REMS Clock Ticking: Sponsors Grapple With Assessment Time Constraints
An FDA-convened panel of experts finds no single best question format for ascertaining patients’ and prescribers’ knowledge about drug risks learned through Risk Evaluation and Mitigation Strategies.
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The agency cited the forthcoming guidance in response to an HHS Inspector General report that questions the effectiveness of the risk management program.
Suggestions to FDA on improving REMS assessments include providing access to patient and physician surveys through a single website and timing assessments based on product launch, not REMS approval.
REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.