Acadia Pharmaceuticals Inc. – FDA EIR, Feb 17, 2016

An FDA inspection of ACADIA Pharmaceuticals Inc. in San Diego, CA, was conducted from January 20 to February 17, 2016. The inspection, carried out under the Bioresearch Monitoring Compliance Program, focused on Good Clinical Practices (GCPs) for NDA 207318, related to pimavanserin for Parkinson's disease psychosis. A directed inspection also addressed an industry complaint about quality assurance deficiencies. The inspection revealed significant objectionable findings documented in Form FDA 483. Key violations included the company's failure to ensure proper study monitoring and adherence to the investigational plan. Specifically, ACADIA failed to adequately monitor the progress of an investigation conducted under an Investigational New Drug (IND). Issues identified involved using an unapproved remote monitoring standard operating procedure (SOP) that inappropriately permitted monitors to use copies of source data. Furthermore, the firm lacked documentation of qualifications (CVs) for several study monitors and did not consistently review monitoring reports. A Serious Adverse Event (SAE) unblinding report also lacked documented investigation into an "unknown injection" pertinent to a subject's SAE and/or death. Additionally, ACADIA did not have SOPs for ClinicalTrials.gov compliance or for database lock procedures during the trial, and the SAE flow diagram lacked IRB notification procedures. ACADIA Pharmaceuticals Inc. was required to provide a written response to the Los Angeles District Office within 15 business days, acknowledging that these observations could lead to further regulatory action, including a warning letter.