Naloxone Still On US House Appropriators’ Radar, But OTC Access Remains Off Screen
FDA FY2022 Budget Report Comments On Switches, Acetaminophen Labeling, Homeopathics
Committee report again includes item concerning FDA’s work on expanding access to opioid antagonist naloxone. It still doesn’t acknowledge agency’s interest in making drug available OTC in a nasal inhaler, but emphasizes access for pregnant and postpartum women.
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Opposition to making naloxone available OTC remains strident because of stigma surrounding drug overdoses, says Bobby Mukkamala, a head and neck surgeon and an AMA Board of Trustees member.
Decisions in US Circuit and District courts for District of Columba are on complaint by Rx drug firm MediNatura, but should resonate for OTC homeopathic firms as well as all businesses across the sector. MediNatura appealed district ruling rejecting request for injunction against FDA’s withdrawal of 1988 homeopathic CPG.
Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.