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Informed Consent Action Network v. FDA, No. 24-1761, 2024 WL 4836405 (D.D.C. Nov. 20, 2024) (Nichols, J.)

Date

Informed Consent Action Network v. FDA, No. 24-1761, 2024 WL 4836405 (D.D.C. Nov. 20, 2024) (Nichols, J.)

Re:  Request for records concerning clinical trial protocols related to the Boostrix vaccine against tetanus, diptheria, and pertussis

Disposition:  Granting in part and denying in part defendant’s motion for “Open America” stay

  • Litigation Considerations, “Open America” Stays of Proceedings:  The court finds that “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.”  “To satisfy the [Pub. Health & Med. Professionals for Transparency v. FDA . . . (“PHMPT I”)] production order, the FDA was required to produce at least 90,000 pages per month from July 2023 to November 2023.” “And to satisfy the [Pub. Health & Med. Professionals for Transparency v. FDA . . . (“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.”  “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.” “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.” “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.’”  “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.”  “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.”
Court Decision Topic(s)
District Court opinions
Litigation Considerations, “Open America” Stays of Proceedings
Updated January 8, 2025