The invite list for the White House’s upcoming “summit” on naloxone pricing and accessibility has some noteworthy omissions.
Two of the most prominent organizations focused on providing cheaper overdose-reversal medications will be conspicuously absent from Tuesday’s event: Harm Reduction Therapeutics, a nonprofit drug manufacturer currently seeking approval for a naloxone nasal spray, and Remedy Alliance, a group that distributes cheap naloxone to harm-reduction groups across the country.
Broadening access to naloxone is a key element of the Biden administration’s strategy to combat the opioid crisis. But the medication’s high price has long been a barrier to individuals and cash-strapped nonprofit groups.
Harm Reduction Therapeutics and Remedy Alliance have long criticized most naloxone manufacturers as prioritizing profits above public health. Both organizations have also cast themselves as part of a potential solution — though they won’t have the chance to make their case next week in front of key White House officials.
“I was very upset to learn we would not be invited,” Michael Hufford, the CEO of Harm Reduction Therapeutics, told STAT in a text message. “It’s enormously frustrating. We were told because our [new drug application] is under review, attending would represent a conflict of interest. At some point, COI is just an excuse to not do things, but I’m also certain they didn’t care about my opinion on the matter.”
Maya Doe-Simkins, the co-director of the Remedy Alliance, confirmed in a statement that the organization was also left out of the summit after being told it was limited to drug manufacturers only.
“Remedy Alliance and the organizations we work with can trace our lineage in increasing naloxone access back over two decades — our harm-reduction community came up with community-based naloxone distribution!” she wrote. “To not extend an invitation to Remedy Alliance conveys a fundamental misunderstanding of how community-based naloxone distribution should work and reveals the enormous extent to which course corrections are necessary if the [Biden] administration values saving lives from overdose.”
While Remedy Alliance accepts naloxone donations and purchases the medication in bulk from pharmaceutical companies, it is not a drug manufacturer itself.
“Next week, administration officials will be meeting with manufacturers who currently have FDA-approved overdose reversal medications on the market to discuss ways to increase access and affordability to save as many lives as possible,” a spokesperson for the White House Office of National Drug Control Policy said in a statement. “We plan to have robust engagements with manufacturers, community organizations, and others working to prevent overdoses and save lives.”
The summit, which STAT first reported last month, would represent the federal government’s most concrete action to date to address high naloxone prices.
“I want to make sure of exactly the concerns here,” Rahul Gupta, the ONDCP director, said then. “I hear it, and we’re going to be having that conversation in the White House.”
At the time, Gupta did not specify which naloxone manufacturers would be invited. Emergent BioSolutions, the manufacturer of Narcan, and US WorldMeds, the manufacturer of an injector pen branded as Zimhi, both confirmed they would be in attendance. Hikma, the manufacturer of Kloxxado, a controversial high-dose nasal spray, did not respond to STAT’s request for comment.
Naloxone manufacturers have taken heat in recent years for hiking prices, and for introducing new, high-priced products to the market, even as the annual U.S. opioid overdose death rate climbed past 80,000.
Kloxxado and Zimhi each retail for roughly $140 for a two-pack, according to the website GoodRx. A two-pack of Evzio, a controversial mechanized auto-injector withdrawn from the market in 2019, at one point retailed for $4,100. By comparison, generic, injectable naloxone is available for as little as a few dollars per dose.
A recent STAT examination, however, revealed that many new, high-priced naloxone products are not medically necessary. Critics charge that products like Kloxxado administer too large a dose, while others, like Zimhi or Evzio, are more mechanically complex than necessary.
The Remedy Alliance this week released a new infographic that it said is based on industry pricing documents it recently obtained. A two-pack of Narcan, which can retail for $80 or more, costs just $32 to manufacture, the infographic concludes — meaning company profits account for more than half of the overall price.
The increasing presence of xylazine in the U.S. illicit opioid supply has also muddied the waters. Xylazine, a sedative often used in veterinary settings, is not an opioid, meaning it doesn’t respond to naloxone. Overdose responders, however, might wrongly interpret some victims’ unresponsiveness as a sign that they simply need a larger dose of naloxone.
The White House event comes on the heels of the FDA granting over-the-counter status to Narcan, making it the first-ever naloxone product that can be sold without a prescription.
Even over-the-counter status, however, has sparked new cost concerns. Most health insurance plans do not cover over-the-counter products, meaning individual consumers could be left to pay full sticker price. Emergent BioSolutions, Narcan’s manufacturer, said in April that it plans to price a two-pack of naloxone at under $50.
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.