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Opioid REMS: FDA Sees No Clear Verdict On Risk Management Program's Impact

 
• By Sue Sutter

Agency raises generalizability concerns with prescriber and patient surveys conducted to assess impact of REMS for extended-release/long-acting opioids; surveillance data provide little evidence the REMS has resulted in changes in safety outcomes but also do not demonstrate the program has been ineffective.

The most recent evaluation of the extended-release/long-acting opioid products REMS reflects an ongoing and frustrating question for both FDA and the biopharma industry: How best to determine whether the risk management programs are truly working?

FDA's analysis of the assessment for the ER/LA Risk Evaluation and Mitigation Strategy suggests that three years after voluntary training for opioids prescribers began under the massive program, the agency still does not know whether the REMS is accomplishing its goals of reducing overdose,

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• By Sarah Karlin-Smith

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• By Sue Sutter

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• By Sarah Karlin-Smith

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More from North America

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
• By Sue Sutter

Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

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• By Jessica Merrill

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