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.
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.
In a statement to The Epoch Times, the FDA said it “does not comment on possible, pending or ongoing litigation.”
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 Pfizer-BioNTech’s COVID-19 vaccine full approval.
“All the documents sought in the FOIA request are urgently needed to allow independent scientists to review the FDA’s work and to provide assurance to the public that the liability-free vaccine [Americans] are being mandated to receive has truly passed the most rigorous review possible,” the group said in its filing in December, adding, “[T]he need for this information will be lost if all the documents are not promptly produced because people and governments are making decisions regarding the Pfizer vaccine now, not in 75 years.”
The FDA added it has to make sure it protects certain confidential information as required under the law, as well as protect other information subject to withholding under FOIA exemptions, and so must carefully review the documents on a line by line basis to apply the redactions.
“In sum, FDA’s proposed processing schedule is fair to plaintiff,” the agency argued at the time.