FDA EIR - Douglas R Schumacher MD - October 03, 2016

An FDA inspection of Douglas R Schumacher MD, located in Columbus, OH, was conducted from September 21 to October 3, 2016. This comprehensive review, under the Bioresearch Monitoring Clinical Investigators Compliance Program, focused on Dr. Schumacher’s conduct of a Prescription Drug User Fee Act (PDUFA) Phase 3 clinical trial (Protocol DV2-HBV-23) for HEPLISAV, sponsored by Dynavax Technologies Corporation. The inspection assessed compliance with regulatory requirements, including 21 CFR Part 50 for informed consent. While no formal FDA Form 483 Inspectional Observations were issued, two significant issues were discussed with management. Firstly, many individual subject files lacked proper source medical records obtained at screening, with medical history primarily collected through verbal accounts. Secondly, a critical oversight was identified where a subject's medical history (previous thyroid surgeries), discovered during an adverse event investigation, was not subsequently updated in their medical records or the electronic system. Dr. Schumacher acknowledged these points, highlighting the importance of robust documentation and complete medical history capture in future studies.