FDA EIR - Richard K. Burt - July 11, 2016

An FDA inspection, conducted from June 17 to July 11, 2016, by the Center for Biologics Evaluation and Research (CBER), reviewed the clinical trial activities of Dr. Richard K. Burt. Dr. Burt, Chief of the Division of Immunotherapy at Northwestern University Feinberg School of Medicine, served as both a sponsor and investigator for clinical trials of investigational biological drugs, including the MIST study for Multiple Sclerosis.

The inspection identified several significant violations, documented in an FDA Form 483. Key issues included Dr. Burt's failure to adequately monitor the progress of investigations, which encompassed insufficient qualification and oversight of external clinical investigators and their sites. There was a lack of documented initial and ongoing training for some investigators. Furthermore, Dr. Burt failed to submit required protocol amendments to the FDA for the addition of new investigators and changes in study protocols. He also promoted an investigational drug as safe and effective on a website without proper Institutional Review Board (IRB) approval. Deficiencies in record-keeping were noted, such as not retaining required study records and lacking delegation logs for study staff. Critically, the inspection revealed failures to report adverse events, specifically patient deaths, to the IRB and the FDA, and to notify the IRB of the multi-center nature of a trial.

These findings indicate non-compliance with regulatory requirements for clinical investigators and sponsors. Dr. Burt stated his intent to provide a written response to the FDA's observations.