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

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...

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