Public Health and Medical Professionals for Transparency v. Food and Drug Administration (2022–2023)

Case summary

Public Health and Medical Professionals for Transparency and Patrick and Stephanie de Garay sued the Food and Drug Administration under the Freedom of Information Act in the U.S. District Court for the Northern District of Texas, Fort Worth Division, No. 4:22-cv-00915, for the biological product files behind the Moderna COVID-19 vaccine licensed January 31, 2022 and the Pfizer-BioNTech vaccine for ages 12 through 15 licensed July 8, 2022. It is a records case, not a relief-program case. The page carries four filings: the complaint of October 11, 2022 (Entry 1), which asks for production at 55,000 pages per month once FDA completes production in the related case No. 4:21-cv-01058-P; FDA's brief of March 31, 2023 (Entry 27), arguing the requests are not entitled to expedited processing and asking the court to adopt its proposed schedule; Judge Mark T. Pittman's order of June 12, 2023 (Entry 38), which sets production of the Pfizer file by January 2, 2024 at rising monthly page rates and of the Moderna file by June 30, 2025, with a status report every 90 days; and a joint notice of June 4, 2025 (Entry 51) asking for an amended order covering both a Pfizer supplemental emergency use authorization file, which FDA agreed to complete by September 2, 2025, and a Moderna file at 180,000 pages a month. The hosted docket shows the June 4, 2025 joint notice as the latest filing.