FDA Advisory Committee Votes for Co-Prescribing Naloxone With Opioids

Regulatory NewsRegulatory News | 18 December 2018 |  By 

With a vote of 12-11, the joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM) voted in favor of adding labeling language that recommends co-prescription of naloxone for all or some patients prescribed opioids.

The close vote was the result of advisory committee members questioning whether co-prescribing necessarily addresses the opioid crisis at hand, while others said that co-prescribing is already the standard of care and therefore should be added to the labeling.

For instance, Kevin Zacharoff of the State University of New York, Stony Brook School of Medicine, voted yes and said he looks at his vote and co-prescribing as a message to health care providers prescribing opioids. “It will promote the discussion” around the use of naloxone, he added.

On the other side, Steven Mesiel of Fairview Health Services/Healtheast Care System in Minneapolis said he voted no because a public health problem requires a public health solution. All of the attention on labels is passive and no one reads the label anyway, he added.

Others who voted no questioned whether a label change was necessary as co-prescribing already happens in vulnerable, high-risk groups. Some even raised questions about the cost of co-prescribing as some naloxone products can cost more than $1,000. And others noted that co-prescribing does not address illicit opioid deaths.

Naloxone manufacturers that presented at the advisory committee meeting were all in favor of co-prescribing naloxone with opioids. Adapt Pharma said it hasn't raised the price of Narcan for three years and there are no plans to do so.


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