Insights and issues from FDA Advisory Committee meetings on abuse-deterrent opioids

Christopher J. Miller, MS; Richard C. Dart, MD; Nathaniel P. Katz, MD, MS; Lynn R. Webster, MD, FACPM, FASAM

doi:10.5055/jom.2017.0416

Authors

Christopher J. Miller, MS
Richard C. Dart, MD
Nathaniel P. Katz, MD, MS
Lynn R. Webster, MD, FACPM, FASAM

DOI:

https://doi.org/10.5055/jom.2017.0416

Keywords:

abuse-deterrent opioid, Food and Drug Administration, Advisory Committee meeting, drug approval, regulation

Abstract

It is the current policy of the US Food and Drug Administration (FDA) to convene expert Advisory Committees to provide input on key regulatory decisions regarding opioid products, including approval and labeling of opioid abuse-deterrent formulations (ADFs). Advisory Committee meetings on ADF opioids consider whether the laboratory and clinical data submitted by the sponsor are sufficient to support marketing approval and labeling of the product with properties expected to deter abuse by specific routes of abuse (ie, oral, intranasal, intravenous). The FDA has typically followed the approval and labeling recommendations for ADFs reviewed by its Advisory Committees, highlighting the importance of these meetings in the regulatory approval process. This review describes common issues considered by Advisory Committees for ADF opioids as well as insights on how to prepare for these meetings based on recent relevant experience and regulatory decisions.

Author Biographies

Christopher J. Miller, MS

3D Communications, Raleigh, North Carolina

Richard C. Dart, MD

Rocky Mountain Poison and Drug Center, Denver Health and Hospital Authority, Denver, Colorado

Nathaniel P. Katz, MD, MS

Analgesic Solutions, Natick, Massachusetts; Adjunct Associate Professor, Department of Anesthesiology, Tufts University School of Medicine, Boston, Massachusetts

Lynn R. Webster, MD, FACPM, FASAM

Vice President of Scientific Affairs, PRA Health Sciences, Salt Lake City, Utah

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