Cost Concerns May Hinder Naloxone Co-Prescribing Ideas
US FDA estimates mandating naloxone co-prescriptions could dramatically increase spending to more than total estimated cost of opioid crisis itself; joint advisory committee to consider options to increase naloxone availability.
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Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Agency's opioid response efforts have pushed advisory committee into unusual territory in recent years. But a two-day meeting to discuss potential labeling changes to recommend co-prescribing of the overdose reversal agent naloxone moved way beyond any of the conventional boundaries of committee meetings.
While arguing that US FDA overestimated inflation and fill rates when calculating annual cost of co-prescribing naloxone with opioids, Adapt Pharma opened door to pricing pledge questions that the Narcan sponsor could not answer.