Pub. Health & Med. Pros. for Transparency v. FDA, No. 22-0915, 2023 WL 3335071 (N.D. Tex. May 9, 2023) (Pittman, J.)
Pub. Health & Med. Pros. for Transparency v. FDA, No. 22-0915, 2023 WL 3335071 (N.D. Tex. May 9, 2023) (Pittman, J.)
Re: Request for records which FDA relied on in licensing pharmaceutical company’s COVID-19 vaccine for individuals between ages of 12 and 15 and licensing other pharmaceutical company’s COVID-19 vaccine for adults
Disposition: Finding that plaintiff is entitled to expedited processing and setting production schedule
- Procedural Requirements, Expedited Processing: The court holds that “[b]ecause Plaintiffs have shown a compelling need, the FDA wrongfully denied their request for expedited processing.” “First, [plaintiff] has shown – and Defendants do not dispute – that it ‘exists for the sole purpose of disseminating to the public the data and information in the biological product files for each of the COVID-19 Vaccines.’” “Second, Plaintiffs have shown an urgent need to inform the public about the health and safety of the COVID-19 vaccines based on the massive push to vaccinate, persistent effort to eradicate COVID-19, and continued government and private efforts to enforce these vaccines.” “The FDA’s own regulations also recognize this urgency – ‘[a]fter a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown: (1) All safety and effectiveness data and information . . . .’”
The court continues to relate that “Defendants propose a production schedule that would take at least 23.5 years [to process the “expected 450,000 pages”].” “And while the Court recognizes the limited resources that the FDA has dedicated to FOIA requests, the number of resources an agency dedicates to such requests does not dictate the bounds of an individual’s FOIA rights.” “Instead, the Court must ensure that the fullest possible disclosure of the information sought is timely provided – as ‘stale information is of little value.’” “To do so and provide the FDA with as much time as possible to comply, the Court orders the FDA to produce all data and information relating to the approval of the two vaccines by June 30, 2025.”