Bioresearch Monitoring Issues at New York Site

An FDA 12/19/2022-1/10/2023 Bioresearch Monitoring Program inspection of the clinical site operated by Dr. Bret Rutherford at the New York State Psychiatric Institute in New York, NY, found objectionable conditions. A 3/21 Warning Letter says Rutherford failed to ensure that the investigation was conducted according to the investigational plan.

The letter cites examples of issues from the two protocols that were the subject of the inspection. It reviews the corrective actions Rutherford proposed and says FDA is unable to make an informed evaluation of the adequacy of the proposed corrections because Rutherford did not provide sufficient details about his plan for implementing additional measures and procedures to address the inspection findings on enrollment of ineligible subjects.

Rutherford was told to reply with a list of specific actions he has taken to prevent similar violations in the future.