Abuse-deterrent formulations approval reform: Will clinical correctness or real-world results be used to address the nation's opioid crisis: “Noninterference” as a new approval standard

Abstract

To further the public policy objectives of Congress and the country, legislators should now insist that abuse-deterrent formulations (ADFs) be deployed for every C-II opioid and stimulant. The need for these innovative technologies has never been greater. And to most efficiently incentivize innovators to develop and deploy the most effective and modern deterrents, a new and simpler regulatory approval standard for ADF should be adopted by the U.S. Food and Drug Administration. That standard, based on a concept of “Noninterference” increases the potential for a much earlier deployment of ADFs in a broad range of products and allows deterrence to play its most effective role in combatting the national opioid crisis.