Lawyers representing the FDA argued that the agency is overwhelmed by court orders demanding the production of records related to the authorization of Pfizer and Moderna COVID-19 vaccines. The FDA requested an 18-month pause in processing a Freedom of Information Act (FOIA) request seeking COVID-19 vaccine safety data mining results, citing an “unprecedented workload.”
U.S. District Judge Reggie Walton sided with the FDA, acknowledging the agency’s “extraordinary circumstances” due to the substantial document production orders imposed by courts, particularly in Texas. The ruling enables the FDA to continue withholding materials related to its analyses of reports to the Vaccine Adverse Event Reporting System (VAERS). The nonprofit Informed Consent Action Network had filed a lawsuit after the FDA refused to provide these materials.
The FOIA requires agencies to respond to requests within specified timeframes, but exceptions can be made if “exceptional circumstances” exist. The FDA argued that the surge in FOIA requests and lawsuits, coupled with previous court orders mandating document production, constituted such exceptional circumstances. Lawyers for the plaintiff countered that the FDA should allocate resources to process FOIA requests as it did for COVID-19 vaccine authorization and questioned the agency’s claim of exceptional circumstances.
Despite the FDA’s efforts to hire additional personnel for FOIA processing, Judge Walton expressed frustration with the limited resources and a dysfunctional government. He issued the order in favor of the FDA, emphasizing that Congress is unlikely to provide additional funding. The judge plans to review the case every six months, with a scheduled conference in May 2024. The case is titled “Informed Consent Action Network v. Food and Drug Administration” in the U.S. District Court for the District of Washington