October 3, 2022
“The affordable naloxone shortage is over,” rejoices Nabarun “Nab” Dasgupta, PhD ’13 (epidemiology), Gillings Innovation Fellow at the UNC Gillings School of Global Public Health and senior scientist at the UNC Injury Prevention Research Center. “We have our own version of naloxone to distribute to public health activists and health departments.”
Dasgupta is describing his work with Remedy Alliance/For The People, which recently shipped the first batches of a new, more affordable version of naloxone — a drug that reverses opioid overdose. In the first month of operations, 147,600 doses were shipped to 28 states, including nearly 20,000 doses for free.
In an industry first, the non-profit organization partnered with pharmaceutical companies to produce its own version of the drug, made specifically for distribution by harm reduction programs and health departments. In a major win for public health, The White House announced new FDA guidance that allows bulk purchasing of low-cost naloxone through Remedy Alliance.
“We were building the evidence base and hashing out policy with federal officials, at the same time as shipping boxes of naloxone,” says Dasgupta. “Looking back at the mobilization required for COVID vaccines, we find ourselves in a new era of immediate impact, where implementation is a natural part of the continuum, from basic science to changing lives.”
The timely work responds to an epidemic with a growing death toll.
The U.S. Centers for Disease Control and Prevention estimate more than 100,000 people died from drug overdose in the 12 months leading up to April 2022 — nearly three times the number of traffic fatalities and more than double the number of gun deaths during the same period.
Naloxone, the generic version of Narcan, is amazingly effective at treating opioid overdose.
A study by Brigham and Women’s hospital found that 93.5% of people given naloxone survived their overdose. By working quickly to block the action of opioids in the brain, the drug reverses respiratory depression and other life-threatening consequences of overdose.
Remedy Alliance started in 2012 as the Opioid Safety and Naloxone Network Buyer’s Club.
With Dasgupta’s help, staffers worked with a network of more than 100 harm reduction programs across the United States to purchase millions of doses of naloxone to community partners. These partners, in turn, distribute the drug to those in the local community who need it most.
Although Dasgupta and the buyer’s club had negotiated a reduced purchase price with Pfizer (one company that produces naloxone) a decade ago, barriers cropped up related to a complicated regulatory environment and manufacturing disruptions during the pandemic: The antidote was more difficult to obtain than the drugs causing overdoses.
Interruptions to the supply of naloxone are extremely costly in terms of human life.
Remedy Alliance experts estimate that a 2021 manufacturing disruption was accompanied by between 12,000 and 18,000 more deaths from overdose than expected.
So, the buyer’s club morphed into Remedy Alliance, directing all their efforts toward solving the naloxone shortage once and for all. Maya Doe-Simkins and Eliza Wheeler co-founded Remedy Alliance with Dasgupta.
Partnering with Pfizer and Hikma, a manufacturer of generic medications, to produce its own version of naloxone, the group secured U.S. Food and Drug Administration approval to distribute their affordable drug to community organizations.
Ensuring a steady supply was just one challenge, however.
While anyone can administer naloxone, FDA guidelines that historically relegated the drug to prescription-only status made distribution through channels other than pharmacies difficult.
Though all 50 states created workarounds, naloxone was often still difficult to obtain, and in many cases, the complicated regulatory environment made corporate and government compliance officers balk.
With commercially available naloxone costing up to 30 times as much as the generic version, this led to far fewer people receiving the lifesaving medication.
After finding an overlooked exemption buried in federal law, Remedy Alliance worked with federal authorities to remove prescription barriers, enabling a wider range of organizations to purchase naloxone in bulk. On September 22, the FDA released updated guidance endorsing this groundbreaking approach.
Now, more programs that distribute naloxone directly to people at risk of overdose — rather than through pharmacies or emergency medical services — can access the cheaper version. Health departments can also order it for half the cost of commercial vendors.
This victory is a decade in the making.
As a doctoral student at the Gillings School, Dasgupta started Project Lazarus, a program that put overdose kits containing naloxone into the hands of chronic pain patients considered at high risk for overdose. More recently, he developed a groundbreaking program to test street drugs for harmful adulterants, devising health communication strategies for issuing public warnings.
By reaching populations that have been historically underserved by both government and health care, these types of harm reduction programs have the potential to contribute to greater health equity.
The decreased price and reduced regulatory burden of supplying naloxone will allow even more community partners to join Remedy Alliance.
Dasgupta notes that, in the past, the alliance had to turn down requests from civic groups, including chapters of Black Lives Matter.
“A lesson from COVID is that there is a diverse and undervalued set of civil society groups involved in public health, especially in neglected communities,” says Dasgupta. “Even routine regulatory requirements are showstoppers for marginalized communities, because we in mainstream public health too often take for granted the tools and professional support at our disposal.”
This includes the erstwhile requirement of having to have a physician on staff to order naloxone. A June report from CDC showing that overdose rates among Black and Native American people surpassed those of white people for the first time underscores the potential damage of such unnecessary barriers.
Kendall LaSane, a doctoral student in the UNC Gillings Department of Health Policy and Management, is researching the impacts of excluding such groups, hoping to build the evidence base for how sound policy can advance health equity.
“We need to better understand the needs of communities who have historically been excluded and where they believe mainstream public health falls short,” says LaSane. “Integrating their narratives and desired outcomes into the current redesign of naloxone distribution will also maximize the benefits in the future. We’re at a critical point and can provide support by trusting that they know how to keep themselves and their communities safe.”
For Dasgupta, program sustainability is a top concern. He and his partners designed Remedy Alliance to be self-sustaining, ensuring that the organization will continue to play a vital role in responding to the overdose epidemic for years to come.
“We liberating millions of doses of cheap naloxone directly to the programs who can reach the most at-risk populations,” Dasgupta says. “Overdose deaths are steadily increasing, but this is a major breakthrough.”
Contact the UNC Gillings School of Global Public Health communications team at email@example.com.