Informed Consent Action Network v. Food and Drug Administration

• Court: District Court, District of Columbia
• Decided: August 28, 2025
• Docket: Civil Action No. 2025-0827
• Status: Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

INFORMED CONSENT ACTION NETWORK,

Plaintiff, Case No. 1:25-cv-0827 (JMC)

v.

FOOD AND DRUG ADMINISTRATION, et al.,

Defendants.

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

1 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.

2 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