Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects.
These communication plans are typically composed of letters, websites, and fact sheets describing the specific safety risks identified in the REMS.
[8] Between 2014 and 2017, the FDA stated they did not have enough data to determine whether the REMS program was sufficiently preventing opioid abuse.
[9] The Health and Human Services Office of the Inspector General recommended that parties in the REMS program provide the FDA more data.
[10] The FDA was habitually late in evaluating that data, reportedly leaving those parties with inadequate time to react to the review before their next assessment.