Is The Opioid REMS Too Big To Study?
US FDA’s workshop to discuss new ideas to assess the impact of the opioid REMS comes after the industry collaboration behind the REMS has deemed the task essentially impossible.
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Commissioner Gottlieb tells opioid scientific workshop that updated REMS will also require training to be available to nurses and pharmacists; agency beginning new study on prescriber perceptions.
Longitudinal studies and possibly a randomized, controlled trial are needed, FDA's advisory committee says; panelists were underwhelmed by product sponsors' survey, surveillance and drug utilization data.
Whether CME for pain management has the intended impact on prescribing is likely focus of new ‘suite of studies’ intended to assess the opioid REMS program. The challenges for FDA include teasing out the impact of the risk management program amid all the other public health efforts on opioids.