"In response to the lawsuit, FDA in November proposed releasing around 500 pages of the review documents each month—which would fulfill the organization's FOIA request in around 55 to 75 years. FDA said the agency branch responsible for handling the request has only 10 employees and is currently processing 400 other FOIA requests, MedPage Today reports. However, U.S. District Judge Mark Pittman of the Northern District of Texas in January issued a court order requiring FDA to significantly speed up the release of the documents.
Under the court order, FDA was required to release approximately 12,000 pages of documents immediately, and then 55,000 pages a month until all documents—totaling more than 300,000 pages—are released. Before the documents can be released, the agency must redact confidential business and trade secret information from Pfizer and BioNTech, as well as private patient information from clinical trials.
Although the court noted that releasing this many documents this quickly would have "unduly burdensome challenges" for FDA, it said releasing the documents is of "paramount public important" and expediting the process is "not only practicable, but necessary.""