FDA WARNING_LETTER - Burzynski Research Institute - March 15, 2013

An FDA inspection at Burzynski Research Institute (BRI) from January to March 2013 revealed significant non-compliance with FDA regulations governing clinical investigations of Antineoplastons A10 and AS2-1, impacting human subject protection and data validity. Key violations included: 1) Failure to ensure proper monitoring and adherence to investigational plans/protocols (21 CFR 312.50, 312.56(a)), resulting in incorrect therapeutic response classifications due to non-compliance with criteria like corticosteroid use. 2) Failure to obtain informed consent per 21 CFR 312.60, 50.25(b)(3), 50.27(b)(1), specifically by omitting additional cost statements in consent forms and presenting billing agreements post-consent. FDA also noted BRI's SOPs incorrectly referenced 45 CFR part 46 and allowed IRB waiver of parental permission for children, which is not permitted under 21 CFR part 50, subpart D. 3) Failure to obtain sufficient financial information from 122 sub-investigators for disclosure statements (21 CFR 312.53(c)(4), Part 54). BRI's proposed corrective actions, including protocol amendments and revised consent wording, were deemed inadequate by the FDA for not fully addressing past non-compliance or committing to correct study records. BRI must address these deficiencies and establish compliant procedures, responding to FDA within 15 working days to prevent further regulatory action.