FDA EIR - Dr. Herman Zaharowitz - December 03, 2004

An FDA "for cause" inspection of Dr. Herman Zaharowitz, a Principal Investigator in St. Petersburg, FL, was conducted from October 19 to December 3, 2004. Initiated by the FDA's Good Clinical Practice Branch, the inspection reviewed Dr. Zaharowitz's involvement in Protocol CO2-010, "A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat vs. Allopurinol in subjects with Gout," specifically during his tenure from July to August 2003. The regulatory framework for this inspection was CP 7348.811, Clinical Investigators, emphasizing Good Clinical Practice. The inspection identified significant deviations, leading to the issuance of an FDA Form 483. Main violations included a lack of investigator oversight, evidenced by the untimely review of adverse events, electrocardiograms, and laboratory test results. Informed consent issues were noted, such as subjects not being re-consented with updated forms and signing expired documents. Additionally, physical examinations were often performed by study coordinators instead of the investigator, and deficiencies in drug accountability, including missing dispensing initials and temperature logs, were observed. The delegation of responsibilities for study staff was also found to be undocumented. Dr. Zaharowitz acknowledged his responsibilities and committed to submitting a written response to the observations.