David W. Mayleben PhD – FDA EIR, Nov 14, 2012

An FDA inspection of David W. Mayleben PhD, a clinical investigator in Crestview Hills, KY, was conducted from November 5 to November 14, 2012. The inspection, performed under regulatory framework CP 7348.811 for clinical investigators and initiated by CDER, focused on a Phase III study of MK-4305 (Suvorexant) for primary insomnia (NDA 204-569). The inspection concluded without the issuance of an FDA Form 483 (Inspectional Observations). However, the review revealed several instances of protocol deviations and data discrepancies. Issues included subjects having inadequate washout periods, taking prohibited medications, improper re-screening after screen failure, and caffeine violations. Critically, some of these protocol deviations were either not formally documented by the site using Sponsor Consultation Forms or were not recognized as deviations by the site, despite being identified by the study sponsor. Furthermore, data listings provided to the FDA from CDER were found to be incomplete, missing subjective polysomnography (PSG) values and dates present in the subjects' e-diaries. During the close-out meeting, the importance of accurate protocol deviation documentation and overall protocol compliance was discussed with Dr. Mayleben and his management team, though no formal actions were required.