FDA Expands Opioid Prescription REMS to IR Formulations

Manufacturers of short-acting opioids will be required to offer the kind of doctor training in administering the medications that their extended-release counterparts have been directed to provide since 2012, FDA Commissioner Scott Gottlieb said.

The application of the Risk Evaluation and Mitigation Strategy training requirement to immediate-release opioid producers, which could take a year to effect fully, will expand the number or drugs covered from 64 to 341, Gottlieb said in an FDA blog post. The training offer also will be broadened to include not just prescribers but nurses and pharmacists.

The agency’s new Opioid Policy Steering Committee is considering whether and how to make the training mandatory, Gottlieb said. The FDA issued a public notice seeking comment on opioid policy.