FDA advances overdose recommendations

The Food and Drug Administration this week issued a report offering recommendations to address the opioid crisis and the role of analgesic oversight in preventing addiction, overdoses and deaths. Part of the FDA’s Overdose Prevention Framework, the report recommends the agency: implement recommendations put forward in a 2017 National Academies for Sciences, Engineering, and Medicine report; seek congressional action to strengthen oversight of opioid analgesic approvals and advertising; and increase transparency related to decision-making for opioid analgesics. Also this week, FDA’s independent advisors unanimously recommended over-the-counter access to Narcan, a nasal spray used to reverse opioid overdoses. FDA will make a final decision by March 29. (FDA statement, 2/16/23)