FDA EIR - Allergan - April 11, 2019

An FDA inspection of Allergan, PLC., located in Madison, NJ, was conducted from April 5 to April 11, 2019. The inspection focused on the company's adherence to the Risk Evaluation and Mitigation Strategies (REMS) program for Kadian, an extended-release morphine sulfate product. This first REMS inspection for Allergan was guided by the Compliance Program Guidance Manual, 7353.001c, pertaining to Opioid Analgesic REMS reporting.

The inspection resulted in two primary observations documented on a Form FDA-483. First, Allergan failed to ensure that the Medication Guide and Prescribing Information (PI) were available for printing on its official REMS Program website (www.opioidanalgesicrems.com), with the provided links being non-functional. Second, the Kadian product website (www.kadian.com) did not include a prominent, REMS-specific link directing users to the central Opioid Analgesic REMS Program website, a requirement to support risk mitigation efforts for consumers and healthcare providers.

These issues represent a failure to fully comply with the established regulatory framework for the Opioid Analgesic REMS, which mandates clear accessibility of crucial safety information. Allergan management acknowledged the findings during the inspection's close-out meeting and committed to submitting a comprehensive plan of action in response to the FDA-483.