Massimo Cristofanilli, MD – FDA EIR, Nov 3, 2004

An FDA inspection was conducted at M.D. Anderson Cancer Center (MDACC) from October 18 to November 3, 2004, targeting clinical investigator Massimo Cristofanilli, M.D. This for-cause inspection, under the regulatory framework for Clinical Investigators (CP 7348.811), aimed to assess compliance with applicable regulations for a pilot study. Significant violations were identified regarding the use of an investigational new drug. Ten human subjects were administered the drug without an Investigational New Drug (IND) application being in effect.

Key issues included the failure to provide the FDA with consistent study protocols and documentation used for review by the Radioactive Drug Research Committee (RDRC). Inaccurate reports were submitted to the Institutional Review Board (IRB), containing erroneous drug identification and dose information. The Informed Consent Document (ICD) was found deficient, lacking details on risks related to the chemical-grade, biohazardous investigational product, radiation exposure, or alternative treatments. It also contained inaccurate statements claiming regulatory compliance and FDA authorization. Furthermore, required purity and sterility testing for the study drug was conducted after patient dosing, and 13 vials of the investigational product were unaccounted for.

Upon conclusion, an FDA Form 483, detailing these inspectional observations, was issued to Dr. Cristofanilli. He was informed of the implications of the findings, including potential violations of Texas State Board of Pharmacy rules, and advised on the process for submitting a formal response to the FDA.