FDA EIR - Ascent Pharmaceuticals Inc - September 15, 2022

An FDA surveillance inspection of Ascent Pharmaceuticals Inc., conducted from September 12-15, 2022, focused on the company's compliance with the Opioid Analgesics (OA) Risk Evaluation and Mitigation Strategies (REMS) program. The inspection, the firm's first dedicated REMS review, was performed under Compliance Program 7353.001c. The primary violation, documented on an FDA Form 483, was Ascent's failure to include a prominent, REMS-specific link to the official OA REMS program website on its product website (ascentpharm.com/products). This omission meant consumers and healthcare providers lacked direct access to crucial REMS information for Ascent's nine opioid products, as mandated by the REMS document under FDCA 505-1(f)(4). Beyond the formal observation, the inspection revealed three discussion items with management: inadequate oversight of vendor activities, discrepancies in reporting periods between continuing education (CE) audit reports and REMS assessment reports, and inconsistencies in CE activity and audit data within REMS assessment reports. In response to the Form 483 finding, Ascent Pharmaceuticals promptly implemented voluntary website modifications to include the required REMS link. Management committed to discussing the broader issues of vendor oversight and reporting discrepancies with their shared REMS consortium and program management office.