FDA EIR - Diane Highum, M.D. - June 27, 2019

An FDA inspection was conducted at the clinical investigator site of Diane Highum, M.D., in Bellflower, CA, from June 18-27, 2019. The dual-purpose inspection, requested by the Center for Drug Evaluation and Research (CDER), included a 'For Cause' assignment and a 'PDUFA' pre-market data validation for two separate clinical drug studies. The inspection aimed to assess compliance with FDA regulations, including Good Clinical Practice (GCP) and investigator responsibilities as outlined in 21 CFR 312.60.

Significant violations were identified, leading to the issuance of an FDA Form 483, Inspectional Observations. Key issues included widespread backdating of subject progress notes and study summary sheets across both audited protocols, with some entries appearing to be added months after the events. Furthermore, critical psychological ratings and other clinical assessments, such as inclusion/exclusion criteria and diagnoses, were reportedly performed by unqualified or non-licensed study personnel, rather than licensed investigators. The inspection also found that certain caregivers/informants were repeatedly used for multiple subjects, raising concerns about potential bias and the objectivity required by the study protocols.

While initial responses from management included some denials, Dr. Highum ultimately admitted to one instance of backdating. Management committed to providing a comprehensive written response to the FDA's observations within 15 days, detailing corrective actions.