FDA WARNING_LETTER - Boyce, Steven W., M. D. - September 15, 2011

The FDA issued a Warning Letter to Steven W. Boyce, M.D., Washington Hospital Center, following an inspection from August 24 to September 15, 2011. The inspection reviewed Dr. Boyce's conduct of a clinical investigation for an investigational drug (Protocol (b)(4)), revealing significant non-adherence to statutory requirements and FDA regulations governing clinical investigations. Key violations identified include: 1) Failure to assure Institutional Review Board (IRB) review and approval (21 CFR 312.66), resulting in five subjects being enrolled after IRB approval expired. 2) Failure to maintain adequate and accurate case histories (21 CFR 312.62(b)), specifically using informed consent forms for these subjects that were inaccurately stamped as IRB-approved. 3) Failure to conduct the investigation according to the investigational plan (21 CFR 312.60), with missed or early postoperative day 28 assessments and unperformed electrocardiograms for multiple subjects. 4) Failure to obtain informed consent in accordance with 21 CFR part 50 (21 CFR 312.60, 21 CFR 50.27), including an undated consent form and the use of unapproved, misleadingly stamped consent forms. The FDA found Dr. Boyce's corrective action plans incomplete, lacking documentation of procedures for regulatory oversight and staff training. These deficiencies raise serious concerns about the protection of human subjects' rights and welfare, and the validity and integrity of the study data. Dr. Boyce is required to respond within fifteen working days, detailing actions taken to prevent recurrence, or face potential regulatory action.