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.
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Module comprising clinical study reports submitted in accordance with Harm Reduction Therapeutics’ rolling review proposal accepted by FDA after the agency in July granted fast track status for the application.
FDA, in unprecedented step, in 2018 published a model DFL for an OTC naloxone nasal spray developed in a study it sponsored, and former FDA Commissioner Scott Gottlieb noted a need for OTC naloxone. Four years later, US remains without OTC naloxone.
Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.