The Pfizer Naloxone Shortage Ends, Leaving Us With Just the Regular One

August 8, 2022

[Read the August 1 story introducing Remedy Alliance’s naloxone distribution here.]

 

In the same way that the United States doesn’t actually have a shortage of insulin or housing, there has never been a shortage of naloxone. There’s been a shortage of affordable naloxone. The thing itself exists in plenty, and has this whole time, it’s simply withheld from most of the people who use it.

Naloxone started percolating into the broader public consciousness around 2016, after the Food and Drug Administration approved Narcan nasal spray. Even generic injectable naloxone is sometimes referred to by the brand name, because that’s what people are more likely to recognize.

The go-to selling point for anyone pushing Narcan is that it’s “needle-free,” even though injectable naloxone is intramuscular—not intravenous—and thus requires no more skill to administer than the nasal sprays. Narcan’s market dominance is very much the result of syringe stigma, but a more accurate characterization is that it’s the result of highly effective lobbying by Emergent BioSolutions to establish its product as the only product.

The state-negotiated rate for a pack of two is $75. For anyone buying Narcan kits retail, it’s more like $150. Branded Narcan has a stranglehold on government funding, even though the state-negotiated rate for two single-dose .4mg/mL vials of generic injectable naloxone hovers around $30.

In 2012, what was then the Opioid Safety and Naloxone Network Buyers Club (now Remedy Alliance) negotiated a historic agreement with what was then Hospira (acquired by Pfizer in 2015) to purchase naloxone at a proprietary discount under $5 per vial. Though harm reduction programs have never had as much as they needed, that deal is what liberated naloxone from medical settings and started putting it directly in the hands of drug users.

“We’ve always known it was sort of a house of cards, to put all of our faith in one benevolent arrangement,” Eliza Wheeler, who codirects Remedy Alliance with Maya Doe-Simkins, told Filter. “Hinging the entire affordable naloxone supply on one company, for all these already vulnerable programs, wasn’t sustainable. [The shortage] just forced us into action.”

Remedy Alliance supplies affiliates in 39 states and DC. Many of them do receive government-funded Narcan, but at volumes so out of touch with the actual need that they have to supplement. Affiliates include some of the most recognizable programs in harm reduction: the DOPE Project in San Francisco; Sonoran Prevention Works in Arizona; Prevention Point Pittsburgh; the Chicago Recovery Alliance, where this work began in the ’90s.

But the majority of affiliates receive no federal funding. In a number of states, Remedy Alliance is 100 percent of the harm reduction naloxone supply.

 

Remedy Alliance’s warehouse received its first shipment, 100,000 .4mg/mL naloxone vials from Pfizer, on August 3. An equivalent shipment of Narcan would require a much bigger warehouse.

 

At the time the Pfizer shortage began, the Harm Reduction Action Center of Denver was doing around 300 reversals a month, typically half with Narcan and half with Remedy Alliance naloxone. But many of the groups scrambling to find new sources amid the shortage started requesting Narcan from the same funders HRAC was getting it from, which created a run on the affordable Narcan supply, which forced HRAC to request more naloxone from Remedy Alliance, which was still in a shortage.

“We were down to 10 or 12 doses of intramuscular left, and then we started running out of intranasal,” Kat Humphries Montoya, former HRAC programs director, told Filter

During the pandemic, many harm reduction programs evolved into something more than their original form. For HRAC, this was a pivot into food service as downtown Denver pantries closed and effectively created a food desert for participants, most of whom live outside. As Humphries Montoya and their coworkers watched HRAC’s naloxone supply dwindle, they knew that buying Narcan at cost meant shutting down the burritos, the snacks, the Gatorade that was getting people through the summer.

It was a nightmarish choice: “Do we let people starve? Or do we not distribute naloxone?”

HRAC is a well-established, well-funded nonprofit. It was a shock to staff to find themselves without naloxone in the first place, let alone unable to get more. By October 12, 2021, HRAC had fewer doses of naloxone than participants would need the following day.

“We were at a point where we were seeing more overdoses than we’d ever seen, where people were the most vulnerable they’d ever been,” Humphries Montoya said. “It was this mounting fent crisis with this mounting COVID crisis and then, right at the tip of that, we ran out of naloxone.”

 

 

Lots of government overdose prevention funding goes to naloxone, but little of that naloxone goes to harm reduction programs. Most of it goes to police departments or hospitals or other entities that make sure anyone who uses drugs works hard to avoid them.

