The Public Citizen Foundation yesterday sued to force the FDA to post unredacted copies of its advisory committee members’ resumes, arguing that the censorship violates federal freedom of information rules.
The FDA’s advsory panels are tasked with reviewing clinical trial data on safety and effectiveness to make recommendations to the agency on approving – or not – medical devices and drugs.
The lawsuit, filed in the U.S. District Court for the District of Columbia, claimed that the foundation wrote the FDA in early 2014 to ask that it stop redacting the curricula vitae for the members of its roughly 50 advisory boards. The FDA later that year declined to issue unredacted CVs, the lawsuit alleged.
“The FDA letter stated that FDA’s practice is to categorically redact certain information from advisory committee members’ CVs including, among other categories, information concerning nongovernment funded grants, pending clinical trials, pending publications, dates degrees were conferred, medical board and professional association certification numbers, names of graduate or doctoral students supervised, military service, and information related to hobbies and outside activities,” according to the complaint.
The FDA redacted 98% of the CVs for the 128 members of its Center for Devices & Radiological Health advisory panels; in fact, according to the lawsuit, only 1 panel’s CVs weren’t censored by the agency: the Science Advisory Board for the National Center for Toxicological Research.
“FDA’s practice of unlawfully redacting the CVs of advisory committee members posted on its website is ongoing. Nearly all CVs currently posted on FDA’s website contain improper redactions,” the lawsuit alleged, claiming that the FDA redacted 92% of the 150 resumes for the Center for Drug Evaluation & Research committees; 86% of the 57 CVs for the Center for Biologics Evaluation & Research panels; and all of those posted for the Tobacco Products scientific advisory panel, the Center for Radiation-Emitting Products committee and the Pediatric advisory committee.
The lawsuit asks the D.C. federal court to order the FDA to publish unredacted copies of the CVs on its website and seeks legal costs and fees.