FDA Reviews NARCAN for Over-the-Counter Use, Follows Joint Advisory Committee Recommendation

On February 15, 2023, the Food and Drug Administration (FDA) held a joint meeting of the Nonprescription Drugs Advisory Committee (NDAC) and Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to consider Emergent Biosolutions’ Narcan (naloxone) as an over-the-counter product. The advisory panels unanimously voted to recommend Narcan becoming an over-the-counter emergency treatment for opioid overdose. If the FDA moves forward with this approval, it would build on existing actions some individual states have taken to facilitate access to Narcan without a prescription. During the meeting, several advisory members urged Emergent Biosolutions to update the packaging to include more straightforward instructions on administering Narcan and make those instructions readily available in each unit rather than just on the box. Emergent Biosolutions expressed willingness to make those adjustments. FDA will decide on final approval on Thursday, March 29, 2023.

Articles & Resources

FDA – Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting

FDA – Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Presentation

Axios – FDA panel: Narcan spray shouldn’t need a prescription

Inside Health Policy – FDA Advisers Recommend OTC Narcan, But With Usage Instructions

FDA Issues Report on Regulation of Opioid Analgesics

On February 16, 2023, FDA Commissioner Califf formally announced the completion of the External Review of FDA Regulation of Opioid Analgesics Final Report. This follows on Califf’s August 2022 announcement of the FDA’s Overdose Prevention Framework, which included a plan to issue an independently-prepared report on the agency’s opioid-related activities. The study that led to the report examined and analyzed the FDA’s implementation of the 2017 National Academies of Science, Engineering, and Medicine recommendations and other important policy focus areas to address the drug overdose and substance abuse crisis. The report reviewed FDA’s approach to opioid analgesic Regulation, specifically, OxyContin, Opana ER, Hydexor, and other opioids. The research also examined FDA’s approach to opioid analgesic approvals, and post-approval oversight. The report concluded that the FDA must continue to implement NASEM’s guidance, seek support from Congress regarding opioid analgesics approval, and increase transparency in the decision-making of opioid analgesics.

Articles & Resources

FDA – FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death

FDA – External Review of FDA Regulation of Opioid Analgesics Final Report

FDA – Overdose Prevention Framework

NASEM – Pain Management and the Opioid Epidemic (2017)

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

AJMC – Continuity of Opioid Prescribing Among Older Adults on Long-term Opioids

Federal Register – Medications for the Treatment of Opioid Use Disorder: Removal of the DATA-2000 Waiver Requirements

FDA – FDA Advances Additional Activities to Prevent Drug Overdoses and Reduce Death

Health Affairs – Optimizing Opioid Settlement Funds to Save Lives: Investing In Equitable Solutions

Implementation Science – De-Implementing Opioids for Dental Extractions (DIODE): A Multi-Clinic, Cluster-Randomized Trial of Clinical Decision Support Strategies in Dentistry

Senator Shelly Moore Capito – Capito, Manchin, Merkley, Klobuchar, Collins Recommend Bipartisan Improvements to Legacy Act Proposed Rule

Senator Ed Markey – Defense Department Releases Overdoes Data, Outlines Plans to Bolster Prevention Among Service Members in Response to Letter from Sen. Markey

Stat – The X-Waiver for buprenorphine prescribing is gone. It’s time to spread the word

UC Davis Health News – Tapering May Have Negative Impacts for Patient Taking Opioids Long Term

Wall Street Journal – ‘Tranq’ a Veterinary Drug, Is Worsening the Fentanyl Crisis

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