The Biden administration’s push to make some forms of opioid overdose reversal drugs available over the counter will likely have little impact on the people that need it most, public health advocates warn.
The Food and Drug Administration (FDA) late last year began encouraging drug companies to apply to switch some forms of the drug away from prescription only, a move that advocates have long been pressing for as a way to increase access to a lifesaving drug.
Naloxone is a medicine that can help reduce opioid overdose deaths and when administered timely, usually within minutes of the first signs of an opioid overdose, can counter the overdose effects.
Rahul Gupta, head of the White House Office of National Drug Control Policy, said at a press conference in December that 80,000 Americans died from opioid overdoses in the past year. With naloxone, many of those deaths would have been avoided.
The FDA’s notice provides a pathway to approval for naloxone products and calls for more information from drugmakers on how the medication would be sold.
But there are only two companies that have been granted fast-track priority review to sell naloxone over the counter, and harm reduction advocates say the cost is a major barrier. The FDA is likely to approve naloxone as a nasal spray, which costs significantly more for harm reduction groups than an injection kit.
“We’re really thrilled to have an OTC [over-the-counter] product on the horizon. But there’s a huge, enormous caveat,” said Maya Doe-Simkins, a co-director of the nonprofit group Remedy Alliance/For The People, which distributes generic naloxone to people in need. “The nasal sprays are just, you know, magnitudes of 10 or 100 more expensive than generic injectables.”
One of the companies granted priority review is Emergent BioSolutions, which manufactures the brand name Narcan nasal spray. The FDA told the company it expects to have a decision on its application by the end of March.
“Accidental overdoses can happen to anyone, anywhere, at any time, and by shifting to OTC status, increased access to NARCAN will help address patient needs as the opioid epidemic continues to evolve,” Emergent said in a statement.
A spokesman told The Hill the company has not yet set a price. A two-pack of Narcan costs about $140, but with discounts the price is about $40 a dose.
The other company with a fast-track application is the nonprofit Harm Reduction Therapeutics. Michael Hufford, co-founder and CEO, said his plan is to give away some doses for free and sell the rest at cost.
He understands the concerns from harm reduction groups, but contends that nasal sprays are easier for lay people to use.
“Glass vials and needles, man, that’s, that’s a big ask right to have people understand how to use a needle, how to draw it up, how to inject it. That’s just a lot tougher hurdle,” Hufford said.
But experts and advocates contend the people who will be using naloxone are already familiar with injecting needles.
“The people who are going to buy it [at the pharmacy] are going to be different from the people who are the most at risk,” said Nabarun Dasgupta, a senior scientist at the University of North Carolina who researches drugs and infectious diseases.
The goal is to “really focus in on getting this into the hands of people who are using drugs and are at risk of overdose. When you’re talking about that population, it’s not your average grandmas at the pharmacy,” Dasgupta said.
Naloxone is currently only available as a prescription, though all 50 states have found workarounds to make the drug available at the pharmacy without a prescription. Yet the people who need naloxone the most are also the least likely to go to a pharmacy and request it.
The cost of the medication, requirements to show ID, and the overall stigma of asking for naloxone are all barriers. Additionally, some pharmacists may not be aware that there is a standing order in their state and refuse to prescribe the drug altogether.
In addition, the workarounds states use to make the drug available to individuals don’t apply to harm reduction groups, which partner with manufacturers and distributors to buy naloxone at a discount.
Those “last mile” groups are one of the primary ways to get naloxone into the hands of the highest risk populations, but they are required to treat naloxone as a prescription drug, and need to abide by strict rules.
For example, an organization like Remedy Alliance/For The People must have a doctor sign for the order. The organization must also have an address that is not a private home to receive shipments, which poses a problem for groups in rural areas.
Granting federal over-the-counter status to naloxone would solve those problems, Doe-Simkins said, but without addressing the cost barrier, the government is only taking a partial step forward.
“We’re thrilled with OTC. It does not solve our problem, because what will come along with it is the cost. And so that leaves us with the only affordable naloxone being a generic injectable that is still prescription only,” Doe-Simkins said.