While naloxone itself does nothing to end the overdose crisis, it’s an extremely effective tool for keeping people alive in the meantime—when it’s in the hands of drug users, who reverse the vast majority of overdoses and always will. We’d be much better equipped to survive the drug war if naloxone access prioritized the first responders who can only get it through Remedy Alliance, rather than the last responders who leave it on shelves to expire and who could have absorbed a 5,000-percent retail markup anyway.

Stored in a cool dry place, naloxone remains effective for decades past its expiration date. The problem is that the government pushes those with expired naloxone to dispose of it instead of giving it to NEXT Distro or to drug users directly. The bigger problem is that naloxone shouldn’t be expiring at all; it should be getting used.

That huge volumes of naloxone pass their expiration dates in storage, while overdose deaths climb by the day, is an indictment of a public health infrastructure that has never allocated naloxone equitably or efficiently. Every expired dose is a policy failure.

Naloxone should obviously not cost $150. It should be available in gas stations and corner stores for a few dollars and in public health settings for free, the way condoms are.

Though it wouldn’t resolve the cost issue completely, one thing that does tend to dramatically lower the price of prescription drugs is switching them to over the counter.

Removing the prescription would essentially do for naloxone what removing the X-waiver would do for buprenorphine.

All 50 states, DC and Puerto Rico have authorized some sort of pathway for accessing naloxone from pharmacies without a prescription (the other territories have not). But this doesn’t really do much for accessibility, due to costs and pharmacy deserts and general pharmacist hostility. Remedy Alliance supplies more naloxone than every pharmacy in the US combined.

Naloxone’s prescription status means that the only harm reduction groups that can order it in bulk are the ones with access to a DEA-licensed prescriber as well as a commercial shipping address—ruling out unincorporated collectives, underground syringe programs in the South, everyone operating out of trunks and parks and backyards and encampments, and all the other people who don’t get state funding in the first place.

Wholesale suppliers hesitate to provide a prescription drug to programs that don’t have a distributor license, even though one isn’t required. County jails are not inclined to host pilot programs that put prescription drugs in vending machines. It’s illegal to send prescription drugs by mail, which is a huge distribution barrier in rural areas, including for Native communities that might otherwise receive naloxone through regional Tribal health boards.

Even when Hikma donated 50,000 doses in October 2021, the cumbersome legal process for receiving donations of prescription drugs meant most affiliates couldn’t access it. In the interest of getting the naloxone out the door, Doe-Simkins and Wheeler just picked the three programs they felt would get the best mileage out of it.

Some states have standing orders that extend a blanket prescription to “community organizations,” but this has historically been moot for Remedy Alliance. Pfizer requires each harm reduction program find a DEA-licensed prescriber who isn’t already being used by another program. Hikma, meanwhile, requires prescribers to write their Remedy Alliance prescriptions for both purchase and distribution, even though some states authorize distributing but not purchasing.

The whole regulatory albatross dissuades a lot of prescribers from engaging with naloxone at all because they’re confused about liability, not unlike what the X-waiver does to buprenorphine

Remedy Alliance, in its new form activated August 1, bypasses all this. What Wheeler and Doe-Simkins, along with Board President Nabarun Dasgupta, have done goes beyond securing the first naloxone supply manufactured for harm reduction. They’ve built out an entirely original public health infrastructure, independent of the one used by the wholesale pharmaceutical distribution system.

Affiliates don’t have to deal with pharmacies. They don’t have to deal with pharma companies. They don’t have to produce a unique DEA-licensed prescriber. They don’t have to have a commercial shipping address.

“The iteration of the Buyers Club before we existed as we do now, it was still non-traditional but it was a little bit more by the rules,” Doe-Simkins told Filter. “There’s not even rules written about what we’re doing.”

At the time of the August 1 launch, about one-quarter of Remedy Alliance affiliates were new—groups that hadn’t met the criteria to set up Buyers Club accounts under the previous model. Remedy Alliance’s private label Hikma naloxone will ship out to the warehouse in the next week or so.

 

The first batch of Remedy Alliance naloxone is labeled at a Hikma manufacturing plant.

 

Many Remedy Alliance affiliates are larger, comparatively well-resourced programs that function as distro hubs in their respective communities. While pharmacy access gets naloxone to lower-risk people one at a time, hub programs might support dozens of entities that are smaller, that do not receive state funding or have the capacity to navigate the inordinate administrative barriers, but do reach higher-risk people. These hubs are where the US naloxone supply needs to go.

