Judge Orders FDA To Produce Pfizer Docs With Accelerated Schedule

On Thursday, a federal judge in Texas ordered the Food and Drug Administration to publicly release the data it used to license Pfizer’s COVID-19 vaccine, imposing a schedule of approximately eight months.

BREAKING REPORT: Judge Gives FDA Just Over 8 Months to PRODUCE Pfizer’s Safety Data, REJECTING FDA's request to release the data over what would be 75 years…

— Chuck Callesto (@ChuckCallesto) January 7, 2022

The FDA originally said it would take approximately 75 years to complete a Freedom of Information Act request with an estimated 450,000 pages of material about the vaccine.

U.S. District Judge Mark Pittman wrote that the court “concludes that this FOIA request is of paramount public importance”. Pittman was appointed to the bench by former President Donald Trump in 2019.

While the FDA never said it wouldn’t release the data, it argued that the short-staffed FOIA office could only review and release 500 pages a month.

In his order, Pittman recognized “the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA”, but chose to change the schedule.

The FDA must produce their safety data on Pfizer's C19 injection, not over 75 years as per the FDA's request, but at the rate of 55,000 pages every 30 days. pic.twitter.com/nOOYKqRSEX

— Mattea Merta (@MatteaMerta) January 7, 2022

Instead of 500 pages per month, Pittman ordered the agency to produce 55,000 a month. The Pfizer vaccine data should be public later this year rather than the year 2097.

Suzann Burk, who heads the FDA’s Division of Disclosure and Oversight Management, said the office that reviews FOIA requests only has 10 employees.

Burk explained that it takes eight minutes per page for a worker “to perform a careful line-by-line, word-by-word review of all responsive records before producing them in response to a FOIA request”.

The FDA will most likely have to move some of its employees to the FOIA office in order to fulfill the request.