FDA auditing health system, admin says

Officials from the Food and Drug Administration are currently at Duke, auditing data from clinical trials that test genomics technologies, according to a report from The Cancer Letter.

Doug Stokke, assistant vice president of communications for Duke University Health System, confirmed that an FDA audit team is on campus but declined to discuss details surrounding the audit. Christopher Kelly, a press officer for the FDA, declined to comment due to FDA policies concerning current investigations.

According to several documents obtained by The Cancer Letter, certain clinical trials commenced without receiving proper clearance from the FDA. These documents also seem to suggest that Joseph Nevins, Barbara Levine Professor of Breast Cancer Genomics, was associated with several trials that were not approved by the FDA, The Cancer Letter reported.

The Cancer Letter reported that in a Dec. 20 presentation before the Institute of Medicine, Dr. Robert Becker, chief medical officer at the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety, implied that technology in the three clinical trials related to the research of Nevins and recently discredited cancer researcher Dr. Anil Potti was not tested under an Investigational Device Exemption. He noted that an IDE would have been required, given the nature of those clinical trials.

The Cancer Letter also noted that four years ago, the FDA did receive a pre-IDE submission for technology similar but not identical to the predictor used in the three clinical trials at Duke.

According to the FDA’s website, IDEs ultimately permit the use of a particular experimental device for a clinical trials. The website also states that all clinical evaluations of devices, unless specifically exempt, are required to have an approved IDE before the study is initiated.