On May 3-4, 2016, the Food and Drug Administration (FDA) hosted a two-day long Joint Meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to discuss results from assessments of the extended-release and long-acting (ER/LA) Opioid Analgesics REMS. The CME Coalition submitted public comments following the meeting, emphasizing that FDA should consider standardizing the REMS process, while allowing more flexibility in content. The Coalition also suggested that REMS should be expanded to include short acting opioids.
As detailed further in the formal comments, the Coalition emphasized that "the strength of CME is that it can produce myriad educational activities that are targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. Added flexibility will allow prescriber education to better address individual prescribers’ educational and practice needs. The effectiveness of REMS can also be measured in terms of how successfully it promotes access to education and draws the attention of the medical profession to a problem."
"... While extended release and long acting opioids can be abused, short acting opioids are even more likely to be abused and therefore, much more difficult to manage. We agree with the FDA’s stated position that REMS be expanded to SA-IR, and create a single blueprint for all opioids. We are encouraged that the FDA sees CME as a valuable tool in combatting the opioids epidemic. Our members have created hundreds of hours of pain education programs and have delivered them to hundreds of thousands of physicians. Through their research and experience, we believe that, rather than requiring the whole three to six hours of content outlined in the blueprint, that counting credit hours towards a goal of three hours of REMS education should be considered."
As detailed further in the formal comments, the Coalition emphasized that "the strength of CME is that it can produce myriad educational activities that are targeted to physicians based on their professional practice gaps, individualized needs, and stages of learning and change. Added flexibility will allow prescriber education to better address individual prescribers’ educational and practice needs. The effectiveness of REMS can also be measured in terms of how successfully it promotes access to education and draws the attention of the medical profession to a problem."
"... While extended release and long acting opioids can be abused, short acting opioids are even more likely to be abused and therefore, much more difficult to manage. We agree with the FDA’s stated position that REMS be expanded to SA-IR, and create a single blueprint for all opioids. We are encouraged that the FDA sees CME as a valuable tool in combatting the opioids epidemic. Our members have created hundreds of hours of pain education programs and have delivered them to hundreds of thousands of physicians. Through their research and experience, we believe that, rather than requiring the whole three to six hours of content outlined in the blueprint, that counting credit hours towards a goal of three hours of REMS education should be considered."
| CME Opioid REMS Comments to FDA.pdf |
