Opioid REMS Prescriber Education Should Be Mandatory, FDA Panel Says
This article was originally published in The Pink Sheet Daily
This time, the agency may be ready to agree with its advisory committee.
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US FDA is moving forward on two fronts to update and improve the Risk Evaluation & Mitigation Strategy to help limit misuse and abuse of opioid pain medications: the agency has a plan to incorporate IR sponsors into the existing REMS, and also a new 'blueprint' for the prescriber education that focuses on pain management.
Opioids May All Require Mandatory Education As US FDA Expands REMS To Immediate-Release Formulations
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.
As Egalet's Arymo ER heads to panel, agency tries to head off discussion about whether it should be approving new opioid products and whether longer clinical efficacy trials should be demanded.