ACCME Response to FDA Proposal for Standardizing and Evaluating REMS

Publish Date: 
Tuesday, December 16, 2014

The ACCME sent this letter in response to the Food and Drug Administration (FDA) report Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS). The letter offers observations and suggestions for improvement in the REMS CE process, based on the experience of the Extended-Release and Long-Acting (ER/LA) Opioid REMS.  In the letter, Murray Kopelow, MD, President and CEO, ACCME, said, “We observe that the project plan has many similarities to the process used to develop the ER/LA Opioid REMS, including the associated CE construct. We believe that we could apply some lessons learned from our recent experience with the ‘effort to develop and implement a class-wide REMS-based CE training module’ to augment the project process – without impinging on the FDA’s independence, authority, or procedural requirements…. We applaud the FDA for its willingness to utilize the accredited CE system as a strategic asset. We are respectful of the due-diligence process the FDA has outlined and look forward to participating.”