Feds refuse to process Just the News founder's COVID vaccine injury FOIA for at least 18 more months

The Department of Health and Human Services says it will need at least 18 months to comply with a the Freedom of Information Act request in response to a lawsuit by Just the News founder, CEO and editor-in-chief John Solomon that asks a federal district court for partial summary judgment in its favor on Solomon's request this summer for expedited processing.

In partnership with America First Legal, Solomon sued HHS in February to force disclosure of records sought from the Food and Drug Administration and the Centers for Disease Control and Prevention, concerning COVID-19 reactions data kept in a back-end, nonpublic system to the nation’s Vaccine Adverse Event Reporting System.

A British Medical Journal investigation found that an FDA official told advocates of VAERS reform about the separate system, which includes hidden corrections and updates to publicly available initial reports, such as "a formal diagnosis, recovery, or death."

"Put simply, this case is not a dispute over the safety of COVID-19 vaccines," the Justice Department said in the cross-motion for partial summary judgment on behalf of HHS on Friday.

"Plaintiff does not dispute that he failed to demonstrate a compelling need during the administrative process before
FDA based on 'an imminent threat to the life or physical safety of an individual'" and didn't even provide "the date by when the records needed to be produced to avoid the posited harm," the motion says. (The CDC determined Solomon's FOIA to that agency was under FDA jurisdiction.)

DOJ dinged Solomon for not including a certification in his FOIA request "attesting to his 'knowledge and belief' that the information provided to demonstrate his compelling need 'is true and correct.'"

The FDA "voluntarily and proactively has made vast amounts of information about COVID-19 vaccines and related FDA activities available to the public on its website, and it continues to do so," the filing says. "The fact that people may have differing views about the safety or efficacy of certain FDA-regulated products does not of itself create 'urgency' within the meaning of the expedited processing standard."

The agency already strained to comply with a 2022 ruling to produce 450,000 pages from an earlier FOIA request for the documents related to its approval of Pfizer's COVID vaccine for ages 15 and up, at a rate of 55,000 a month, the motion says. (The FDA initially said that would take 55 years.) 

A second ruling in related litigation for approval data for Pfizer's vaccine ages 12-15 and Moderna's adult vaccine required the FDA to turn over 180,000 pages a month by January 2025.

The agency accused Solomon of conflating HHS and the FDA for the purpose of the FOIA request, when the latter is responsible for fulfilling requests. "If the historic, expedited production schedules" in the vaccine approval disclosure rulings "do not constitute exceptional circumstances" justifying a stay of the lawsuit, "nothing does."

The "current situation" facing the FDA's Center for Biologics Evaluation and Research's FOIA office "makes it impractical for it to process any complex requests for at least the next 18 months, according to the motion.

It's irrelevant that "FDA’s overall budget and resources are greater than that of the Branch alone," the filing says. Solomon's argument "wrongly suggests that the agency must prioritize its record response role above its core functions" in protecting public health.

"It would be manifestly inefficient to re-direct resources" to CBER "because performing disclosure reviews is a specialized skill that requires training and expertise that most FDA staff do not have," DOJ told the court. 

Disclosure staff are also not "interchangeable" across components, it said. "Thus, a FOIA reviewer in the Center for Tobacco Products will not be trained in, or have familiarity with, reviewing a biologics license application or a vaccine-related record."

The FDA is already dealing with a crush of FOIA requests, with 11 percent more in fiscal year 2023 than the prior year, it said, and it's constrained in its ability to hire more FOIA staff because it's an "unfunded mandate," the motion says.