Drug Policy

FDA Holds Hearing to Consider Over-the-Counter Naloxone Sales


Naloxone, a very little-known but amazing drug (which we've written about here at Reason in the past) that can save the lives of opiate overdose sufferers, might get made street-legal by the Food and Drug Administration, a no-brainer that is nonetheless controversial.

Reason contributor Maia Szalavitz has the facts in Time:

"Why didn't I know about this when my child was alive?" That was the question raised over and over at a U.S. Food and Drug Administration (FDA) hearing on Thursday by parents whose families make up the terrible statistics on opioid overdose, which now kills some 15,000 Americans each year.

Parents testified at an open meeting called by the FDA to consider whether the lifesaving antidote to opioid overdose — a non-addictive, non-toxic drug called naloxone (Narcan) — should be made available over-the-counter, so that everyone can keep it in their first aid kit, just in case…

 The hearing was emotional and, at times, heated. Dozens of people talked about losing family members and friends, and testified to the power of naloxone to save lives. Joanne Peterson, who runs Learn to Cope, a program for family members of drug-addicted people, testified that within two weeks of starting naloxone distribution: "We had a mom save a daughter and a father save a son." But what was most surprising about the meeting was the underlying sense of consensus. Whether or not the FDA changes the labeling on naloxone, which currently can be acquired only with a doctor's prescription, the majority of people who attended the hearing appeared to be in favor of wider access; some explicitly said that access needs to be expanded, or presented data that supports broader availability.

I hope Szalavitz's sense of where this is going is correct; that this is available only by prescription is nuts. And how does it do its lifesaving?

Naloxone is an opioid antagonist, which means that it attaches to and blocks receptors for opioid drugs like Vicodin and heroin in the brain and body. Because naloxone is more strongly attracted to the receptors than the opioids are, when it is given after an overdose, it displaces these drugs and reverses their effects.

Opioid overdose kills by slowly stopping a person's breathing, so typically there is time to intervene — and often there are other people around when a drug user overdoses. Even though most opioid overdoses involve mixtures of drugs, not just opioids, naloxone is effective even in these cases, and it is not harmful if given in error….

So what's stopping this great drug from being available to anyone who thinks they might need it?

Despite the widespread support for naloxone, however, there are significant barriers to change. For one thing, a drug company would need to submit an application to the FDA to change the status of the drug, which would require presenting a great deal of data. Alternatively, a citizen could petition the agency to make the drug available over-the-counter, but that procedure would take years longer than it would with a drug company involved, an FDA official said.

Since naloxone is off-patent, any company seeking over-the-counter approval would be able to market it exclusively for only three years; if it wanted to seek a longer period of exclusivity by patenting a new method of delivering the drug, that would require more data and more expense….

Right now, only one manufacturer produces naloxone in the U.S. Not only is there currently a national shortage of the drug, its price has also risen dramatically….

The rest of Szalavitz's story details examples of existing naloxone distribution programs that seem to have had unambiguously good effects, including at least 10,000 overdoses reversed. In a better world, this proven safe and effective drug could just hit the market without insanely expensive FDA hoops.

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  1. I have to think the FDA is, at this point, completely immune to the effects of its victims’ tears.

    1. Have you done tons of clinical trials to prove that victim tears have no effect on the FDA?

      I’d be worried if I were you, making any claims about the harmlessness of any product before submitting your trial results to the FDA.

  2. It is good to see your average person understand the costs of “What Is Not Seen”. Maybe there is hope after all.

  3. OT: Must not be in the union

    Sheriff’s office employee is charged with assault


    1. more like there must be evidence sufficient to charge him, which is the metric used, just as its been used a half dozen times recently just in my own AREA to charge cops with assault and other criminal charges.

      one committed suicide, but apart from that, i’m trying to remember the last that was actually convicted.

      there’s been a couple of hung juries and a bunch of acquittals. the most recent acquittal was the SPD cop who placed his foot on the suspect’s head/neck area after he was in handcuffs.

      never ceases to amaze me the way reasonoids are like creationists when it comes to ignoring evidence that goes against their irrational beliefs.

      i suggest you peruse the BJS reports.

      one stat that is compelling, and i often comment on is that cops have a much lower conviction rate

      an anticopper would automatically assume that’s because prosecutors are throwing cases or whatnot

      a more rational analysis would conclude there is probably a combination of two factors

      1) juries, ceteris paribus, give cops more credibility than the average defendant. therefore, given a similar fact pattern, they are goiing to be less likely to convict a cop given the same amount of evidence

