Hungry for details on Pfizer's COVID-19 vaccine? Just file a Freedom of Information Act (FOIA) request and wait until the U.S. tricentennial in 2076. That's the schedule the FDA proposed in documents filed in a U.S. District Court this week.
According to the documents filed (PDF) in a U.S. District Court for the Northern District of Texas, the FDA asked a federal judge for 55 years to complete a FOIA request for data and information on the approval of Pfizer-BioNTech's COVID-19 vaccine, Comirnaty.
If the judge grants the FDA's request, the plaintiffs, Public Health and Medical Professionals for Transparency, would have to wait until the U.S. celebrates its 300th year anniversary in 2076 to view the full report.
The FDA's request comes about a month after the plaintiffs, comprising more than 30 professors and scientists from some of the country's top schools, filed suit (PDF) to expedite their FOIA request. The group originally asked for documentation after the vaccine's approval in August, but the FDA has yet to turn anything over.
The plaintiffs' lawyers say the FDA needs to fork over the information to "settle the ongoing public debate" around the agency's review process as well as to confirm its conclusion that the Pfizer vaccine is safe, effective and worthy of the public's trust.
The plaintiffs' request covers some 329,000 pages, which must first be processed and redacted before the FDA can hand them over, Department of Justice (DOJ) lawyers representing the regulator stated in court documents.
The group asked the FDA to satisfy their request by no later than March 3, 2022, giving the agency the same 108 days "from when Pfizer started producing the records for licensure on May 07, 2021, to when the product was licensed on August 23, 2021."
To meet that deadline, the FDA would need to process some 80,000 pages a month. That simply isn't feasible, the DOJ lawyers argued.
"Reviewing and redacting records for exempt information is a time-consuming process that often requires government information specialists to review each page line-by-line," the defense said in this week's court filing. "When a party requests a large amount of records, like Plaintiff did here, courts typically set a schedule whereby the processing and production of the nonexempt portions of records is made on a rolling basis," they added.
Meanwhile, the time it takes an agency to process a FOIA request varies "depending on the complexity of the request and any backlog of requests pending at the agency," the U.S. says on a FOIA fact page.
The branch that would be in charge of processing the plaintiffs' FOIA request only has 10 employees and is already saddled with about 400 outstanding bids for information, lawyers for the defense said.
Instead, the FDA has proposed to release 500 pages per month. "By processing and making interim responses based on 500-page increments, FDA will be able to provide more pages to more requesters, thus avoiding a system where a few large requests monopolize finite processing resources," the agency's defense said.
U.S. District Judge Mark Pittman has set a scheduling conference for Dec. 14, 2021, to weigh the timeline for the plaintiffs' request, Reuters reported Friday.