FDA EIR - Ascent Pharmaceuticals Inc - November 07, 2018

An FDA Postmarketing Adverse Drug Experience (PADE) surveillance inspection of Ascent Pharmaceuticals, Inc. in Central Islip, NY, was conducted from November 5-7, 2018. The inspection, guided by Compliance Program Guidance Manual 7353.001, focused on the firm's PADE surveillance, receipt, evaluation, processing, and reporting systems for their generic pharmaceutical drug products. This included a review of Periodic Safety Reports (PADERs), 15-day Alert reports, Annual Product Reports, associated Standard Operating Procedures (SOPs), and Pharmacovigilance Quality Agreements. While no Form FDA 483 was issued, several significant issues were discussed with management. Key violations included discrepancies in defining the "Initial Receipt Date" for adverse events, leading to the late submission of two 15-day Alert reports and multiple Periodic Adverse Drug Experience Reports (PADERs). Furthermore, the company's SOPs and Quality Agreements incorrectly specified a "five business days" timeframe for reporting adverse drug events to application holders, instead of the required "five calendar days." The inspection also identified the absence of written procedures for reconciling adverse drug events with the firm's marketing partners, despite the activity being performed. Ascent Pharmaceuticals' management acknowledged these issues and committed to implementing corrective actions. These included updating PADE procedures to accurately define the Initial Receipt Date, revising SOPs and Quality Agreements to reflect the correct "five calendar days" reporting timeframe, and developing written procedures for the reconciliation of adverse drug events. These actions are crucial for ensuring timely and compliant adverse event reporting, aligning with regulatory expectations for post-market drug safety.