FDA Can Withhold Key COVID Vaccine Safety Records for Now: Judge

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

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.”

FOIA

The Freedom of Information Act (FOIA) requires agencies to respond to FOIA requests in certain timeframes but agencies can skirt the requirements if they show that “exceptional circumstances” exist and they are conducting “due diligence.”

Two suits brought against the FDA for not adhering to timelines in FOIA requests for documents relating to the agency’s authorizations of the COVID-19 vaccines yielded rulings in favor of plaintiffs. The court in those cases ordered the FDA to produce a certain amount of documents responsive to the requests on a monthly basis.

Those orders required the agency to produce at least 90,000 pages per month starting in July, though the FDA has since finished production in one of the cases.

Those orders, coupled with an increase in FOIA requests and lawsuits in recent years, meet the criteria of exceptional circumstances, government lawyers said. They said most FDA FOIA workers are tied up with the orders.

Lawyers representing the plaintiff countered that the FDA did not slow down COVID-19 vaccine authorization due to a lack of resources and that it should apply the same focus to processing FOIA requests. They also said the FDA had not met the criteria of exceptional circumstances, noting that FOIA requests have been on the rise since before the COVID-19 pandemic.

“As the law currently stands, in order to show exceptional circumstances, it must be for the relevant time period. And the FDA’s papers have shown that they’ve known about this uptick and have been able to see it happening since 2019,” Elizabeth Brehm, one of the lawyers, said during the recent hearing.

The FDA also did not exercise due diligence because it initially denied the FOIA request outright, and failed to process an appeal in the time proscribed by the law, which prompted the lawsuit, she added.

The FDA has since done some work on the request. It identified 150 responsive records. But it said it needed more time to review those records and make redactions, as well as conduct additional searches that could turn up additional relevant materials.

More Hiring

Steven Levy, a lawyer representing the FDA, said that the agency has made “incredible efforts” to hire more people to process FOIAs following the 2022 court order forcing it to produce information on Pfizer’s COVID-19 vaccine. The FDA had nine staff and one branch chief at the time and has hired 10 contractors since. This spring, it received approval to hire six more full-time workers.

The hiring didn’t start until after the order because it was “an extraordinary unforeseen order,” Mr. Levy said.

Judge Walton, appointed under President George H. W. Bush, said that Congress was unlikely to approve more money for the FDA and expressed frustration at how he has multiple FOIA cases involving thousands of documents that need to be processed. He claimed the FDA, which received $8.4 billion from Congress for fiscal year 2023, has “limited resources.”

“To a large degree we have a dysfunctional government that doesn’t have, it seems, the capacity to address some of these issues related to legislation that Congress has passed,” Judge Walton said. The government “has, in fact, made an effort to increase its capacity to process documents where requests are made to this agency pursuant to FOIA, and realistically I have no reason to believe that greater efforts would have resulted in greater resources,” he added.

That’s when he entered the order in favor of the FDA.

Ms. Brehm declined to comment.

Judge Walton said he hoped circumstances change in the future, so he'll review the case every six months. He scheduled a conference in May 2024.

The case is Informed Consent Action Network v. Food and Drug Administration, in the U.S. District Court for the District of Washington.