The FDA Is Doing Something That Could Actually Cut Overdose Deaths
Naloxone could be available without a prescription by spring.
By spring, a drug used to reverse opioid overdoses may become available at your local pharmacy without a prescription.
Last week Emergent BioSolutions Inc. announced that the U.S. Food and Drug Administration (FDA) was fast-tracking approval of over-the-counter sales of Narcan, a nasal spray of naloxone, which can quickly treat and reverse an opioid overdose before it kills.
In November, the FDA issued an assessment that some naloxone nasal sprays might be safe for nonprescription use without the assistance of a health care practitioner. The agency is currently collecting additional data and taking comments until January before making a final decision, but FDA Commissioner Robert Califf has a positive outlook on the outcome.
"[November's] action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone," he said at the time. "The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible."
The goal date for approval, according to an Emergent BioSolutions release, is March 29, 2023. If it is accomplished, this would be a wonderful and long-overdue development in efforts to rein in opioid overdoses. Deaths from opioid overdoses in America reached a record high of more than 71,000 in 2021. Total overdose deaths topped 100,000 that year. Easier access to medicine that can prevent these deaths is something the government should permit as part of its harm reduction strategy.
Filter magazine notes that in September the FDA took action to exempt naloxone from certain federal distribution restrictions. The federal government declared a public health emergency in 2017 over opioid addiction and overdoses, and as such, the FDA wanted to reduce barriers to wholesale access to naloxone. Remedy Alliance, a naloxone buyers' club, has been working to make the drug more accessible through making mass wholesale purchases that members then distribute across communities. The September decision by the FDA makes it possible for suppliers to buy naloxone in bulk without possibly running afoul of federal regulations of drug supply chains.
Allowing people to simply pick up Narcan at a pharmacy without a prescription would provide even greater access and be a boon to anybody who knows somebody at risk of overdose. We don't know yet what the over-the-counter price might be, but GoodRx lists the average prescription retail price at $89.70 for a box of two naloxone nasal sprays. Some are below $40 with special offers.
Right now, it appears that Emergent BioSolutions' product may be the first to reach the market, but it is likely to quickly have competition from other naloxone providers, which will help drive prices down. Perhaps the market will provide a solution that our misguided drug war clearly has not, assuming the FDA gets out of the way and allows it to happen.