FDA EIR - Ruemu E. Birhiray, M.D. - September 05, 2013

An FDA inspection of Clinical Investigator Ruemu Birhiray, MD, in Indianapolis, IN, was conducted from August 12 to September 5, 2013. This directed inspection focused on Dr. Birhiray's conduct under two specific clinical protocols, in accordance with FDA guidelines for Clinical Investigators (CP 7348.811).

The inspection resulted in a four-point FDA-483 list of inspectional observations, highlighting significant deviations from regulatory requirements. Key violations included the failure to maintain accurate case histories regarding informed consent (21 CFR 312.62(b)), where tissue and blood samples were collected without proper consent or changes in consent were not communicated. The investigator also failed to promptly report unanticipated serious adverse events to the Institutional Review Board (IRB) within the required timeframe (21 CFR 312.66).

Furthermore, the investigation was not conducted according to the investigational plan and signed statement of investigator (21 CFR 312.60). This involved numerous instances of essential pre-enrollment tests not being performed, failure to hold or reduce study drug doses in response to adverse events (such as renal insufficiency or severe rash), and inadequate reporting of adverse events to sponsors. Many study visits and laboratory analyses were also conducted outside of protocol-specified windows. Finally, there was a failure to report protocol violations to the IRB.

Prior to the FDA inspection, the St. Vincent Hospital IRB had already suspended and subsequently terminated Dr. Birhiray's approval for all studies they oversaw due to internal investigations. Dr. Birhiray acknowledged the observations, attributing some to oversight or protocol misunderstanding, and indicated plans for improved self-monitoring and transitioning to electronic medical records to mitigate future issues. He committed to responding to the FDA-483 in writing.