FDA's Gottlieb taking aim at opioid epidemic, wants post-market studies to confirm abuse-deterrent claims, meeting next month with KOLs

|By:, SA News Editor

FDA Commissioner Scott Gottlieb, M.D. believes the agency can do more to fight the opioid epidemic in the U.S. Recently announced policy steps included the formation of a steering committee that will explore new regulatory and policy actions to fight the crisis, specifically actions aimed at reducing new cases of addiction.

One of the initiatives requires opioid manufacturers to conduct post-marketing studies to determine the effects of their abuse-deterrent offerings on abuse/misuse in real-world settings.

The steering committee will host external thought leaders in meeting July 10 - 11 to discuss ways to better leverage existing data sources and methods to evaluate the impact of the products once dispensed considering that abuse-deterrent pain meds are not abuse-proof or addiction-proof.

Dr. Gottlieb says the FDA needs better scientific information to understand how to optimize its assessment of abuse-deterrent formulations.

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