A federal judge in the Northern District of Texas ruled in January 2022 that the FDA must expedite the release of documents related to the licensing of Pfizer’s COVID-19 vaccine. This decision followed a lawsuit filed by scientists and medical researchers under the Freedom of Information Act (FOIA). The FDA initially proposed releasing only 500 pages per month, a pace that would have taken 75 years to disclose all 451,000 pages of data. The agency cited limited resources and the need to redact sensitive information as reasons for this slow pace. However, U.S. District Judge Mark T. Pittman found this timeline unreasonable and ordered the FDA to release at least 55,000 pages per month[1][2].
The case highlighted tensions between the FDA’s commitment to transparency and its handling of public requests for vaccine-related information. Critics argued that the public deserved immediate access to the data, especially given the widespread mandates for vaccination and concerns about potential side effects. Judge Pittman emphasized that transparency was essential for public trust and accountability, quoting historical figures like James Madison and John F. Kennedy to underscore the importance of open government[1].
Citations:
[1] https://news.bloomberglaw.com/health-law-and-business/why-a-judge-ordered-fda-to-release-covid-19-vaccine-data-pronto
[2] https://www.allsides.com/news/2021-12-08-1553/fda-says-it-now-needs-75-years-fully-release-pfizer-covid-19-vaccine-data
[3] https://www.fda.gov/media/150386/download
[4] https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
Source: midtowntribune.com