The same way HRAC realized it needed to become a food distributor during the pandemic, food pantries and mutual aid collectives and prison re-entry support groups realized they needed to distribute naloxone. Removing the prescription requirement expands naloxone access not only to more corners of harm reduction, but into adjacent social justice work that reaches people at risk of overdose whom even harm reduction groups aren’t reaching.

“Maybe they’re not doing syringe access,” Wheeler said. “Maybe they’re doing sandwiches. And organizing, and tenants rights activism, and realizing that people who are living in encampments or living in single-room occupancy places are extremely high risk for overdose death. And so they want to start giving out naloxone, but they don’t meet the requirements.”

The FDA has said numerous times that it’s open to OTC naloxone. Yet for a decade its approach has been to punt back to the pharma companies and say it really hopes someone will do something, belying the fact that it has the authority to force a switch from prescription status to OTC without them.

“I think it would be fair to say that we’ve been working on this for over a decade … and it’s because the FDA is not pushing naloxone products over the counter.”

In 2023, a proposed rule in the Drug Supply Chain Security Act will exempt drugs from standard wholesale distribution restrictions if they’re relevant to a declared public health emergency. Remedy Alliance has requested the FDA make it clear that harm reduction nonprofits qualify, and that states should recognize this immediately rather than wait until the Act is finished phasing in.

This wouldn’t make naloxone OTC. But it would functionally waive the prescription requirement for eligible harm reduction programs—for instance, the larger Remedy Alliance affiliates that serve as distro hubs. Once exempt, those programs could send their naloxone wherever it was needed.

“It was a sort of eureka moment [from] our pharmacist brain trust,” Doe-Simkins said, referring to an informal roster of veteran harm reduction-based pharmacists who’ve been getting creative with naloxone over the years.

“I think it would be fair to say that we’ve been working on this for over a decade, and that this particular workaround—and it is a workaround, right, it’s not actually a solution—is because the FDA … is not pushing naloxone products over the counter. So we are forced to come up with workarounds.”

In the 13 months between when Pfizer announced the shortage and when it filled the last of Remedy Alliance’s backorders, hundreds of thousands of doses, many of them expired, crossed the country from the programs that had anything to spare to those that had none. In 2021, Remedy Alliance had 104 affiliates; 79 of them shared naloxone this way.

“We were hoping we’d have a little more support from the folks that have all the resources,” Humphries Montoya said. “But it was very much … the support of other community orgs, that also didn’t have resources.” After HRAC put out an SOS in October 2021, people drove across town just to drop off a single expired dose.

The 2021 affordable naloxone shortage was a pressurized chapter of all the same things harm reductionists were going through already. Unfunded collectives mailing expired naloxone back and forth to each other in a panic, while overfunded cops stockpiled Narcan and left it in storage. Syringe programs crowdfunding to buy paltry quantities of naloxone at retail price, while the government touted a harm reduction grant that most harm reduction programs couldn’t apply for. Doe-Simkins and Wheeler putting shipping charges on credit cards while Emergent BioSolutions—which made millions off the Pfizer shortage—laughed at them when they asked for donations. Since 2020, the global naloxone nasal spray market has ballooned from $285 million to $432 million.

Between 1996 and 2014, at least 152,283 naloxone kits were distributed to community members, mostly to people who use drugs, resulting in at least 26,463 overdoses reversed, mostly by people who use drugs. The majority of this was before the original Pfizer deal, before fentanyl; some of it was before the CDC was even tracking overdose deaths.

Remedy Alliance, which it bears repeating is just three people, expects to distribute more than 2 million doses of naloxone in the next year. At least 100,000 people will likely die of overdose during that time; it could be twice that number if not for community distribution, and a fraction of it if naloxone were liberated for good.

 


 

Correction, August 8: A previous version of this article stated that Remedy Alliance codirectors are unpaid. Effective August 1, Open Society Foundations has put both Wheeler and Doe-Simkins on payroll. They’re awaiting their first checks at the time of this writing.

The Influence Foundation, which operates Filter, previously received a restricted grant from the Open Society Foundations to support promotions related to the film Liquid Handcuffs.

Top photograph and inset photographs of Remedy Alliance naloxone courtesy of Bridget Horgan Bell. Inset photographs of Remedy Alliance warehouse courtesy of Eliza Wheeler.

Kastalia Medrano

Kastalia is Filter's deputy editor. She previously worked at a number of other media outlets and wouldn’t recommend the drug coverage at any of them. She’s also a peer worker at a Brooklyn syringe program, where she does outreach hep C testing and navigates people through treatment, and has never figured out how to balance that job with this one which is why she’s sorry for missing your email. She uses meth daily and other drugs sometimes.

Disqus Comments Loading...