Harm reduction programs will soon be able to more easily bulk buy medication that can treat opioid overdoses, thanks to new guidance from the Food and Drug Administration. The guidance centers around naloxone, which reverses overdoses. Advocacy groups have been pushing for this change, which will make it much easier for them to distribute the lifesaving drug.
Naloxone is currently a prescription drug at the federal level, even though state-level laws make it so people don’t need a prescription to obtain it. But because of the federal rules, manufacturers normally have to follow specific requirements around how they can distribute the drug. Those guidelines made it hard for harm reduction groups, which work to prevent overdoses, to get the naloxone that they needed.
Tens of thousands of people in the United States die from overdoses each year, and most deaths involve opioids. Naloxone, which is easy for bystanders to administer, is a key part of public health efforts against overdose deaths.
The new FDA guidance clarifies that naloxone is exempt from some of the requirements for prescription drugs because the opioid crisis in the US is still classed as a public health emergency. That guidance will make it easier for harm reduction programs to purchase naloxone in bulk, tweeted Nabarun Dasgupta, the co-founder of the group Remedy for the People, which works with groups distributing naloxone.
The American Medical Association also applauded the move. “Throughout the drug overdose epidemic, harm reduction organizations have been at the front lines, offering care and hope in hundreds of communities. These organizations have accomplished amazing work despite shoestring budgets and bureaucratic challenges. The American Medical Association is grateful the Food and Drug Administration recognizes the importance of that work,” said Bobby Mukkamala, chair of the substance abuse and pain care task force, in a statement.
The FDA’s move is part of the agency’s overdose prevention framework. But there are still other challenges to naloxone access, including the prescription-only status, Marta Sokolowska, deputy center director for substance use and behavioral health in the Center for Drug Evaluation and Research at the FDA, said in a statement. “Thus, there is still more work ahead of us as deaths from drug overdoses remain at historically high levels,” she said.