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FDA’s Role in Preventing Opioid Abuse

Timeline

The FDA has compiled a timeline to provide chronological information about agency activities and significant events related to opioids. Included on this page is a summary timeline of key events, followed by tabbed years that provide selected additional actions and more detail about the items listed in the summary.

In February 2016, FDA leadership authored a Special Report published in the New England Journal of Medicine, which put forth a broad range of immediate and specific actions to help address opioid abuse. In this report FDA committed to: reassessing the risk/benefit analysis FDA applies to opioid drug product approvals, gaining expert input from Advisory Boards and the Scientific Board at FDA, reviewing label and postmarket requirements, prioritizing abuse-deterrent formulations and overdose treatments and supporting a range of research efforts in areas such as pain management in children and the development of non-opioid alternatives for pain management.

Action Plan

In response to the current opioid crisis the FDA has established a far-reaching action plan to reassess the agency’s approach to opioid medications. The plan focuses on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

Currently, Extended-Release and Long-Acting (ER/LA) Opioids are subject to Risk Evaluation and Mitigation Strategy (REMS) program. A REMS program may be required by the FDA as part of the approval of a new product, or for an approved product when new safety information arises. Essentially, a REMS is a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. On May 3 and 4, 2016, FDA Advisory Committees discussed results from assessments of the ER/LA Opioid Analgesics REMS.