The Food and Drug Administration has officially approved the sale of Narcan, one company’s version of the opioid overdose-reversing drug naloxone, over the counter (OTC). It is the first naloxone product approved for use without a prescription, a move that could help save countless lives, though advocates also worry that cost will remain a barrier to those who need it most.
Naloxone, when administered in time, can reverse an overdose in minutes by attaching to opioid receptors and reversing and blocking the effects of opioids. While naloxone has technically been available in pharmacies without a prescription in all 50 states, D.C., and all U.S. territories for years, it has been kept behind pharmacist’s counters, meaning that people would need to ask for it. It was also not guaranteed that pharmacists would stock naloxone, or that pharmacists would give it if requested. The FDA’s designation means that Narcan, a brand of naloxone sold by the pharmaceutical company Emergent BioSolutions, can now be stocked on shelves alongside other OTC medications, such as Advil or Tylenol. With this decision, the drug can now be sold in easily accessible locations, such as gas stations, grocery stores.
The FDA announced the move on Wednesday in a press release, which also notes that the price and timeline for over the counter availability are up to the manufacturer. The company declined to disclose the price plans to the New York Times, but stated that it would “work with public interest groups” to make the price accessible. Health economists told the Times that the price is predicted to fall somewhere between $35 and $65, though retailers could also charge more.
The FDA notes that drug overdose remains a major public health issue in the U.S., with 101,750 reported fatal overdoses occurring in the year leading up to October 2022. Advocates have long maintained that greater access to naloxone is essential to ending the overdose crisis, and while making Narcan more widely available is a step in the right direction, some argue that it doesn’t go far enough.
Taylor Edelmann, an LGBTQ+ health and harm reduction manager with the Lighthouse Learning Collective, an organization dedicated to LGBTQ+ people who use drugs, called the move a “delayed reaction” in a statement to Them, and one that “community advocates have been fighting for over the last few decades.” He added that the FDA should move to make injectable naloxone available OTC as well, “which many folks rely on due to cost.” According to Filter, a publication that covers drugs and drug policy, the cost for two single-dose vials of generic injectable naloxone is generally less expensive than a two-pack of Narcan.
“Although just a part of the overall arsenal of tools we need to address the overdose epidemic, one can't stress enough how vital it is to get naloxone into more hands,” Edelmann said. “We need to normalize having it available in queer nightlife spaces and LGBTQIA+ drop-in centers. With the instability of the current drug supply and the use and enjoyment of drugs in queer spaces, it's necessary to save lives. It's not enough anymore to have an HIV testing event without discussing things like drug use — and with naloxone being so effective and easy to use, there's really no excuse.”
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