In late April 2021, a manufacturing disruption brought Pfizer’s naloxone production to a standstill, leaving more than half the country’s harm reduction programs without access as overdose reached an all-time high. Now, a new naloxone product is being manufactured for harm reduction programs exclusively.
On August 1, Remedy Alliance/For the People, formerly known as the Opioid Safety and Naloxone Network Buyers Club, launched its online store and and began processing orders for injectable naloxone. It will fill them not only through its long-standing contract with Pfizer, but also through a second naloxone manufacturer, which Remedy Alliance cofounders confirmed to Filter is Hikma Pharmaceuticals.
They estimate the supply chain disruption at Pfizer resulted in 12,000 to 18,000 excess deaths in 2021.
In fall 2021, Remedy Alliance struck a deal with Hikma for exclusive access to a line of custom-produced naloxone at a discounted price. Though Remedy Alliance has received discounted .4mg/mL naloxone vials from Pfizer since 2012, the arrangement with Hikma marks the first time naloxone has ever been manufactured for harm reduction programs, with harm reduction community input. The final contract was signed on June 3.
The naloxone itself is the same as what Hikma already manufactures, but has its own National Drug Code designating it as a new product with the FDA. Remedy Alliance is the only customer. Its name is on the label. Hikma, which operates a subdivision focused on substance use and community health, told Filter the partnership was a “natural extension” of its efforts.
Remedy Alliance Codirectors Eliza Wheeler and Maya Doe-Simkins, and Board President Dr. Nabarun Dasgupta, said that so far 108 affiliates (formerly known as Buyers Club members) have submitted applications, putting their target volume for the coming year at more than 2 million doses.
Though this is a jump from the 1.3 million doses they distributed in 2020 (the chaos of the shortage meant 2021 was a wash, data-wise), barring a catastrophe that manages to take out both Pfizer and Hikma they should be able to meet all of it.
Remedy Alliance is the only access point for affordable naloxone in the US.
The first shipment—100,000 doses from Pfizer—is scheduled to arrive at Remedy Alliance’s Berkeley, California, warehouse on August 3. Hikma is currently manufacturing and labeling the Remedy Alliance product, and will begin shipping to the warehouse on a similar timeline.
Remedy Alliance’s new distribution structure bypasses the one used by the wholesale pharmaceutical system. Rather than being required to order from Pfizer or Hikma directly, affiliates have Remedy Alliance as an intermediary. Rather than shipping through one of the usual big medical supply distributors like Cardinal or McKesson, Remedy Alliance orders ship by freight to the Berkeley warehouse, where Wheeler awaits with a recently acquired pallet jack. Small shipments—anything under 10,000-ish vials—arrive in boxes via FedEx, UPS or the United States Postal Service. From there, Wheeler breaks down the boxes into their respective orders and ships them out to affiliates.
Pfizer resumed production around the beginning of the year, but its .4mg/mL single-use vials have remained in limited supply. The last of Remedy Alliance’s backorders weren’t filled until late May.
“We are currently filling 100% of our naloxone single dose vial orders each week,” a Pfizer representative told Filter on August 1. “At this time, we are optimistic that we will achieve full inventory recovery for the single dose vial early in August.”
Remedy Alliance is the only access point for affordable naloxone in the US. Though Wheeler and Doe-Simkins received start-up funding from Open Society Foundations to operate Remedy Alliance in its current form, for the past decade they have worked for free.
“Harm reduction programs fucking invented distribution of naloxone and have been systemically relegated to the fringe of public health for 30 years,” Wheeler told Filter. “And they still don’t get the resources they need.”
[Read Filter‘s second article on Remedy Alliance and the affordable naloxone shortage here.]
Image via New York City Department of Health and Mental Hygiene
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.