INFORMED CONSENT ACTION NETWORK v. FOOD AND DRUG ADMINISTRATION et al

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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
INFORMED CONSENT ACTION
NETWORK,
Plaintiff,
v. Civil Action No. 1:25-cv-00826 (CJN)
FOOD AND DRUG ADMINISTRATION,
et al.,
Defendants.
ORDER
The government moves to stay the proceedings in this FOIA case (in which Plaintiff seeks
information from the FDA about clinical trial protocols for the polio vaccine) until December 14,
2026. See ECF 1 at 2; ECF 14; ECF 19 at 1 n.1. For the reasons that follow, the Court grants in
part and denies in part the motion and issues a stay through October 1, 2026.
An agency that receives a FOIA request ordinarily must “determine within 20 days . . .
whether to comply with such request,” and then—if it decides to comply—make the requested
records “promptly available.” 5 U.S.C. §§ 552(a)(6)(A)(i), (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 retain jurisdiction and allow the agency additional time to complete
its review of the records.” Id. § 552(a)(6)(C)(i). “‘[E]xceptional circumstances exist’ when an
agency . . . is deluged with a volume of requests for information vastly in excess of that anticipated
by Congress” and its “existing resources are inadequate to deal with the volume of such requests
within the [otherwise applicable] time limits.” Open Am. v. Watergate Special Prosecution Force,
547 F.2d 605, 616 (D.C. Cir. 1976). And an agency can demonstrate its “due diligence” in
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complying with the requirements of FOIA by showing that it has a satisfactory “present procedure
for processing FOIA requests”—such as one that categorizes requests by difficulty, seeks to
proceed on a “first-in, first-out basis,” and is staffed by an adequate number of personnel.1 Id. at
612–13.
The government has demonstrated that a stay under 5 U.S.C. § 552(a)(6)(C)(i) (also known
as an Open America stay) is warranted here. In the past several years, court orders in two FOIA
cases in the Northern District of Texas have compelled the Food and Drug Administration, through
its Center for Biologics Evaluation and Research, to produce approximately 9.1 million pages of
COVID-19 vaccine records within a highly compressed timeframe. See Pub. Health & Med. Pros.
for Transparency v. FDA, Civ. A. No. 21-1058 (N.D. Tex.) (“PHMPT I”); Pub. Health & Med.
Pros. for Transparency v. FDA, Civ. A. No. 22-915 (N.D. Tex.) (“PHMPT II”); see also ECF 14-
2 ¶¶ 7–10. The FDA was initially required to produce at least 90,000 pages per month from July
2023 to November 2023. ECF 14-2 ¶ 8. Then, to satisfy a later production order in PHMPT II,
the FDA needed to produce at least 230,000 pages per month through June 2025. Id. And most
recently, the FDA was ordered to produce additional records in PHMPT II at a rate of at least
180,000 pages per month to meet an October 1, 2026, deadline. Id. ¶ 10. This unprecedentedly
demanding production schedule—which has prompted the FDA to hire new employees and
substantially reallocate its existing staff, id. ¶¶ 30–36—far exceeds a “predictable” agency
workload and thus constitutes “exceptional circumstances” within the meaning of FOIA, Elec.
1 Despite Plaintiff’s suggestions to the contrary, ECF 16 at 8–17, the Court cannot ignore or
overrule the Court of Appeals’s binding holding in Open America permitting stays when these
requirements are met, see United States v. Torres, 115 F.3d 1033, 1036 (D.C. Cir. 1997)
(“[D]istrict judges, like panels of this court, are obligated to follow controlling circuit precedent
until either we, sitting en banc, or the Supreme Court, overrule it.”); Resol. Tr. Corp. v. Burke, 869
F. Supp. 15, 18 (D.D.C. 1994) (“[T]his Court is bound to follow the law set forth by the Court of
Appeals in this Circuit.”).
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Frontier Found. v. Dep’t of Just., 517 F. Supp. 2d 111, 119 (D.D.C. 2007) (citations omitted); see
also Informed Consent Action Network v. FDA, No. 25-cv-832, 2026 WL 310004, at *3 (D.D.C.
