Narcan Is Safe to Sell Over the Counter, Advisers to the FDA Conclude

The unusual unanimity of the vote “underscores the importance of moving this drug to greater access and also highlights the terrible risk of not acting in terms of making the drug more accessible,” said Maria C. Coyle, chairwoman of the advisory panel and an associate clinical professor at the Ohio State University College of Pharmacy.

The panel said that over the years that Narcan had been deployed, a handful of severe outcomes, such as death, had not been directly connected to Narcan itself but to attendant issues, such as delayed application or other drugs involved.

The F.D.A. had encouraged companies to submit applications to be considered for over-the-counter naloxone; the manufacturer of Narcan, Emergent BioSolutions, stepped forward.

Many voting and nonvoting experts, who included emergency responders, toxicologists, pharmacists, pediatricians and addiction medicine specialists, said that improvements were needed in the proposed labeling and packaging of over-the-counter Narcan. They suggested improvements to the company’s font, color choices and pictograms, which are intended to quickly guide panicky helpers through administering the medicine.

Such refinements were important, they said, also recommending that instructions specify the number of doses. They also said that the manufacturer had not evaluated whether young children can follow the directions and administer the medicine to siblings and parents. But the panelists emphasized that such adjustments should not be an impediment to releasing an urgently needed drug.

Still, Dr. Leslie R. Walker-Harding, a panel member who is a pediatrician at Seattle Children’s Hospital, criticized the company for not enrolling people under 15 in studies looking at whether children could readily understand how to use the drug.

“What is traumatizing to a kid is watching their loved one be unconscious, dying, and not being able to do anything about it,” she said, adding, “Children can protect us and protect themselves and are humans all on their own.”