F.D.A. Approves Narcan for Over-the-Counter Sales
Narcan, a prescription nasal spray that reverses opioid overdoses, can now be sold over the counter, the Food and Drug Administration said on Wednesday, authorizing a move long-sought by public health officials and treatment experts, who hope wider availability of the medicine will reduce the nation’s alarmingly high drug fatality rates.
By late summer, over-the-counter Narcan, could be for sale in big-box chains, vending machines, supermarkets, convenience stores, gas stations and even online retailers.
The commissioner of the F.D.A., Dr. Robert M. Califf, said in a statement that the over-the-counter authorization was meant to address a “dire public health need.”
“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country. We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”
Narcan is a nasal spray version of the drug naloxone, which blocks an opioid’s effect on the brain. As the overdose crisis has worsened, with more than 100,000 drug-related deaths in the United States for each of the last two years, millions of doses have been administered by outreach workers, health care providers and emergency responders.
But for people who use drugs, as well as for their friends and relatives, ready access to the prescription medication has been elusive.
Naloxone access laws in every state allow pharmacists to have a standing prescription so they can dispense Narcan or a generic brand to anyone who requests it. But many pharmacies choose not to do so, preferring not to engage customers around illicit drug use, especially without a doctor’s oversight. Of the nearly 17 million naloxone doses distributed in 2021, only 2.64 million were from pharmacies, according to a recent report.
Though over-the-counter status will in theory make it far easier to obtain Narcan, the cost of the medicine could be a deterrent.
Currently, a two-dose pack of prescription Narcan is often free to people covered by Medicaid or private insurance, or has a co-pay of less than $10. But public and private insurance programs do not cover most over-the-counter medicines. Whether an exception will be made for Narcan could take months to resolve.
This month, a big-box pharmacy in Manhattan was charging $98 for the two-dose box of prescription Narcan to customers without insurance. Another pharmacy chain in New Jersey charged $73.
The company that makes Narcan, Emergent BioSolutions has declined to disclose the price it plans for an over-the-counter version of Narcan, while the F.D.A. was reviewing its over-the-counter application. On Wednesday morning the company did not mention a price in a statement released after the F.D.A.’s announcement.
“We are dedicated to improving public health and assisting those working hard to end the opioid crisis — so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with Narcan to help save a life,” said Robert G. Kramer, the chief executive officer of Emergent BioSolutions, which manufactures the nasal spray.
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