FDA Issues Final Guidance on the Evaluation and Labeling of Abuse-Deterrent Opioids

On April 1, the U.S. Food and Drug Administration (FDA) issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.  When used properly, opioids can be safe and effective in some patients.  However, there is a serious problem with diversion and abuse of these prescription drugs, which can result in death.  ASA is supportive of FDA’s efforts to make opioid use safer, and applauds the final guidance as a step forward for patient safety and responsible prescription use. 

ASA has a long history of being involved in discussions surrounding safe use of opioids.  ASA is involved in a task force, led by the American Medical Association, which is examining potential actions to take on opioid abuse. The task force, composed of several medical societies and health organizations, has been meeting for well over a year to discuss best practices and potential actions.  The last meeting took place in March 2015 and an “action” document is being finalized for release later this year.

FDA’s document, Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling, explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. It also makes recommendations about how those studies should be performed and evaluated, and discusses what labeling claims may be approved based on the results of those studies.  The final guidance document comes shortly after the Health and Human Services (HHS) Secretary Burwell announced a plan to address opioid use.

Several stakeholders are coming together to address this problem; along with the FDA and HHS, there has been bipartisan work across the federal government, partnerships with states and private industry, as well as efforts within the Centers for Disease Control and Prevention (CDC). ASA welcomes opportunities to collaborate and make opioid use safer.

Learn about ASA’s efforts to address prescription drug abuse.

Read more about the HHS initiative to address opioid-drug related overdose, death and dependence.