FDA WARNING_LETTER - Wise, John M. M.D. - March 28, 2014

The FDA issued a Warning Letter to Dr. John M. Wise of Bozeman Urgent Care Center following an inspection conducted from March 24-28, 2014. The inspection reviewed the conduct of clinical investigations for the investigational drug peramivir (BCX-1812) under Protocols BCX1812-211, BCX1812-212, and BCX1812-311 for BioCryst Pharmaceuticals, Inc. The FDA concluded that Dr. Wise failed to adhere to applicable statutory requirements and FDA regulations governing clinical investigations, specifically 21 CFR 312.62(c) regarding record retention. Key violations included the failure to retain required records for two years following a marketing application decision or investigation discontinuation. Specifically, the firm failed to retain records of drug disposition and adequate, accurate case histories, including informed consent forms and supporting data, for Protocols BCX1812-211 and BCX1812-311. All original study records for these protocols were erroneously shredded on January 24, 2014, despite an NDA having been filed. The firm's Standard Operating Procedure (SOP) for study-record retention was deemed insufficiently detailed to prevent such violations, even though boxes were appropriately labeled. The FDA stated that the failure to retain study records significantly compromises data validity and integrity, rendering the data from the affected protocols unreliable for research or marketing applications. Dr. Wise is required to respond within fifteen working days, detailing corrective and preventive actions taken to ensure future compliance with investigator recordkeeping and retention requirements under 21 CFR 312.62. Failure to address these violations promptly may result in further regulatory action.