FDA Considering Over-the-Counter Narcan

    FDA Considering Over-the-Counter Narcan
    Last updated Feb 16, 2023
    Image credit: Adapt Pharma [via CNBC]


    • On Wednesday, independent advisors to the US Food and Drug Administration (FDA) voted unanimously to recommend the over-the-counter sale of Narcan, known generically as naloxone. Narcan is used to reverse the effects of opioid overdoses by blocking the effect of opiates on the brain.
    • Late in 2022, a Baltimore-area pharmaceutical company, Emergent BioSolutions, Inc., submitted an application to sell the generic nasal spray to the public, which could help support the opioid overdose problem in the US.
    • According to the US Centers for Disease Control and Prevention (CDC), more than 560K people have died from opioid use in the US in the past 24 years. The deaths occurred in three distinct phases of crises — first prescription opioids, then heroin, and more recently fentanyl.
    • The panel’s recommendation will now go to the FDA, which is expected to make its final decision by March 29. If approved, consumers will be able to purchase the drug in common locations, such as grocery stores, convenience stores, and possibly even vending machines.
    • In 2017, former Pres. Trump’s administration was the first to classify the opioid crisis as a public health emergency. Since then, Pres. Biden’s administration has renewed the declaration every 90 days.
    • No determination has been made on how much the drug will cost.


    Narrative A

    Naloxone should be as accessible as common headache medications and cold and flu remedies, and the American Medical Association is urging the FDA to make this happen. The wider availability of this life-saving drug will go a long way in destigmatizing drug use and will help in fighting the horrors of the opioid crisis.

    Narrative B

    While everyone should have access to Narcan, much more must be done to teach people how to use it. In particular, kids must be able to administer it to their parents or siblings. Labels and instructions can be negotiated to ensure that anyone legally allowed to purchase it can then safely administer the medication for the intended outcome. Implementing this solution is more complex than the FDA approval alone.

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