FDA argued it’s overburdened by another case accepted by federal court.
The U.S. Food and Drug Administration (FDA) is being allowed to withhold COVID-19 vaccine safety data for at least six months, under a recent order from a federal judge.
Lawyers representing the FDA said that the agency is overburdened by court orders forcing it to produce a certain amount of records pertaining to the authorization of the Pfizer and Moderna COVID-19 vaccines.
The FDA’s Center for Biologics Evaluation and Research is “dealing with an unprecedented workload” and “specific and unprecedented hardships,” the lawyers said in a motion for a stay. They asked for an 18-month pause in processing a Freedom of Information Act request that seeks the results of COVID-19 vaccine safety data mining.
U.S. District Judge Reggie Walton sided with the government.
“Unfortunately I would have to conclude that because of the extraordinary orders that have been issued by the courts down in Texas … requiring just an exorbitant amount of document production within a relatively short period of time, considering the number of documents involved and all of the other litigation I know that agencies have, I would have to conclude that extraordinary circumstances have been established,” Judge Walton said in a Nov. 20 hearing in Washington, according to a transcript reviewed by The Epoch Times.
Judge Walton eliminated pending deadlines in the case.
The ruling means the FDA can continue withholding materials on its analyses of reports to the Vaccine Adverse Event Reporting System, which have spiked since the introduction of COVID-19 vaccines. The nonprofit Informed Consent Action Network sued after the FDA declined to provide any of the materials. The agency also refused to provide them to The Epoch Times.
Companion analyses that were obtained by The Epoch Times showed U.S. authorities detected hundreds of safety signals for the COVID-19 vaccines, many of which authorities have never provided evidence of examining further. Authorities said the analyses the FDA ran were “more robust.”
By Zachary Stieber
