If foreigners dispersed throughout the United States a poison that killed hundreds of thousands of Americans, and drug makers had a safe, easy-to-administer antidote, would the federal government dare restrict its distribution?
It’s an easy answer — because just that scenario is happening right now.
Drug overdoses are poisonings (they’re officially classified as such). The United States is in the midst of a drug poisoning epidemic, with Chinese fentanyl and Mexican-and-Columbian heroin having driven overdose death rates to unprecedented levels. For these opioid poisonings, an antidote exists, but the federal government insists that you get a prescription first.
The Food and Drug Administration has approved naloxone, better known by the brand name Narcan, for use by prescription only. You might have read stories reporting that naloxone is available “over the counter” in New Hampshire and other states. That is not precisely true.
In an October memo on the drug’s availability, FDA Commissioner Scott Gottlieb explained why it remains available by prescription only.
“Although the auto-injector and nasal spray formulations have instructions for use, they don’t have the consumer-friendly Drug Facts Label (DFL), which is required for OTC drug products,” he wrote.
“Before submitting a new drug application or supplement for an OTC drug product, companies need to develop this DFL and conduct the required studies to show that consumers can understand how to use the product without the help of a health care professional.”
People are dying needlessly because the FDA doesn’t think Americans can safely inhale a nasal spray “without the help of a health care professional.”
States have managed to save some lives by offering work-arounds. New Hampshire and other states have passed what are called “standing order” laws. Those allow doctors to give a pharmacy a standing prescription the pharmacist can use to dispense the drug to anyone who asks for it.
Many pharmacies in New Hampshire now stock naloxone, but the price remains high, and not all pharmacies carry it.
Even with standing-order laws, naloxone is not as widely available — or as cheap — as it would be were it classified as an over-the-counter drug. The FDA acknowledges this.
“We recognized the important public health opportunity to bring naloxone OTC,” Gottlieb wrote in October.
In December, the state estimated that drug overdose deaths in New Hampshire will finally fall below the previous year’s level, but by a small percentage. Had the FDA approved naloxone for over-the-counter sales years ago, a downward trend might have been realized much earlier, saving untold numbers of lives.
OTC naloxone will not get to the root causes of this epidemic. But it would let a lot of people live while policymakers seek solutions. The governor and legislators can help by formally requesting that the FDA quickly approve naloxone for sale without a prescription.
If the governor got all other New England governors to join him, it would put pressure on the Trump administration to speed this approval process.