Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations

20 Dec 2016

• By Michael Cipriano

Agency has been hesitant to take the steps because of logistical difficulties of creating an enormous program, but has been pushed by its risk management advisory committee, among others.

Following the urging from advisory committee members, the US FDA appears to be changing gears in its position on adding immediate-release (IR) opioids to the Risk Evaluation and Mitigation Strategy (REMS) program, as well as mandatory education.

FDA said in an announcement that it intends to require a REMS for all forms of opioids, with the purpose being "to ensure the benefits of these drugs continue to outweigh the risks of misuse, abuse, addiction, overdose and death

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