OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
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Sponsors would be required to furnish patients with pre-paid envelopes to mail back unused opioid medications for disposal. Comments on FDA's proposal could follow industry concerns about burden on health care system voiced when the idea was floated in 2018.
The US FDA commissioner also suggests the pain medications along with marijuana products should be regulated differently than other drugs.
In response to highest number of overdose deaths in US history in 2021, 30 members from both chambers of Congress sign letters sent to seven CEOs of naloxone manufacturers.