Informed Consent Action Network v. United States Food and Drug Administration

Background

Informed Consent Action Network (ICAN), a nonprofit organization that advocates for informed consent concerning medical interventions, submitted a Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA). ICAN sought reports for each pre-licensure clinical trial relied on to approve Engerix-B for babies and children in 1989, but only for trials that had a “safety review period longer than seven days” after the vaccine was administered.

The FDA told ICAN that the request did not reasonably describe the records in a way that would allow the agency to identify and locate them. ICAN clarified that it wanted pre-licensure trials but did not further define the phrase “safety review period longer than seven days.” The FDA then offered to provide the full set of clinical-trial reports submitted for the original application for Engerix-B. The FDA identified approximately 3,000 pages of potentially responsive reports, but ICAN declined to change its request or accept the broader production. The FDA closed the request, and ICAN filed this action.

Motions and legal standard

The parties filed cross-motions for summary judgment, a procedure used when the record shows no genuine dispute about a material fact and one side is entitled to judgment as a matter of law. In FOIA cases, courts may rely on agency affidavits or declarations when they adequately describe a thorough search and are entitled to a presumption of good faith.

A FOIA request must reasonably describe the records sought. The court explained that a request satisfies this requirement when an agency employee familiar with the subject can locate the records with a reasonable amount of effort. If a request is ambiguous, FDA regulations require the agency to notify the requester of the problem and make every reasonable effort to help identify and locate the records.

Court’s analysis

The court held that ICAN’s request did not reasonably describe the records. It recognized that “safety review period” could have an ordinary meaning and that ICAN specified a period longer than seven days. But the court found that the request contained important ambiguities.

First, Engerix-B was administered in several doses over a period of months. The request did not identify whether the seven-day period began after the first dose, the final dose, or another administration. The court also found that “safety review period” was not a technical term with an authoritative definition that resolved this issue.

Second, the request did not explain what it meant to review a trial for safety. The court considered examples involving monitoring patients’ temperatures and complaints for a set number of days, while also requiring reporting of serious adverse experiences or tracking adverse reactions over longer periods. These examples showed that a reviewer could reasonably disagree about whether a trial had a safety-review period longer than seven days.

The court further concluded that the FDA satisfied its obligation to assist ICAN. The agency identified the phrase causing difficulty, explained why it could not search the records using that phrase, and offered to provide the approximately 3,000 pages of clinical-trial reports so ICAN could determine which records it considered responsive. ICAN refused that broader production. The court also stated that FOIA requires agencies to produce records, not to perform the kind of sorting and analysis necessary to answer an unclear request.

Disposition

The court GRANTED the FDA’s motion for summary judgment and DENIED ICAN’s motion for summary judgment. The order resolved docket numbers 14 and 17, directed the Clerk of Court to enter judgment, and closed the case.