Advocates in Maine’s recovery community praised the approval on Wednesday by the Food and Drug Administration of non-prescription, over-the-counter Narcan, an opioid overdose medicine that has saved tens of thousands of lives across the country.
The move by the Biden administration to make Narcan, the brand name of the generic medication naloxone, available without a prescription will pave the way for the medicine to be sold to consumers around the country in drug stores, convenience stores, gas stations, grocery stores and online.
“We can prevent overdoses and save lives by making naloxone more accessible, and at the same time, we can ensure equitable access to essential health care,” U.S. Department of Health and Human Services Secretary Xavier Becerra said. “Today’s FDA action to allow access to naloxone without a prescription is another strong step forward in advancing HHS’s Overdose Prevention Strategy.”
The move by President Joe Biden, the first president to support harm reduction practices — which aim to reduce the negative consequences associated with drug use — reflects the fact that Maine and the country as a whole are in the grips of an overdose crisis. Maine set a grim record in 2022 for most overdoses in a single year — 716, or nearly two people a day. That surpassed the state’s 630 overdose deaths in 2021. Seeking to turn the tide, advocates are pushing a slate of reforms in the Maine Legislature to treat substance use as a public health issue rather than criminalizing people who use drugs.
Wednesday’s action by the FDA comes after Maine, via an order by Gov. Janet Mills in 2019, directed officials to make naloxone available without prescriptions in pharmacies, through health care providers and emergency rooms.
Jeanne Marquis, an organizer for the Maine Recovery Advocacy Project (ME-RAP), said the FDA announcement builds on that standing policy in Maine, as she’s hopeful the action by the federal government will make it more likely that pharmacies in the state have a strong supply of Narcan.
“It is a step forward,” she said. “The recovery community has been working on this for a long time, so overall, we’re very pleased.”
Even so, Marquis said advocates still have some worries about the accessibility of Narcan going forward. The FDA order only applies to brand name nasal spray Narcan, which Marquis said is much more expensive than the generic, injectable version that is still harder to access.
She added that ME-RAP recently did a survey of pharmacies in Kennebec County and found that the Narcan there can range from $100 to $150, which can be prohibitively expensive for some people.
“We do have concerns,” Marquis said, calling on policymakers to make the generic version more available to people so that opioid medication can be accessible and normalized.
Chasity Tuell, northern Maine director of harm reduction services for the group Maine Access Points, had a similar assessment.
“The FDA’s approval of [over-the-counter] naloxone is a huge victory and we should celebrate it. We also must acknowledge that increasing naloxone availability and accessibility are two different things,” Tuell said.
“Questions still remain on how much it will cost and what implementation will look like. Keeping it affordable and accessible to people who need it most — people who use drugs and their loved ones — is the most important thing and is not likely going to be the case” under this policy, she added.
Tuell also said many harm reduction groups rely heavily on the less expensive, intramuscular (IM) injectable version of naloxone that is still prescription only. She worries that having Narcan nasal spray available without a prescription but not the injectable naloxone could “increase the stigma surrounding IM and create a two tier system regardless of the fact many lay people safely use it already and most research is based upon IM naloxone.”
As a result, Maine Access Points is hoping that the FDA’s move is just the beginning of larger policy changes and initiatives to normalize additional harm reduction measures, Tuell said.