Opioid REMS less onerous than expected

FDA is requiring a classwide REMS for extended-release and long-acting opioids that will provide educational programs and materials for prescribers and patients, but will not be mandatory as requested by an FDA advisory panel last year. FDA said a mandatory program would be "overly burdensome" on the healthcare system and would create a new registration system that would duplicate the existing Drug Enforcement Agency system. Instead, FDA said the Obama administration would seek legislation to require prescriber education as a condition of obtaining DEA registration.

The REMS requires companies to develop a single shared educational program on the dangers of misuse and abuse, as well as directions for patient selection and how to recognize evidence of misuse and abuse. FDA said it expects companies "to work together to provide the educational materials as part of a class-wide single shared system to reduce the burden of the REMS on the healthcare system." Companies will be required to track the number of prescribers completing the program and whether the program is adversely affecting patient access to medications. Companies now have 120 days to submit a draft REMS. ...