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ASAM Submits Comments to FDA Regarding Strategies to Increase Naloxone Availability

by | December 19, 2018
ASAM’s Comments to FDA

On December 14, ASAM submitted comments to the Food and Drug Administration (FDA) in response to a request for comment ahead of a public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. At the meeting, the committees provided expert guidance regarding strategies to increase the availability of naloxone products intended for use in the community.

ASAM’s comments echo many of the recommendations included in ASAM’s 2016 public policy statement, Use of Naloxone for the Prevention of Opioid Overdose. Specifically, the comments emphasize the well-established safety and efficacy of naloxone to reverse opioid overdose and prevent fatalities and details ASAM’s support for increased use of naloxone in cases of opioid overdose to prevent or reverse respiratory arrest. Moreover, the letter expresses ASAM’s support for broadened accessibility to naloxone for family members and medical, law enforcement, and other professionals who may need to be able to respond readily to an opioid overdose.

The comment letter outlines changes that could increase access to naloxone and reduce overdose deaths in the United States. First, ASAM encourages the co-prescribing of naloxone for people at risk of overdose, which includes those receiving non-acute opioid treatment for pain and those being treated for opioid use disorder. The prescription should be complemented by appropriate education about the risks of overdose, the sign/symptoms of overdose, the proper instruction on how to administer the medication, and the need for referral to treatment after revival. In addition, the letter urges the FDA to designate at least one naloxone product as an over-the-counter medication through an approval process that demonstrates consumers understand the new label and can administer the medication. The need for a prescription serves as a barrier to accessing naloxone, especially in rural and medically underserved areas.

This timely public advisory committee meeting follows other administration initiatives which aim to bring attention to the importance of naloxone access. In the President’s Commission on Combating Drug Addiction and the Opioid Crisis’ recommendations to combat the addiction crisis in the US, the Commission recommended that all law enforcement and first responders be equipped with naloxone, model legislation be provided to states to allow naloxone dispensing via standing orders, and ‘Good Samaritan’ laws be enacted to empower the public to seek help. In addition, Surgeon General Jerome Adams, MD, MPH released a public health advisory  encouraging more individuals, including family, friends, and those at risk for opioid overdose, to keep on hand naloxone.

While naloxone is not considered treatment for opioid use disorder, it is essential to reduce opioid-related overdose deaths and can serve potential gateway to ongoing medical care and opioid addiction treatment. ASAM looks forward working with the FDA and the Administration to ensure that patients have access to this lifesaving medication and improving public health for people with substance use disorder and their loved ones.

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