OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule
Executive Summary
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.
You may also be interested in...
US FDA Considering Opioid Mail-Back Envelope Mandate, But Industry Has Heard This Before
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.
Califf Says Opioid Labeling Changes, Withdrawals Still Possible
The US FDA commissioner also suggests the pain medications along with marijuana products should be regulated differently than other drugs.
Naloxone OTC Switch Urged By Congressional Coalition Of 30 Democrats And Republicans
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.