In recent news, a federal judge has granted the U.S. Food and Drug Administration (FDA) permission to withhold COVID-19 vaccine safety data for at least six months. The FDA argued that it is overwhelmed by court orders demanding the production of records related to the authorization of Pfizer and Moderna COVID-19 vaccines. The agency’s lawyers cited an “unprecedented workload” and requested an 18-month pause in processing a Freedom of Information Act (FOIA) request seeking COVID-19 vaccine safety data.
U.S. District Judge Reggie Walton supported the FDA’s argument, acknowledging the extraordinary orders from other courts, particularly in Texas, requiring extensive document production within a short timeframe. The ruling eliminates pending deadlines in the case, allowing the FDA to continue withholding materials related to its analyses of reports to the Vaccine Adverse Event Reporting System.
The FOIA request, filed by the Informed Consent Action Network, sought information on COVID-19 vaccine safety data mining. The FDA’s refusal to provide the materials prompted the lawsuit. Despite the FDA identifying 150 responsive records, the agency argued it needed more time for review, redactions, and additional searches.
The court’s decision aligns with the FDA’s claim of facing exceptional circumstances, including an increase in FOIA requests and lawsuits, coupled with prior court orders to produce documents on a monthly basis. Lawyers representing the plaintiff argued that the FDA did not lack resources when authorizing COVID-19 vaccines and should prioritize FOIA requests.
The FDA stated it made substantial efforts to hire additional staff for FOIA processing after a 2022 court order. Judge Walton expressed frustration at the government’s limited resources, suggesting a dysfunctional system, and approved the FDA’s request to withhold vaccine safety records. The judge plans to review the case every six months, scheduling a conference in May 2024