Judge Gives FDA Just Over 8 Months to Produce Pfizer’s Safety Data

The decision rejects the FDA's request to release the data over what would be 75 years

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

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.