FDA WARNING_LETTER - Tuller, Betty Ph.D. - February 14, 2011

An FDA inspection conducted between January 18 and February 14, 2011, by Mr. Sean Creighton, reviewed Dr. Betty Tuller's conduct of clinical investigations involving the investigational drug (b)(4). The FDA determined that these studies were not exempt from 21 CFR Part 312 requirements, as they involved a route of administration or dosage level that significantly increased risks, thus requiring an Investigational New Drug (IND) application. The inspection revealed several violations of FDA regulations governing clinical investigations and human subject protection. Dr. Tuller failed to obtain informed consent in accordance with 21 CFR Part 50 [21 CFR 312.60], omitting critical information such as experimental procedures, alternative treatments, FDA inspection possibility, compensation for injury, and reasonably foreseeable risks like hypokalemia. This omission compromised subjects' rights, safety, and welfare. Additionally, Dr. Tuller failed to maintain adequate and accurate case histories, including subject enrollment, withdrawal, and completion data, as required by 21 CFR 312.62(b), raising concerns about data integrity. Finally, Dr. Tuller failed to promptly report unanticipated problems involving risk to human subjects or others to the IRB, as mandated by 21 CFR 312.66, despite collecting adverse event lists that included hospitalizations. This prevented the IRB from making informed safety determinations. Dr. Tuller is required to respond in writing within fifteen working days, detailing corrective actions to prevent future violations, with potential regulatory action if not adequately addressed.