FDA Approves Over the Counter Narcan to Combat Drug Overdoses

The Food and Drug Administration announced today that Narcan, an essential tool in combating opioid overdoses, can now be sold over the counter. The move is aimed to increase the availability of the drug at a time when opioid-related deaths remain high across the U.S. Over 106,000 people died of drug-related overdoses in 2021 alone, according to the National Institute of Health. The FDA said OTC Narcan will be made available in stores, vending machines, online, and even in gas stations by the end of the summer.

FDA commissioner Dr. Rober M. Califf said in a public statement that the policy change is 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,” he said.

Narcan delivers the drug naloxone, which reduces opioid’s effect on the brain, as a nasal spray that can easily be administered in the event of an overdose. Consumers, including opioid users and their loved ones, have long needed a prescription to access the drug. But that isn’t the only hurdle. Many pharmacies don’t offer the drug because they refuse to serve individuals who engage in illegal drug use. But anyone will soon be able to buy it at their local pharmacy or grocery store.

Public health experts and providers who treat patients who use opioids welcomed the news.

The decision “represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths,” Chuck Ingoglia of the National Council for Mental Wellbeing, said in a statement. But some are still worried that the cost of the drug is too high.

Narcan is currently free to anyone on Medicaid or private insurance. Some plans require a co-pay of $10. But most insurance plans don’t cover the cost of OTC medications. It’s still not clear if these companies will make an exception for Narcan. Out of pocket costs for Narcan vary widely across the country. A two-dose box of Narcan currently sells for $98 in major cities like New York, but the average price is around $50 per box.

The drug is manufactured by Emergent BioSolution, but it has yet to disclose the retail price of OTC Narcan.

“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. <sic>

The FDA has little control over the retail price of the drug, but Califf encouraged the company to make the drug available “at an affordable price.”

Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services including handing out free naloxone, said the move could increase access to the drug in places where people don’t typically seek treatment, such as rural areas where doctors and substance abuse programs remain scarce.

“Putting it out on the shelves is going to allow people just to pick it up, not have stigma attached to it,” he said.

There is also a fear that Emergent BioSolutions will stop manufacturing the drug if it isn’t profitable as an OTC medication. Others are concerned that consumers and patients may not know how to properly use the drug. That’s why it’s still important to call an ambulance in the event of an overdose.