FDA WARNING_LETTER - Bret R. Rutherford, M.D. - January 10, 2023

The FDA issued a Warning Letter to Dr. Rutherford following an inspection from December 19, 2022, to January 10, 2023, under the Bioresearch Monitoring Program. The inspection revealed that Dr. Rutherford failed to ensure clinical investigations for Protocols (b)(4) and (b)(4) were conducted according to the investigational plan, specifically regarding subject eligibility criteria [21 CFR 312.60].

The protocols required exclusion of subjects on current or recent (within 4 weeks) antidepressants, antipsychotics, or mood stabilizers, or a specific tapering and washout period (5 elimination half-lives or 2 weeks, whichever is longer) for those on antidepressants who had not responded to adequate trials. Numerous subjects in both protocols were randomized and received study drug without completing the required medication tapering and washout period.

While Dr. Rutherford acknowledged the oversight and stated that the medication-free period was primarily for data validity, the FDA noted that failure to adhere to this requirement significantly impacted data integrity and subject safety, as ineligible subjects were enrolled.

Corrective actions included reviewing involved subjects for harm (none found), closing Protocol (b)(4) and initiating closure for Protocol (b)(4), suspending enrollment for Protocol (b)(4) in September 2021, and withdrawing the associated IND in January 2023. No further research under these protocols will be conducted, and data will not be used