US FDA Serves Notice: Approval Of OTC Naloxone Could Close Prescription Sales
Agency signals assurance about making naloxone available OTC, so much so that firms with approved NDAs for Rx products should prepare for an all-nonprescription market. After offering model label to spur OTC switch NDAs, FDA notice about OTC assessment is second unprecedented step on its naloxone journey since opioid crisis declared a public health emergency in 2017.
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FDA and non-profit firm Harm Reduction Therapeutics head Michael Hufford agree consumers could pay more out-of-pocket for OTC product than they do in co-pays for insurance plans. But Hufford says consumers’ costs for HRT’s OTC naloxone product won’t be impediment to expanding access.
The move should increase the visibility of the FDA’s wide-ranging, and widely criticized, opioid epidemic response.
Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.