Naloxone Can Prevent Opioid Overdose Deaths. Why Isn't the FDA Allowing Over-the-Counter Sales?

Federal drug prohibition played a big role in creating the opioid crisis. Unfortunately, the government is also slowing the spread of one possible solution to it.


America's opioid crisis is really a fentanyl crisis, and the fentanyl crisis is really a prohibition crisis. So why aren't we doing more to prevent fentanyl deaths?

As demand for black market opioids has increased in response to the reduced availability of prescription opioids, there's been a corresponding spike in the use of illicit fentanyl, which is 50 times more potent than heroin and widely available on the street. A powerful drug being marketed as a less powerful drug has produced a corresponding increase in overdose deaths—48,000 Americans overdosed on opioids in 2017, according to the U.S. Centers for Disease Control and Prevention (CDC), with synthetic opioids like fentanyl responsible for 29,000 (and likely more) of those fatalities. While the overall number of overdose deaths has doubled since 2013, the number of deaths resulting from the use of synthetic opioids has increased ninefold.

Federal drug prohibition played a big role in creating this mess. Unfortunately, the federal government is also playing a role in limiting the availability of naloxone, a drug that blocks opioid receptors and can reverse an otherwise fatal overdose.

"Everyone agrees—no matter where they stand on the drug war—everyone agrees this is a lifesaver," says Jeffrey Singer, a medical doctor and senior fellow at the Cato Institute.

Singer, who has written previously for Reason and has co-authored a paper with Reason's Jacob Sullum, co-hosted an event on Wednesday for congressional staffers in the hopes of jump-starting an apparently stalled effort to get naloxone to be approved for over-the-counter sales (something that many other countries already allow). If the FDA changes the designation for naloxone, it could be sold in more than 750,000 retail stores across the country, or even out of vending machines. That would mean better, easier access to a life-saving drug for the people who are most likely to need it: those using heroin or illicit fentanyl in public spaces without access to a pharmacy.

For now, Naloxone is available in most states by going to a pharmacy and asking for it, no doctor's prescription needed. The drug is easy-to-use and can be safely administered without training—either in the form of a nasal spray (sold under the brand name Narcan) or an intramuscular auto-injector (Evzio). The drug was first approved by the FDA all the way back in 1971.

"There are a lot of people, because of the stigma attached to opioid use in general, who are hesitant to go up to the counter," says Singer. "Just being able to take it off the shelf with a box of Band-Aids and take it up to the counter—or, better yet, to pay a robot in the form of a vending machine."

There are some who worry that such widespread access to naloxone could create a moral hazard. That is, if it becomes easier to avoid a deadly consequence, more people might be willing to engage in dangerous behavior, like doing heroin, in the first place. That was the stated reason why, for example, Maine's Gov. Paul LePage (R) vetoed a bill allowing pharmacists to dispense naloxone (the state legislature overrode his veto).

Studies into whether those fears are grounded in reality have been mixed. While some have found an increase in opioid-related emergency room visits after access to naloxone was expanded in some states, others have found a reduction in opioid-related deaths. A study published in the journal Addictive Behavior found that opioid use generally declined among individuals who used or have been trained to use naloxone—suggesting that close brushes with death discourage drug use.

So why isn't naloxone available over-the-counter? The FDA isn't entirely at fault. The agency has actually been asking drug companies to petition them for a reclassification of the drug. But under FDA rules, the agency doesn't necessarily have to wait until the drug companies ask for that change. Technically, any "interested person" can request a review, or the FDA commissioner can institute one preemptively.

The FDA has worked to raise awareness about naloxone. In 2018, Surgeon General Jerome Adams issued a statement encouraging more people to carry naloxone. Later that same year, the Department of Health and Human Services outlined guidance for health care providers and patients detailing how naloxone can help save lives. The FDA has even taken the unusual step of pre-approving an official "drug facts label"—something required for all over-the-counter medications—that can be slapped on packages of Narcan once naloxone is reclassified. Those are all encouraging signs, even against the backdrop of President Donald Trump's threats to double-down on failed "get tough" prohibition policies.

