FDA to Revisit Opioid Labeling for Chronic Pain

Regulatory Failures & Conflicts of Interest - The FDA failed in its oversight of opioids, contributing to the opioid epidemic [1] - Regulatory capture at the FDA is suspected, though unproven, with reviewers moving to Purdue Pharma after approving OxyContin for chronic pain based on a 14-day study [2] - Industry members have been removed from FDA advisory committees where possible to address potential conflicts of interest [3] - A conflict of interest exists if the team that approved a drug is responsible for evaluating its safety post-approval [6] Post-Market Drug Monitoring & Safety - The industry emphasizes the need for continuous monitoring of drugs and devices after approval [4] - The industry should not wait 19 years after a drug's approval to discover potentially deadly downstream effects, such as the alleged million deaths linked to OxyContin [5] - The industry advocates for using big data and epidemiology to monitor drugs for emerging safety signals [5] - The FDA previously had a system where bureaucrats could block safety epidemiology studies, which is being eliminated [5][6] Labeling & Scientific Integrity - The industry aims to ensure the accuracy and consistency of OxyContin and similar medications' labels with scientific evidence [3] - The industry is committed to preserving the scientific process in drug evaluation [4]