Informed Consent Action Network v. Food and Drug Administration

• Court: District Court, District of Columbia
• Decided: November 20, 2024
• Docket: Civil Action No. 2024-1761
• Status: Published

Opinion

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

INFORMED CONSENT ACTION NETWORK,

Plaintiff,

v. Civil Action No. 1:24-cv-1761 (CJN)

FOOD AND DRUG ADMINISTRATION, et al.,

Defendants.

ORDER This matter is before the Court on the FDA’s motion for an eighteen-month stay of its

obligations to respond to Plaintiff’s FOIA request, which seeks clinical trial protocols related to

the Boostrix vaccine against tetanus, diptheria, and pertussis. See ECF No. 13 (Stay Mot.); ECF

No. 1 (Compl.). For the reasons discussed below, the Court will grant the motion in part and deny

it in part.

Generally, an agency that receives a FOIA request 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

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. Id. at

612–13.

The FDA has demonstrated that a stay under 5 U.S.C. § 552(a)(6)(C)(i), or an “Open

America stay,” is warranted here. In the past three years, the FDA received two court orders that

together compelled it to produce approximately 5.7 million pages of COVID-19 vaccine records

within a highly compressed timeframe. See Pub. Health & Med. Professionals for Transparency

v. FDA, Civ. A. No. 21-1058 (N.D. Tex.) (“PHMPT I”); Pub. Health & Med. Professionals for

Transparency v. FDA, Civ. A. No. 22-915 (N.D. Tex.) (“PHMPT II”); see also ECF No. 13-1

(Burk Decl.) ¶¶ 7, 22. To satisfy the PHMPT I production order, the FDA was required to produce

at least 90,000 pages per month from July 2023 to November 2023. Burk Decl. ¶ 7. And to satisfy

the PHMPT II production order by the court’s June 2025 deadline, the FDA will need to produce

at least 230,000 pages per month between now and then. Id. ¶¶ 7, 25B. This unprecedentedly

demanding production schedule—which has prompted the FDA to hire new employees and

substantially reallocate its existing staff—far exceeds a “predictable” agency workload and thus

constitutes “exceptional circumstances” within the meaning of FOIA. Elec. Frontier Found. v.

Dep’t of Just., 517 F. Supp. 2d 111, 119 (D.D.C. 2007); see also Child.’s Health Def. v. FDA, 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”); Burk Decl. ¶¶ 24, 26. The FDA has also exercised due diligence in responding to the FOIA requests it receives.

FOIA requests submitted to the FDA 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. Burk Decl. ¶¶ 12–13. 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 . . . and are sufficient [to do so] here.” Child.’s Health Def.,

2024 WL 147851, at *3.

It is clear that an Open America stay of some duration is appropriate. But the eighteen-

month stay sought by the FDA is too long, at least at present. As Plaintiff notes, production in the

PHMPT matters will be completed by June 2025, and the FDA should have a better sense of its

capacity to process Plaintiff’s request after that time. See ECF No. 15 (Opp.) at 1. The Court will

therefore stay this case only until the June 2025 deadline has passed, subject to further

consideration with the benefit of new information following that date. It is accordingly

ORDERED that Defendants’ Motion to Stay, ECF No. 13, is GRANTED IN PART AND

DENIED IN PART;

ORDERED that this action is STAYED for approximately eight months, until and

including July 21, 2025, with respect to any FDA processing of records (i.e., search, review, and

redaction) for Plaintiff’s FOIA Request No. 2020-7656; and it is further

ORDERED that the Parties shall file a joint status report on or before July 23, 2025, 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.

SO ORDERED. November 20, 2024 _______________________ CARL J. NICHOLS United States District Judge