The US Food and Drug Administration on Wednesday approved the over-the-counter sale of a version of the overdose-reversing drug naloxone, a move that advocates celebrated for potentially easing access to an important tool against overdose deaths.
The FDA said its decision will allow the drug to be sold without a prescription “directly to consumers in places such as drug stores, convenience stores, grocery stores, and gas stations, as well as online.”
But questions remain about how the decision will affect access in states such as Massachusetts where naloxone is already widely available behind the pharmacy counter, for little or no cost to consumers. Over-the-counter drugs are not usually covered by insurance, and the manufacturer has not announced a price.
Traci C. Green, professor and director of the Opioid Policy Research Collaborative at Brandies University, was thrilled by the news.
“It’s about time,” said Green. “This is the best news you could possibly hear. It wasn’t all that long ago, naloxone wasn’t even covered [by insurance]. It took a lot of advocacy to shift that.”
Green envisions naloxone being sold at restaurants, highway rest stops, even vending machines.
“The safety profile, it doesn’t get much better than naloxone,” Green added. The drug acts only if a person has opioids in their system, by blocking the brain receptors the opioids work on. “Otherwise it pretty much just passes through the body,” she said.
More than 2,000 people die of opioid-related overdoses each year in Massachusetts, a toll that changed little since 2016.
The FDA’s approval applies only to the Narcan nasal spray made by Emergent BioSolutions, based in Maryland, which plans to make it available over the counter by late summer. Other formulations of naloxone remain prescription-only. The agency said the manufacturer will determine the price and establish the timing of the switch to over-the-counter status.
Currently, anyone in Massachusetts can go to a pharmacy counter and buy naloxone, without a prescription from their own doctor. Instead, a “statewide standing order” from the state Department of Public Health makes the prescription available to everyone. MassHealth, the state’s Medicaid program, pays for it in full, as do most insurers. Additionally many harm-reduction programs distribute naloxone to their clients.
But the prescription goes to the individual buying the drug, who often doesn’t intend to use it personally but wants it on hand in case they are present when a relative, or even a stranger, overdoses. Some people balk at having the drug listed in their insurance records, a problem that over-the-counter sales will end.
The requirement to speak with a pharmacist before obtaining naloxone creates a shame barrier, said Dr. Alexander Walley, an addiction specialist at Boston Medical Center and professor of medicine at the Boston University Chobanian & Avedisian School of Medicine.
Naloxone should be just as available as other preventative health measures, such as condoms. ”We don’t require someone to talk to a pharmacist every time they needed condoms and, if we did, we would see more sexually transmitted infections,” he said.
But will insurers cover over-the-counter Narcan? That question remains unresolved. The largest health insurer in Massachusetts, Blue Cross Blue Shield of Massachusetts, said it would review federal and state guidance and remains “committed to ensuring our members have access to the substance use disorder treatment they need, when they need it.” Lora Pellegrini, President and CEO of the Massachusetts Association of Health Plans, which represents the state’s other insurers, said many had indicated that they plan to continue to cover Narcan. “As further regulatory guidance is released, health plans will continue to assess their coverage policies,” she said in a statement.
Dr. Bisola Ojikutu, Boston’s public health commissioner, called the FDA’s decision “smart public health policy.” Expanding access to the drug will not only decrease the amount of overdose deaths, she said, but also reduce the stigma associated with substance use disorders.
“This is a major moment of hope for individuals, families, and communities that have experienced the trauma of the opioid epidemic,” Ojikutu said.
Last year, the Boston Public Health Commission distributed 14,803 doses of naloxone, and its outreach workers reversed up to five opioid-related overdoses per day, according to a spokesperson for the commission.
Each year, the city of Boston trains roughly 10,000 people to administer the life-saving medication and offers education and training to opioid users, their families, and community partners who work with people at risk of overdosing.
Julie Burns, president and CEO of RIZE Massachusetts, a nonprofit working to end the opioid overdose crisis, applauded the FDA decision but added in a statement: “We hope that the agency will work with manufacturers to ensure it is also affordable to those who need it most. …No one has to die from overdose. Greater access to harm reduction practices and tools like naloxone is key to saving lives.”