A federal court has granted a six-month extension of a stay in a Freedom of Information Act (FOIA) case involving the Informed Consent Action Network (ICAN) and the Food and Drug Administration (FDA). The decision affects ICAN's request for records related to pertussis, also known as whooping cough, and highlights ongoing challenges faced by the FDA in processing FOIA requests.
The court's ruling is significant as it underscores the difficulties federal agencies face in managing a surge in information requests, particularly in the wake of the COVID-19 pandemic. This extension means that ICAN will have to wait longer to receive the documents it requested, which could impact its efforts to inform the public about vaccine safety and efficacy.
Background
ICAN, a nonprofit organization focused on vaccine safety and informed consent, submitted a FOIA request to the FDA's Center for Biologics Evaluation and Research (CBER) in 2020. The request sought records pertaining to pertussis, a highly contagious respiratory disease. When the FDA did not fulfill the request by June 2024, ICAN filed a lawsuit to compel the agency to respond.
This case, identified as Civil Action No. 2024-1905, has been marked by multiple stays since it was filed. The court initially stayed the case in February 2025 for six months, citing exceptional circumstances due to the volume of FOIA requests the FDA was handling, particularly those related to the pandemic. The stay was renewed multiple times as the FDA struggled to keep up with the demand for information.
The Ruling
In its latest ruling, the court decided to extend the stay for an additional six months, until April 14, 2027. Judge John D. Bates noted that the FDA continues to face “exceptional circumstances” and is exercising “due diligence” in processing ICAN's FOIA request. The court stated, “Defendants continue to face exceptional circumstances and to exercise due diligence and are thus entitled to a stay under Section 552(a)(6)(C)(i).”
The court emphasized that the FDA had been overwhelmed with FOIA requests, particularly due to two significant cases in Texas that required the agency to produce millions of pages of documents. Judge Bates acknowledged the ongoing staffing challenges faced by the FDA, which have compounded the difficulties in processing requests. The court ordered the parties to file a joint status report before the stay expires, proposing a schedule for processing ICAN's request.
Impact
The court's decision to extend the stay means that ICAN will have to wait longer to access the requested documents. This delay could affect the organization's ability to disseminate information regarding pertussis and vaccine safety to the public. The ruling also highlights the broader challenges that federal agencies face in managing FOIA requests, particularly in the context of increased demand for transparency following the pandemic.
Furthermore, this ruling may set a precedent for how courts handle similar cases involving FOIA requests and the concept of “exceptional circumstances.” As agencies continue to grapple with backlogs and staffing issues, this case could influence future litigation regarding the timeliness of FOIA responses.
What's Next
ICAN and the FDA must now prepare for the upcoming joint status report due by April 13, 2027. This report will outline the FDA's progress in processing FOIA requests ahead of ICAN's request and propose a schedule for addressing ICAN's specific request. The possibility of further appeals or related cases remains uncertain, as the court has not indicated any immediate plans for additional litigation.