FDA Asks Court for 18-Month Pause in Key COVID-19 Vaccine Safety Data Cases

The agency was sued after rejecting Freedom of Information Act requests.

Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) wants an 18-month pause in litigation over its refusal to hand over key safety data on the COVID-19 vaccines.

The request is opposed by two groups that sued the FDA, trying to force the release of the records on possible COVID-19 vaccine side effects following Freedom of Information Act (FOIA) denials.

FDA officials say a federal court should implement the pause because of orders in other cases that require the agency to produce a certain amount of records each month.

After the FDA asked for 75 years to produce documents it analyzed before authorizing the Pfizer-BioNTech COVID-19 vaccine, a federal judge ordered in 2022 the agency to produce the documents in about eight months. The FDA is still producing the records.

In a similar case concerning records on Moderna’s COVID-19 vaccine, the FDA is also being required to produce the documents in a few years, rather than the 23.5 years it sought.

Under the current schedule, the FDA must produce at least 90,000 to 110,000 pages per month, increasing to at least 180,000 pages per month starting in December.

“These unprecedented productions have been ordered alongside a backdrop of other increased workload obligations, including a tremendous increase in incoming FOIA requests and FOIA litigation stemming, in large part, from requests related to the center’s work pertaining to the COVID-19 pandemic,” FDA officials said in recent filings.

The Access Litigation and Freedom of Information Branch (ALFOI) within the FDA’s Center for Biologics Evaluation and Research is responsible for reviewing and producing the records under the orders.

The ALFOI received 255 to 343 requests per year from fiscal years 2015 to 2019 but has received at least 391 requests in each of the following fiscal years. It received 633 requests in fiscal year 2022.

“Given the substantial effect that [the orders] have had on ALFOI’s workload, ALFOI does not have the bandwidth at this time to concurrently produce records in response to the request at issue in this litigation,” Suzanne Burk, a disclosure officer with the FDA, told the court.

‘Exceptional Circumstances’

The orders mean there are “exceptional circumstances,” which release the FDA from deadlines to produce the possible side effect records being sought by two nonprofits, according to the FDA.

FOIA requires agencies to produce requested records with various deadlines but contains exceptions for exceptional circumstances.

A U.S. Circuit Court ruling in 1976 defined such circumstances as when an agency is “deluged” with FOIA requests “vastly in excess of that anticipated by Congress” and “when the existing resources are inadequate to deal with the volume of such requests within the time limits.”

The court should enter an 18-month stay, after which the FDA “will be better situated to update the Court on its ability to process any responsive records” to the suits, the FDA said.

The suits were brought by nonprofits Children’s Health Defense and the Informed Consent Action Network after the FDA refused to release the results of its data mining of reports of adverse events following COVID-19 vaccination.

The FDA helps manage the Vaccine Adverse Event Reporting System, which accepts the reports, and is believed to have started the data mining in 2021.

The FDA denied FOIA requests for the data from the nonprofits and The Epoch Times, claiming that the agency could not segregate factual information from information it was withholding under FOIA exceptions.

The data mining uncovered multiple safety signals for the vaccines, according to the U.S. Centers for Disease Control and Prevention (CDC). The CDC performed a different type of data mining on the adverse event reports.

The CDC’s director said in 2022 that the results from its mining were “generally consistent” with the mining the FDA did.

The Epoch Times later found that the CDC detected hundreds of signals for the shots. Signals are indications vaccines might be causing an adverse event. Some of the signals have since been confirmed, including for myocarditis, a form of heart inflammation.

Opposition

Both Children’s Health Defense and the Informed Consent Action Network oppose the FDA’s request, noting its focus was on FOIA requests to a single branch, not the entire agency.

Children’s Health Defense noted that FOIA requests to the FDA as a whole have actually dropped during the COVID-19 pandemic.

The FDA received no more than 9,951 requests per year in fiscal years 2020, 2021, and 2022, after receiving at least 10,256 and as many as 11,578 in the four fiscal years prior.

“The FDA has a multi-billion-dollar budget and thousands of employees, so with fewer requests to process and more employees to process those requests at the agency level, any bottleneck in ALFOI’s work appears to be a result of the FDA’s own staffing choices,” Children’s Health Defense lawyers said in an Oct. 11 filing.

Informed Consent Action Network lawyers also said the backlog appeared to be a result of the FDA’s choices, including “chronically underfunding its FOIA offices.”

“Congress made billions of dollars available to FDA to address Covid-19 and an appropriate portion should have been devoted to transparency and accountability to those providing these funds: the public,” they said.

The nonprofits asked the U.S. District Court for the District of Columbia to deny the FDA’s requested pause.