FDA WARNING_LETTER - Picus, Dr. Joel - October 28, 2009

On September 20, 2010, the FDA issued a Warning Letter to Joel Picus, M.D., of Washington University of St. Louis, following an inspection from October 14-28, 2009. The inspection reviewed Dr. Picus's conduct of three clinical investigations (Protocols (b)(4), (b)(4), and (b)(4)) as part of the Bioresearch Monitoring Program.

The FDA concluded that Dr. Picus failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection. Key violations include:

1. **Failure to Personally Conduct or Supervise:** Dr. Picus did not adequately supervise delegated study tasks, leading to significant problems. (21 CFR 312.60) 2. **Failure to Conduct Investigation According to Plan and Protect Subjects:** * For Protocol (b)(4), Subject 040-001 was dosed on April 3, 2009, despite elevated Liver Function Test (LFT) results that, per protocol, required dose withholding. The subject later died of multiorgan failure, with the death "probable" related to the study drug. * Study drugs for Subject 040-001 were prepared by an individual (b)(6) without documentation of being a trained pharmacist or designee for handling cytotoxic agents. (2