The decision rejects the FDA’s request to release the data over what would be 75 years
A federal judge on Thursday ordered the U.S. Food and Drug Administration to produce, at a rate of 55,000 pages per month, the documents it relied on to license the Pfizer-BioNTech COVID-19 vaccine.
The rate of 55,000 pages a month would mean the FDA has just over eight months to fully produce all of Pfizer’s pre-licensure safety data. That is much faster than the 500 pages-per-month rate the FDA proposed in December 2021. That rate would have effectively given the agency roughly 75 years to fully produce the data, Aaron Siri, a lawyer working on the case, previously observed.
U.S. District Judge Mark Pittman ordered the FDA to produce more than 12,000 pages on or before Jan. 31, which was what the FDA had proposed in part. Pittman then ordered the agency to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete.”
“Here, the court recognizes the ‘unduly burdensome’ challenges that this FOIA request may present to the FDA … But, as expressed at the scheduling conference, there may not be a ‘more important issue at the Food and Drug Administration … than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not rush[ed] on behalf of the United States.
“Accordingly, the court concludes that this FOIA request is of paramount public importance,” Pittman wrote in the order (pdf).
The FDA did not immediately respond to a request for comment on the latest ruling.
The case was brought by the Public Health and Medical Professionals for Transparency (PHMPT), which said the data should be made public quickly because the FDA took just 108 days to review the data before granting the Pfizer-BioNTech COVID-19 vaccine full approval.
“Pfizer began its rolling submission on May 7, 2021, and the vaccine was licensed on August 23, 2021, a total of 108 days from initial submission to licensure,” the non-profit group noted in a December filing (pdf).