FDA EIR - Jorge Lascano, M.D. - February 26, 2019

An FDA inspection of Sponsor-Investigator Jorge Lascano, M.D., conducted from February 19-26, 2019, focused on an expanded access protocol for single patient Investigational New Drugs (INDs). This 'for cause' inspection, initiated by an Institutional Review Board (IRB) report, was performed under regulatory frameworks for Sponsors and Clinical Investigators (Compliance Programs 7348.810 and 7348.811). The inspection revealed significant deviations, documented in a Form FDA 483. Key violations included a failure to secure appropriate informed consent (21 CFR 50.20), evidenced by a patient receiving investigational product for over a year without valid consent and another with a missing consent form. Dr. Lascano also failed to submit multiple annual reports to the FDA for 8 of 25 reviewed IND files (21 CFR 312.56(c)), resulting in IND terminations. Furthermore, there was a critical lack of documentation for investigational product accountability, specifically regarding its receipt, dispensing, and use. Serious adverse event reports, including two subject deaths, were not promptly submitted to the IRB, and the investigational plan was not followed concerning the informed consent process and reporting of each approved IND to the IRB. During the closing meeting, Dr. Lascano acknowledged awareness of these issues, largely due to a prior IRB audit. While instructed to provide a written response to the FDA 483, he did not confirm intent to do so. The FDA investigator emphasized the critical need for proper investigational product accountability documentation, which was not part of the IRB's previous corrective actions.