Gilead Sciences, Inc. – FDA EIR, Jan 15, 2014

An FDA inspection of Gilead Sciences, Inc.'s Foster City, CA facility was conducted from January 8-15, 2014. The inspection comprehensively covered compliance with Post-Marketing Adverse Drug Experience (PADE) reporting regulations, the Risk Evaluation and Mitigation Strategy (REMS) for Truvada's Pre-Exposure Prophylaxis indication, and Drug Quality Reporting System (DQRS) requirements related to Field Alert Reports (FARs). The main violation documented on a one-item FDA Form 483 was the company's "Failure to report adverse drug experiences that are both serious and unexpected within 15-days." This included 130 late reports for the drug Cayston received from a specialty pharmacy, with 12 submitted more than 800 days overdue, indicating a failure to adequately monitor adverse event reporting from these partners. Additionally, verbal observations included the need for Gilead to provide hard copies of scientific literature search articles with all expedited 15-day reports and to ensure medical professionals involved in drug safety triage assessments are trained on the most current versions of applicable procedures. David J. Pizzuti, M.D., Vice President, Regulatory Affairs, committed to correcting these deficiencies, including revising the literature search procedure and updating staff training. A written response outlining proposed corrective actions was required within 15 business days following the inspection.