Burzynski, Stanislaw R. MD – FDA Warning Letter, Mar 15, 2013

This Warning Letter details objectionable conditions observed during an FDA inspection of Stanislaw R. Burzynski, M.D., Ph.D.'s clinical site from January 7 to March 15, 2013. The inspection reviewed his conduct of clinical investigations and expanded access use of investigational drugs Antineoplastons A10 and AS2 for various brain and adrenal gland tumor protocols (BT-09, BT-10, BT-21, BT-22, AD-02).

The FDA concluded that Dr. Burzynski failed to adhere to statutory requirements and FDA regulations. Key violations include:

1. **Failure to conduct investigations according to the investigational plan (21 CFR 312.60):** * **Incorrect therapeutic response assignments:** For 9 of 27 subjects reviewed, Dr. Burzynski incorrectly classified Complete Response, Partial Response, and Stable Disease, often due to subjects being on corticosteroids above physiologic levels when protocols required them to be "off corticosteroids," or not meeting duration criteria for tumor response. His response, citing proposed protocol amendments and maintaining original assessments, was deemed inadequate as it did not address current protocol requirements or commit to correcting study records. * **Failure to report adverse events:** Subject 023612 experienced multiple adverse events (rash, fever, weakness, nausea, etc.) that were not reported to the sponsor. His response