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.