      2) prosecutors, probably for political reasons, are more likely to prosecute cops with weak cases against them, because they want to seem as strongly anti-corruption. iow,show trials to give the anticoppers their pound of flesh

      1. also, something i have seen anecdotally … in the last 4 cops trials i have followed, the cop defendants in every case testified on their own behalf.

        i suspect cops are more likely to testify on their own behalf than the average criminal suspect.

        ime, despite the idea that a person’s silence cannot theoretically be held against him, from my conversations with, and study of jurors, jurors DO want the defendant’s testimony and unless he is obviously guilty as fuck, it may be more beneficial for them to testify than many defense attorneys, who routinely advocate against it (probably out of feeling of loss of control of the trial as much as anything) recognize. heck, all other factors aside, even OJ testified on his own behalf and he was found not guilty 🙂

  4. When naloxone is over the counter, we can prosecute drug users for negligent homicide when one of their buddies ODs at a party.

  5. We use Narcan (naloxone) in the ED all the time for opiate ODs (instead of epinephrine, which Pulp Fiction made it seem was the preferred agent). It is amazing to see completely obtunded individuals pop back to life almost instantaneously. Magic stuff.

    1. yup, as a former firefighter/medic, and currently working as a cop, i have seen the stuff literally bring back people from the dead. fucking amazing stuff.

      1. *adds firefighter/medic to dunphy’s resume*

        1. something i’ve mentioned at least a dozen times. i started out as a lifeguard in college. love the rescue schtick. but being a firefighter was boring as fuck

  6. … it is not harmful if given in error….

    Well, that part isn’t exactly true. Naloxone causes acute withdrawal syndrome in physically dependent patients, and it can cause deadly ventricular arrhythmias in cardiac patients.

    Of course, the benefits far outweigh the potential risks in the case of an actual overdose, but it’s a bit disingenuous to claim that erroneous administration is necessarily harmless.

    1. yea, i agree that the benefits outweigh the risks, but like all drugs, there are risks and benefits.

      acute withdrawal symptoms of course SUCK , but what is interesting about opioid vs. say alcohol withdrawal is that the latter can be deadly and the former just makes you wish you were dead and is in fact not deadly.

      considering that you would hope narcan wouldn’t be used unless the patient had already gone into respiratory arrest, i think it’s a no brainer – over the counter that stuff

    2. yea, i agree that the benefits outweigh the risks, but like all drugs, there are risks and benefits.

      acute withdrawal symptoms of course SUCK , but what is interesting about opioid vs. say alcohol withdrawal is that the latter can be deadly and the former just makes you wish you were dead and is in fact not deadly.

      considering that you would hope narcan wouldn’t be used unless the patient had already gone into respiratory arrest, i think it’s a no brainer – over the counter that stuff

      1. I’ve heard that, but after seeing several people I knew go to the hospital after they got stuck on methadone and tried to quit, I wonder…..

  7. narcan imo should be over the counter. similar to why syringes should be (they are in my state)

    even if the only people who od’d from opioids were unlawful opioid users (which of course is not the case), and even if one was pro war on drugs, one should still not want people to die merely for using opioids.

    the VAST majority imo and ime of opioid deaths involving illicit use, comes from people who have a strong habit/dependence, who try to quit, lose their tolerance, and then go back and use and don’t account for the substantially lower tolerance they have after their period of cold turkey.

    people who use can get some astonishing levels of tolerance. i’ve seen people who can pop a 80 mg oxycontin, crushed (iow pure oxycodone with no time release effect) and feel only moderate impairment

    if the average person took that much, in an IR dose, that would be … um… not good

    (it’s the equivalent of 16 percocets at once, without the pesky APAP complications of course)

    1. The tolerance isn’t just with illegal use. I saw a guy in the Army who had multiple surgeries and fused vertebrae after a helicopter crash. He was on something like 800 mg of morphine every 12 hours, and never appeared inpaired. He was extremely irritable, however, when it was an hour or two until his next dose.

        1. of course it isn’t. i hope i didn’t imply that.

          i have dealt with people in the field who take doses of opioids PER PRESCRIPTION that are staggering, due ot years and and years of use for chronic pain

          sadly, many states, including my own (passed this year) are passing or passed very draconian laws that make it difficult to impossible for MD’s to prescribe opioids for longterm use/chronic pain and literally thousands of people are getting their needed pain meds taken away out of overreaction.

          iow, some people die of overdoses, quite frequently because they take doses well in excess of what is prescribed per day/etc. and the reaction is – let’s take opioids away from everybody

          it’s fucking disgusting, frankly.

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