If the drug companies won't pick up the pace and get naloxone approved for over-the-counter sales—perhaps because they are worried that it would cause the drug's price to fall, something that often happens when drugs are made available over-the-counter—then acting FDA Commissioner Norman Sharpless should do it unilaterally. The agency does not exist to protect drug companies' profits; it exists to evaluate the risks of allowing wider access to certain drugs. In this case, opioid overdoses are an exponentially greater threat to Americans than the misuse of naloxone.

"The fact that you have to, in this country, go up to a pharmacy counter to get naloxone," Singer tells Reason, "is standing in the way of getting access to the people who need it."

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  1. Not sure if not having it on the counter is causing a problem.

    Actually the pharmacy counter is more discreet than the checkout. Anyone can see what you have at the checkout and you are always running into people you know in those places.

    Most pharmacies now have a more private consultation area. You could talk with the pharmacist there and your naloxone will be ready for you at the pharmacy counter in a white paper bag.

    Don’t have a problem if they want to reclassify it either way but I do not see the current system as necessarily limiting access.

    1. I want it in a vending machine right between the Cheez-Its and the Sun Chips.

      1. Next to the pineapple flavored heroin vapes, right?

        1. No.
          Vaping is as deadly as heroin.

  2. So now we’re going to have tariffs on fucking liquor from Europe? I’d like to hear what that has to do with national security.

    1. Good thing I am a bourbon/rye (wry) guy.

      1. That is until people switch to domestics to save money and the price of bourbon goes up because supply and demand is a bitch.

  3. Rally Eric? Asking the federal government to apply logic and reason?
    Where you been?

  4. Has Reason had anything yet about the Harvard affirmative-action court decision? Is there a post I missed?

  5. I have 2 comments here that may sound contradictory, but they’re not really, in my mind at least…

    ‘1) “Moral hazard” in saving people’s lives?!?! WTF, you prudes!!! Selling bandages and band-aids are a “moral hazard” that encourages kids to play with knives! Improving highway and automobile safety features is a moral hazard that lets people drive faster with less risk! Motorbike helmets and safety seat belts and all, they are EVIL, then! Mind your own business, meddling assholes!

    ‘2) So many-many states have put in place, laws that allow ONE doctor to write a state-wide prescription for EVERYONE in the state, to “access” Narcan. Yet when I wrote a letter to MY state rep, asking her to do the same thing for cheap plastic “lung flutes”, I never even got a response!

    So I do hold heroin junkies to SOME moral self-responsibility. But THOSE fuckers are more “politically correct” than I am, and they get bypasses from silly, stupid prescription requirements… But not for me! What evil or immoral or at least less-than-responsible thing did I do, that I get no prescription bypasses, yet they do?

    To find precise details on what NOT to do, to avoid the flute police, please see http://www.churchofsqrls.com/DONT_DO_THIS/ … This has been a pubic service, courtesy of the Church of SQRLS!

  6. For now, Naloxone is available in most states by going to a pharmacy and asking for it, no doctor’s prescription needed.

    The interactive linked map shows it’s available not in ‘most states’ but all 51 of them. And while I have no problem with Naloxone being available over-the-counter, this single statement makes the tone of this article puzzling.

    1. Does the jurisdiction have a naloxone access law?

    No data

    1. Ok, upon further digging I find this on the interactive map:

      Are pharmacists allowed to dispense or distribute naloxone without a patient-specific prescription from another medical professional?

      No data

      Apparently, Nebraska is the lone holdout, demanding some form of prescription from “other medical professional”.

      1. Hmm. I know here that they get around it because the state allows a doctor, like the chief medical officer, to write a blanket prescription covering all pharmacies. Maybe the pharmacy has to fill out something.

        Perhaps they don’t have that mechanism there.

