FDA WARNING_LETTER - Simmons, John F, M. D. - August 10, 2010

An FDA inspection conducted between July 26 and August 10, 2010, reviewed Dr. John F. Simmons' conduct of clinical investigations for investigational drug (b)(4) under two protocols. The inspection, part of the Bioresearch Monitoring Program, concluded that Dr. Simmons failed to adhere to statutory requirements and FDA regulations for clinical investigations and human subject protection. Key violations include: 1) Failure to personally conduct or adequately supervise the clinical investigation (21 CFR 312.60), leading to significant study problems. 2) Failure to conduct studies according to the investigational plan and protect subjects (21 CFR 312.60), evidenced by enrolling ineligible subjects (e.g., with allergies, severe renal insufficiency, high (b)(4), or prohibited concomitant therapy), not performing required screening tests, and not completing efficacy procedures within protocol timeframes. 3) Failure to promptly report changes in research activity to the IRB (21 CFR 312.66), such as sponsor-imposed recruitment holds or site closure due to noncompliance. 4) Failure to obtain legally effective informed consent (21 CFR part 50, 21 CFR 312.60), specifically for one subject where the consent form was signed by an unauthorized person. Dr. Simmons' responses were deemed inadequate due to a lack of detailed corrective actions and staff retraining plans. The FDA requires a written response within fifteen working days outlining actions to prevent future violations, warning that failure to comply may result in further regulatory action. These deficiencies jeopardized subject safety and welfare and compromised the validity of the investigational endpoints.