Court Order (Six-Month Open America Stay) — Ican v. FDA, No. 1:25-cv-0827 (D.D.C. No. 1:25-cv-0827)

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U.S. District Court for the District of Columbia · No. 1:25-cv-00827-JMC · Doc. 18 · 2025-08-28 · Docket on CourtListener

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UNITED STATES DISTRICT COURT 
FOR THE DISTRICT OF COLUMBIA 
 
 
 
 
INFORMED CONSENT ACTION NETWORK, 
 
Plaintiff, 
 
v. 
 
 
FOOD AND DRUG ADMINISTRATION, et al.,  
 
 
Defendants. 
 
 
 
Case No. 1:25-cv-0827 (JMC) 
 
 
 
ORDER 
The Court ORDERS that Defendants’ Motion to Stay, see ECF 14, is GRANTED in part 
and DENIED in part: for the reasons stated below, this matter shall be stayed for approximately 
six months until and including Friday, February 27, 2026. It is further ORDERED that the parties 
shall file a joint status report on or before February 27, 2026, stating their positions on whether the 
stay should be lifted and, if so, proposing 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. 
FOIA provides that agencies shall make requested records “promptly available,” 5 U.S.C. 
§ 552(a)(3)(A), 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). 
An agency may obtain a stay of proceedings under that provision if it “is deluged with a volume 
of requests for information vastly in excess of that anticipated by Congress, when the existing 
resources are inadequate to deal with the volume of such requests within the time limits of 
subsection (6)(A), and when the agency can show that it ‘is exercising due diligence’ in processing 
Case 1:25-cv-00827-JMC     Document 18     Filed 08/28/25     Page 1 of 3

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the requests.” Open Am. v. Watergate Special Prosecution Force, 547 F.2d 605, 616 (D.C. Cir. 
1976). Here, the FDA has shown both exceptional circumstances and due diligence justifying 
an Open America stay. 
Turning first to exceptional circumstances: Plaintiff requests records from FDA’s Center 
for Biologics Evaluation and Research (CBER). But CBER has been ordered by another court to 
produce approximately 9.1 million pages of COVID-19 vaccine records in a compressed 
timeframe—“an extraordinary workload . . . that FDA could not have predicted.” ECF 14-2 at 3-
4 (describing litigation in Pub. Health & Med. Pros. for Transparency v. FDA, No. 21-CV-1058 
(N.D. Tex.) (“PHMPT I”), and Pub. Health & Med. Pros. for Transparency v. FDA, No. 22-CV-
0915 (N.D. Tex.) (“PHMPT II”)). “The unprecedented rate at which the PHMPT orders require 
the FDA to produce records is exceptional, and it is, if anything more overwhelming than the 
extraordinary increase in FOIA workloads that past decisions have found sufficient to warrant 
stays.” Child.’s Health Def. v. FDA, No. 23-CV-220, 2024 WL 147851, at *3 (D.D.C. Jan. 12, 
2024). 
The FDA must also demonstrate due diligence. The agency states that it has “a multi-track 
process for handling FOIA requests . . . and requests in each queue are generally assigned to 
reviewers for processing on a first-in, first-out basis,” and that it has undertaken “aggressive efforts 
to hire and train additional staff and contractors, reassign staff as available to assist in review of 
some records, seek funding, and reorganize its resources.” ECF 14-1 at 18; ECF 14-2 at 15. “Both 
the onboarding and reassignment of new staff, as well as the first-in, first-out multi-track system 
for processing requests have been found sufficient to establish due diligence in other cases... and 
are sufficient here.” Child.’s Health Def., 2024 WL 147851, at *3. 
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Because the FDA has demonstrated both exceptional circumstances and due diligence, 
an Open America stay is warranted here. This Court’s conclusion is consistent with the conclusion 
of at least 10 other courts who have issued stays in similar cases involving the FDA. See ECF 14-
2 at 17–19 (collecting cases).    
However, the Court is sensitive to Plaintiff’s concern that staying this case for 18 months, 
as FDA requests, could “render the disclosures stale and the public debate irretrievably distorted.” 
ECF 16 at 38. The Court also notes that some other courts in this district faced with similar requests 
for an 18-month stay have instead imposed—at least initially—a six-month stay. See Child.’s 
Health Def., 2024 WL 147851, at *5 (staying case for six months); Child.’s Health Def. v. Ctrs. 
for Disease Control & Prevention, No. 23-CV-00431, 2024 WL 3521593, at *6 (D.D.C. July 24, 
2024) (staying case for six months); May 24, 2024 Minute Entry, Informed Consent Action 
Network v. FDA, No. 23-CV-219 (D.D.C.) (staying case for six months); but see Oct. 13, 2023 
Order, Wright v. Dep’t of Health & Hum. Servs., No. 22-CV-1378 (D.D.C.) (granting unopposed 
motion for 18-month stay); Dec. 13, 2023 Minute Order, Child.’s Health Def. v. FDA, No. 23-CV-
2316 (D.D.C) (staying case for 18 months). The Court therefore finds it appropriate to impose a 
six-month stay at this time.  
SO ORDERED.  
            
 
 
 
 
 
__________________________ 
 
 
 
 
 
 
 
JIA M. COBB 
 
 
 
 
 
 
 
United States District Judge 
 
Date: August 28, 2025 
Case 1:25-cv-00827-JMC     Document 18     Filed 08/28/25     Page 3 of 3

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