 3d 1, 13 (D.D.C. 2015).  The statute permits a stay only if the responding agency can 
demonstrate that it faces “exceptional circumstances” and has responded to its pending requests 
with “due diligence.”  5 U.S.C. § 552(a)(6)(C)(i).  The Court finds that CBER meets both criteria 
and that an eighteen-month stay is thus warranted. 
1. 
Exceptional Circumstances 
First, CBER has faced skyrocketing FOIA requests since 2019 that show no signs of 
abating.  Compare ECF No. 15-2 (Suzann Burk Declaration), ¶ 26 (range of 255 to 343 annual 
requests from 2015–18), with id., ¶ 27 (range of 391 to 633 annual requests from 2019–24).  The 
increase in requests has meant that even when CBER’s disclosure office “was able to close more 
requests” in 2024 than in 2023, “the number of pending requests increased,” leaving CBER with 
a significant and growing backlog.  Id., ¶ 27.  Attendant litigation rates have also exploded, 
requiring more of CBER’s resources: nearly 50 FOIA suits were filed between 2019 and 2024, 
compared to a single case from 2015 to 2018.  Id., ¶¶ 26–27.   
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Sharp, unpredictable increases in FOIA requests and litigation are precisely the type of 
events that courts have held constitute exceptional circumstances warranting a stay.  See, e.g., 
Democracy Forward Found., 354 F. Supp. 3d at 60 (finding unexpected “near doubling of FOIA 
demands over a two-year period” constituted “exceptional circumstances”).  Nor do there appear 
to be either cyclical patterns of requests or a period of steady increase that would have put CBER 
on notice that a period of acceleration was coming.  Cf. Daily Caller News Found. v. FBI, 387 F. 
Supp. 3d 112, 117–18 (D.D.C. 2019) (FOIA requests to FBI not “unexpected” when agency 
experienced prior increases connected to predictable events, like presidential elections). 
What is more, Plaintiff is a major contributor to the onslaught.  “Since 2019, Plaintiff has 
submitted more than 350 FOIA requests seeking CBER records,” and it is the plaintiff in two-
thirds of CBER’s open FOIA lawsuits.  See Burk Decl., ¶ 29.  When a single party’s FOIA 
requests are “unusually voluminous,” it is unlikely that an agency could have anticipated the 
“massive scope and scale” of resources required to respond.  Shapiro v. U.S. Dep’t of Just., 2014 
WL 12912625, at *1–2 (D.D.C. Dec. 8, 2014).  Plaintiff can hardly overload CBER with 
hundreds of requests and then complain about the consequences of the backlog it created.  See 
ICAN v. FDA, 23-3675, ECF No. 25 (Order) at 2 (granting stay and recognizing “to some 
extent, this is a problem of Plaintiff’s own design”). 
Beyond the unanticipated “virtual deluge” of requests by Plaintiff and others in recent 
years, Open Am., 547 F.2d at 610, CBER must contend with another exceptional disclosure 
requirement: two mandated production orders in separate litigation, Public Health & Medical 
Professionals for Transparency v. FDA, No. 21-1058 (N.D. Tex.) (PHMPT I), and Public Health 
& Medical Professionals for Transparency v. FDA, No. 22-915 (N.D. Tex.) (PHMPT II).  See 
Burk Decl., ¶¶ 7–8.  In those cases, a federal judge in the Northern District of Texas ordered 
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CBER to produce between 90,000 and 230,000 pages of records per month, starting in July 2023, 
in response to two particularly voluminous FOIA requests.  See PHMPT I, ECF No. 35 (Produc. 
Order I) at 3 (requiring 55,000 pages per month); PHMPT II, ECF No. 38 (Produc. Order II) at 1 
(after ramp-up period, requiring 180,000 pages per month); Burk Decl., ¶ 8 (“Collectively, 
PHMPT I and PHMPT II required CBER’s disclosure staff to produce at least 90,000 to 110,000 
pages per month” initially, and “at times more than 230,000 pages per month.”). 
