In a recently published article, FDA commissioner Scott Gottlieb and Center for Drug Evaluation and Research Director Janet Woodcock discussed how the FDA assesses the risks and benefits of opioids and integrates public health and clinical research into opioid approvals, marketing, restrictions, and labeling. They noted the recent removal of Opana ER from the market as an example of risk/benefit assessment for existing products. Going forward, the FDA is “working to identify which tools are best suited for application to prescription opioid assessment.” They acknowledged that addressing the opioid crisis is a national priority and the role prescription opioids play in that crisis “is a critical focus for FDA.” (JAMA 2017;318:421-422)
In a separate statement, Gottlieb said that reducing the scope of the epidemic of opioid addiction is his highest immediate priority. To that end, he announced that the FDA plans to update and modify the existing Risk Evaluation and Mitigation Strategy (REMS) for extended-release/long-acting opioids and, for the first time, include immediate-release opioids in the REMS program. The REMS program includes physician education regarding pain management and enhanced information about safe opioid prescribing. Gottlieb also outlined a strategy that calls for most opioid products on the market to feature abuse-deterrent properties in the future. (http://bit.ly/2v1XfDl).
FDA says reducing the scope of the epidemic of opioid addiction is the agency's highest immediate priority.
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