Hawkins, Douglas, MD – FDA EIR, Jul 2, 2014

An FDA inspection of Dr. Douglas Hawkins, a Clinical Investigator associated with Seattle Children's Hospital, was conducted from June 10 to July 2, 2014. This high-priority inspection, focused on clinical investigator data validation for a New Drug Application (NDA) pre-approval and joint with the European Medicines Agency (EMA), evaluated Dr. Hawkins's conduct of a Phase III clinical study (ANBL0032) for the investigational drug Unituxin (dintuximab, ch14.18) in high-risk neuroblastoma. The study was sponsored by the NCI under IND 4308 and later transferred to United Therapeutics Corporation. The inspection identified significant issues, resulting in the issuance of an FDA Form 483. Main violations included the failure to promptly report Serious Adverse Events (SAEs) and disease relapse events to the NCI Web-based Adverse Event Expedited Reporting System (AdEERS) and the Children's Oncology Group (COG) data system within protocol-specified timeframes, with some reports delayed by months or even years. Additionally, there was a lack of adequate records documenting the process for grading and assessing the attribution of adverse events in randomized subjects. Further concerns discussed during the close-out meeting, though not formally on the FDA 483, highlighted deficiencies such as insufficient documentation of delegated responsibilities, missing signatures from some sub-investigators on FDA Form 1572s and financial disclosures, and several critical shortcomings in pharmacy record-keeping for drug preparation, dosage calculation, and lot number tracking. Issues with outdated computer systems affecting record availability and poor chronological organization of microfiche records were also noted. Dr. Hawkins committed to providing a written response to the FDA regarding the observations.