In today's Federal Register, FDA reopened the comment period for its Risk Evaluation and Mitigation Strategies, or REMS, for certain opioid drug products. The new deadline for comments--a year from today, 10/19/2010--indicates that no action will be taken for a long while.
The move shows that the agency recognizes the problems identified in the comments filed about the development of an opioid REMS, which has important implications for the daily practice of pharmacists, is rethinking its approach, and reflects the impact of the nearly 2000 comments that FDA received on this topic. APhA was a key voice in calling for modifications to the REMS plan.
In the notice, FDA wrote that it recognizes the challenges and need for an opioid REMS to be "carefully designed" (due to the number of prescribers, pharmacists, and patients involved with these medications) and the need to ensure a REMS does not unduly burden the health care system or limit patient access.
We will monitor this development and keep you posted as needed.