Morning Briefing
Summaries of health policy coverage from major news organizations
Anti-Overdose Naloxone Could Soon Be OTC As FDA Fast-Tracks Review
Axios: FDA Fast-Tracks Review Of Over-The-Counter Opioid Drug
A nasal spray for reversing opioid overdoses could become available over-the-counter as early as next March after the Food and Drug Administration gave it priority review. Advocacy groups, medical associations and federal agencies have said expanding the availability of naloxone is critical to addressing the addiction epidemic that killed more than 100,000 Americans last year. (Moreno, 12/7)
CBS News: Narcan Maker Says Anti-Opioid Nasal Spray Will Soon Be Available Over The Counter
Emergent BioSolutions on Tuesday said the Food and Drug Administration has fast-tracked its application for an over-the-counter version of Narcan, a nasal-spray form of naloxone. Approved in 2015, Narcan and its somewhat less expensive generic competitors are widely used by first responders and laypeople to treat known or suspected opioid overdoses that kill tens of thousands of Americans in the U.S. each year. (Gibson, 12/6)
In related news about FDA drug approvals —
AP: Speedier Drug Approvals Hit Slowdown As FDA Faces Scrutiny
Expedited drug approvals slowed this year as the Food and Drug Administration’s controversial accelerated pathway came under new scrutiny from Congress, government watchdogs and some of the agency’s own leaders. With less than a month remaining in the year, the FDA’s drug center has granted 10 accelerated approvals — fewer than the tally in each of the last five years, when use of the program reached all-time highs. (Perrone, 12/7)
