In an attempt to make naloxone more accessible amid the massive human toll of the opioid crisis, the FDA recently approved over-the-counter naloxone. Naloxone is the one solution that has remained constant through the evolving opioid crisis. A safe and effective medication that can quickly reverse an overdose, it is a critical tool in the public health response to the opioid crisis. Until now, naloxone availability has been a bit confusing, with each state taking a slightly different approach. Generally, harm reduction and public health organizations have offered direct distribution for people at risk of an opioid overdose; it was also available prescription at many pharmacies.
The new OTC status is a no-brainer: There’s no good reason why it shouldn’t be available easily and readily. But as people who work to fight the opioid epidemic, we fear that many others may be overstating the victory here.
Some seem to believe that the OTC status will make naloxone more affordable, more available, and less stigmatized. But OTC status will not meaningfully improve naloxone access for people who need it the most. In fact, it will likely do very little besides increase pharma profits and may, paradoxically, make naloxone harder to access. To truly increase access to this lifesaving medication, solutions need to address longstanding challenges related to medication affordability and distribution, as well as stigma related to addiction.
For years, companies have profited handsomely from naloxone development and sales. The most egregious (but far from only) example of this being Kaleo’s Evzio naloxone product. After FDA approval in 2014, the Evzio price fluctuated from $575 for two-doses of naloxone at launch to $4,100 in 2017. It was only in 2018, following investigations from “60 Minutes” and the U.S. Senate into the shameful price hike, that the company released a generic version for $178. After an accompanying scandal that the company engaged in kickback schemes to providers and submitted false claims to insurance to try and extract that high pricing, the device was pulled from the market in 2020.
Unfortunately, Evzio’s approach to the opioid crisis is not an outlier.
The most well-known version of naloxone is Narcan, an Emergent BioSolutions brand-name product the FDA approved in 2015. Narcan has generated $1.44 billion in revenue since 2018 and, like Xerox or Kleenex, marketing has helped it to become the brand that stands for naloxone. To entrench this position, Emergent BioSolutions has lobbied to be the preferred option for states purchasing naloxone, a significant act because states are receiving $50 billion in opioid settlement money.
Like Evzio, profiteering has long been an issue for Narcan. Prior reporting has found that the medication costs approximately 5 cents to manufacture, but it can cost as much as $150. This for a drug that was developed primarily with extensive support from our tax dollars and public investment through the NIH.
There was a time when it seemed that generics would lower the price of naloxone. In 2021, the FDA approved two generic nasal naloxone products. Available generic products are widely considered an important step toward lower prices, and analysts had expected a 20%-30% discount, yet generic nasal naloxone formulations launched at only about 5% less than name-brand Narcan.
It’s unclear how OTC naloxone will be priced, but there are three reasons to think that it won’t be much less than prescribed naloxone: a 17% increase in Emergent BioSolutions stock price after OTC naloxone approval, limited pricing pressure from generics, and high name recognition among state purchasers. Together, it seems that there will be only a small difference in cost, leaving this lifesaving medicine still high-priced and out of reach for the people who need it most.
Another argument for OTC naloxone is that this will reduce stigma — if you can buy it without interacting with a pharmacist, the argument goes, then it’s no different than buying, say, Plan B. However, the stigma and dehumanization of people who use drugs is far too entrenched to be swayed by common sense. Myths persist about “Narcan parties” where the presence of naloxone leads to excessive opioid consumption. Many people also falsely believe that naloxone allows people to maintain their addiction longer.
Additionally, just because OTC naloxone can be sold in more places does not mean it will be sold in more places. This claim about access belies the experience of accessing other lifesaving medications. Many pharmacies already don’t stock buprenorphine (a medication for opioid use disorder) or naloxone because they don’t want “those people” at their place of business. Is a gas station or Target really going to stock OTC naloxone? If they do, won’t it be in a locked container? Will it need prior authorization for insurance coverage, or will it be out of pocket?
Some might argue pharma has a vested interest in reducing stigma because that will sell more naloxone — but that’s another theory not grounded in reality. States remain major purchasers of naloxone because it is an evidence-based way to reduce mortality and widely agreed upon method by which to spend opioid settlement funds. To increase sales to individual buyers, pharma can create a massive market through fear, not stigma reduction.
Now that naloxone will be available OTC, we need more substantial efforts to reduce cost and increase access to this lifesaving medication. While there is still much to be done related to insulin pricing, pressure to reduce costs for another chronic disease offers a useful roadmap for activists.
The first step would be to explore activating Bayh-Dole Act of 1980 “march-in” rights, which would allow the federal government to take over naloxone manufacturing. The significant federal support in the development of Narcan and other overdose reversal products justifies this approach, can address the health and safety needs of people who use drugs, and rectify the mismatch between taxpayer investment and pharma profiteering. In parallel, states should continue to explore manufacturing generic nasal naloxone. Insulin provides a template for this as well, with California and Michigan both interested in manufacturing insulin to better control costs. It is encouraging that California already appears to be exploring manufacturing generic naloxone, but it’s not clear how OTC naloxone could affect that plan or if it will expand to other medications for opioid use disorder. State opioid settlement money could be used to cover the costs of state manufacturing and create legitimate pricing pressure as well as increase access.
Unlike insulin, there has been little concerted outrage and effort to bring down the price of naloxone. Unless stakeholders prioritize cost control, Narcan and other overdose reversal products will continue to eat large parts of the state opioid crisis response budget, eroding funds available for other public health measures and doing little to help those who need it the most.
Jonathan JK Stoltman is director of the Opioid Policy Institute and co-director of Reporting on Addiction. Mishka Terplan is medical director/senior research scientist at Friends Research Institute and senior physician research scientist at the Opioid Policy Institute.