This level of judicially ordered production belies practicality.  The common practice for 
courts in this district, whose FOIA docket dwarfs that of any other district in the country, is to 
require processing 300–500 pages per month — orders of magnitude below what the judge 
required in the PHMPT litigation.  See, e.g., Middle East F. v. U.S. Dep’t of Homeland Sec., 297 
F. Supp. 3d 183, 187 (D.D.C. 2018) (ordering 500 pages processed per month); Energy Future 
Coal. v. OMB, 200 F. Supp. 3d 154, 163 (D.D.C. 2016) (declining to increase production from 
500 pages per month); Martínez v. Dep’t of Just., 2023 WL 9781681, at *1 (D.D.C. Sep. 27, 
2023) (similar, and crediting agency’s assertion that higher rate would be “detrimental to other 
requestors”) (quotation marks omitted).  Just as agencies cannot predict when “a single citizen 
[will] consume such a vast quantity of [their] FOIA resources,” Shapiro, 2014 WL 12912625, at 
*2, so, too, is it impossible to anticipate that one judge will impart production demands that 
wildly outstrip other courts’ requirements.  These outlier orders have forced CBER to reallocate 
staff, enter new contracts, and hire new employees to focus on PHMPT production — diverting 
resources from other FOIA requests in the process.  See, e.g., Burk Decl., ¶ 32 (reallocation left 
“small team of six” to “assume primary responsibilities for all other FOIA requests”).   
  The Court generally agrees with Judge Randolph Moss’s assessment that “it might seem 
unfair to the plaintiff in this case . . . to see the bulk of the agency’s resources devoted to 
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satisfying the demands of a single requester, who obtained an extraordinary court order before 
others were able to obtain more limited judicial relief.”  Children’s Health Def. v. U.S. FDA, 
2024 WL 147851, at *3 (D.D.C. Jan. 12, 2024).  That sentiment is diluted, however, by the fact 
that the plaintiffs in PHMPT have the same counsel as the Plaintiff here.  See Mem. Supp. at 14.  
While this Court cannot review another district court’s order, it can take into account the effects 
of that atypical demand on the agency’s FOIA processing capacity.  The Court thus finds that 
CBER faces exceptional circumstances warranting a stay. 
2. 
Due Diligence 
CBER has responded to the massive strain on its resources with due diligence.  The office 
maintains a six-tiered response system to FOIA requests based on the “volume, complexity, or 
subject matter of the requested records.”  Burk Decl., ¶ 17.  Courts in this district have found that 
a “first-in, first-out multitrack system for processing requests” like CBER’s indicates due 
diligence.  Children’s Health Def., 2024 WL 147851, at *3; see also Elec. Frontier Found. v. 
Dep’t of Just., 517 F. Supp. 2d 111, 119 (D.D.C. 2007) (same).  CBER has also acted in good 
faith to respond to the increased demands it faces by hiring new staff, including two assigned to 
process non-PHMPT FOIA requests, reassigning staff, and engaging contractors.  See Burk 
Decl., ¶¶ 34–35; see also Judicial Watch, Inc. v. U.S. Dep’t of Homeland Sec., 895 F.3d 770, 
783 (D.C. Cir. 2018) (“[A]gency good faith effort and due diligence are the touchstones 
underlying FOIA’s statutory scheme.”) (internal quotation omitted).  And as CBER completes 
the “labor-intensive process” to train those new hires, more employees will be available to 
address its backlog moving forward.  Id., ¶ 36.   
The Court credits CBER’s conscientious reorganization efforts and attempt to balance the 
mammoth requirements in the PHMPT litigation with the need to continue processing other 
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FOIA requests.  It joins other courts in this district in finding that consistent FOIA policies and 
targeted hiring in response to exceptional demands are sufficient to demonstrate due diligence.  
See Children’s Health Def., 2024 WL 147851, at *3; Democracy Forward Found., 354 F. Supp. 
3d at 62–63 (“modest” staff additions, combined with a first-in, first-out processing system, “are 
sufficient to establish the agency’s diligence”).  The Court furthermore agrees with Defendants 
that, given the magnitude of demands it faces, an eighteen-month stay with intervening status 
reports is appropriate. 
IV. 
Conclusion 
Because the Court finds a stay is warranted under 5 U.S.C. § 552(a)(6)(C)(i), it need not 
consider CBER’s alternative argument that the Court should exercise its equitable powers to stay 
litigation under Landis v. North American Co., 299 U.S. 248 (1936).  See Mem. Supp. at 1.  A 
separate Order so stating will issue this day. 
 
/s/ James E. Boasberg 
JAMES E. BOASBERG 
Chief Judge 
Date:  October 16, 2025 
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