    2. Then there are some unintentionally funny categories:

      10.2. Are laypeople required to act with reasonable care?

      No data

      So in 19 states, you don’t even have to give a shit.

    3. 51 states?

      1. 51st = Puerto Rico? Washington DC? Guam? Afghanistan? The orange hair and the lice on Dear Leader’s Head? Ah dunno…

  7. Well actually, in all 50 states, you had BETTER give a shit, or you can die of constipation!

    “Ashes to ashes,
    Dust to dust,
    If we didn’t have assholes,
    Our bodies would bust!”

    Also, please note that, along with “giving a shit”, EATING a shit is nearly mandatory in modern America today! Unless you want to forego ALL eating of foods derived from mass-processed grains & other foods!

    The FDA has maximum-tolerable levels of acceptable rat and mice turds, insect parts, etc., in flour for humans to eat…

    Maggots, rat hair, mouse poop and more: Gross things the FDA allows in food

  8. Obviously SQRLSY you know your stuff. That line comes from Genesis in the third chapter. the first humans are beginning. The Stone Age will become the bronze, the iron, and eventually the space age.

    יט בְּזֵעַת אַפֶּיךָ, תֹּאכַל לֶחֶם, עַד שׁוּבְךָ אֶל-הָאֲדָמָה, כִּי מִמֶּנָּה לֻקָּחְתָּ: כִּי-עָפָר אַתָּה, וְאֶל-עָפָר תָּשׁוּב. 19 In the sweat of thy face shalt thou eat bread, till thou return unto the ground; for out of it wast thou taken; for dust thou art, and unto dust shalt thou return.

    All we are is dust in the wind.

    Also a semi good song by Kansas. Great performance.


  9. And while we’re at it, can we make inhalers, birth control pills and some antibiotics over the counter too?

    1. About the only drugs for which I think the government has a semi-plausible argument for restricting access via prescription are antibiotics, given their incredible utility and the mechanics of bacterial resistance. Mind you, I’m not saying that they should, but if anything was gonna require a prescription it should be antibiotics, since they’re the only class of drug whose use can impose real, direct negative externalities on others – everyone, in fact.

      1. Not amiodorone, adenosine, atropine, esmolol, lasix, chemotherapy drugs, biologicals for cancer and immune disease, anticoagulants, immunosuppressive agents, general anesthetics, paralyzing agents, pentobarbital, propofol…

        Anybody can handle those with a quick WebMD reference.

        In truth the government does not have as much to do with it as most people think. The medical profession is highly internally regulated. The government mostly just oversees. Perhaps more than it should.

  10. Naloxone is not aspirin; it being on the shelf next to the gummy bears probably isn’t a good idea.

    Actually, strike that. Sounds like a good time.

  11. There are some who worry that such widespread access to naloxone could create a moral hazard. That is, if it becomes easier to avoid a deadly consequence, more people might be willing to engage in dangerous behavior, like doing heroin, in the first place. That was the stated reason why, for example, Maine’s Gov. Paul LePage (R) vetoed a bill allowing pharmacists to dispense naloxone (the state legislature overrode his veto).

    Studies into whether those fears are grounded in reality have been mixed.

    It’s not like we don’t have other issues we can see this happening…

    Like condom availability and increase in STD rates (not everyone uses them right, but they sure act like they do!) Or birth control availability and out of wedlock / single parent incidence. No problem, let’s introduce abortion… hmmm… not helping!

    Why would drugs be any different than sex?

  12. “The agency (FDA) does not exist to protect drug companies’ profits; it exists to evaluate the risks of allowing wider access to certain drugs.” Yes, and somehow they always decide that the risk of allowing wider access always outweighs the benefits. Funny how that works. One might reasonably conclude that “weighing” isn’t exactly what they’re doing.

  13. “Why Isn’t the FDA Allowing Over-the-Counter Sales?”

    A Libertarian magazine would ask this for *all* drugs. Anyone know of one?

  14. I wonder how much of the fentanyl overdose epidemic is a suicide by fentanyl epidemic.

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