Judge rules FDA can’t keep vaccine docs secret ‘until 2096’
A federal judge said the drug regulator must radically accelerate its release of hundreds of thousands of files on the Pfizer jab
The US Food and Drug Administration (FDA) has been ordered to hasten the publication of documents related to Pfizer’s coronavirus vaccine by more than one-hundred-fold, after the agency claimed the disclosure would take decades.
In a ruling on Thursday, District Judge Mark Pittman rejected previous arguments from the FDA after it said it might take decades, possibly until 2096, to complete the Freedom of Information Act (FOIA) request. Though the agency said it could only process and publish around 500 pages each month, Pittman said it would have to pick up the pace – instead ordering it to put out 55,000 pages in the same time span.
“The court concludes that this FOIA request is of paramount public importance,” the judge wrote, adding that the timely completion of the release is “not only practicable, but necessary.”
Pittman accepted an earlier proposal from the FDA for an initial publication of some 12,000 pages by the end of this month, but said it must drastically speed up the process by March. He allowed the regulator to redact records only when it has “privilege, exemption, or exclusion” over information, and told the plaintiffs and FDA to submit a “joint status report” detailing the progress of the rolling disclosure by April 1, and again every 90 days afterward until it is complete.
The FOIA suit was brought in September by attorney Aaron Siri on behalf of the Public Health and Medical Professionals for Transparency organization, a group of professors and scientists who previously complained the FDA was dragging its feet on sharing Pfizer’s vaccine data. Because the agency was able to process the whole trove of Pfizer docs in a lightning-fast 108 days in order to license the vaccine, the plaintiffs insisted it did not need decades to review, redact and hand over the documents as claimed.
Commenting on Thursday’s ruling in a Substack post, Siri deemed the decision a “great win for transparency” that will break a government “stranglehold” on the vaccine data.
In a ruling on Thursday, District Judge Mark Pittman rejected previous arguments from the FDA after it said it might take decades, possibly until 2096, to complete the Freedom of Information Act (FOIA) request. Though the agency said it could only process and publish around 500 pages each month, Pittman said it would have to pick up the pace – instead ordering it to put out 55,000 pages in the same time span.
“The court concludes that this FOIA request is of paramount public importance,” the judge wrote, adding that the timely completion of the release is “not only practicable, but necessary.”
Pittman accepted an earlier proposal from the FDA for an initial publication of some 12,000 pages by the end of this month, but said it must drastically speed up the process by March. He allowed the regulator to redact records only when it has “privilege, exemption, or exclusion” over information, and told the plaintiffs and FDA to submit a “joint status report” detailing the progress of the rolling disclosure by April 1, and again every 90 days afterward until it is complete.
The FOIA suit was brought in September by attorney Aaron Siri on behalf of the Public Health and Medical Professionals for Transparency organization, a group of professors and scientists who previously complained the FDA was dragging its feet on sharing Pfizer’s vaccine data. Because the agency was able to process the whole trove of Pfizer docs in a lightning-fast 108 days in order to license the vaccine, the plaintiffs insisted it did not need decades to review, redact and hand over the documents as claimed.
Commenting on Thursday’s ruling in a Substack post, Siri deemed the decision a “great win for transparency” that will break a government “stranglehold” on the vaccine data.