Feb. 5, 2026) (“[T]he judges in this district [have] f[ound] that the workload imposed on CBER
by the [PHMPT] orders, compounded by an overall increase in FOIA requests and related
litigation, demonstrate ‘exceptional circumstances.’” (citation omitted)); Child.’s Health Def. v.
FDA, No. 23-cv-220, 2024 WL 147851, at *3 (D.D.C. Jan. 12, 2024) (describing the same
schedule as “more overwhelming than the extraordinary increase in FOIA workloads that past
decisions have found sufficient to warrant stays”); ECF 19 at 4–5.
The FDA has also exercised due diligence in responding to the FOIA requests it receives,
including the one at issue in this case. FOIA requests that seek documents maintained by the
CBER are placed into one of six “queues” based on their “volume, complexity, or subject matter,”
and requests in each queue are generally processed in the order submitted. ECF 14-2 ¶¶ 17–18.
These standard protocols, in addition to the FDA’s efforts to hire new staff in the wake of the
PHMPT I and PHMPT II orders, “have been found sufficient to establish due diligence in other
cases.” Child.’s Health Def., 2024 WL 147851, at *3. Seeking to avoid this consistent conclusion,
Plaintiff now alleges in supplemental briefing that the FDA’s practices have changed because the
government’s latest filing uses “first-in, first-processed” rather than “first-in, first-out” to describe
its processing system. ECF 20 at 1 (quoting ECF 19-1 ¶ 20). But this change in terminology has
little effect on the due-diligence inquiry. The evidence that Plaintiff points to regarding the FDA’s
overall FOIA statistics does not show that the CBER—the department within the FDA that
possesses the records at issue and that has been subject to the PHMPT orders—is reviewing
requests within the same track out of order. See ECF 20-1 at 2 (chart with data about the processing
of subsequent requests that does not specify the department assigned to the requests being
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compared). Indeed, it is entirely unsurprising that some of the FDA’s FOIA requests are processed
faster than the one at issue here given that many fall under different departments within the FDA
that are not affected by the PHMPT orders and others assigned to the CBER are simple enough to
not need placed on the complex track. See ECF 14-2 ¶ 18 (“[S]ome queues move faster than other
queues, so the number of requests ahead of a particular request in one queue may not reflect
whether it will be processed before a particular request in a different queue.”). The Court therefore
“joins other courts in this district in finding that [the FDA’s] consistent FOIA policies and targeted
hiring in response to exceptional demands are sufficient to demonstrate due diligence.” Informed
Consent Action Network v. FDA, No. 25-cv-823, 2025 WL 2938703, at *4 (D.D.C. Oct. 16, 2025).
It is clear that an Open America stay of some duration is appropriate.2 The stay through
December 14, 2026, sought by the government, however, is too long—at least at present. As the
government admits, production in PHMPT I is finished and production in PHMPT II will be
completed by October 1, 2026. ECF 19 at 2–3. The Court therefore stays this case only until
October 1, 2026, subject to further consideration with the benefit of new information following
that date. Upon conclusion of the stay, the Court requires the Parties to submit a joint status report
on or before November 1, 2026, which gives the government a month to assess next steps for this
FOIA request after production finishes in the PHMPT matters. Accordingly, it is hereby
ORDERED that the government’s motion to stay, ECF 14, is GRANTED IN PART and
DENIED IN PART; and it is further
2 Because the Court concludes that an Open America stay is appropriate, it does not address the
government’s alternative argument that it also meets the requirements for a stay under Landis v.
North American Co., 299 U.S. 248 (1936). See ECF 14-1 at 21–23.
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ORDERED that this case is STAYED until and including October 1, 2026, with respect
to any FDA processing of records (i.e., search, review, and redaction) for Plaintiff’s FOIA Request
No. 2020-7563; and it is further
ORDERED that the Parties shall file a joint status report on or before November 1, 2026,
that provides an update about this FOIA request and proposes a schedule for further proceedings.
If circumstances change while the case is stayed that warrant lifting the stay or otherwise affect
the posture of this case, the Parties may file a joint status report before then.
DATE: March 23, 2026
CARL J. NICHOLS
United States District Judge
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