FDA EIR - Bristol-Myers Squibb Company - June 27, 2018

The FDA conducted a routine inspection of Celgene Corporation's facility in Summit, NJ, from June 25 to June 27, 2018. The inspection focused on evaluating the company's adherence to the Risk Evaluation and Mitigation Strategies (REMS) program for its drug Thalomid. The regulatory framework for this inspection was based on the Thalomid REMS, which aims to prevent embryo-fetal exposure to the drug and ensure prescribers, patients, and pharmacists are informed of its serious risks and safe-use conditions.During the three-day inspection, investigators reviewed Celgene's REMS operations, including processes for certifying prescribers and pharmacies, enrolling and deactivating patients, and managing supporting database systems. The review encompassed standard operating procedures, training programs for relevant personnel, and educational materials distributed to certified pharmacies.Crucially, at the conclusion of the inspection, the FDA did not issue a Form FDA-483, Inspectional Observations, indicating that no significant regulatory violations were identified. However, the report noted minor observations: a discrepancy in the version date of a prescriber enrollment form provided to the FDA compared to the version in use; the absence of a system for regularly verifying the operational status of the company's REMS website; and the REMS database not consistently documenting reasons for deactivated pharmacy and prescriber certifications. Although 198 dispenses between 2012 and 2018 lacked initial Celgene authorization, a review of selected instances found no discrepancies in Celgene's documented actions. No formal corrective actions were mandated by the FDA as a result of this inspection.