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


  • Dan Cohen, MA/LS




Abuse-deterrent formulations, opioids, drug abuse


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.

Author Biography

Dan Cohen, MA/LS

Abuse Deterrent Coalition,§§ Washington, DC




How to Cite

Cohen, MA/LS, D. “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”. Journal of Opioid Management, vol. 13, no. 6, Dec. 2017, pp. 357-62, doi:10.5055/jom.2017.0413.

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