FDA EIR - Servier Pharmaceuticals, LLC. - March 24, 2022

An FDA inspection of Servier Pharmaceuticals LLC was conducted from March 9 to March 24, 2022, focusing on two key areas: clinical study sponsor responsibilities for a high-priority, life-extending therapy, and postmarketing adverse drug experience (PADE) reporting. This was Servier's inaugural FDA inspection, performed under Compliance Programs 7348.810 for sponsors and 7353.001 for PADE reporting. During the PADE portion, inspectors identified a significant issue: 647 expedited adverse drug experience reports were submitted late to the FDA on February 14, 2022. This delay stemmed from the company's misunderstanding that adverse events originating from non-sponsored clinical trials also required reporting to their Biologic License Applications (BLA) or New Drug Applications (NDA). Although the reporting requirement was identified in August 2021, the batch submission of these cases was not made until February 2022, a duration acknowledged by the CEO. Regarding sponsor responsibilities, an inaccuracy was noted in data listing 16.2.1-1.5 concerning the "EFS event/censoring date," although the correct data was confirmed to have been used in the study's sensitivity analysis. Additionally, Servier had not secured a blanket waiver from the FDA for obtaining signed FDA Form 1572 from all non-U.S. clinical investigators, although equivalent investigator statements were collected. No formal Form FDA 483 was issued at the close of the inspection, and Servier's CEO committed to internal discussions addressing the matters raised.