FDA Extends REMS Requirements to Immediate-Release Opioids
On the heels of the sweeping opioid legislation package that passed the Senate on Monday, the US Food and Drug Administration (FDA) expanded its Risk Evaluation and Mitigation Strategy (REMS) program to include all immediate-release opioid analgesics intended for outpatient use.Manufacturers of extended release and long-acting opioid analgesics have been subject to the requirements under the Opioid Analgesic REMS since 2012, which is when the initial shared systems received approval. The new program expanded the total number of products from 62 to a total of 347, impacting a greater number of firms now required to provide educational grants.
“Today’s action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements,” FDA Commissioner Scott Gottlieb said Tuesday. “The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications.”
The agency expects continuing education training on the separately released education blueprint for health care providers to be available under the expanded REMS by next March.
Earlier this year, the agency released two draft guidance documents to describe how it envisions a shared REMS for prescription drugs and how sponsors' requests for waivers of the single, shared system requirement would be evaluated by agency staff. Commenters on both documents have expressed mixed reactions to the drafted policies.