FDA WARNING_LETTER - Summers, Timothy, MD - March 27, 2009

An FDA inspection conducted between March 25-27, 2009, by Ms. Barbara Wright at Alliance Health Center reviewed Dr. Timothy Summers' conduct of a clinical investigation (Protocol (b)(4)) of an investigational drug. The inspection, part of the Bioresearch Monitoring Program, found that Dr. Summers failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection. A Form FDA 483 was issued, and while Dr. Summers did not respond, Alliance Health Center acknowledged failures and stated Dr. Summers was no longer conducting clinical research there. Key violations included: 1) Failure to conduct studies according to the investigational plan and protect subjects (21 CFR 312.60), exemplified by enrolling ineligible subjects, improper dosing, missing assessments, and not informing the IRB about enrolling wards of the state. 2) Failure to maintain adequate and accurate case histories (21 CFR 312.62(b)), with issues like unbound records, lack of controls, conflicting information, and missing pages. 3) Failure to obtain legally-effective informed consent (21 CFR Part 50, 21 CFR 312.60), specifically for a ward of the state where only a parent, not the legally authorized representative, signed. 4) Failure to promptly report research changes to the IRB and making changes without IRB approval (21 CFR 312.66), such as using a hand-altered consent form without IRB approval. These deficiencies jeopardized subject safety and data validity. Dr. Summers must respond within fifteen working days, outlining corrective actions to prevent future violations, or face further regulatory action.